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Tratamientos tópicos para la psoriasis crónica en placas

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Referencias

Agrup 1981 {published data only}

Agrup G, Bjornberg A, Elmros T, Groth O, Hannuksela M, Lassus A, et al. Clinical Trial of a Potent Non‐Halogenated Topical Steroid, Budesonide. Acta Dermato Venereologica 1981;61(2):180‐2. [PUBMED: 6165205]

Alora‐Palli 2010 {published and unpublished data}

Alora‐Palli MB, Kimball AB, Van Cott A. A new topically applied liquor carbonis distillate (coal tar) solution helps reduce regression of plaque psoriasis after 12 weeks of treatment: A 6‐week comparison to calcipotriol cream. Journal of the American Academy of Dermatology 2009;60(3 Suppl 1):AB174.
Alora‐Palli Maria B, Perkins Alexis C, Van Cott Alicia, Kimball Alexandra B. Efficacy and tolerability of a cosmetically acceptable coal tar solution in the treatment of moderate plaque psoriasis: a controlled comparison with calcipotriene (calcipotriol) cream. American Journal of Clinical Dermatology 2010;11(4):275‐83. [PUBMED: 20513160]
Brouda I, Edison B, Van Cott A, Green BA. Tolerability and cosmetic acceptability of liquor carbonis distillate (coal tar) solution 15% as topical therapy for plaque psoriasis. Cutis 2010;85(4):214‐20.

Austad 1998 {published and unpublished data}

Austad J, Bjerke JR, Gjertsen BT, Helland S, Livden JK, Morken T, et al. Clobetasol Propionate Followed by Calcipotriol Is Superior to Calcipotriol Alone in Topical Treatment of Psoriasis. Journal of the European Academy of Dermatology & Venereology 1998;11(1):19‐24. [PUBMED: 9731961]

Baiocchi 1997 {published data only}

Baiocchi R, Bertani E, Biggio P, Calandra P, De Marchi R, Franchi A, et al. Controlled Trial of the Efficacy and Safety of Calcipotriol Ointment Applied Once or Twice a Day in Psoriasis Vulgaris Studio [Controllato Per Emiparti Sull'efficacia E La Tollerabilita Di Calcipotriolo Unguento 1 Applicazione/Die Versus 2 Applicazioni/Die, Nella Psoriasi Volgare]. Giornale Italiano di Dermatologia e Venereologia 1997;132(2):139‐47.

Barker 1999 (H) {published and unpublished data}

Barker N, Ashton RE, Marks R, Harris RI, Berth‐Jones J. Topical maxacalcitol for the treatment of psoriasis vulgaris: a placebo‐controlled, double‐blind, dose‐finding study with active comparator. British Journal Of Dermatology 1999;141(2):274‐8. [MEDLINE: 10468799]

Barker 1999 (P) {published and unpublished data}

Barker N, Ashton RE, Marks R, Harris RI, Berth‐Jones J. Topical maxacalcitol for the treatment of psoriasis vulgaris: a placebo‐controlled, double‐blind, dose‐finding study with active comparator. British Journal Of Dermatology 1999;141(2):274‐8. [PUBMED: 10468799]
Berth‐Jones J. Maxacalcitol ‐ a new, potent and safe vitamin D analogue for treatment of psoriasis. British Journal Of Dermatology 1999;141:992.

Barrett 2005 {published and unpublished data}

Barrett C, Lowson D, Blades K J, investigators Mcs Int. Limited benefit of combined use of tar‐based shampoo with 50 microg/ml calcipotriol solution in scalp psoriasis. Journal of Dermatological Treatment 2005;16(3):175. [PUBMED: 16211775]

Bernhard 1991 (1) {published data only}

Bernhard J, Whitmore C, Guzzo C, Kantor I, Kalb RE, Ellis C, et al. Evaluation of Halobetasol Propionate Ointment in the Treatment of Plaque Psoriasis: Report on Two Double‐Blind, Vehicle‐Controlled Studies. Journal of the American Academy of Dermatology 1991;25(6 Pt 2):1170‐4. [PUBMED: 1757612]

Bernhard 1991(2) {published data only}

Bernhard J, Whitmore C, Guzzo C, Kantor I, Kalb RE, Ellis C, et al. Evaluation of Halobetasol Propionate Ointment in the Treatment of Plaque Psoriasis: Report on Two Double‐Blind, Vehicle‐Controlled Studies. Journal of the American Academy of Dermatology 1991;25(6 Pt 2):1170‐4. [PUBMED: 1757612]

Bernstein 2006 {published data only}

Bernstein S, Donsky H, Gulliver W, Hamilton D, Nobel S, Norman R. Treatment of mild to moderate psoriasis with Relieva, a Mahonia aquifolium extract‐‐a double‐blind, placebo‐controlled study. American Journal of Therapeutics2006; Vol. 13, issue 2:121‐6. [PUBMED: 16645428]

Berth Jones 1992b {published data only}

Berth Jones J, Chu AC, Dodd WA, Ganpule M, Griffiths WA, Haydey RP, et al. A Multicentre, Parallel‐Group Comparison of Calcipotriol Ointment and Short‐Contact Dithranol Therapy in Chronic Plaque Psoriasis. British Journal Of Dermatology 1992;127(3):266‐71. [PUBMED: 1390171]

Beutner 2006 {published data only}

Beutner K, Chakrabarty A. An intra‐individual safety and efficacy comparison of clobetasol propionate 0.05% spray and its vehicle in the treatment of plaque psoriasis. [Abstract P2858.] American Academy of Dermatology 64th Annual Meeting 3‐7 March 2006. Journal of the American Academy of Dermatology 2006;54(3 Suppl):AB212.
Beutner K, Chakrabarty A, Lemke S, Yu K. An intra‐individual randomized safety and efficacy comparison of clobetasol propionate 0.05% spray and its vehicle in the treatment of plaque psoriasis. Journal of Drugs in Dermatology 2006;5(4):357‐60. [PUBMED: 16673804]

Bourke 1993b {published data only}

Bourke JF, Berth‐Jones J, Hutchinson PE. Occlusion enhances the efficacy of topical calcipotriol in the treatment of psoriasis vulgaris. Clinical & Experimental Dermatology 1993;18(6):504‐6. [PUBMED: 8252786]

Bourke 1997 {published and unpublished data}

Bourke JF, Featherstone S, Iqbal SJ, Hutchinson PE. A Double‐Blind Comparison of Topical Calcitriol (3 mcg/g) and Calcipotriol (50 mcg/g) in the Treatment of Chronic Plaque Psoriasis Vulgaris. British Journal Of Dermatology 1995;133(Suppl 45):17.
Bourke JF, Iqbal SJ, Hutchinson PE. A Randomized Double‐Blind Comparison of the Effects on Systemic Calcium Homeostasis of Topical Calcipotriol (3 Mu G/G) and Calcipotriol (50 U M/G) in the Treatment of Chronic Plaque Psoriasis Vulgaris. Acta Dermato Venereologica 1997;77(3):228‐30. [PUBMED: 9188878]

Brown 2005 {published and unpublished data}

Brown AC, Koett J, Johnson DW, Semaskvich NM, Holck P, Lally D, et al. Effectiveness of kukui nut oil as a topical treatment for psoriasis. International Journal of Dermatology2005; Vol. 44, issue 8:684‐7. [PUBMED: 16101874]

Bruce 1994 {published and unpublished data}

Bruce S, Epinette WW, Funicella T, Ison A, Jones EL, Loss RJ, et al. Comparative Study of Calcipotriene (Mc 903) Ointment and Fluocinonide Ointment in the Treatment of Psoriasis. Journal of the American Academy of Dermatology 1994;31(5 Pt 1):755‐9. [PUBMED: 7929921]
Siskin SB. Efficacy and Safety of Calcipotriol Ointment Compared to Fluocinonide. 2nd International Symposium on Calcipotriol. Monaco, 1993.

Buckley 1978 {published data only}

Buckley DB. A Double‐Blind Comparison of 0.1% Dithranol in a 17% Urea Base ("Psoradrate") and Base Alone in the Treatment of Active Chronic Psoriasis. Current Medical Research & Opinion 1978;5(6):489‐94. [PUBMED: 350501 ]

Buckley 2008 {published and unpublished data}

Buckley C, Hoffmann V. Calcipotriol plus betamethasone dipropionate gel is effective and safe in the treatment of scalp psoriasis (a phase II study). [Abstract P06.57.] 14th Congress of the European Academy of Dermatology and Venereology, 12‐15th October 2005, London UK. Journal of the European Academy of Dermatology & Venereology 2005;19(Suppl 2):175.
Buckley C, Hoffmann V, Shapiro J, Saari S, Cambazard F, Milsgaard M. Calcipotriol plus betamethasone dipropionate scalp formulation is effective and well tolerated in the treatment of scalp psoriasis: a phase II study. Dermatology2008; Vol. 217, issue 2:107‐13. [PUBMED: 18463448]

Camarasa 2003 {published data only}

Camarasa JM, Ortonne JP, Dubertret L. Calcitriol shows greater persistence of treatment effect than betamethasone dipropionate in topical psoriasis therapy. Journal of Dermatological Treatment 2003;14(1):8‐13. [PUBMED: 12745849]

Cheesbrough 1992 {published data only}

Cheesbrough MJ. Treatment of psoriasis with 30% Dead Sea salt lotion. Journal Of Dermatological Treatment 1992;3(4):201‐203. [EMBASE: 1993020259]

Christensen 1999 {published data only}

Christensen OB, Mork NJ, Ashton R, Daniel F, Anehus S. Comparison of a treatment phase and a follow‐up phase of short‐contact dithranol and calcipotriol in outpatients with chronic plaque psoriasis. Journal Of Dermatological Treatment 1999;10(4):261‐5. [EMBASE: 2000044219]

Cook‐Bolden 2010 {published and unpublished data}

Cook‐Bolden FE, Goffe BS, Hudson CP, Sofen HL. Efficacy and safety results from a randomized, double‐blind, vehicle‐controlled study of clobetasol propionate spray for the treatment of moderate to severe plaque psoriasis of the scalp [Abstract]. Conference: 68th Annual Meeting of the American Academy of Dermatology, AAD Miami, FL United States. Conference Start: 20100305 Conference End: 20100309. Journal of the American Academy of Dermatology 2010;62(3 Suppl 1):AB140. [EMBASE: 70142994; NCT00881868]
Cook‐Bolden FE, Goffe BS, Hudson CP, Sofen HL. Patient satisfaction with clobetasol propionate spray, 0.05% for the management of moderate to severe plaque psoriasis of the scalp [Abstract]. Conference: 70th Annual Meeting of the American Academy of Dermatology San Diego, CA United States. Conference Start: 20120316 Conference End: 20120320. Journal of the American Academy of Dermatology 2012;66(4 Suppl 1):AB197. [EMBASE: 70704639]
Cook‐Bolden FE, Goffe BS, Sofen HL, Colon LE, Gottschalk RW. Successful treatment of moderate to severe plaque psoriasis of the scalp with clobetasol propionate spray, 0.05% [Abstract]. Conference: 69th Annual Meeting of the American Academy of Dermatology New Orleans, LA United States. Conference Start: 20110204 Conference End: 20110208. Journal of the American Academy of Dermatology 2011;64(2 Suppl 1):AB157. [EMBASE: 70331905]
Cook‐Bolden FE, Goffe BS, Sofen HL, Hudson CP, Colon LE, Gottschalk RW, et al. Patient satisfaction with clobetasol propionate spray, 0.05% for the management of moderate to severe plaque psoriasis of the scalp [Abstract]. Conference: 36th Annual Hawaii Dermatology Seminar of the Skin Disease Education Foundation Waikoloa, HI United States. Conference Start: 20120219 Conference End: 20120224.. Seminars in Cutaneous Medicine & Surgery 2012;31(1):A9‐A10. [EMBASE: 70706927]
Jarratt M, Sofen HL, Caveney S. The effects of clobetasol propionate spray, 0.05% vs. vehicle spray on the signs of plaque psoriasis on the body and scalp [Abstract]. Conference: 36th Annual Hawaii Dermatology Seminar of the Skin Disease Education Foundation Waikoloa, HI United States. Conference Start: 20120219 Conference End: 20120224. Seminars in Cutaneous Medicine & Surgery 2012;31(1):A11. [EMBASE: 70706930]
Jarratt M, Sofen HL, Caveney SW. The effects of clobetasol propionate spray, 0.05% versus vehicle spray on the signs of plaque psoriasis on the body and scalp [Abstract]. Conference: 70th Annual Meeting of the American Academy of Dermatology San Diego, CA United States. Conference Start: 20120316 Conference End: 20120320. Journal of the American Academy of Dermatology 2012;66(4 Suppl 1):AB204. [EMBASE: 70704666]
NCT00881868. Clobetasol Propionate Spray Versus Vehicle Spray for the Management of Moderate to Severe Plaque Psoriasis of the Scalp. clinicaltrials.gov/ct2/show/NCT00881868(accessed 2011).
Sofen H, Hudson CP, Cook‐Bolden FE, Preston N, Colon LE, Caveney SW, et al. Clobetasol propionate 0.05% spray for the management of moderate‐to‐severe plaque psoriasis of the scalp: results from a randomized controlled trial. Journal of Drugs in Dermatology 2011;10(8):885‐92. [MEDLINE: 21818510]

Crosti 1997 {published data only}

Crosti C, Finzi AF, Mian E, Scarpa C. Calcipotriol in psoriasis vulgaris: a controlled trial comparing betamethasone dipropionate + salicylic acid. International Journal Of Dermatology 1997;36(7):537‐9. [PUBMED: 9268756]

Cunliffe 1992 {published data only}

Cunliffe WJ, Berth Jones J, Claudy A, Fairiss GM, Goldin D, Gratton D, et al. Comparative study of calcipotriol (MC 903) ointment and betamethasone 17‐valerate ointment in patients with psoriasis vulgaris. Journal of the American Academy of Dermatology 1992;26(5 Pt 1):736‐43. [MEDLINE: 1583173]

Decroix 2004 {published data only}

Decroix J, Pres H, Tsankov N, Poncet M, Arsonnaud S. Clobetasol propionate lotion in the treatment of moderate to severe plaque‐type psoriasis. Cutis 2004;74(3):201‐6. [PUBMED: 15499763]

De Simone 1993 {published data only}

De Simone C, Guerriero C, Morini P, Venier A. Treatment of Psoriasis with Topical Calcipotriol [Il Calcipotriol Nella Terapia Locale Della Psoriasi]. Giornale Italiano di Dermatologia e Venereologia 1993;128(10):Ic‐Ciii.

Douglas 2002 {published and unpublished data}

Douglas WS, Poulin Y, Decroix J, Ortonne JP, Mrowietz U, Gulliver W, et al. A new calcipotriol/betamethasone formulation with rapid onset of action was superior to monotherapy with betamethasone dipropionate or calcipotriol in psoriasis vulgaris. Acta Dermato Venereologica 2002;82(2):131‐5. [PUBMED: 12125943 ]

Dubertret 1992 {published and unpublished data}

Dubertret L, Wallach D, Souteyrand P, Perussel M, Kalis B, Meynadier J, et al. Efficacy and Safety of Calcipotriol (Mc 903) Ointment in Psoriasis Vulgaris. A Randomized, Double‐Blind, Right/Left Comparative, Vehicle‐Controlled Study. Journal of the American Academy of Dermatology 1992;27(6 Pt 1):983‐8. [PUBMED: 1479106]

Durakovic 2001 {published data only}

Durakovic C, Malabanan A, Holick MF. Rationale for use and clinical responsiveness of hexafluoro‐1,25‐dihydroxyvitamin D3 for the treatment of plaque psoriasis: a pilot study. British Journal Of Dermatology 2001;144(3):500‐6. [PUBMED: 11260006]

Durakovic 2004 {published data only}

Durakovic C, Ray S, Holick MF. Topical paricalcitol (19‐nor‐1 alpha,25‐dihydroxyvitamin D2) is a novel, safe and effective treatment for plaque psoriasis: a pilot study. British Journal of Dermatology 2004;151(1):190‐5. [PUBMED: 15270890]

Duweb 2000 {published data only}

Duweb GA, Abuzariba O, Rahim M, al‐Taweel M, Abdulla SA. Scalp psoriasis: topical calcipotriol 50 micrograms/g/ml solution vs. betamethasone valerate 1% lotion. International Journal of Clinical Pharmacology Research 2000;20(3‐4):65‐8. [PUBMED: 11314240 ]

Elie 1983 {published data only}

Elie R, Durocher LP, Kavalec EC. Effect of Salicylic Acid on the Activity of Betamethasone‐17,21‐Dipropionate in the Treatment of Erythematous Squamous Dermatoses. Journal of International Medical Research 1983;11(2):108‐12. [PUBMED: 6852357 ]

Ellis 1988 {published data only}

Ellis CN, Horwitz SN, Menter A. Amcinonide Lotion 0.1% in the Treatment of Patients with Psoriasis of the Scalp. Current Therapeutic Research ‐ Clinical & Experimental 1988;44(2):315‐24. [EMBASE: 1989002095]

Escobar 1992 {published data only}

Escobar SO, Achenbach R, Iannantuono R, Torem V. Topical fish oil in psoriasis‐‐a controlled and blind study. Clinical & Experimental Dermatology 1992;17(3):159‐62. [PUBMED: 1451289 ]

Farkas 1999 {published and unpublished data}

Farkas B, Dobozy A. Comparison of Tacalcitol with Dithranol. 3rd European Hermal Symposium. Hamburg, 1995.
Farkas B, Dobozy A, Horvath A, Hunyadi J, Schneider I. Comparison of tacalcitol ointment with short‐contact dithranol therapy in the treatment of psoriasis vulgaris: a randomized multicentre, open prospective study on efficacy and safety. Journal of Dermatological Treatment 1999;10(2):93‐9. [EMBASE: 1999259658]

Feldman 2010 (1) {published data only (unpublished sought but not used)}

Feldman S, Wyres M, Markowitz O, Matheson R, Bruce S. Calcipotriene foam for the treatment of plaque‐type psoriasis: Results of two phase III studies. Journal of the American Academy of Dermatology 2010;62(3 Suppl 1):AB138. [NCT00689481]
Feldman SR, Matheson R, Bruce S, Grande K, Markowitz O, Kempers S, et al. Efficacy and safety of calcipotriene 0.005% foam for the treatment of plaque‐type psoriasis: Results of two multicenter, randomized, double‐blind, vehicle‐controlled, phase III clinical trials. American Journal of Clinical Dermatology 2012;13(4):261‐71. [EMBASE: 2012323159]
NCT00689481. Study to Compare U0267 Against Vehicle in Subjects With Plaque‐type Psoriasis Two of Two Phase 3 Studies. clinicaltrials.gov/ct2/results?term=NCT00689481(accessed 2010).

Feldman 2010 (2) {published data only (unpublished sought but not used)}

Feldman S R, Matheson R, Bruce S, Grande K, Markowitz O, Kempers S, et al. Efficacy and safety of calcipotriene 0.005% foam for the treatment of plaque‐type psoriasis: Results of two multicenter, randomized, double‐blind, vehicle‐controlled, phase III clinical trials. AMERICAN JOURNAL OF CLINICAL DERMATOLOGY 2012;13(4):261‐71.
Feldman S, Wyres M, Markowitz O, Matheson R, Bruce S. Calcipotriene foam for the treatment of plaque‐type psoriasis: Results of two phase III studies. Journal of the American Academy of Dermatology 2010;62(3 Suppl 1):AB138. [NCT00689481]
NCT00688519. Study to Compare U0267 Against Vehicle in Subjects With Plaque‐type Psoriasis One of Two Phase 3 Studies. clinicaltrials.gov/ct2/results?term=NCT00688519(accessed 2010).

Fleming 2010 (H) {published and unpublished data}

Fleming C, Ganslandt C, Guenther L, Johannesson A, Buckley C, Simon JC, et al. Calcipotriol plus betamethasone dipropionate gel compared with its active components in the same vehicle and the vehicle alone in the treatment of psoriasis vulgaris: a randomised, parallel group, double‐blind, exploratory study. European Journal of Dermatology 2010;20(4):465‐71. [PUBMED: 20413372]
Fleming C, Ganslandt C, Leese GP. Short‐ and long‐term safety assessment of a two‐compound ointment containing calcipotriene/betamethasone dipropionate (Taclonex/Daivobet/Dovobet ointment): hypothalamic‐pituitary‐adrenal axis function in patients with psoriasis vulgaris. Journal of Drugs in Dermatology 2010;9(8):969‐74. [PUBMED: 20684147]

Fleming 2010 (P) {published and unpublished data}

Fleming C, Ganslandt C, Guenther L, Johannesson A, Buckley C, Simon JC, et al. Calcipotriol plus betamethasone dipropionate gel compared with its active components in the same vehicle and the vehicle alone in the treatment of psoriasis vulgaris: a randomised, parallel group, double‐blind, exploratory study. European Journal of Dermatology 2010;20(4):465‐71. [PUBMED: 20413372]
Fleming C, Ganslandt C, Leese GP. Short‐ and long‐term safety assessment of a two‐compound ointment containing calcipotriene/betamethasone dipropionate (Taclonex/Daivobet/Dovobet ointment): hypothalamic‐pituitary‐adrenal axis function in patients with psoriasis vulgaris. Journal of Drugs in Dermatology 2010;9(8):969‐74. [PUBMED: 20684147]

Franz 1999 {published data only}

Franz TJ, Parsell DA, Halualani RM, Hannigan JF, Kalbach JP, Harkonen WS. Betamethasone valerate foam 0.12%: a novel vehicle with enhanced delivery and efficacy. International Journal Of Dermatology 1999;38(8):628‐32. [PUBMED: 10487457 ]

Franz 2000 {published data only}

Franz TJ, Parsell DA, Myers JA, Hannigan JF. Clobetasol propionate foam 0.05%: a novel vehicle with enhanced delivery. International Journal Of Dermatology 2000;39(7):535‐8. [PUBMED: 10940121 ]

Geilen 2000 {published data only}

Geilen CC, Mrowietz U. Lack of efficacy of topical mycophenolic acid in psoriasis vulgaris. Journal of the American Academy of Dermatology 2000;42(5 Pt 1):837‐40. [PUBMED: 10775867 ]

Gottlieb 2003 {published data only}

Gottlieb AB, Ford RO, Spellman MC. The efficacy and tolerability of clobetasol propionate foam 0.05% in the treatment of mild to moderate plaque‐type psoriasis of nonscalp regions. Journal of Cutaneous Medicine & Surgery 2003;7(3):185‐92. [PUBMED: 12704534 ]

Grattan 1997 (H) {published data only}

Grattan CEH, Hallam F, Whitefield M. A New Aqueous Dithranol Gel for Psoriasis: Comparison with Placebo and Calcipotriol Ointment. Journal Of Dermatological Treatment 1997;8(1):11‐5. [EMBASE: 1997109958]

Grattan 1997 (P) {published data only}

Grattan CEH, Hallam F, Whitefield M. A New Aqueous Dithranol Gel for Psoriasis: Comparison with Placebo and Calcipotriol Ointment. Journal Of Dermatological Treatment 1997;8(1):11‐5. [EMBASE: 1997109958]

Green 1994 {published and unpublished data}

Green C, Ganpule M, Harris D, Kavanagh G, Kennedy C, Mallett R, et al. Comparative Effects of Calcipotriol (Mc903) Solution and Placebo (Vehicle of Mc903) in the Treatment of Psoriasis of the Scalp. British Journal Of Dermatology 1994;130(4):483‐7. [PUBMED: 8186114 ]

Greenspan 1993 {published and unpublished data}

Greenspan A, Herndon JJ, Baker MD, Cheney T. Controlled Evaluation of 0.05% Desonide Lotion and Desonide Cream in Psoriasis. Current Therapeutic Research ‐ Clinical & Experimental 1993;53(6):614‐20. [EMBASE: 1993261649]

Gribetz 2004 {published and unpublished data}

Gribetz C, Ling M, Lebwohl M, Pariser D, Draelos Z, Gottlieb AB, et al. Pimecrolimus cream 1% in the treatment of intertriginous psoriasis: A double‐blind, randomized study. Journal of the American Academy of Dermatology 2004;51(5):731‐8. [PUBMED: 15523351]

Guenther 2000 {published data only}

Guenther LC, Poulin YP, Pariser DM. A comparison of tazarotene 0.1% gel once daily plus mometasone furoate 0.1% cream once daily versus calcipotriene 0.005% ointment twice daily in the treatment of plaque psoriasis. Clinical Therapeutics 2000;22(10):1225‐38. [PUBMED: 11110233]

Guenther 2002 (H) {published and unpublished data}

Guenther L, Van De Kerkhof PCM, Kragballe K, Chu AC, Tegner E, Garcia‐Diez A, et al. Efficacy and safety of a new combination of calcipotriol and betamethasone dipropionate (once or twice daily) compared to calcipotriol (twice daily) in the treatment of psoriasis vulgaris: a randomized, double‐blind, vehicle‐controlled clinical trial. British Journal Of Dermatology 2002;147(2):316‐23. [PUBMED: 12174105]
Van De Kerkhof PCM. Once daily vs. twice daily applications of topical treatments in psoriasis [15]. British Journal of Dermatology2005; Vol. 153, issue 6:1245.
Van de Kerkhof PC. The impact of a two‐compound product containing calcipotriol and betamethasone dipropionate (Daivobet/ Dovobet) on the quality of life in patients with psoriasis vulgaris: a randomized controlled trial. British Journal of Dermatology 2004;151(3):663‐8. [PUBMED: 15377355]
Van de Kerkhof PCM. A fixed combination of calcipotriol/betamethasone dipropionate improves quality of life in patients with psoriasis vulgaris. 11th Congress of the European Academy of Dermatology and Venereology; 2002 Oct 2‐6; Prague. 2002:27‐2.

Guenther 2002 (P) {published and unpublished data}

Guenther L, Van De Kerkhof PCM, Kragballe K, Chu AC, Tegner E, Garcia‐Diez A, et al. Efficacy and safety of a new combination of calcipotriol and betamethasone dipropionate (once or twice daily) compared to calcipotriol (twice daily) in the treatment of psoriasis vulgaris: a randomized, double‐blind, vehicle‐controlled clinical trial. British Journal Of Dermatology 2002;147(2):316‐23. [PUBMED: 12174105]
Van De Kerkhof PCM. Once daily vs. twice daily applications of topical treatments in psoriasis [15]. British Journal of Dermatology2005; Vol. 153, issue 6:1245.
Van de Kerkhof PC. The impact of a two‐compound product containing calcipotriol and betamethasone dipropionate (Daivobet/ Dovobet) on the quality of life in patients with psoriasis vulgaris: a randomized controlled trial. British Journal of Dermatology 2004;151(3):663‐8. [MEDLINE: 15377355]
Van de Kerkhof PCM. A fixed combination of calcipotriol/betamethasone dipropionate improves quality of life in patients with psoriasis vulgaris. 11th Congress of the European Academy of Dermatology and Venereology; 2002 Oct 2‐6; Prague. 2002:P27‐2.

Han 2001 {published data only}

Han GW, Yu BT, Li H, Zhu XJ, Wang BX, Li GM, et al. A randomized controlled multicenter clinical trial on tazarotene gel versus calcipotriol ointment in the treatment of plaque psoriasis vulgaris. Chinese Journal of Clinical Pharmacology 2001;17(6):419‐22.

Harrington 1996a {published data only}

Harrington CI, Goldin D, Lovell CR, Van De Kerkhof P, Nieboer C, Austad J, et al. Comparative Effects of Two Different Calcipotriol (Mc 903) Cream Formulations Versus Placebo in Psoriasis Vulgaris. A Randomised, Double‐Blind, Placebo‐Controlled, Parallel Group Multi‐Centre Study 1. Journal of the European Academy of Dermatology & Venereology 1996;6(2):152‐8. [EMBASE: 1996096735]

Helfrich 2007 {published and unpublished data}

Helfrich YR, Kang S, Hamilton TA, Voorhees JJ. Topical becocalcidiol for the treatment of psoriasis vulgaris: a randomized, placebo‐controlled, double‐blind, multicentre study. British Journal of Dermatology2007; Vol. 157, issue 2:369‐74.

Henneicke‐v. Z. 1993 {published data only}

Henneicke‐von Zepelin HH, Mrowietz U, Farber L, Bruck‐Borchers K, Schober C, Huber J, et al. Highly purified omega‐3‐polyunsaturated fatty acids for topical treatment of psoriasis. Results of a double‐blind, placebo‐controlled multicentre study. British Journal Of Dermatology 1993;129(6):713‐7. [PUBMED: 8286257]

Highton 1995 {published data only}

Highton A, Quell J, Breneman D, Cullen S, Goffe B, Griffiths C, et al. Calcipotriene ointment 0.005% for psoriasis: A safety and efficacy study. Journal of the American Academy of Dermatology 1995;32(1):67‐72. [PUBMED: 7822519]

Hindsén 2006 (H) {published and unpublished data}

Hindsén M, Traulsen J. Calcipotriol ointment under occlusion gives a fast onset of action. Journal of the European Academy of Dermatology & Venereology 2006;20(6):764‐5. [PUBMED: 16836527]

Hindsén 2006 (P) {published and unpublished data}

Hindsén M, Traulsen J. Calcipotriol ointment under occlusion gives a fast onset of action. Journal of the European Academy of Dermatology & Venereology 2006;20(6):764‐5. [PUBMED: 16836527]

Holick 2003 {published data only}

Holick MF, Chimeh FN, Ray S. Topical PTH (1‐34) is a novel, safe and effective treatment for psoriasis: a randomized self‐controlled trial and an open trial. British Journal of Dermatology 2003;149(2):370‐6. [PUBMED: 12932245]

Huang 2009 {published data only}

Huang L, Ma L, Huang Q, Yang QP, Zheng ZZ, Zhu XJ, et al. Calcipotriol betamethasone ointment in the treatment of psoriasis vulgaris: a randomized, double‐blind, active‐controlled, parallel group study. Zhonghua Pifuke Zazhi (Chinese Journal of Dermatology) 2009;42(10):691‐4. [NCT00248456]

Hutchinson 2000 {published data only}

Hutchinson PE, Marks R, White J. The efficacy, safety and tolerance of calcitriol 3 microg/g ointment in the treatment of plaque psoriasis: a comparison with short‐contact dithranol. Dermatology 2000;201(2):139‐45. [PUBMED: 11053917]

Jarratt 2004 {published data only}

Jarratt M, Breneman D, Gottlieb AB, Poulin Y, Liu Y, Foley V. Clobetasol propionate shampoo 0.05%: a new option to treat patients with moderate to severe scalp psoriasis. Journal of Drugs in Dermatology 2004;3(4):367‐73. [PUBMED: 15303780]

Jarratt 2006 {published and unpublished data}

Jarratt M, Sofen HL, Caveney S. The effects of clobetasol propionate spray, 0.05% vs. vehicle spray on the signs of plaque psoriasis on the body and scalp [Abstract]. Conference: 36th Annual Hawaii Dermatology Seminar of the Skin Disease Education Foundation Waikoloa, HI United States. Conference Start: 20120219 Conference End: 20120224. Seminars in Cutaneous Medicine & Surgery 2012;31(1):A11. [EMBASE: 70706930]
Jarratt MT, Clark SD, Savin RC, Swinyer LJ, Safley CF, Brodell RT, et al. Evaluation of the efficacy and safety of clobetasol propionate spray in the treatment of plaque‐type psoriasis. Cutis2006; Vol. 78, issue 5:348‐54. [PUBMED: 17186795]

Jekler 1992 {published data only}

Jekler J, Swanbeck G. One‐Minute Dithranol Therapy in Psoriasis: A Placebo‐Controlled Paired Comparative Study. Acta Dermato Venereologica 1992;72(6):449‐50. [PUBMED: 1362841]

Jemec 2008 (H) {published and unpublished data}

Combemale P. A new treatment in scalp psoriasis: Xamiol (R) formulation and results at 8 weeks. Annales de Dermatologie et de Venereologie 2009;136(Suppl 3):S42‐5.
Jemec GBE, Burden D, Poulin Y, Ortonne JP. A new scalp formulation of calcipotriene plus betamethasone in the treatment of scalp psoriasis compared to its active ingredients and the vehicle [Abstract P2733.] American Academy of Dermatology 65th Annual Meeting 2‐6 February 2007. Journal of the American Academy of Dermatology2007; Vol. 56, issue 2:AB182.
Jemec GBE, Ganslandt C, Ortonne J‐P, Poulin Y, Burden AD, de Unamuno P, et al. A new scalp formulation of calcipotriene plus betamethasone compared with its active ingredients and the vehicle in the treatment of scalp psoriasis: a randomized, double‐blind, controlled trial. Journal of the American Academy of Dermatology2008; Vol. 59, issue 3:455‐63. [PUBMED: 18694678]

Jemec 2008 (P) {published and unpublished data}

Combemale P. A new treatment in scalp psoriasis: Xamiol (R) formulation and results at 8 weeks. Annales de Dermatologie et de Venereologie 2009;136(Suppl 3):S42‐5.
Jemec GBE, Burden D, Poulin Y, Ortonne JP. A new scalp formulation of calcipotriene plus betamethasone in the treatment of scalp psoriasis compared to its active ingredients and the vehicle [Abstract P2733.] American Academy of Dermatology 65th Annual Meeting 2‐6 February 2007. Journal of the American Academy of Dermatology2007; Vol. 56, issue 2:AB182.
Jemec GBE, Ganslandt C, Ortonne J‐P, Poulin Y, Burden AD, de Unamuno P, et al. A new scalp formulation of calcipotriene plus betamethasone compared with its active ingredients and the vehicle in the treatment of scalp psoriasis: a randomized, double‐blind, controlled trial. Journal of the American Academy of Dermatology2008; Vol. 59, issue 3:455‐63. [PUBMED: 18694678]

Ji 2008 {published data only}

Gottschalk RW, Johnson LA. Calcitriol 3 micrograms/g versus calcipotriol 50 micrograms/g for plaque psoriasis: treatment, maintenance and cost [Abstract P2720.] American Academy of Dermatology 65th Annual Meeting 2‐6 February 2007. Journal of the American Academy of Dermatology2007; Vol. 56, issue 2:AB179.
Ji S, Chen X, Wang B, Jin H, Zhao G, Wang Y, et al. Calcitriol ointment versus calcipotriol ointment in the treatment of psoriasis: a single‐blind, randomized, multicenter trial. Zhonghua Pifuke Zazhi (Chinese Journal of Dermatology)2008; Vol. 41, issue 3:153‐6.
Xuejun Z, Baoxi W, Guang Z, Jun G, Zhiqiang C, Briantais P, et al. A comparison of the efficacy and safety of twice daily applications of calcitriol 3 lg/g ointment versus calcipotriol 50 mcg/g ointment in subjects with mild to moderate chronic plaque‐type psoriasis. [Abstract P0647.] 14th Congress of the European Academy of Dermatology and Venereology, 12‐15th October 2005, London, UK. Journal of the European Academy of Dermatology & Venereology 2005;19(Suppl 2):172.
Zhu X, Wang B, Zhao G, Gu J, Chen Z, Briantais P, et al. An investigator‐masked comparison of the efficacy and safety of twice daily applications of calcitriol 3 microg/g ointment vs. calcipotriol 50 microg/g ointment in subjects with mild to moderate chronic plaque‐type psoriasis. Journal of the European Academy of Dermatology & Venereology2007; Vol. 21, issue 4:466‐72. [PUBMED: 17373972]

Jin 2001 {published data only}

Jin HZ, Wang JB, He ZX, Xie Y. A Randomized, Placebo Controlled, Double Blind Trial Study on IL‐8 Monoclonal Antibody Cream in the Treatment of Psoriasis Vulgaris. Chinese Journal of Clinical Pharmacology 2001;17(1):36‐40.

Jorizzo 1997 {published data only}

Jorizzo Jl, Magee K, Stewart DM, Lebwohl MG, Rajagopalan R, Brown JJ. Clobetasol propionate emollient 0.05 percent: hypothalamic‐pituitary‐adrenal‐axis safety and four‐week clinical efficacy results in plaque‐type psoriasis. Cutis 1997;60(1):55‐60. [PUBMED: 9252738]

Jorizzo 2007 {published data only (unpublished sought but not used)}

Jorizzo J. Efficacy with calcipotriene and betamethasone dipropionate ointment in patients with moderate and severe psoriasis [Abstract P2780.] American Academy of Dermatology 65th Annual Meeting 2‐6 February, 2007. Journal of the American Academy of Dermatology2007; Vol. 56, issue 2:AB194.

Kang 1998 {published and unpublished data}

Kang S, Yi S, Griffiths CEM, Fancher L, Hamilton TA, Choi JH. Calcipotriene‐Induced Improvement in Psoriasis Is Associated with Reduced Interleukin‐8 and Increased Interleukin‐10 Levels within Lesions. British Journal Of Dermatology 1998;138(1):77‐83. [PUBMED: 9536226]

Kanzler 1993 {published and unpublished data}

Kanzler MH, Gorsulowsky DC. Efficacy of topical 5% liquor carbonis detergens vs. its emollient base in the treatment of psoriasis. British Journal Of Dermatology 1993;129(3):310‐4. [PUBMED: 8286230]

Katz 1987a {published data only}

Katz HI, Hien NT, Prawer S, Scot JC, Grivna EM. Betamethasone Dipropionate in Optimized Vehicle. Intermittent Pulse Dosing for Extended Maintenance Treatment of Psoriasis. Archives of Dermatology 1987;123(10):1308‐11. [PUBMED: 3662562]

Katz 1991a {published data only}

Katz HI, Prawer SE, Medansky RS, Krueger GG, Mooney JJ, Jones ML, et al. Intermittent corticosteroid maintenance treatment of psoriasis: a double‐blind multicenter trial of augmented betamethasone dipropionate ointment in a pulse dose treatment regimen. Dermatologica 1991;183(4):269‐74. [PUBMED: 1809589]

Katz 1991b {published data only}

Katz HI, Gross E, Buxman M, Prawer SE, Schwartzel EH, Gibson JR. A double‐blind, vehicle‐controlled paired comparison of halobetasol propionate cream on patients with plaque psoriasis. Journal of the American Academy of Dermatology 1991;25(6 Pt 2):1175‐8. [PUBMED: 1757613]

Kaufmann 2002 (H) {published and unpublished data}

Kaufmann R, Bibby AJ, Bissonnette R, Cambazard F, Chu AC, Decroix J, et al. A New Calcipotriol/Betamethasone Dipropionate Formulation (Daivobet(TM)) Is an Effective Once‐Daily Treatment for Psoriasis vulgaris. Dermatology 2002;205(4):389‐93. [PUBMED: 12444337]

Kaufmann 2002 (P) {published and unpublished data}

Kaufmann R, Bibby AJ, Bissonnette R, Cambazard F, Chu AC, Decroix J, et al. A New Calcipotriol/Betamethasone Dipropionate Formulation (Daivobet(TM)) Is an Effective Once‐Daily Treatment for Psoriasis vulgaris. Dermatology 2002;205(4):389‐93. [PUBMED: 12444337]

Kim 1994 {published data only}

Kim JY, You YH, Kim TY, Kim CW. Comparative Study of Calcipotriol and Desoxymethasone Ointments in the Treatment of Psoriasis Vulgaris. The Clinical Effect and Immunohistochemical Change. Korean Journal of Dermatology 1994;32(6):1054‐63. [EMBASE: 1995058111]

Kiss 1996 {published data only}

Carder KR. A randomized double blind parallel group dose‐ranging comparison of the efficacy and safety of calcipotriene solution in the treatment of scalp psoriasis [Abstract 844]. Journal of Investigative Dermatology 1996;106(4):946.
Kiss I, McCreary HL, Siskin SB, Epinette WW. A Randomized, Double‐ Blind, Parallel Group, Dose‐Ranging Comparison of the Efficacy and Safety of Calcipotriene Solution in the Treatment of Scalp Psoriasis. 54th Annual Meeting of the American Academy of Dermatology, 10‐15 February 1996. Journal of the American Academy of Dermatology. 1996:P301.

Klaber 1994 {published data only}

Klaber MR, Hutchinson PE, Pedvis‐Leftick A, Kragballe K, Reunala TL, Van de Kerkhof PC, et al. Comparative effects of calcipotriol solution (50 micrograms/ml) and betamethasone 17‐valerate solution (1 mg/ml) in the treatment of scalp psoriasis. British Journal Of Dermatology 1994;131(5):678‐83. [PUBMED: 7999600]

Klaber 2000b {published and unpublished data}

Klaber MR, McKinnon C. Calcipotriol (DovonexR) scalp solution in the treatment of scalp psoriasis: Comparative efficacy with 1% coal tar/1% coconut oil/0.5% salicylic acid (CapasalR) shampoo, and long‐term experience. Journal Of Dermatological Treatment 2000;11(1):21‐8. [EMBASE: 2000114933]

Koo 2006 {published data only (unpublished sought but not used)}

Koo J, Blum RR, Lebwohl M. A randomized, multicenter study of calcipotriene ointment and clobetasol propionate foam in the sequential treatment of localized plaque‐type psoriasis: short‐ and long‐term outcomes. Journal of the American Academy of Dermatology2006; Vol. 55, issue 4:637‐41. [PUBMED: 17010744]

Köse 1997 {published data only}

Köse O. Calcipotriol ointment vs clobetasol solution in scalp psoriasis. Journal Of Dermatological Treatment 1997;8:287. [EMBASE: 1998022654]

Kragballe 1988b {published and unpublished data}

Kragballe K, Beck HI, Søgaard H. Improvement of Psoriasis by a Topical Vitamin D3 Analogue (Mc 903) in a Double‐Blind Study. British Journal Of Dermatology 1988;119(2):223‐30. [EMBASE: 1988203615]

Kragballe 1991a {published and unpublished data}

Kragballe K, Gjertsen BT, De Hoop D, Karlsmark T, van de Kerkhof PC, Larko O, et al. Double‐blind, right/left comparison of calcipotriol and betamethasone valerate in treatment of psoriasis vulgaris. Lancet 1991;337(8735):193‐6. [PUBMED: 1670840]

Kragballe 1998b {published and unpublished data}

Glade CP, Van Erp PE, Van De Kerkhof PC. Epidermal cell DNA content and intermediate filaments keratin 10 and vimentin after treatment of psoriasis with calcipotriol cream once daily, twice daily and in combination with clobetasone 17‐butyrate cream or betamethasone 17‐valerate cream: a comparative flow cytometric study. British Journal Of Dermatology 1996;135(3):379‐84. [PUBMED: 8949429]
Kragballe K, Barnes L, Hamberg KJ, Hutchinson P, Murphy F, Moller S, et al. Calcipotriol Cream with or without Concurrent Topical Corticosteroid in Psoriasis: Tolerability and Efficacy. British Journal Of Dermatology 1998;139(4):649‐54. [MEDLINE: 9892908]
Van de Kerkhof PC. Calcipotriol cream and concurrent corticosteroids in psoriasis. Journal of the European Academy of Dermatology & Venereology1995; Vol. 5, issue Suppl 1:S184.

Kragballe 2004 {published and unpublished data}

Kragballe K, Noerrelund KL, Lui H, Ortonne JP, Wozel G, Uurasmaa T, et al. Efficacy of once‐daily treatment regimens with calcipotriol/betamethasone dipropionate ointment and calcipotriol ointment in psoriasis vulgaris. British Journal of Dermatology 2004;150(6):1167‐73. [PUBMED: 15214905]

Kragballe 2006 {published and unpublished data}

Gold LS. Correlation between amount of drug used versus efficacy of calcipotriene/betamethasone in severe psoriasis during a 52‐week study [Abstract P2873.] American Academy of Dermatology 64th Annual Meeting 3‐7 March, 2006. Journal of the American Academy of Dermatology 2006;54(3 Suppl):AB216.
Kragballe K, Austad J, Barnes L, Bibby A, de la Brassinne M, Cambazard F, et al. A 52‐week randomized safety study of a calcipotriol/betamethasone dipropionate two‐compound product (Dovobet/Daivobet/Taclonex) in the treatment of psoriasis vulgaris. British Journal of Dermatology2006; Vol. 154, issue 6:1155‐60. [PUBMED: 16704648]
Kragballe K, Austad J, Barnes L, Bibby A, de la Brassinne M, Cambazard F, et al. Efficacy results of a 52‐week, randomised, double‐blind, safety study of a calcipotriol/betamethasone dipropionate two‐compound product (Daivobet/Dovobet/Taclonex) in the treatment of psoriasis vulgaris. Dermatology2006; Vol. 213, issue 4:319‐26. [PUBMED: 17135738]
Kragballe K, Bibby A. Long‐term efficacy of a calcipotriene/betamethasone dipropionate two compound product in Psoriasis vulgaris [Abstract P2891] American Academy of Dermatology 64th Annual Meeting 3‐7 March, 2006. Journal of the American Academy of Dermatology 2006;54(3 Suppl):AB220.

Kragballe 2009 {published and unpublished data}

Kragballe K, Ganslandt C, Ortonne J P. A calcipotriol plus betamethasone dipropionate scalp formulation significantly reduces itching in scalp psoriasis. Journal of the American Academy of Dermatology 2009;60(3 Suppl 1):AB172.
Kragballe K, Hoffmann V, Ortonne J P, Tan J, Nordin P, Segaert S. Efficacy and safety of calcipotriol plus betamethasone dipropionate scalp formulation compared with calcipotriol scalp solution in the treatment of scalp psoriasis: a randomized controlled trial. British Journal of Dermatology 2009;161(1):159‐66. [PUBMED: 19416259]
Ortonne JP, Ganslandt C, Tan J, Nordin P, Kragballe K, Segaert S. Quality of life in patients with scalp psoriasis treated with calcipotriol/betamethasone dipropionate scalp formulation: a randomized controlled trial. Journal of the European Academy of Dermatology & Venereology 2009;23(8):919‐26.

Kreuter 2006 (H) {published data only (unpublished sought but not used)}

Kreuter A, Sommer A, Hyun J, Brautigam M, Brockmeyer NH, Altmeyer P, et al. 1% pimecrolimus, 0.005% calcipotriol, and 0.1% betamethasone in the treatment of intertriginous psoriasis: a double‐blind, randomized controlled study. Archives of Dermatology2006; Vol. 142, issue 9:1138‐43. [PUBMED: 16983001]

Kreuter 2006 (P) {published data only (unpublished sought but not used)}

Kreuter A, Sommer A, Hyun J, Brautigam M, Brockmeyer NH, Altmeyer P, et al. 1% pimecrolimus, 0.005% calcipotriol, and 0.1% betamethasone in the treatment of intertriginous psoriasis: a double‐blind, randomized controlled study. Archives of Dermatology2006; Vol. 142, issue 9:1138‐43. [PUBMED: 16983001]

Krueger 1998 {published data only}

Krueger GG, Drake LA, Elias PM, Lowe NJ, Guzzo C, Weinstein GD, et al. The safety and efficacy of tazarotene gel, a topical acetylenic retinoid, in the treatment of psoriasis. Archives of Dermatology 1998;134(1):57‐60. [PUBMED: 9449910]

Lahfa 2003 {published data only (unpublished sought but not used)}

Lahfa M, Mrowietz U, Koenig M, Simon JC. Calcitriol ointment and clobetasol propionate cream: a new regimen for the treatment of plaque psoriasis. European Journal of Dermatology2003; Vol. 13, issue 3:261‐5.

Landi 1993 {published data only}

Landi G. Efficacy and safety of calcipotriol ointment compared to clobetasol ointment in psoriasis vulgaris. 3rd Congress of the European Academy of Dermatology & Venereology. Copenhagen, Denmark, 1993:199.
Landi G, Pierleoni M, Polverelli M, Fioravanti F. Calcipotriol, a New Topical Product in the Therapy of Psoriasis: Controlled Study Versus Clobetasol [Il Calcipotriol, Nuovo Topico Nella Terapia Della Psoriasi: Studio Controllato Versus Clobetasol]. Giornale Italiano di Dermatologia e Venereologia 1993;128(9):89‐93. [EMBASE: 1993360641]

Lane 1983 {published data only}

Lane AT, Wachs GN, Weston WL. Once‐Daily Treatment of Psoriasis with Topical Glucocorticosteroid Ointments. Journal of the American Academy of Dermatology 1983;8(4):523‐5. [PUBMED: 6853785]

Langley 2011 (H) {published and unpublished data}

Langley R, Gupta A, Papp K, Wexler D, Østerdal M, Ćurčić D. Calcipotriol plus Betamethasone Dipropionate Gel Compared with Tacalcitol Ointment and the Gel Vehicle Alone in Patients with Psoriasis Vulgaris: A Randomized, Controlled Clinical Trial. Dermatology2011; Vol. 222, issue 2:148‐56. [PUBMED: 21293107]
Langley R, Gupta A, Wexler D, Curcic D, Papp K. Efficacy and safety of calcipotriene plus betamethasone dipropionate gel compared to tacalcitol ointment and gel vehicle alone in patients with psoriasis vulgaris: A randomized controlled trial. Journal of the American Academy of Dermatology 2010;62(3 Suppl 1):AB134.
NCT00670241. Efficacy and Safety of Calcipotriol Plus Betamethasone Dipropionate Gel Compared With Tacalcitol Ointment and the Gel Vehicle Alone in Patients With Psoriasis Vulgaris. clinicaltrials.gov/ct2/results?term=NCT00670241(accessed 2010).

Langley 2011 (P) {published and unpublished data}

Langley R, Gupta A, Papp K, Wexler D, Østerdal M, Ćurčić D. Calcipotriol plus Betamethasone Dipropionate Gel Compared with Tacalcitol Ointment and the Gel Vehicle Alone in Patients with Psoriasis Vulgaris: A Randomized, Controlled Clinical Trial. Dermatology2011; Vol. 222, issue 2:148‐56. [PUBMED: 21293107]
Langley R, Gupta A, Wexler D, Curcic D, Papp K. Efficacy and safety of calcipotriene plus betamethasone dipropionate gel compared to tacalcitol ointment and gel vehicle alone in patients with psoriasis vulgaris: A randomized controlled trial. Journal of the American Academy of Dermatology 2010;62(3 Suppl 1):AB134.
NCT00670241. Efficacy and Safety of Calcipotriol Plus Betamethasone Dipropionate Gel Compared With Tacalcitol Ointment and the Gel Vehicle Alone in Patients With Psoriasis Vulgaris. clinicaltrials.gov/ct2/results?term=NCT00670241(accessed 2010).

Langner 1992 {published data only}

Langner A, Verjans H, Stapor V, Mol M, Fraczykowska M. 1 Alpha 25‐Dihydroxyvitamin D‐3 (Calcitriol) Ointment in Psoriasis. Journal Of Dermatological Treatment 1992;3(4):177‐80. [EMBASE: 1993020253]

Langner 1993 {published data only}

Langner A, Verjans H, Stapor V, Mol M, Fraczykowska M. Topical Calcitriol in the Treatment of Chronic Plaque Psoriasis: A Double‐Blind Study. British Journal Of Dermatology 1993;128(5):566‐71. [PUBMED: 8504051]

Langner 2001 (H) {published data only}

Langner A, Stapor W, Ambroziak M. Efficacy and tolerance of topical calcitriol 3 microg g(‐1) in psoriasis treatment: a review of our experience in Poland. British Journal Of Dermatology 2001;58:11‐16. [PUBMED: 11501507]

Langner 2001 (P) {published data only}

Langner A, Stapor W, Ambroziak M. Efficacy and tolerance of topical calcitriol 3 microg g(‐1) in psoriasis treatment: a review of our experience in Poland. British Journal Of Dermatology 2001;58:11‐16. [PUBMED: 11501507]

Lassus 1991 {published data only}

Lassus A, Forsstrom S. A double‐blind study comparing oleum horwathiensis with placebo in the treatment of psoriasis. Journal of International Medical Research 1991;19(2):137‐46. [PUBMED: 1864450]

Lebwohl 2002 {published data only}

Lebwohl M, Scher RK, Washenik K, Krueger G, Menter A, Koo J, et al. A randomized, double‐blind placebo‐controlled study of the safety and efficacy of clobetasol propionate 0.05% foam in the treatment of non‐scalp psoriasis. Skin Pharmacology & Applied Skin Physiology 2001;14:168.
Lebwohl M, Sherer D, Washenik K, Krueger GG, Menter A, Koo J, Feldman SR. A randomized, double‐blind, placebo‐controlled study of clobetasol propionate 0.05% foam in the treatment of nonscalp psoriasis. International Journal Of Dermatology 2002;41(5):269‐74. [PUBMED: 12100701]

Lebwohl 2004 {published data only (unpublished sought but not used)}

Lebwohl M, Freeman AK, Chapman MS, Feldman SR, Hartle JE, Henning A. Tacrolimus ointment is effective for facial and intertriginous psoriasis. Journal of the American Academy of Dermatology 2004;51(5):723‐30. [PUBMED: 15523350]

Lebwohl 2007 {published and unpublished data}

Lebwohl M, Menter A, Weiss J, Clark SD, Flores J, Powers J, et al. Calcitriol 3 microg/g ointment in the management of mild to moderate plaque type psoriasis: results from 2 placebo‐controlled, multicenter, randomized double‐blind, clinical studies. Journal of Drugs in Dermatology2007; Vol. 6, issue 4:428‐35. [PUBMED: 17668541]

Lee 2007 {published data only}

Lee J, Youn J, Kim N, Kim K, Kim T, Choi J, et al. A randomized investigator‐blinded comparative study of calcitriol twice a day vs. diflucortolone valerate morning plus calcitriol evening application in the treatment of mild to moderate psoriasis. Journal of the European Academy of Dermatology & Venereology2007; Vol. 21, issue Suppl 1:19.

Lepaw 1978 {published data only}

Lepaw MI. Double‐Blind Comparison of Halcinonide Solution and Placebo Control in Treatment of Psoriasis of the Scalp. Cutis 1978;21(4):571‐3. [PUBMED: 346315]

Levine 2010 (H) {published and unpublished data}

Levine D, Even‐Chen Z, Lipets I, Pritulo OA, Svyatenko TV, Andrashko Y, et al. Pilot, multicenter, double‐blind, randomized placebo‐controlled bilateral comparative study of a combination of calcipotriene and nicotinamide for the treatment of psoriasis. Journal of the American Academy of Dermatology 2010;63(5):775‐81. [PUBMED: 20599292]

Levine 2010 (P) {published and unpublished data}

Levine D, Even‐Chen Z, Lipets I, Pritulo OA, Svyatenko TV, Andrashko Y, et al. Pilot, multicenter, double‐blind, randomized placebo‐controlled bilateral comparative study of a combination of calcipotriene and nicotinamide for the treatment of psoriasis. Journal of the American Academy of Dermatology 2010;63(5):775‐81. [PUBMED: 20599292]

Liao 2007 {published and unpublished data}

Liao YH, Chiu HC, Tseng YS, Tsai TF. Comparison of cutaneous tolerance and efficacy of calcitriol 3 microg g(‐1) ointment and tacrolimus 0.3 mg g(‐1) ointment in chronic plaque psoriasis involving facial or genitofemoral areas: a double‐blind, randomized controlled trial. British Journal of Dermatology2007; Vol. 157, issue 5:1005‐12. [PUBMED: 17935517]

Lin 2007 {published and unpublished data}

Lin YK, Wong WR, Chang YC, Chang CJ, Tsay PK, Chang SC, et al. The efficacy and safety of topically applied indigo naturalis ointment in patients with plaque‐type psoriasis. Dermatology 2007;214(2):155‐61. [PUBMED: 17341866]

Lin 2008 {published data only}

Lin YK, Chang CJ, Chang YC, Wong WR, Chang SC, Pang JHS. Clinical assessment of patients with recalcitrant psoriasis in a randomized, observer‐blind, vehicle‐controlled trial using indigo naturalis. Archives of Dermatology 2008;144(11):1457‐64. [PUBMED: 19015420]

Lister 1997 {published data only}

Lister RK, Woodrow Sl, Hughes JH, Cerio R, Norris PG, Griffiths CEM, et al. Can dithranol have a lasting effect and be more acceptable to patients? Micanol Cream ‐ a trial of 171 patients with psoriasis. British Journal of Dermatology 1997;137(Suppl 50):17.

Lowe 2005 {published data only}

Lowe N, Feldman SR, Sherer D, Weiss J, Shavin JS, Lin YL, et al. Clobetasol propionate lotion, an efficient and safe alternative to clobetasol propionate emollient cream in subjects with moderate to severe plaque‐type psoriasis. Journal of Dermatological Treatment2005; Vol. 16, issue 3:158‐64. [PUBMED: 16096182]

Luger 2008 {published and unpublished data}

Cambazard F. Xamiol, a new treatment in scalp psoriasis: short‐ and long‐term results [Un nouveau traitement dans le psoriasis du cuir chevelu : Xamiol : Resultats court terme et a long terme]. Annales de Dermatologie et de Venereologie 2009;136(Suppl 3):546‐50.
Luger T, Kidson P, Cambazard F, Larsen FG. A 1‐year, randomized, double‐blind safety study of long‐term treatment of a new gel formulation containing calcipotriene plus betamethasone dipropionate in scalp psoriasis. Journal of the American Academy of Dermatology2008; Vol. 58, issue 2:AB134.
Luger TA, Cambazard F, Larsen FG, Bourcier M, Gupta G, Clonier F, et al. A Study of the Safety and Efficacy of Calcipotriol and Betamethasone Dipropionate Scalp Formulation in the Long‐Term Management of Scalp Psoriasis. Dermatology2008; Vol. 217, issue 4:321‐8. [PUBMED: 18787325]

Maier 2004 {published data only}

Maier H. Prospective, randomized controlled double‐blind study on the efficacy and safety of a series of herbal skin‐care products for stable chronic plaque psoriasis [Abstract P061] European Congress on Psoriasis 2004. Journal of the European Academy of Dermatology & Venereology 2004;18(6):794.

Medansky 1987 {published data only}

Medansky RS, Brody NI, Kanof NB, Russo GJ, Peets EA. Clinical Investigations of Mometasone Furoate ‐ a Novel Nonfluorinated, Topical Corticosteroid. Seminars In Dermatology 1987;6(2):94‐100. [EMBASE: 1988051740]

Medansky 1996 {published data only}

Medansky RS, Greenspan A, Kraus SJ, Todd Plott R. The Comparative Efficacy of Diflorasone Diacetate Ointment 0.05% (Psorcon®) vs Calcipotriene Ointment (Dovonex®) in the Treatment of Psoriasis. Journal of Geriatric Dermatology 1996;4(1):20‐24.

Menter 2009 {published and unpublished data}

Menter A, Abramovits W, Colon LE, Johnson LA, Gottschalk RW. Comparing clobetasol propionate 0.05% spray to calcipotriene 0.005% betamethasone dipropionate 0.064% ointment for the treatment of moderate to severe plaque psoriasis. Journal of Drugs in Dermatology 2009;8(1):52‐7. [PUBMED: 19180896]
Menter A, Colon L, Johnson L, Gottschalk R. Results from a randomized study comparing clobetasol propionate 0.05% spray to calcipotriene 0.005%, betamethasone dipropionate 0.064% ointment for the treatment of plaque psoriasis. Journal of the American Academy of Dermatology2008; Vol. 58, issue 2:AB124.

Molin 1997 {published and unpublished data}

Molin L, Cutler TP, Helander I, Nyfors B. Calcipotriol cream and betamethasone valerate cream of equal efficacy in psoriasis. Journal of the European Academy of Dermatology & Venereology 1995;5(Suppl 1):S92.
Molin L, Cutler TP, Helander I, Nyfors B. Comparative Efficacy of Calcipotriol Cream and Betamethasone Valerate Cream in the Treatment of Psoriasis. Journal of Investigative Dermatology. Symposium Proceedings 1996;1(1):110.
Molin L, Cutler TP, Helander I, Nyfors B, Downes N. Comparative Efficacy of Calcipotriol (Mc903) Cream and Betamethasone 17‐Valerate Cream in the Treatment of Chronic Plaque Psoriasis. A Randomized, Double‐Blind, Parallel Group Multicentre Study. Calcipotriol Study Group. British Journal Of Dermatology 1997;136(1):89‐93. [PUBMED: 9039301]

Monastirli 2000 {published data only}

Monastirli A, Zografakis CH, Braun H, Pasmatzi E, Georgiou S, Sakkis TH, et al. Calcipotriol vs. Anthralin in the treatment of chronic plaque psoriasis. H+G Zeitschrift Fur Hautkrankheiten. 2000;75(11):626‐9. [EMBASE: 2000428558]

Mortensen 1993b {published and unpublished data}

Mortensen L, Kragballe K, Wegmann E, Schifter S, Risteli J, Charles P. Treatment of Psoriasis Vulgaris with Topical Calcipotriol Has No Short‐Term Effect on Calcium or Bone Metabolism. A Randomized, Double‐Blind, Placebo‐Controlled Study. Acta Dermato Venereologica 1993;73(4):300‐4. [PUBMED: 7904106]

Olsen 1991 {published data only}

Olsen EA, Cram DL, Ellis CN, Hickman JG, Jacobson C, Jenkins EE, et al. A double‐blind, vehicle‐controlled study of clobetasol propionate 0.05% (Temovate) scalp application in the treatment of moderate to severe scalp psoriasis. Journal of the American Academy of Dermatology 1991;24(3):443‐7. [PUBMED: 2061442]

Olsen 1996 (1) {published data only}

Olsen EA. Efficacy and Safety of Fluticasone Propionate 0.005% Ointment in the Treatment of Psoriasis. Cutis 1996;57(2 Suppl):57‐61. [PUBMED: 8646872]

Olsen 1996 (2) {published data only}

Olsen EA. Efficacy and Safety of Fluticasone Propionate 0.005% Ointment in the Treatment of Psoriasis. Cutis 1996;2 Suppl:57‐61. [PUBMED: 8646872]

Oranje 1997 {published data only}

Oranje AP, Marcoux DSA, Prendiville J, Krafchik B, Toole J, Rosenthal D, et al. Topical calcipotriol in childhood psoriasis. Journal of the American Academy of Dermatology 1997;36(2 Pt 1):203‐8. [PUBMED: 9039169]

Ormerod 1997 {published and unpublished data}

Ormerod AD, Dwyer CM, Weller R, Cox DH, Price R. A comparison of subjective and objective measures of reduction of psoriasis with the use of ultrasound, reflectance colorimetry, computerized video image analysis, and nitric oxide production. Journal of the American Academy of Dermatology 1997;37(1):51‐7. [PUBMED: 9216523 ]

Ormerod 2000 {published data only}

Ormerod AD, Copeland P, Shah SA. Treatment of psoriasis with topical NG‐monomethyl‐L‐arginine, an inhibitor of nitric oxide synthesis. British Journal Of Dermatology 2000;142(5):985‐90. [PUBMED: 10809860]

Ormerod 2005 {published data only}

Ormerod AD, Shah SA, Copeland P, Omar G, Winfield A. Treatment of psoriasis with topical sirolimus: preclinical development and a randomized, double‐blind trial. British Journal of Dermatology 2005;152(4):758‐64. [PUBMED: 15840110 ]

Ortonne 1994 {published data only}

Ortonne JP, Bazex J, Binet O, Bombart M, Brun P, Carreau O, et al. Psoriasis: new Therapeutic Modality by Calcipotriol and Betamethasone Dipropionate. Nouvelles Dermatologiques 1994;13(10):746‐51. [EMBASE: 1995010294]

Ortonne 2003 {published data only}

Nicolas JF. Calcitriol vs calcipotriol in psoriasis of sensitive areas [Abstract]. 20th World Congress of Dermatology 1‐5 July 2002, Paris. Paris, 2002:SA1048.
Ortonne JP, Humbert P, Nicolas JF, Tsankov N, Tonev SD, Janin A, et al. Intra‐individual comparison of the cutaneous safety and efficacy of calcitriol 3 microg g(‐1) ointment and calcipotriol 50 microg g(‐1) ointment on chronic plaque psoriasis localized in facial, hairline, retroauricular or flexural areas. British Journal of Dermatology 2003;148(2):326‐33. [PUBMED: 12588387]

Ortonne 2004 {published and unpublished data}

Ortonne JP, Kaufmann R, Lecha M, Goodfield M. Efficacy of treatment with calcipotriol/betamethasone dipropionate followed by calcipotriol alone compared with tacalcitol for the treatment of psoriasis vulgaris: A randomised, double‐blind trial. Dermatology 2004;209(4):308‐13. [PUBMED: 15539894]
Ortonne JP, Traulsen J, Kaufmann R, Lecha M, Goodfield M. Calcipotriol/betamethasone dipropionate ointment once daily versus tacalcitol once daily in psoriasis vulgaris [Abstract P27‐49.] 12th Congress of the European Academy of Dermatology and Venereology. 15‐18 October 2003, Barcelona, Spain. Journal of the European Academy of Dermatology & Venereology 2003;17(Suppl 3):374.

Ortonne 2006 {published data only}

Ortonne JP, van de Kerkhof PCM, Prinz JC, Bieber T, Lahfa M, Rubins A, et al. 0.3% Tacrolimus gel and 0.5% Tacrolimus cream show efficacy in mild to moderate plaque psoriasis: Results of a randomized, open‐label, observer‐blinded study. Acta Dermato‐Venereologica2006; Vol. 86, issue 1:29‐33. [PUBMED: 16585986]
Vissers W H, van Vlijmen I, van Erp P E, de Jong E M, van de Kerkhof P C. Topical treatment of mild to moderate plaque psoriasis with 0.3% tacrolimus gel and 0.5% tacrolimus cream: the effect on SUM score, epidermal proliferation, keratinization, T‐cell subsets and HLA‐DR expression. British Journal of Dermatology 2008;158(4):705‐12.

Ortonne 2010 {published and unpublished data}

Ortonne JP, Noerrelund KL, Papp K, Van Herpe L, Sebastian M, Herrera E, et al. Comparison of two different dose combinations of calcipotriol/hydrocortisone ointment used once daily for the treatment of psoriasis vulgaris on the face and body. European Journal of Dermatology 2010;20(5):585‐9. [PUBMED: 20732849]

Papakostantinou 2005 {published data only}

Papakostantinou E, Xenos K, Markantonis S L, Druska S, Stratigos A, Katsambas A. Efficacy of 2 weeks' application of theophylline ointment in psoriasis vulgaris. Journal of Dermatological Treatment 2005;16(3):169‐70. [PUBMED: 16096184]

Papp 2003 (H) {published and unpublished data}

Papp KA, Guenther L, Boyden B, Larsen FG, Harvima RJ, Guilhou JJ, et al. Early onset of action and efficacy of a combination of calcipotriene and betamethasone dipropionate in the treatment of psoriasis. Journal of the American Academy of Dermatology 2003;48(1):48‐54. [PUBMED: 12522370]

Papp 2003 (P) {published and unpublished data}

Papp KA, Guenther L, Boyden B, Larsen FG, Harvima RJ, Guilhou JJ, et al. Early onset of action and efficacy of a combination of calcipotriene and betamethasone dipropionate in the treatment of psoriasis. Journal of the American Academy of Dermatology 2003;48(1):48‐54. [PUBMED: 12522370]

Pariser 1996 {published data only}

Pariser DM, Pariser RJ, Breneman D, Lebwohl M, Kalb R, Moore J, et al. Calcipotriene ointment applied once a day for psoriasis: A double‐ blind, multicenter, placebo‐controlled study. Archives of Dermatology 1996;132(12):1527. [PUBMED: 8961897]

Pauporte 2004 {published and unpublished data}

Pauporte M, Maibach H, Lowe N, Pugliese M, Friedman DJ, Mendelsohn H, et al. Fluocinolone acetonide topical oil for scalp psoriasis. Journal of Dermatological Treatment 2004;15(6):360‐4. [PUBMED: 15764047]

Perez 1996 {published and unpublished data}

Perez A, Chen TC, Turner A, Raab R, Bhawan J, Poche P, et al. Efficacy and Safety of Topical Calcitriol (1,25‐Dihydroxyvitamin D3) for the Treatment of Psoriasis. British Journal Of Dermatology 1996;134(2):238‐46. [PUBMED: 8746336]

Pinheiro 1997 {published and unpublished data}

Pinheiro N. Comparative Effects of Calcipotriol Ointment (50 Micrograms/G) and 5% Coal Tar/2% Allantoin/0.5% Hydrocortisone Cream in Treating Plaque Psoriasis. British Journal of Clinical Practice 1997;51(1):16‐9. [PUBMED: 9158266]

Poulin 2010 {published and unpublished data}

Poulin Y, Papp K, Bissonnette R, Barber K, Kerrouche N, Villemagne H, et al. Clobetasol propionate shampoo 0.05% is efficacious and safe for long‐term control of moderate scalp psoriasis. Journal of Dermatological Treatment 2010;21(3):185‐92. [PUBMED: 20131980]
Poulin Y, Papp K, Bissonnette R, Guenther L, Tan J, Lynde C, et al. Clobetasol propionate shampoo 0.05% is efficacious and safe for long‐term control of scalp psoriasis. Cutis 2010;85(1):43‐50. [PUBMED: 20184211]
Poulin Y, Papp K, Guenther L, Bissonnette R. Twice‐weekly use of clobetasol propionate 0.05% shampoo is effective and safe for the long‐term control of scalp psoriasis. Journal of the American Academy of Dermatology2010; Vol. 62, issue 3 Suppl 1:AB132. [0190‐9622]

Powers 2005 {published and unpublished data}

Powers J. Assessment of the Efficacy and Safety of Calcitriol 3mcg/g Ointment in the Treatment of Chronic Plaque Psoriasis. 7th Asian Congress of Dermatology incorporating the 5th Regional Conference of Paediatric Dermatology Kuala Lumpur, Malaysia 28 September ‐1 October, 20052005:367.
Powers J, Balin AK, Kempers S, Glinert RJ, Fleming T, Graeber M. Assessment of the efficacy and safety of calcitriol 3ugg‐1 ointment in the treatment of chronic plaque psoriasis [Abstract P‐40.] 85th BAD Annual Meeting 5‐8 July 2005, Glasgow, UK. British Journal of Dermatology2005; Vol. 153, issue Suppl 1:32.

Reygagne 2005 {published and unpublished data}

Reygagne P, Mrowietz U, Decroix J, De Waard‐Van Der Spek FB, Acebes LO, Figueiredo A, et al. Clobetasol propionate shampoo 0.05% and calcipotriol solution 0.005%: A randomized comparison of efficacy and safety in subjects with scalp psoriasis. Journal of Dermatological Treatment2005; Vol. 16, issue 1:31‐6. [PUBMED: 15897165]
Reygagne P, Mrowietz U, Decroix J, Van der Spek W, Olmos Acebes L, Figueiredo A, et al. Four‐week efficacy and safety comparison of a new clobetasol shampoo and calcipotriol solution 0.005% in subjects with scalp psoriasis. 11th Congress of the European Academy of Dermatology & Venereology, 2‐6 October, 2002, Prague. 2002:27‐36.

Ruzicka 1998 {published data only}

Ruzicka T, Kallinschnigg G, Lorenz B, Schroder G. Clinical Efficacy of a Monotherapy with Calcipotriol‐Ointment Compared to Combination Therapy with Calcipotriol Ointment and Betamethasone Valerate Ointment in Psoriasis Vulgaris. Journal of Investigative Dermatology 1996;1(1):107.
Ruzicka T, Lorenz B. Comparison of Calcipotriol Monotherapy and a Combination of Calcipotriol and Betamethasone Valerate after 2 Weeks' Treatment with Calcipotriol in the Topical Therapy of Psoriasis Vulgaris: A Multicentre, Double‐Blind, Randomized Study. British Journal Of Dermatology 1998;138(2):254‐8. [PUBMED: 9602870]

Salmhofer 2000 {published data only}

Salmhofer W, Maier H, Soyer HP, Honigsmann H, Hodl S. Double‐blind, placebo‐controlled, randomized, right‐left study comparing calcipotriol monotherapy with a combined treatment of calcipotriol and diflucortolone valerate in chronic plaque psoriasis. Acta Dermato Venereologica 2000;Suppl 211:5‐8. [PUBMED: 11234559]

Sanchez 2001 {published and unpublished data}

Sanchez RM, Iglesias SM, Umbert MP. Treatment of plague‐type psoriasis with topical propylthiouracil. Actas Dermo Sifiliograficas 2001;92(4):174‐6. [EMBASE: 2001206374]

Santoianni 2001 {published data only}

Santoianni P, Di Iorio S, Giannetti A, Manfredi G, Rebora A, Landi G, et al. Short‐term clinical efficacy of the association betamethasone 17‐valerate 21‐acetate + tretinoine + salicylic acid in outpatients affected with disseminated keratotic plaque psoriasis: A double blinded placebo‐controlled multicentric randomized clinical trial. Giornale Italiano di Dermatologia e Venereologia 2001;136(1):77‐83. [EMBASE: 2001160666]

Saraceno 2007 {published data only (unpublished sought but not used)}

Saraceno R, Andreassi L, Ayala F, Bongiorno MR, Giannetti A, Lisi P, et al. Efficacy, safety and quality of life of calcipotriol/betamethasone dipropionate (Dovobet) versus calcipotriol (Daivonex) in the treatment of psoriasis vulgaris: a randomized, multicentre, clinical trial. Journal of Dermatological Treatment2007; Vol. 18, issue 6:361‐5. [PUBMED: 17934937]

Scarpa 1994 {published data only}

Scarpa C. Calcipotriol: Clinical Trial Versus Betamethasone Dipropionate + Salicylic Acid. Acta Dermato Venereologica 1994;186(Suppl):47. [PUBMED: 8073835]

Scarpa 1996 {published data only}

Scarpa C. Tacalcitol Ointment Is an Efficacious and Well Tolerated Treatment for Psoriasis. Journal of the European Academy of Dermatology & Venereology 1996;6(2):142‐6. [EMBASE: 1996096733]
Scarpa C, Kokelj F, Plozzer C, Lavaroni G. Efficacy and Tolerability of Tacalcitol Ointment on Psoriatic Skin: Study in 63 Patients. Journal of Investigative Dermatology. Symposium Proceedings 1996;1(1):110.

Scarpa 1997 {published data only}

Scarpa C, Kokelj F, Plozzer C, Lavaroni G, Torsello P. Efficacy and Tolerability of Tacalcitol Administered Once Daily in the Treatment of Psoriasis Vulgaris (Double‐Blind, Randomized, Placebo Controlled Italian Multicenter Study). Giornale Italiano di Dermatologia e Venereologia 1997;132(5):335‐8. [EMBASE: 1997363332]

Sears 1997 {published data only}

Sears HW, Bailer JW, Yeadon A. A Double‐Blind, Randomized, Placebo‐Controlled Evaluation of the Efficacy and Safety of Hydrocortisone Buteprate 0.1% Cream in the Treatment of Psoriasis. Advances In Therapy 1997;14(3):140‐9. [EMBASE: 1997223749]

Seidenari 1997 (H) {published data only}

Seidenari S, Magni R, Giannetti A. Assessment of the Activity of Tacalcitol on Psoriatic Plaques by Means of Colorimetry and High‐Frequency Ultrasound: A Double‐Blind Intrasubject Half‐Side Right‐Left Comparison with Betamethasone Valerate and Placebo. Skin Pharmacology 1997;10(1):40‐7. [EMBASE: 1997139265]

Seidenari 1997 (P) {published data only}

Seidenari S, Magni R, Giannetti A. Assessment of the Activity of Tacalcitol on Psoriatic Plaques by Means of Colorimetry and High‐Frequency Ultrasound: A Double‐Blind Intrasubject Half‐Side Right‐Left Comparison with Betamethasone Valerate and Placebo. Skin Pharmacology 1997;10(1):40‐7. [EMBASE: 1997139265]

Shuttleworth 1998 {published data only}

Shuttleworth D, Galloway DB, Boorman GC, Donald AE. A double‐blind, placebo‐controlled study of the clinical efficacy of ciclopirox olamine (1.5%) shampoo for the control of scalp psoriasis. Journal Of Dermatological Treatment 1998;9(3):163‐7. [EMBASE: 1998346163]

Staberg 1989 {published data only}

Staberg B, Roed‐Petersen J, Menne T. Efficacy of Topical Treatment in Psoriasis with Mc903, a New Vitamin D Analogue. Acta Dermato Venereologica 1989;69(2):147‐50. [PUBMED: 2564233]

Stein 2001 {published data only}

Stein LF, Sherr A, Solodkina G, Gottlieb AB, Chaudhari U. Betamethasone valerate foam for treatment of nonscalp psoriasis. Journal of Cutaneous Medicine & Surgery 2001;5(4):303‐7. [PUBMED: 11907840]

Stuecker 2001 {published and unpublished data}

Hoffmann M, Memmel U, Altmeyer P, Stuecker M. Topical treatment of chronic‐stationary plaque psoriasis with vitamin B12. Zeitschrift Fur Hautkrankheiten 2001;Suppl 1(76):S12.
Stuecker M, Memmel U, Hoffmann M, Hartung J, Altmeyer P. Vitamin B(12) cream containing avocado oil in the therapy of plaque psoriasis. Dermatology 2001;203(2):141‐7. [PUBMED: 11586013]

Stutz 1996 {published data only}

Stutz JA, Ellis CN, Kang S. Failure of topical polymyxin B to improve mild plaque psoriasis [letter]. Archives of Dermatology 1996;132(2):231. [PUBMED: 8629837]

Sudilovsky 1981 {published data only}

Sudilovsky A, Muir JG, Bocobo FC. A Comparison of Single and Multiple Applications of Halcinonide Cream. International Journal Of Dermatology 1981;20(9):609‐13. [PUBMED: 7030988]

Sutton 2001 {published data only}

Sutton L, Swinehart JM, Cato A, Kaplan AS. A clinical study to determine the efficacy and safety of 1% methotrexate/Azone (MAZ) gel applied topically once daily in patients with psoriasis vulgaris. International Journal Of Dermatology 2001;40(7):464‐7. [MEDLINE: 11679005]

Syed 1996 {published data only}

Syed TA, Ahmad SA, Holt AH, Ahmad SA, Ahmad SH, Afzal M. Management of psoriasis with Aloe vera extract in a hydrophilic cream: a placebo‐controlled, double‐blind study. Tropical Medicine & International Health 1996;1(4):505‐9. [PUBMED: 8765459]

Syed 2001b {published data only}

Syed TA, Hadi SM, Qureshi ZA, Nordstrom CG, Ali SM. Management of psoriasis vulgaris with methotrexate 0.25% in a hydrophilic gel: a placebo‐controlled, double‐blind study. Journal of Cutaneous Medicine & Surgery 2001;5(4):299‐302. [PUBMED: 11907839]

Tham 1994 {published data only}

Tham SN, Lun KC, Cheong WK. A comparative study of calcipotriol ointment and tar in chronic plaque psoriasis. British Journal Of Dermatology 1994;131(5):673‐7. [PUBMED: 7999599]

Tyring 2010 {published and unpublished data}

Tyring S, Mendoza N, Appell M, Bibby A, Foster R, Hamilton T, et al. A calcipotriene/betamethasone dipropionate two‐compound scalp formulation in the treatment of scalp psoriasis in Hispanic/Latino and Black/African American patients: Results of the randomized, 8‐week, double‐blind phase of a clinical trial. International Journal of Dermatology 2010;49(11):1328‐33. [PUBMED: 20964660]

Tzung 2005 {published data only}

Tzung TY, Wu JC, Hsu NJ, Chen YH, Ger LP. Comparison of tazarotene 0.1% gel plus petrolatum once daily versus calcipotriol 0.005% ointment twice daily in the treatment of plaque psoriasis. Acta Dermato Venereologica2005; Vol. 85, issue 3:236‐9. [PUBMED: 16040409]

Vali 2005 {published data only}

Vali A, Asilian A, Khalesi E, Khoddami L, Shahtalebi M, Mohammady M. Evaluation of the efficacy of topical caffeine in the treatment of psoriasis vulgaris. Journal of Dermatological Treatment2005; Vol. 16, issue 4:234‐7. [PUBMED: 216249145]
Vali A, Asilian A, Khalesi E, Khoddami L, Shahtalebi M, Mohammady M. Evaluation of the efficacy of topical caffeine in the treatment of psoriasis vulgaris: A randomized, double‐blind clinical trial [Abstract]. Iranian Journal of Dermatology2006; Vol. 8, issue 6:87.

Van de Kerkhof 1989 {published data only}

Van de Kerkhof PCM, van Bokhoven M, Zultak M, Czarnetzki BM. A Double‐Blind Study of Topical 1 Alpha,25‐Dihydroxyvitamin D3 in Psoriasis. British Journal Of Dermatology 1989;120(5):661‐4. [PUBMED: 2667612]

Van de Kerkhof 1996a {published data only}

Van de Kerkhof PCM, Werfel T, Haustein UF, Luger T, Czarnetzki BM, Niemann R, et al. Tacalcitol Ointment in the Treatment of Psoriasis Vulgaris: A Multicentre, Placebo‐ Controlled, Double‐ Blind Study on Efficacy and Safety. British Journal Of Dermatology 1996;135(5):758‐65. [PUBMED: 8977677]

Van de Kerkhof 2002a {published data only}

Van de Kerkhof PCM, Green C, Hamberg KJ, Hutchinson PE, Jensen JK, Kidson P, et al. Safety and efficacy of combined high‐dose treatment with calcipotriol ointment and solution in patients with psoriasis. Dermatology 2002;204(3):214‐21. [PUBMED: 12037450]

Van de Kerkhof 2006 {published and unpublished data}

De Korte J, van der Valk PG, Sprangers MA, Damstra RJ, Kunkeler AC, Lijnen RL, et al. A comparison of twice‐daily calcipotriol ointment with once‐daily short‐contact dithranol cream therapy: quality‐of‐life outcomes of a randomized controlled trial of supervised treatment of psoriasis in a day‐care setting. British Journal of Dermatology2008; Vol. 158, issue 2:375‐81.
Van de Kerkhof PC, van der Valk PG, Swinkels OQ, Kucharekova M, de Rie MA, de Vries HJ, et al. A comparison of twice‐daily calcipotriol ointment with once‐daily short‐contact dithranol cream therapy: a randomized controlled trial of supervised treatment of psoriasis vulgaris in a day‐care setting. British Journal of Dermatology2006; Vol. 155, issue 4:800‐7. [PUBMED: 16965431]

Van de Kerkhof 2009 {published and unpublished data}

Van de Kerkhof P, Anstey A, Barnes L, Bolduc C. A new scalp formulation of calcipotriene plus betamethasone in the treatment of scalp psoriasis compared to its active ingredients in the same vehicle [Abstract P2734.] American Academy of Dermatology 65th Annual Meeting 2‐6 February, 2007. Journal of the American Academy of Dermatology 2007;56(2):AB182.
Van de Kerkhof PCM, Hoffmann V, Anstey A, Barnes L, Bolduc C, Reich K, et al. A new scalp formulation of calcipotriol plus betamethasone dipropionate compared with each of its active ingredients in the same vehicle for the treatment of scalp psoriasis: a randomized, double‐blind, controlled trial. British Journal of Dermatology2009; Vol. 160, issue 1:170‐6. [PUBMED: 18694678]

Vanderploeg 1976 {published data only}

Vanderploeg DE. Betamethasone Dipropionate Ointment in the Treatment of Psoriasis and Atopic Dermatitis: A Double‐Blind Study. Southern Medical Journal 1976;69(7):862‐3. [PUBMED: 781848]

Van der Vleuten 1995 {published data only}

Van der Vleuten CJM, de Jong EMGJ, Rulo EHFC, Gerritsen MJP, Van de Kerkhof PCM. In‐Patient Treatment with Calcipotriol Versus Dithranol in Refractory Psoriasis. European Journal of Dermatology 1995;5(8):676‐9. [EMBASE: 1996010645]

Veien 1997 {published and unpublished data}

Veien NK, Bjerke JR, Rossmann‐Ringdahl I, Jakobsen HB. Once daily treatment of psoriasis with tacalcitol compared with twice daily treatment with calcipotriol. A double‐blind trial. British Journal Of Dermatology 1997;137(4):581‐6. [PUBMED: 9390335]

Vladimirov 1994 {published data only}

Vladimirov VV, Tcherjomukchina IJ, Kurjanova ON, Menshikova LV, Mazina NM. Efficacy of calcipotriol ointment compared to betamethasone 17‐valerate ointment in the treatment of psoriasis [Abstract]. Skin Therapy Update '94. Crete, Greece, 1994:219.

Volden 1992 {published data only}

Volden G, Bjornberg A, Tegner E, Pedersen NB, Arles UB, Agren S, et al. Short‐Contact Treatment at Home with Micanol. Acta Dermato Venereologica 1992;172(Suppl):20‐2. [PUBMED: 1585757]

Wall 1998 {published and unpublished data}

Wall AR, Poyner TF. Psoriasis; the Burden of Disease Before, During and After Treatment with Dovonex Ointment or Dithrocream. British Journal Of Dermatology 1997;137(Suppl 50):55.
Wall ARJ, Poyner TF, Menday AP. A comparison of treatment with dithranol and calcipotriol on the clinical severity and quality of life in patients with psoriasis. British Journal Of Dermatology 1998;139(6):1005‐11. [PUBMED: 9990363]

Weinstein 1996 {published data only}

Weinstein GD. Safety, Efficacy and Duration of Therapeutic Effect of Tazarotene Used in the Treatment of Plaque Psoriasis. British Journal Of Dermatology 1996;135(Suppl 49):32‐6. [PUBMED: 9035703]
Weinstein GD, Krueger GG, Lowe NJ, Duvic M, Friedman DJ, Jegasothy BV, et al. Tazarotene gel, a new retinoid, for topical therapy of psoriasis: vehicle‐controlled study of safety, efficacy, and duration of therapeutic effect. Journal of the American Academy of Dermatology 1997;37(1):85‐92. [PUBMED: 9216528]

Weinstein 2003 {published data only}

Weinstein GD. Tazarotene cream in the treatment of plaque psoriasis [Abstract]. 20th World Congress of Dermatology, 1‐5 July 2002, Paris. 2002:P2043.
Weinstein GD, Koo JY, Krueger GG, Lebwohl MG, Lowe NJ, Menter MA, et al. Tazarotene cream in the treatment of psoriasis: Two multicenter, double‐blind, randomized, vehicle‐controlled studies of the safety and efficacy of tazarotene creams 0.05% and 0.1% applied once daily for 12 weeks. Journal of the American Academy of Dermatology 2003;48(5):760‐7. [PUBMED: 12734506]

White 2006 (H) {published data only}

White S, Vender R, Thaci D, Haverkamp C, Naeyaert J‐M, Foster R, et al. Use of calcipotriene cream (Dovonex cream) following acute treatment of psoriasis vulgaris with the calcipotriene/betamethasone dipropionate two‐compound product (Taclonex): a randomized, parallel‐group clinical trial. American Journal of Clinical Dermatology2006; Vol. 7, issue 3:177‐84. [PUBMED: 16734505]

White 2006 (P) {published data only}

White S, Vender R, Thaci D, Haverkamp C, Naeyaert J‐M, Foster R, et al. Use of calcipotriene cream (Dovonex cream) following acute treatment of psoriasis vulgaris with the calcipotriene/betamethasone dipropionate two‐compound product (Taclonex): a randomized, parallel‐group clinical trial. American Journal of Clinical Dermatology2006; Vol. 7, issue 3:177‐84. [PUBMED: 16734505]

Wolska 1995 {published data only}

Wolska H, Laws S, Schulz‐Kiesow M, Grossman R, Jablonska S, Stadlers R, et al. Clinical evaluation of a PAF‐antagonist in psoriasis vulgaris. Journal Of Dermatological Treatment 1995;6(1):43‐5. [EMBASE: 1995125049]

Wortzel 1975 (1) {published data only}

Wortzel MH. A new corticosteroid for moderate/severe dermatoses. Clinical Medicine 1975;82(3):23‐6.

Wortzel 1975 (2) {published data only}

Wortzel WH. A new corticosteroid for moderate/severe dermatoses. Clinical Medicine 1975;82(3):23‐6.

Wozel 2001 {published and unpublished data}

Wozel G. Treatment of chronic‐stationary psoriasis with fluocinolone acetonide and calcipotriol. Zeitschrift Fur Hautkrankheiten 2001;76(7‐8):482.

Yang 2009 {published data only}

Yang DQ, Zhang LX, Bai YP. Clinical observation of sequential therapy of calcipotriol cream with halometasone cream in plaque type psoriasis. Journal of Clinical Dermatology 2009;38(6):401‐3. [EMBASE: 2010312999]

Zonneveld 1998 (H) {published data only}

Zonneveld IM, Rubins A, Jablonska S, Dobozy A, Ruzicka T, Kind P, et al. Topical tacrolimus is not effective in chronic plaque psoriasis. A pilot study. Archives of Dermatology 1998;134(9):1101‐2. [PUBMED: 9762021]

Zonneveld 1998 (P) {published data only}

Zonneveld IM, Rubins A, Jablonska S, Dobozy A, Ruzicka T, Kind P, et al. Topical tacrolimus is not effective in chronic plaque psoriasis. A pilot study. Archives of Dermatology 1998;134(9):1101‐2. [PUBMED: 9762021]

Agrawal 2010 {published data only}

Agrawal Y, Petkar KC, Sawant KK. Development, evaluation and clinical studies of Acitretin loaded nanostructured lipid carriers for topical treatment of psoriasis. International Journal of Pharmaceutics2010; Vol. 401, issue 1‐2:93‐102. [0378‐5173]

Akerman 2009 {published data only (unpublished sought but not used)}

Akerman L, Sredni B, Albeck M, David M. Topical Ammonium‐trichlorotellurate (AS101) in the treatment of mild plaque‐type psoriasis; double‐blind placebo controlled study. Journal of Investigative Dermatology 2009;129(Suppl. 1):S50.

Ambroziak 2002 {published data only}

Ambroziak M, Stapor W, Langner A, Kwiek B. Clinical evaluation of the scalp psoriasis treatment with clobetasol propionate 0.05% lotion [Ocena skutecznosci I bezpieczenstwa stosowania plynu zawierajacego 0,05% propionianu klobetazolu w leczeniu przewleklej luszczycy plackowatej skory owlosionej glowy]. Przeglad Dermatologiczny 2002;89(3):237‐40.

Baadsgaard 1995 {published data only}

Baadsgaard O, Traulsen J, Roed Petersen J, Jakobsen HB. Optimal concentration of tacalcitol in once‐daily treatment of psoriasis. Journal Of Dermatological Treatment 1995;6(3):145‐50.

Baran 1999 {published data only}

Baran R, Tosti A. Topical treatment of nail psoriasis with a new corticoid‐containing nail lacquer formulation. Journal Of Dermatological Treatment 1999;10:201‐4.

Bianchi 2003 {published data only}

Bianchi L, Soda R, Diluvio L, Chimenti S. Tazarotene 0.1% gel for psoriasis of the fingernails and toenails: an open, prospective study. British Journal of Dermatology 2003;149(1):207‐9.

Brodell 2011a {published data only (unpublished sought but not used)}

Brodell R, Goffe BS, Weiss JS, Bruce S. Safety and efficacy of two regimens involving clobetasol spray, 0.05% and calcitriol ointment, 3 mug/g for moderate plaque psoriasis. Journal of the American Academy of Dermatology2011; Vol. 64, issue 2 Suppl 1:AB149.

Buder 2010 {published data only}

Buder K, Knuschke P, Wozel G. Evaluation of methylprednisolone aceponate, tacrolimus and combination thereof in the psoriasis plaque test using sum score, 20‐MHz‐ultrasonography and optical coherence tomography. International Journal of Clinical Pharmacology & Therapeutics 2010;48(12):814‐20.

Callen 1996 {published data only}

Callen J. Comparison of Safety and Efficacy of Fluticasone Propionate Cream, 0.05%, and Betamethasone Valerate Cream, 0.1%, in the Treatment of Moderate‐to‐Severe Psoriasis. Cutis 1996;57(2 Suppl):45‐50.

Cannavo 2003 {published and unpublished data}

Cannavo SP, Guarneri F, Vaccaro M, Borgia F, Guarneri B. Treatment of psoriatic nails with topical cyclosporin: a prospective, randomized placebo‐controlled study. Dermatology2003; Vol. 206, issue 2:153‐6. [MEDLINE: 12592084]
Cannavo SP, Guarneri F, Vaccaro M, Borgia FAD, Institute of Dermatology University of Messina Italy. Treatment of psoriatic nails with topical cyclosporin. 11th Congress of the European Academy of Dermatology and Venereology. 2002:P27‐89.

Carroll 2005 {published data only}

Carroll CL, Clarke J, Camacho F, Balkrishnan R, Feldman SR. Topical tacrolimus ointment combined with 6% salicylic acid gel for plaque psoriasis treatment. Archives of Dermatology 2005;141(1):43‐6.

De Jong 1999 {published and unpublished data}

De Jong EM, Menke HE, Van Praag MC, Van De Kerkhof PC. Dystrophic psoriatic fingernails treated with 1% 5‐fluorouracil in a nail penetration‐enhancing vehicle: a double‐blind study. Dermatology 1999;199(4):313‐8.

Elias 1994 {published data only}

Elias AN, Dangaran K, Barr RJ, Rohan MK, Goodman MM. A controlled trial of topical propylthiouracil in the treatment of patients with psoriasis. Journal of the American Academy of Dermatology 1994;31(3 Pt 1):455‐8.

Esposito 2009 {published data only}

Esposito M. The therapeutic advantages on BMV plaster in chronic plaque psoriasis. Results from a new European multicentric study [Les avantages therapeutiques d'un topique bio‐adhesif a base de VBM dans le traitement du psoriasis en plaques. Presentation des resultats d'une nouvelle etude europeenne, multicentrique]. Annales de Dermatologie et de Venereologie2009; Vol. 136, issue Suppl 8:S476‐80. [0151‐9638]

Friedrich 2004 {published data only}

Friedrich M, Vollhardt K, Zahlten R, Sterry W, Wolff G. Demonstration of antipsoriatic efficacy of a new topical formulation of the small molecule selectin antagonist bimosiamose [Abstract P016]. European Congress on Psoriasis 2004. Journal of the European Academy of Dermatology & Venereology2004; Vol. 18, issue 6:779.

Hsia 2010 {published data only}

Hsia E, Hofland H, Therrien J‐P, Chern W. In vitro activity and safety assessment of a novel calcipotriene foam formulation. 68th Annual Meeting of the American Academy of Dermatology, Miami, FL United States. Journal of the American Academy of Dermatology 2010;62(3 Suppl 1):AB138.

Insa 2009 {published data only}

Insa R, de la Cruz G, Gassmueller J, Leon M. Topical cyclosporin proves efficacy in psoriatic patients in a phase I/II clinical trial. 67th Annual Meeting of the American Academy of Dermatology, San Francisco, CA United States. Journal of the American Academy of Dermatology2009; Vol. 60, issue 3 Suppl 1:AB180. [0190‐9622]

Iraji 2010 {published data only}

Iraji F, Faghihi G, Siadat AH, Enshaieh S, Shahmoradi Z, Joia A, et al. Efficacy of 15% azelaic acid in psoriasis vulgaris: a randomized, controlled clinical trial. Journal of Drugs in Dermatology 2010;9(8):964‐8.

Ito 2005 {published data only}

Ito Y, Nakagawa H. A comparative study of maxacalcitol monotherapy, clobetasol propionate monotherapy and the combination of each agent as a premixed ointment for the treatment of psoriasis. [Japanese]. Nishinihon Journal of Dermatology 2005;67(5):522‐6.

Jansen 1986 {published data only}

Jansen C, Lammintausta K, Bullingham RES, Forsstrom S. A Clinical Trial of Lonapalene Fluocinolone Acetonide and Vehicle in Psoriasis [Abstract]. Journal of Investigative Dermatology 1986;86(4):483.

Kaur 2004 {published data only}

Kaur I, Jain R, Kumar B. Comparative study of calcipotriol (0.005%) vs tazarotene (0.05%, 0.1%) in stable plaque psoriasis [Abstract P015]. European Congress on Psoriasis 2004. Journal of the European Academy of Dermatology & Venereology2004; Vol. 18, issue 6:779.

Kleyn 2005 {published data only}

Kleyn CE, Woodcock D, Sharpe GR. The efficacy of 0.1% tacrolimus ointment compared with clobetasone butyrate 0.05% ointment in patients with facial, flexural or genital psoriasis [Abstract P‐41]. The 85th BAD Annual Meeting 5‐8th July 2005, Glasgow, UK. British Journal of Dermatology 2005;153(Suppl 1):33.

Kragballe 1989 {published data only}

Kragballe K. Treatment of psoriasis by the topical application of the novel cholecalciferol analogue calcipotriol (MC 903). Archives of Dermatology 1989;125(12):1647‐52.

Kragballe 1994 {published data only}

Kragballe K, Dam TN, Hansen ER, Baadsgaard O, Gronhoj Larsen F, Sondergaard J, et al. Efficacy and Safety of the 20‐Epi‐Vitamin D3 Analogue Kh 1060 in the Topical Therapy of Psoriasis: Results of a Dose‐Ranging Study. Acta Dermato‐Venereologica 1994;74(5):398‐402.

Lebwohl 1998b {published data only}

Lebwohl M, Yoles A, Lombardi K, Lou W. Calcipotriene Ointment and Halobetasol Ointment in the Long‐Term Treatment of Psoriasis: Effects on the Duration of Improvement. Journal of the American Academy of Dermatology 1998;39(3):447‐50.

Lebwohl 2001 {published data only}

Lebwohl M, Lombardi K, Tan MH. Duration of improvement in psoriasis after treatment with tazarotene 0.1% gel plus clobetasol propionate 0.05% ointment: comparison of maintenance treatments. International Journal Of Dermatology 2001;40(1):64‐6. [MEDLINE: 11277960]

Levin 2003 {published data only}

Levin C, Fiorentino DF, Vosganian G, Chon S, Kimball AB. The safety of topical cyclosporin A conjugate (CGC1072) in the treatment of mild to moderate psoriasis [Abstract 1201] International Investigative Dermatology. The 4th Joint Meeting of the ESDR, Japanese SID & SID, 30th April‐4th May 2003, Florida, USA. Journal of Investigative Dermatology 2003;121(1):201.

Meyrat 1996 {published and unpublished data}

Meyrat R, Muller I. Daivonex registered trade mark ointment twice a day versus Daivonex registered trade mark cream in the morning and Daivonex registered trade mark ointment in the evening [Daivonex Salbe zwei mal taglich versus Daivonex Creme morgens und Daivonex Salbe abends]. Ars Medici 1996;86(20):1218‐20.

Palazon 2005 {published data only}

Palazon DAB, Sanchez‐Regana M, Mateos FL, Ezquerra GM, Acosta EH, Vidal I, et al. A double blind aleatory and prospective study of topical vitamin b12 in psoriasis [Abstract P06.21]. The 14th Congress of the European Academy of Dermatology and Venereology, London, UK. 12‐15th October 2005. Journal of the European Academy of Dermatology & Venereology 2005;19(Suppl 2):165.

Reygagne 2002a {published data only}

Reygagne P, Diaconu J, Près H, Ernst TM, Meyer KG, S.A.D.A. Efficacy and safety comparison of clobetasol propionate shampoo, gel and vehicle in scalp psoriasis. 11th Congress of the European Academy of Dermatology and Venereology. 2002:P27‐9.

Rhemus 2006 {published data only}

Rhemus W, Kim J, Kern D, Murase J. A double‐blind, placebo‐controlled study of a natural topical anti‐inflammatory for treatment of atopic dermatitis and psoriasis [Abstract P2849]. American Academy of Dermatology 64th Annual Meeting March 3‐7, 2006. Journal of the American Academy of Dermatology 2006;54(3 Suppl):AB210.

Ruzicka 2004 {published data only}

Ruzicka T, Trompke C. Treatment of scalp psoriasis. An effective and safe tacalcitol emulsion [Behandlung der kopfhaut‐psoriasis. Gute wirksamkeit und sicherheit durch Tacalcitol‐emulsion]. Hautarzt 2004;55(2):165‐70.

Sander 1998 {published data only}

Sander P, Stucker M, Hermes N, Hoffmann K, Altmeyer P. Mometasone and calcipotriol optimise the initial therapeutic effect of dithranol on chronic plaque psoriasis [Mometason Und Calcipotriol Optimieren Den Therapeutischen Initialeffekt Von Dithranol Auf Die Chronisch Stationare Psoriasis (CSP)]. Hautarzt 1998;49(4):291‐4.

Saraswat 2007 {published data only}

Saraswat A, Agarwal R, Katare OP, Kaur I, Kumar B. A randomized, double‐blind, vehicle‐controlled study of a novel liposomal dithranol formulation in psoriasis. Journal of Dermatological Treatment2007; Vol. 18, issue 1:40‐5.

Scher 2001 {published data only}

Scher R. Tazarotene 0.1% gel in the treatment of nail psoriasis [Abstract]. 20th World Congress of Dermatology, 1st to 5th July 2002. 2002:P0791.
Scher RK, Stiller M, Zhu YI. Tazarotene 0.1% gel in the treatment of fingernail psoriasis: a double‐blind, randomized, vehicle‐controlled study. Cutis 2001;68(5):355‐8. [PUBMED: 11766122 ]
Scher RK, Stiller M, Zhu YI. Treating fingernail psoriasis with tazarotene 0.1% gel: A vehicle‐controlled study [Abstract]. 2nd Joint Meeting International Psoriasis Symposium and European Congress on Psoriasis. Skin Pharmacology & Applied Skin Physiology 2001;14(3):170.

Sefton 1984 {published data only}

Sefton J, Loder JS, Kyriakopoulos AA. Clinical Evaluation of Hydrocortisone Valerate 0.2% Ointment. Clinical Therapeutics 1984;6(3):282‐93.

Sharma 2003 {published data only}

Sharma V, Kaur I, Kumar B. Calcipotriol versus coal tar: a prospective randomized study in stable plaque psoriasis. International Journal of Dermatology 2003;42(10):834‐8.

Syed 2001a {published data only}

Syed TA, Qureshi ZA. Management of psoriasis of the scalp with methotrexate (0.25%) in an aerosolized spray gel. A placebo‐controlled, double‐blind study [Abstract]. 2nd Joint Meeting International Psoriasis Symposium and European Congress on Psoriasis. Skin Pharmacology & Applied Skin Physiology 2001;14(3):167.

Tokura 2004 {published data only}

Tokura Y. Effectiveness of Combination between Diflucortolone Valerate and Vitamin D3 Analogue in the Treatment of Psoriasis Vulgaris. [Japanese]. Nishinihon Journal of Dermatology 2004;66(2):188‐191.

Tosti 1998 {published data only}

Tosti A, Piraccini BM, Cameli N, Kokely F, Plozzer C, Cannata GE, et al. Calcipotriol Ointment in Nail Psoriasis: A Controlled Double‐Blind Comparison with Betamethasone Dipropionate and Salicylic Acid. British Journal Of Dermatology 1998;139(4):655‐9. [MEDLINE: 9892909]

Tzaneva 2003 {published data only}

Tzaneva S, Honigsmann H, Tanew A. Observer‐blind, randomized, intrapatient comparison of a novel 1% coal tar preparation (Exorex) and calcipotriol cream in the treatment of plaque type psoriasis. British Journal of Dermatology 2003;149(2):350‐3. [EMBASE: 2003371589]

van de Kerkhof 1996b {published data only}

van de Kerkhof PCM, Kuypers A. A randomised, double blind, left right study to compare hydrocortisone 17‐butyrate 0.1% emulsion with vehicle in the treatment of patients suffering from psoriasis vulgaris [Poster P16]. 6th International Skin Symposium. Brussels, 1996.

Vena 2005 {published data only}

Vena GA, Cassano N, Agnusdei CP, Bellini M, Calabretta S, Centofanti S, et al. Treatment of psoriasis vulgaris with calcipotriol betamethasone dipropionate combination followed by calcipotriol and assessment of the adjuvant basic use of urea‐based emollients. European Journal of Inflammation2005; Vol. 3, issue 1:37‐41.

Referencias de los estudios en espera de evaluación

Bissonnette 2011 {published data only}

Bissonnette R, Bolduc C, Maari C, Nigen S, Webster JM, Tang L, et al. Efficacy and safety of topical WBI‐1001 in patients with mild to moderate psoriasis: results from a randomized double‐blind placebo‐controlled, phase II trial. Journal of the European Academy of Dermatology & Venereology 2012;26(12):1516‐21. [DOI: 10.1111/j.1468‐3083.2011.04332.x; NCT01098721; PUBMED: 22077962]
NCT01098721. A Safety/Efficacy Study of a Non‐steroid, Topical Cream Treatment of Psoriasis Over 12‐weeks (134993). clinicaltrials.gov/ct2/show/NCT01098721(accessed January 2013).

Callis Duffin 2010 {published data only}

Callis Duffin K, Luchi M, Fidelus‐Gort R, Newton R, Fridman J, Burn T, et al. Novel mechanism for topical treatment of plaque psoriasis – results of a randomized, double blind, concentration ranging, vehicle controlled 12 week study with JAK 1/2 inhibitor INCB018424 cream (Abstract 261). 2010 Annual Meeting of the Society for Investigative Dermatology, Hilton Atlanta, Atlanta, Georgia, May 5‐8. Journal of Investigative Dermatology 2010;130(Suppl 1):S44.
NCT00778700. A Dose Ranging Study of the Effect of INCB018424 Phosphate Cream When Applied to Patients With Plaque Psoriasis. clinicaltrials.gov/show/NCT00778700(accessed January 2013).

Calzavara‐Pinton 2011 {published data only}

Calzavara‐Pinton P, Rossi M T, Sala R, Venturini M. The separate daily application of tacalcitol 4 microg/g ointment and budesonide 0.25 mg/g cream is more effective than the single daily application of a two compound ointment containing calcipotriol 50 microg/g and betamethasone dipropionate 0.5 mg/g. Giornale Italiano di Dermatologia e Venereologia 2011;146(4):295‐9.

Henry 2011 {published data only}

Henry M, Frankel A, Emer J, Lebwohl M. Bilateral comparison study on the order of application of combination clobetasol proprionate spray and calcitriol ointment in the treatment of plaque psoriasis. (Abstract P3343). Conference: 69th Annual Meeting of the American Academy of Dermatology New Orleans, LA United States. Conference Start: 20110204 Conference End: 20110208. Conference Publication. Journal of the American Academy of Dermatology 2011;64(2 Suppl 1):AB156.

Katoh 2003 {published data only}

Katoh N, Kishimoto S. Combination of calcipotriol and clobetasol propionate as a premixed ointment for the treatment of psoriasis. European Journal of Dermatology 2003;13(4):382‐4. [MEDLINE: 12948920]

Matheson 2011 {published data only}

Matheson R, Hsia E, Ge X. Safety and bioavailability of two calcipotriene formulations in subjects with mild to moderate plaque‐type psoriasis. (Abstract P3348). Conference: 69th Annual Meeting of the American Academy of Dermatology New Orleans, LA United States. Conference Start: 20110204 Conference End: 20110208. Journal of the American Academy of Dermatology 2011;64(2 Suppl 1):AB157.

Paulsen 2005 {published data only}

Paulsen E, Korsholm L, Brandrup F. A double‐blind, placebo‐controlled study of a commercial Aloe vera gel in the treatment of slight to moderate psoriasis vulgaris. Journal Of The European Academy Of Dermatology & Venereology 2005;19(3):326‐31. [MEDLINE: 15857459]

Sadeghian 2011 {published data only}

Sadeghian G, Ziaei H, Nilforoushzadeh M A. Treatment of localized psoriasis with a topical formulation of zinc pyrithione. Acta Dermatovenerologica Alpina, Panonica et Adriatica 2011;20(4):187‐90.

Vahlquist 2004 {published data only}

Vahlquist A, Torma H, Carlsson B. Inefficacy of topical thyroid hormone analogue TriAc in plaque psoriasis: results of a double‐blind placebo‐controlled trial. British Journal of Dermatology 2004;151(2):489‐91. [MEDLINE: 15327560]

Yang 1999 {published data only}

Yang XY, Lin L, Cui PG, Jia H, Jin PY, Liu XQ. Comparison of the efficacy of tacalcitol ointment and 17 a hydrocortisone cream in the treatment of psoriasis (Chinese). Chinese Journal of Dermatology 1999;32(6):425.

NCT00824980 {unpublished data only}

NCT00824980. Combined Inhibition of Dipeptidyl Peptidase IV (DPIV/CD26) and Aminopeptidase N (APN/CD13) in the Treatment of Psoriasis. clinicaltrials.gov/ct2/show/NCT00824980(accessed December 2011).

NCT01018134 {unpublished data only}

NCT01018134. Desoximetasone Spray 0.05%, 0.25%; Dose Ranging Study. clinicaltrials.gov/ct2/show/NCT01018134(accessed December 2011).

NCT01206387 {unpublished data only}

NCT01206387  . Effects of Desoximetasone Spray 0.25% on Moderate to Severe Plaque Psoriasis. clinicaltrials.gov/ct2/show/NCT01206387(accessed December 2011).

NCT01206660 {unpublished data only}

NCT01206660. Effects of Desoximetasone Spray 0.25% in Patients With Moderate to Severe Plaque Psoriasis. clinicaltrials.gov/ct2/show/NCT01206660(accessed December 2011).

NCT01246583 {unpublished data only}

NCT01246583. CP‐690‐550 Ointment For Chronic Plaque Psoriasis. clinicaltrials.gov/ct2/show/NCT01246583(accessed December 2011).

NCT01247818 {unpublished data only}

NCT01247818  . Randomized Study of PH‐10 for Psoriasis. clinicaltrials.gov/ct2/show/NCT01247818(accessed December 2011).

NCT01422434 {unpublished data only}

NCT01422434. LEO 90105 Ointment in Japanese Subjects With Psoriasis. clinicaltrials.gov/ct2/show/results/NCT01422434(accessed December 2011).

NCT01465282 {unpublished data only}

NCT01465282. Evaluation of the Efficacy, Safety and Toleration of CT327 Ointment in Patients With Psoriasis Vulgaris. clinicaltrials.gov/ct2/show/NCT01465282(accessed December 2011).

NCT01536886 {unpublished data only}

NCT01536886. LEO 90100 Compared With Calcipotriol Plus Betamethasone Dipropionate Ointment, LEO 90100 Vehicle and Ointment Vehicle in Subjects With Psoriasis Vulgaris. clinicaltrials.gov/show/NCT01536886(accessed August 2012).

NCT01536938 {unpublished data only}

NCT01536938. LEO 90100 in the Treatment of Psoriasis Vulgaris. clinicaltrials.gov/show/NCT01536938(accessed August 2012).

Afifi 2005

Afifi T, de Gannes G, Huang C, Zhou Y. Topical therapies for psoriasis: evidence‐based review. Canadian Family Physician2005; Vol. 51:519‐25. [MEDLINE: 15856971]

Andres 2006

Andres P, Poncet M, Farzaneh S, Soto P. Short‐term safety assessment of clobetasol propionate 0.05% shampoo: hypothalamic‐pituitary‐adrenal axis suppression, atrophogenicity, and ocular safety in subjects with scalp psoriasis. Journal of Drugs in Dermatology2006; Vol. 5, issue 4:328‐32. [MEDLINE: 16673799]

Ashcroft 2000

Ashcroft DM, Li Wan Po A, Williams HC, Griffiths CE. Cost‐effectiveness analysis of topical calcipotriol versus short‐contact dithranol in the treatment of mild to moderate plaque psoriasis. Pharmacoeconomics 2000;18(5):469‐76. [MEDLINE: 11151400]

Ashcroft 2000a

Ashcroft DM, Po AL, Williams HC, Griffiths CE. Systematic review of comparative efficacy and tolerability of calcipotriol in treating chronic plaque psoriasis. BMJ2000; Vol. 320, issue 7240:963‐7. [MEDLINE: 10753146]

Aste 2004

Aste N. Tacalcitol ointment in the treatment of psoriasis [Tacalcitolo unguento nel trattamento della psoriasi]. Giornale Italiano di Dermatologia e Venereologia 2004;139(1):81‐4. [EMBASE: 2004234976]

Atkinson 2004

Atkinson MJ, Sinha A, Hass SL, Colman SS, Kumar RN, Brod M, et al. Validation of a general measure of treatment satisfaction, the Treatment Satisfaction Questionnaire for Medication (TSQM), using a national panel study of chronic disease. Health & Quality of Life Outcomes 2004;2(1):12. [MEDLINE: 14987333]

Balkrishnan 2003

Balkrishnan R, Carroll CL, Camacho FT, Feldman SR. Electronic monitoring of medication adherence in skin disease: Results of a pilot study. Journal of the American Academy of Dermatology 2003;49(4):651‐4. [MEDLINE: 14512911]

Barisic‐Drusko 1994

Barisic‐Drusko V, Dobric I, Pasic A, Paljan D, Jukic Z, Basta‐Juzbasic A, et al. Frequency of psoriatic arthritis in general population and among the psoriatics in department of dermatology. Acta Dermato‐Venereologica. Supplementum. 1994;186:107‐8. [MEDLINE: 8073803]

Barker 1991

Barker JN. The pathophysiology of psoriasis. Lancet 1991;338(8761):227‐30. [MEDLINE: 1676787]

Barnes 2000

Barnes L, Altmeyer P, Forstrom L, Stenstrom MH. Long‐term treatment of psoriasis with calcipotriol scalp solution and cream. European Journal of Dermatology 2000;10(3):199‐204. [MEDLINE: 10725818]

Berth‐Jones 1992c

Berth‐Jones J. Immediate and long term effects of topical calcipotriol on calcium homeostasis during treatment of psoriasis [Abstract]. British Journal of Dermatology 1992;127(Suppl 40):17.

Berth‐Jones 1993

Berth‐Jones J, Bourke JF, Iqbal SJ, Hutchinson PE. Urine Calcium Excretion During Treatment of Psoriasis with Topical Calcipotriol. British Journal Of Dermatology 1993;129(4):411‐4. [MEDLINE: 8217755]

Bhalerao 1998

Bhalerao J, Bowcock AM. The genetics of psoriasis: a complex disorder of the skin and immune system. Human Molecular Genetics 1998;7(10):1537‐45. [MEDLINE: 9735374]

Bleiker 1998

Bleiker TO, Bourke JF, Mumford R, Hutchinson PE. Long‐Term Outcome of Severe Chronic Plaque Psoriasis Following Treatment with High‐Dose Topical Calcipotriol. British Journal Of Dermatology 1998;139(2):285‐6. [MEDLINE: 9767244]

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Joint Formulary Committee. British National Formulary (BNF) 63. London: Pharmaceutical Press, 2012.

Bonifati 1998

Bonifati C, Carducci M, Mussi A, D'Auria L, Ameglio F. Recognition and treatment of psoriasis: special considerations in elderly patients. Drugs & Aging 1998;12(3):177‐90. [MEDLINE: 9534019]

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Bos JD. Topical tacrolimus and pimecrolimus are not associated with skin atrophy. British Journal of Dermatology 2002;146(2):342. [MEDLINE: 11903264]

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Bos JD, Spuls PI. Topical treatments in psoriasis: today and tomorrow. Clinics in Dermatology2008; Vol. 26, issue 5:432‐7. [MEDLINE: 18755361]

Bourke 1993a

Bourke JF, Berth‐Jones J, Iqbal SJ, Hutchinson PE. High‐dose topical calcipotriol in the treatment of extensive psoriasis vulgaris. British Journal of Dermatology 1993;129(1):74‐6. [MEDLINE: 8369213]

Bourke 1994

Bourke JF, Berth‐Jones J, Mumford R, Iqbal SJ, Hutchinson PE. High dose topical calcipotriol consistently reduces serum parathyroid hormone levels. Clinical Endocrinology 1994;41(3):295‐7. [MEDLINE: 7955435]

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Brandrup F, Hauge M, Henningsen K, Eriksen B. Psoriasis in an unselected series of twins. Archives of Dermatology 1978;114(6):874‐8. [MEDLINE: 566529]

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Breneman D, Sheth P, Berger V, Naini V, Stevens V. Phase II clinical trial of bexarotene gel 1% in psoriasis. Journal of Drugs in Dermatology2007; Vol. 6, issue 5:501‐6. [MEDLINE: 17679184; 1545‐9616]

Brodell 2011b

Brodell RT, Bruce S, Hudson CP, Weiss JS, Colon LE, Johnson LA, et al. A multi‐center, open‐label study to evaluate the safety and efficacy of a sequential treatment regimen of clobetasol propionate 0.05% spray followed by Calcitriol 3 mg/g ointment in the management of plaque psoriasis. Journal of Drugs in Dermatology2011; Vol. 10, issue 2:158‐64. [MEDLINE: 21283920; 1545‐9616]

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Brownell I, Strober BE. Folate with methotrexate: big benefit, questionable cost. British Journal of Dermatology2007; Vol. 157, issue 1:213. [MEDLINE: 17578449]

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Bruner CR, Feldman SR, Ventrapragada M, Fleischer AB. A systematic review of adverse effects associated with topical treatments for psoriasis. Dermatology Online Journal2003; Vol. 9, issue 1:2. [MEDLINE: 12639460]

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Camp RDR. Psoriasis. In: Champion RH, Burton JL, Ebling FJG editor(s). Textbook of Dermatology. Oxford: Blackwell Science, 1992:1391‐458.

Carboni 2005

Carboni I, de Felice C, Bergamin A, Chimenti S. Topical use of calcitriol 3 microg/g ointment in the treatment of mild‐to‐moderate psoriasis: results from an open‐label study. Journal of the European Academy of Dermatology & Venereology2005; Vol. 19, issue Suppl 3:11‐3. [MEDLINE: 16274406; 0926‐9959]

Carey 2006

Carey W, Glazer S, Gottlieb AB, Lebwohl M, Leonardi C, Menter A, et al. Relapse, rebound, and psoriasis adverse events: an advisory group report. Journal of the American Academy of Dermatology2006; Vol. 54, issue 4 Suppl 1:S171‐81. [MEDLINE: 16488339]

Carroll 2004a

Carroll CL, Feldman SR, Camacho FT, Balkrishnan R. Better medication adherence results in greater improvement in severity of psoriasis. British Journal of Dermatology 2004;151(4):895‐7. [MEDLINE: 15491434]

Carroll 2004b

Carroll CL, Feldman SR, Camacho FT, Manuel JC, Balkrishnan R. Adherence to topical therapy decreases during the course of an 8‐week psoriasis clinical trial: commonly used methods of measuring adherence to topical therapy overestimate actual use. Journal of the American Academy of Dermatology 2004;51(2):212‐6. [MEDLINE: 15280839]

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Chalmers RJ, O'Sullivan T, Owen CM, Griffiths CE. Interventions for guttate psoriasis. Cochrane Database of Systematic Reviews 2000, Issue 2. [DOI: 10.1002/14651858.CD001213]

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Chalmers R, Hollis S, Leonardi‐Bee J, Griffiths CEM, Marsland A. Interventions for chronic palmoplantar pustulosis. Cochrane Database of Systematic Reviews 2006, Issue 1.

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Chen X, Cheng Y, Yang M, Liu GJ, Zhang M. Narrow‐band ultraviolet B phototherapy versus broad‐band ultraviolet B or psoralen‐ultraviolet A photochemotherapy for psoriasis. Cochrane Database of Systematic Reviews 2011, Issue 12. [DOI: 10.1002/14651858.CD009481]

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Uhoda I, Quatresooz P, Hermanns‐Le T, Pierard‐Franchimont C, Arrese JE, Pierard GE. Histometric assessment of psoriatic plaques treated by vitamin D3 derivatives. Dermatology 2003;206(4):366‐9. [MEDLINE: 12771488]

Unna 1916

Unna PG. Cignolin als Heilmittel der Psoriasis. Dermatologische Wochenschrift 1916;62:116‐37.

van de Kerkhof 1996c

van de Kerkhof PCM, van Harten J, Verjans H. A Long‐Term Assessment of the Safety and Tolerability of Calcitriol Ointment in the Treatment of Chronic Plaque Psoriasis. Journal Of Dermatological Treatment 1996;7(Suppl 1):S11‐14. [EMBASE: 1996266413]

van de Kerkhof 1997a

van de Kerkhof PC. Combinations and comparisons. Clinics in Dermatology 1997;15(5):831‐4. [MEDLINE: 9313980]

van de Kerkhof 1997b

van de Kerkhof P, van der Vleuten C, Gerritsen M, Glade C, Luger T, Werfel T, et al. Long‐Term Efficacy and Safety of Once Daily Treatment of Chronic Plaque Psoriasis with Tacalcitol Ointment. European Journal of Dermatology 1997;7(6):421‐5. [EMBASE: 1997293421]

van de Kerkhof 1998

van de Kerkhof PC. An update on vitamin D3 analogues in the treatment of psoriasis. Skin Pharmacology & Applied Skin Physiology 1998;11(1):2‐10. [MEDLINE: 9603664]

van de Kerkhof 1998c

van de Kerkhof PCM, Steegers Theunissen RP, Kuipers MV. Evaluation of topical drug treatment in psoriasis. Dermatology 1998;197(1):31‐6. [MEDLINE: 9693182]

van de Kerkhof 2000

van de Kerkhof PC, de Hoop D, de Korte J, Cobelens SA, Kuipers MV. Patient compliance and disease management in the treatment of psoriasis in the Netherlands. Dermatology 2000;200(4):292‐8. [MEDLINE: 10894958]

van de Kerkhof 2001

van de Kerkhof PC, Franssen M, de La Brassine M, Kuipers M. Calcipotriol cream in the morning and ointment in the evening: a novel regimen to improve compliance. Journal of Dermatological Treatment 2001;12(2):75‐9. [MEDLINE: 12243662]

van de Kerkhof 2002c

van de Kerkhof PC, Berth‐Jones J, Griffiths CE, Harrison PV, Honigsmann H, Marks R, et al. Long‐term efficacy and safety of tacalcitol ointment in patients with chronic plaque psoriasis. British Journal of Dermatology 2002;146(3):414‐22. [MEDLINE: 11952541]

van de Kerkhof 2004

van de Kerkhof PC. The impact of a two‐compound product containing calcipotriol and betamethasone dipropionate (Daivobet/ Dovobet) on the quality of life in patients with psoriasis vulgaris: a randomized controlled trial. British Journal of Dermatology 2004;151(3):663‐8. [MEDLINE: 15377355]

Van de Kerkhof 2008

Van de Kerkhof PC, Barker J, Griffiths CE, Kragballe K, Mason J, Menter A, et al. Psoriasis: Consensus on topical therapies. Journal of the European Academy of Dermatology & Venereology2008; Vol. 22, issue 7:859‐70. [MEDLINE: 18081748]

Vazquez‐Lopez 2004

Vazquez‐Lopez F, Marghoob AA. Dermoscopic assessment of long‐term topical therapies with potent steroids in chronic psoriasis. Journal of the American Academy of Dermatology 2004;51(5):811‐3. [MEDLINE: 15523365]

Velema 2009

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Veraldi 2006

Veraldi S, Caputo R, Pacifico A, Peris K, Soda R, Chimenti S. Short contact therapy with tazarotene in psoriasis vulgaris. Dermatology2006; Vol. 212, issue 3:235‐7. [MEDLINE: 16549919; 1018‐8665]

Vissers 2004

Vissers WH, Berends M, Muys L, van Erp PE, de Jong EM, van de Kerkhof PC. The effect of the combination of calcipotriol and betamethasone dipropionate versus both monotherapies on epidermal proliferation, keratinization and T‐cell subsets in chronic plaque psoriasis. Experimental Dermatology 2004;13(2):106‐12. [MEDLINE: 15009104]

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Watts J. Helping people to remain in control of their psoriasis. Community Nurse 1998;4(7):19‐21. [MEDLINE: 9763988]

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Wishart JM. Calcitriol (1 alpha,25‐dihydroxyvitamin D3) ointment in psoriasis, a safety tolerance and efficacy multicentre study. Dermatology1994; Vol. 188, issue 2:135‐9. [MEDLINE: 8136540; 1018‐8665]

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Zaghloul 2004

Zaghloul SS, Goodfield MJ. Objective assessment of compliance with psoriasis treatment. Archives of Dermatology 2004;140(4):408‐14. [MEDLINE: 15096368]

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Referencias de otras versiones publicadas de esta revisión

Mason 2002a

Mason J, Mason AR, Cork MJ. Topical preparations for the treatment of psoriasis: a systematic review. British Journal Of Dermatology 2002;146(3):351‐64. [MEDLINE: 11952534]

Mason 2002b

Mason J, Mason A, Cork M. Topical preparations for the treatment of psoriasis in primary care: a systematic review. University of York (OP41). York: University of York, 2002.

Mason 2009

Mason AR, Mason J, Cork M, Dooley G, Edwards G. Topical treatments for chronic plaque psoriasis. Cochrane Database of Systematic Reviews 2009, Issue 2. [DOI: 10.1002/14651858.CD005028.pub2]

Characteristics of studies

Characteristics of included studies [ordered by study ID]

Agrup 1981

Methods

DESIGN

Within‐patient
Participant delivery
ALLOCATION
Random
Method of randomisation: unclear
Concealment: unclear
BLINDING
Double‐blind (participant/investigator)
WITHDRAWAL/DROPOUT
Described

Participants

N: 11

Treatment duration: 3 wks; FU: 3 wks

LF: 0 (0%)

BC: not reported

Age: not reported

Gender (per cent men): not reported

Severity: not reported

INCLUSION CRITERIA

  • Chronic plaque psoriasis

  • Stable symmetrical lesions of the same morphology

  • Adult

EXCLUSION CRITERIA

  • Pregnancy

  • Receiving steroid preparations

Interventions

  • Budesonide ointment 0.025% BD (B)

  • Placebo (vehicle) BD (P)

Outcomes

  1. Investigator's preference

  2. Patient's preference

Notes

The trial did not report sponsorship.

Risk of bias

Bias

Authors' judgement

Support for judgement

Allocation concealment (selection bias)

Unclear risk

The trial reported insufficient details.

Blinding (performance bias and detection bias)
All outcomes

Low risk

The trial was double‐blind (participant/investigator).

Randomisation method reported

Unclear risk

The trial did not report this.

Loss to follow up

Low risk

0.0%

Baseline assessments

Low risk

These were partially done.

Baseline comparability demonstrated

Unclear risk

The trial did not report this.

Alora‐Palli 2010

Methods

DESIGN
Between‐patient
Participant delivery
ALLOCATION
Random
Method of randomisation: computer‐generated list
Concealment: unclear
BLINDING
Single‐blind (investigator)
WITHDRAWAL/DROPOUT
Described

Participants

N: 60

Treatment duration: 12 wks; FU: 18 wks

LF: 5 (8.3%)

BC: Yes

Age: 48.5 (15.4SD); range = 19 to 77

Gender (per cent men): 56.7%

Severity: mPASI = 7.09 (3.14SD); PGA = 3.05

Duration (yrs): 16.5 (13.0SD); range = 1 to 62

INCLUSION CRITERIA

  • People aged > = 18 with moderate plaque psoriasis

  • BSA: 3% to 15% (excluding head, groin, palms, and soles)

EXCLUSION CRITERIA

  • Pregnancy or lactation

  • Topical or UVB therapy within previous 2 wks

  • Systemic corticosteroids, PUVA, or laser phototherapy within previous 4 wks

  • Other systemic therapies or biologicals within previous 12 wks

Interventions

  • Calcipotriol cream 0.005% BD (C)

  • Liquid carbonis distillate (LCD) 15% solution BD (T)

Outcomes

  1. Per cent change modified PASI (0 to 64.8)

  2. Physician's Global Assessment (PGA): 6‐pt (0 = no disease to 5 = very severe).

  3. Overall Patient Symptom Score (erythema, thickness, burning, flaking, etc): 7‐pt continuous scale (0 = none to 6 = severe)

  4. Success rates

  5. Participant satisfaction (cosmetic acceptability)

  6. Dermatology Quality of Life Index (DLQI) (0 to 30, where higher scores indicate poorer QoL)

  7. Recurrence rates

    • loss of PASI 50 response achieved at wk 12

    • PGA score at wk18 = score at wk 0

Notes

NeoStrata company, Inc. sponsored the trial.

There was significant improvement in DLQI scores relative to baseline in both groups.

Compliance: 96% of participants in both groups reported they applied the study medication twice daily on most days.

Recurrence rates (loss of PASI50 response): C: 7/9; T: 4/16

Recurrence rates (PGA): C: 14/20; T: 5/22

The trial author supplied unpublished data.

There was SD imputation (TSS).

Risk of bias

Bias

Authors' judgement

Support for judgement

Allocation concealment (selection bias)

Unclear risk

The trial reported insufficient details.

Blinding (performance bias and detection bias)
All outcomes

High risk

The study was single‐blind (investigator).

Randomisation method reported

Low risk

A computer‐generated list was used for randomisation.

Loss to follow up

Low risk

8.3%

Baseline assessments

Low risk

The trial reported demographic and clinical characteristics.

Baseline comparability demonstrated

Low risk

This was demonstrated.

Austad 1998

Methods

DESIGN
Within‐patient
Participant delivery
ALLOCATION
Random
Method of randomisation: not stated
Concealment: unclear
BLINDING
Double‐blind (participant/investigator)
WITHDRAWAL/DROPOUT
Described

Participants

N: 49

Treatment duration: 6 wks; FU: 10 wks

LF: 3 (6.1%)

BC: yes

Age: 42.4 (13.9SD; range = 18 to 68)

Gender (per cent men): 63%

Severity: TSS (0 to 9) = 6.4 (0.5SD; range = 6.0 to 8.0)

Duration: 15.6 (12.3SD; range = 1 to 57)

INCLUSION CRITERIA

  • Adults

  • Symmetrical plaque psoriasis

  • Total Severity Score ≥ 6/9

EXCLUSION CRITERIA

  • Widespread psoriasis

  • Hypercalcaemia

  • Liver or renal disease

  • Risk of pregnancy

  • Pregnancy

  • Relevant concomitant medication or conditions

  • Previous adverse response

Interventions

  • Clobetasol propionate ointment 0.05% BD (2/52), followed by calcipotriol 50 mcg/g BD (4/52) (CP)

  • Calcipotriol 50 mcg/g BD (6/52) (C)

Outcomes

  1. Overall severity score (0 to 9)

  2. Investigator Global Assessment (6‐pt: worsened to cleared)

  3. Treatment preferences, investigator

  4. Treatment preferences, patients

  5. Compliance

Notes

Glaxo Wellcome Research and Development, Norway, sponsored the trial.

Risk of bias

Bias

Authors' judgement

Support for judgement

Allocation concealment (selection bias)

Unclear risk

The trial reported insufficient details.

Blinding (performance bias and detection bias)
All outcomes

Low risk

The trial was double‐blind (participant/investigator).

Randomisation method reported

High risk

The trial did not report this.

Loss to follow up

Low risk

6.1%

Baseline assessments

Low risk

The trial did not report these.

Baseline comparability demonstrated

Low risk

Baiocchi 1997

Methods

DESIGN
Within‐patient
Participant delivery
ALLOCATION
Random
Method of randomisation: block randomisation (4 participants)
Concealment: unclear
BLINDING
Open
WITHDRAWAL/DROPOUT
Described

Participants

N: 132

Treatment duration: 8 wks; FU: 8 wks

LF: 2 (1.5%)

BC: yes

Age: 46.8 (15.2SD; range = 18 to 89)

Gender (per cent men): 67.4%

Severity: PASI = 4.4 (2.1SD)

INCLUSION CRITERIA

  • Adult

  • Symmetrical mild‐to‐moderate chronic plaque psoriasis

EXCLUSION CRITERIA

  • Recent topical or systemic antipsoriatic therapy

  • Rapidly worsening psoriasis

  • Concurrent vitamin D

  • Renal or hepatic disease

  • Pregnancy

  • Lactation

Interventions

  • Calcipotriol ointment 50 mcg/g OD (C1)

  • Calcipotriol ointment 50 mcg/g BD (C2)

Outcomes

  1. PASI

  2. Severity: erythema, scaling, induration (0 to 4 each)

  3. Global improvement score (7‐pt: 0% to 90 ‐ 100%)

  4. Cosmetic acceptability

Notes

The trial did not report on sponsorship.
All participants had a bath with salicylic acid 3 to 4 days before starting study treatments.

Risk of bias

Bias

Authors' judgement

Support for judgement

Allocation concealment (selection bias)

Unclear risk

The trial reported insufficient details.

Blinding (performance bias and detection bias)
All outcomes

High risk

The trial was open.

Randomisation method reported

Low risk

Block randomisation was used.

Loss to follow up

Low risk

1.5%

Baseline assessments

Low risk

These were reported.

Baseline comparability demonstrated

Low risk

Barker 1999 (H)

Methods

DESIGN
Within‐patient
Participant delivery
Method of randomisation: unclear
Concealment: unclear
BLINDING
Double‐blind (participant/assessor)
WITHDRAWAL/DROPOUT
Described

Participants

N: 30

Treatment duration: 8 wks; FU: 8 wks

LF: 4 (13.3%)

BC: demographics similar; clinical characteristics not reported

Age: 47.2 (14.5SD, N = 144) (range = 20 to 75)

Gender (per cent men): 59.7% (86/144)

Severity: not reported

INCLUSION CRITERIA

  • Chronic plaque psoriasis

  • Stable bilateral lesions affecting < 20% total body surface area

  • Adult (aged 18 to 85)

EXCLUSION CRITERIA

  • Pregnancy

  • Concomitant disease

  • Known hypersensitivity to vitamin D derivatives

  • Systemic treatments within previous 1 mth

  • Systemic retinoids within previous 2 mths

  • Plaques < 10 cm² or > 150 cm²

Interventions

Dose‐ranging study including placebo; calcipotriol 50 mcg/g; maxacalcitol 6, 12.5, 25, and 50 mcg/g OD.

Contrast included the following:

  • maxacalcitol 25 mcg/g OD

  • Calcipotriol 50 mcg/g OD

Outcomes

  1. Psoriasis Severity Index (PSI): sum scores for erythema, induration, and scaling (0 to 24)

  2. IAGI (6‐pt: worse to cleared)

  3. PAGI (6‐pt: worse to cleared)

  4. Investigator side preference

  5. Patient side preference

Notes

Non‐target plaques received emollient or coal tar throughout.
Chugai Pharma Europe sponsored the trial.

Risk of bias

Bias

Authors' judgement

Support for judgement

Allocation concealment (selection bias)

Unclear risk

The trial reported insufficient details.

Blinding (performance bias and detection bias)
All outcomes

Low risk

The trial was double‐blind (participant/assessor).

Randomisation method reported

Unclear risk

The trial did not report this.

Loss to follow up

Low risk

13.3%

Baseline assessments

Low risk

These were partially reported (demographics only).

Baseline comparability demonstrated

Unclear risk

This was partially demonstrated.

Barker 1999 (P)

Methods

DESIGN
Between‐patient
Participant delivery
ALLOCATION
Random
Method of randomisation: unclear
Concealment: unclear
BLINDING
Double‐blind (unclear)
WITHDRAWAL/DROPOUT
Described

Participants

N: 60

Treatment duration: 8 wks; FU: 8 wks

LF: 6 (10.0%)

BC: demographics similar; clinical characteristics not reported

Age: 47.2 (14.5SD, N = 144) (range = 20 to 75)

Gender (per cent men): 59.7% (86/144)

Severity: not reported

INCLUSION CRITERIA

  • Chronic plaque psoriasis

  • Stable bilateral lesions affecting < 20% total body surface area

  • Adult (aged 18 to 85)

EXCLUSION CRITERIA

  • Pregnancy

  • Concomitant disease

  • Known hypersensitivity to vitamin D derivatives

  • Systemic treatments within previous 1 mth

  • Systemic retinoids within previous 2 mths

  • Plaques < 10 cm² or > 150 cm²

Interventions

Dose‐ranging study including placebo; calcipotriol 50 mcg/g; maxacalcitol ointment 6, 12.5, 25, and 50 mcg/g OD.

Contrast included the following:

  • Calcipotriol ointment 50 mcg/g OD (C)

  • Placebo ointment (vehicle) (P)

Outcomes

  1. Psoriasis Severity Index (PSI): sum scores for erythema, induration and scaling (0 to 24)

  2. IAGI (6‐pt: worse to cleared)

  3. PAGI (6‐pt: worse to cleared)

  4. Investigator side preference

  5. Patient side preference

Notes

Non‐target plaques received emollient or coal tar throughout the study.
Chugai Pharma Europe sponsored the trial.

Risk of bias

Bias

Authors' judgement

Support for judgement

Allocation concealment (selection bias)

Unclear risk

The trial reported insufficient details.

Blinding (performance bias and detection bias)
All outcomes

Low risk

The trial was double‐blind (participant/assessor).

Randomisation method reported

Unclear risk

The trial did not report this.

Loss to follow up

Low risk

10.0%

Baseline assessments

Low risk

These were partially reported (demographics only).

Baseline comparability demonstrated

Unclear risk

These were partially done.

Barrett 2005

Methods

DESIGN
Between‐patient
Participant delivery
ALLOCATION
Random
Method of randomisation: not stated
Concealment: unclear
BLINDING
Open
WITHDRAWAL/DROPOUT
Not described

Participants

N: 420

Treatment duration: 8 wks; FU: 8 wks

LF: unclear

BC: not reported

Age: not reported

Gender (per cent men): not reported

Severity: not reported

INCLUSION CRITERIA

  • People with mild plaque psoriasis

EXCLUSION CRITERIA

  • Not reported

Interventions

  • Calcipotriol scalp 50 mcg/g solution BD, plus non‐medicated shampoo twice/wk (Johnson's baby shampoo®) (CP)

  • Calcipotriol scalp 50 mcg/g solution BD, plus tar shampoo (Polytar liquid ®) twice/wk (CT)

 

At visit 1, all participants were treated with calcipotriol scalp solution twice daily. Participants were randomly assigned to treatment with either twice‐weekly Polytar® liquid or a non‐medicated shampoo twice weekly.

Outcomes

  1. Investigator assessment of global improvement (6‐pt: worse to cleared)

  2. Total Sign Score (scale: 0 to 12)

Notes

Leo Pharmaceuticals sponsored the trial. The sponsor supplied unpublished outcomes data.

Risk of bias

Bias

Authors' judgement

Support for judgement

Allocation concealment (selection bias)

Unclear risk

The trial did not report this.

Blinding (performance bias and detection bias)
All outcomes

High risk

The trial was open (impossible to blind participants when tar‐based products are used).

Randomisation method reported

Unclear risk

The trial did not report this.

Loss to follow up

Unclear risk

The trial did not report this.

Baseline assessments

Unclear risk

The trial did not report these.

Baseline comparability demonstrated

Unclear risk

The trial did not report this.

Bernhard 1991 (1)

Methods

DESIGN
Within‐patient
Delivery unclear
ALLOCATION
Random
Method of randomisation: not reported
Concealment: unclear
BLINDING
Double‐blind (participant/investigator)
WITHDRAWAL/DROPOUT
Described

Participants

N: 100

Treatment duration: 2 wks; FU: 2 wks

LF: 4 (4%)

BC: yes

Age: 49 (range = 20 to 77)

Gender (per cent men): 61.5%

Severity: at least 2 signs or symptoms ≥ 2 on a 4‐pt scale

Duration (yrs): 18.2 (range = 1 to 53)

INCLUSION CRITERIA

  • Bilateral, comparable psoriasis of at least moderate severity

  • Adult

  • At least 2 signs or symptoms ≥ 2 on a 4‐pt scale

EXCLUSION CRITERIA

  • Not reported

Interventions

  • Halobetasol 0.05% ointment BD (H)

  • Placebo (Vehicle) (P)

Outcomes

  1. Signs: erythema, plaque elevation, scaling, overall lesion severity

  2. Patient Global Assessment (5‐pt: poor to excellent)

  3. Skin atrophy

Notes

Westwood‐Squibb Pharmaceuticals (BMS) sponsored the trial with an educational grant.

Risk of bias

Bias

Authors' judgement

Support for judgement

Allocation concealment (selection bias)

Unclear risk

The trial reported insufficient details.

Blinding (performance bias and detection bias)
All outcomes

Unclear risk

The trial was double‐blind (participant/investigator).

Randomisation method reported

Unclear risk

The trial did not report this.

Loss to follow up

Low risk

4.0%

Baseline assessments

Low risk

These were reported.

Baseline comparability demonstrated

Low risk

Bernhard 1991(2)

Methods

DESIGN
Between‐patient
Delivery unclear
ALLOCATION
Random
Method of randomisation: not reported
Concealment: unclear
BLINDING
Double‐blind (participant/investigator)
WITHDRAWAL/DROPOUT
Described

Participants

N: 72

Treatment duration: 2 wks; FU: 2 wks

LF: 0 (0%)

BC: yes (demographics); clinical comparability unclear

Age: 53 (range = 23 to 86)

Gender (per cent men): 52.8%

Severity: signs > = 4 on a 7‐pt scale; BSA = 1% to 20%

Duration: 22.7 (range = 1 to 62)

INCLUSION CRITERIA

  • Plaque psoriasis of at least moderate severity

  • Adult

  • Signs ≥ 4 on a 7‐pt scale

  • BSA 1% to 20%

EXCLUSION CRITERIA

  • Not reported

Interventions

  • Halobetasol 0.05% ointment, BD (H)

  • Placebo (Vehicle) (P)

Outcomes

  1. Signs: erythema, induration, scaling

  2. Investigator Global Assessment (5‐pt: worse to clear)

Notes

Westwood‐Squibb Pharmaceuticals (BMS) sponsored the trial with an educational grant.

Risk of bias

Bias

Authors' judgement

Support for judgement

Allocation concealment (selection bias)

Unclear risk

The trial reported insufficient details.

Blinding (performance bias and detection bias)
All outcomes

Low risk

The trial was double‐blind (participant/investigator).

Randomisation method reported

Unclear risk

The trial did not report this.

Loss to follow up

Low risk

0.0%

Baseline assessments

Low risk

These were reported.

Baseline comparability demonstrated

Unclear risk

This was partially demonstrated.

Bernstein 2006

Methods

DESIGN
Between‐patient
Participant delivery
ALLOCATION
Random
Method of randomisation: not stated
Concealment: unclear
BLINDING
Double‐blind (participant/investigator)
WITHDRAWAL/DROPOUT
Described

Participants

N: 200

Treatment duration: 12 wks; FU: 12 wks

LF: 29 (14.5%)

BC: yes

Age: 48.3 (13.9SD)

Gender (per cent men): 46.5%

Severity: PASI (0 to 12) = 6.89 (2.8SD); QLI (0 to 120) = 58.74 (31.5SD)

INCLUSION CRITERIA

  • People aged 18 to 80 with mild to moderate plaque psoriasis (BSA < 15%)

  • Good general health

EXCLUSION CRITERIA

  • Painful/inflamed lesions

  • Intertriginous psoriasis

  • Hypertrophic lesions

  • Severe psoriasis

  • Use of topical antipsoriatics within previous 2 wks

  • Use of systematic antipsoriatics within previous 4 wks

  • Concurrent use of steroids, immunosuppressants, COX2s

  • Pregnancy or risk thereof

  • Lactation

Interventions

  • Mahonia aquifolium (Reliéva™) in Novasome cream® BD (MA)

  • Placebo (vehicle) BD (P)

Outcomes

  1. PASI, assessed by physician on a 4 x 4 cm section of skin "typical of the patient's psoriasis involvement" (E+I+S) x per cent involvement (0 to 12)

  2. QLI (Quality of Life Index) assessed by participant. 12 questions each scored 0 (not at all) to 10 (very much). Maximum score = 120 (equating to very poor quality of life)

  3. Also covers adverse events.

Notes

Apollo Pharmaceuticals sponsored the trial.

'PASI' is similar to TSS (range = 0 to 12) as it examines small BSA. However, the PASI score was also adjusted by area.

Risk of bias

Bias

Authors' judgement

Support for judgement

Allocation concealment (selection bias)

Unclear risk

The trial reported insufficient details.

Blinding (performance bias and detection bias)
All outcomes

Low risk

The trial was double‐blind (participant/investigator).

Randomisation method reported

Unclear risk

The trial did not report this.

Loss to follow up

Low risk

14.5%

Baseline assessments

Low risk

The trial reported this.

Baseline comparability demonstrated

Low risk

Berth Jones 1992b

Methods

DESIGN
Between‐patient
Participant delivery
ALLOCATION
Random
Method of randomisation: balanced blocks of 4 using computer‐generated random numbers
Concealment: unclear
BLINDING
Open
WITHDRAWAL/DROPOUT
Described

Participants

N: 478

Treatment duration: 8 wks; FU: 8 wks

LF: for PASI: 56 (11.7%); for Response: 20 (4.2%)

BC: yes

Age: 44 (range = 18 to 85)

Gender (per cent men): 55%

Severity: PASI = 9.3

Duration (yrs): 18 (12SD)

INCLUSION CRITERIA

  • Outpatients

  • Adults

  • Chronic stable plaque psoriasis

EXCLUSION CRITERIA

  • Previous non‐response to study medications

  • Recent systemic treatment

  • Hypercalcaemia

  • Abnormal renal/hepatic function

  • Calcium or vitamin D intake

  • Relevant concomitant medication

  • Pregnancy

  • Risk of pregnancy

Interventions

  • Calcipotriol ointment 50 mcg/g BD (C)

  • Dithranol cream (dose titration 0.1% to 2%) OD (D)

Outcomes

  1. PASI

  2. Investigator Global Assessment (5‐pt: worse to cleared)

  3. Patient Global Assessment (5‐pt: worse to cleared)

  4. Cosmetic acceptability

  5. Compliance

Notes

Leo Pharmaceutical Products, Denmark, sponsored the trial.

Risk of bias

Bias

Authors' judgement

Support for judgement

Allocation concealment (selection bias)

Unclear risk

The trial reported insufficient details.

Blinding (performance bias and detection bias)
All outcomes

High risk

The trial was open.

Randomisation method reported

Low risk

A computer‐generated block list was used for randomisation.

Loss to follow up

Low risk

11.7%

Baseline assessments

Low risk

These were reported.

Baseline comparability demonstrated

Low risk

Beutner 2006

Methods

DESIGN
Within‐patient
Participant delivery
ALLOCATION
Random
Method of randomisation: not stated
Concealment: unclear
BLINDING
Double‐blind (participant/investigator)
WITHDRAWAL/DROPOUT
Described

Participants

N: 27

Treatment duration: 4 wks; FU: 4 wks

LF: 2 (7.4%)

BC: yes

Age: 51.6 (12.8SD); range = 21 to 75

Gender (per cent men): 67%

Ethnicity (% white): 85%

Severity: overall target severity score (0 to 4) = 2.67 (0.58SD)

INCLUSION CRITERIA

  • People aged > = 18 with moderate to severe plaque psoriasis (overall plaque severity score (0 to 8) > = 5)

  • 2 bilateral plaques of equivalent size (5 cm^2 to 10 cm^2)

EXCLUSION CRITERIA

  • Use of topical antipsoriatic therapy or UV exposure within previous 4 wks

  • Pregnancy or risk thereof

Interventions

  • Clobetasol propionate 0.05% spray BD (CP)

  • Placebo (vehicle) spray BD (P)

Outcomes

  1. Overall target plaque severity score using a collapsed 9‐pt scale: none (0 to 1), mild (2 to 3), moderate (4 to 5), severe (6 to 7), and very severe (8)

  2. Signs: scaling, erythema, and plaque elevation (each scored 0 to 8)

  3. Adverse events (burning, stinging, pruritus, telangiectasias, skin atrophy)

Notes

Galderma Laboratories, L.P. sponsored the study.

There was SD imputation (TSS).

Risk of bias

Bias

Authors' judgement

Support for judgement

Allocation concealment (selection bias)

Unclear risk

The trial reported insufficient details.

Blinding (performance bias and detection bias)
All outcomes

Low risk

The trial was double‐blind (participant/investigator).

Randomisation method reported

Unclear risk

The trial did not report this.

Loss to follow up

Low risk

7.4%

Baseline assessments

Low risk

These were reported.

Baseline comparability demonstrated

Low risk

Bourke 1993b

Methods

DESIGN
Within‐patient
Participant delivery
ALLOCATION
Random
Method of randomisation: participants were randomised into groups A and B, then randomised to left/right application with sealed envelopes
Concealment: unclear
BLINDING
Single‐blind (investigator)
WITHDRAWAL/DROPOUT
Described

Participants

N: 19 (evaluable)

Treatment duration: 8 wks; FU: 8 wks

LF: NR

BC: yes (clinical only)

Age: not reported

Gender (per cent men): not reported

Severity: TSS = 7.9

INCLUSION CRITERIA

  • Adult

  • Symmetrical chronic plaque psoriasis

  • Outpatients

EXCLUSION CRITERIA

  • UV or systemic antipsoriatic therapy

Interventions

  • Calcipotriol BD (C)

  • Calcipotriol BD plus polythene film at night (O)

Outcomes

  1. Signs: erythema, induration, scale

  2. Total Sign Score (0 to 12)

Notes

Participants were randomised into groups A (calcipotriol BD) and B (occlusion ON), then each participant was randomised to left/right application: group A (occlusion ON/no occlusion); group B (calcipotriol BD or placebo BD). The study reported findings for group A.
The trial did not report sponsorship.

Risk of bias

Bias

Authors' judgement

Support for judgement

Allocation concealment (selection bias)

Unclear risk

The trial reported insufficient details.

Blinding (performance bias and detection bias)
All outcomes

Low risk

The trial was single‐blind (investigator).

Randomisation method reported

Low risk

Envelopes were used.

Loss to follow up

Unclear risk

The trial did not report this.

Baseline assessments

Low risk

These were partially done.

Baseline comparability demonstrated

Unclear risk

This was partially demonstrated.

Bourke 1997

Methods

DESIGN
Between‐patient
Participant delivery
ALLOCATION
Random
Method of randomisation: not reported
Concealment: unclear
BLINDING
Double‐blind (participant/assessor)
WITHDRAWAL/DROPOUT
Described

Participants

N: 24

Treatment duration: 8 wks

LF: 4 (16.7%)

BC: yes (clinical only reported)

Age: not reported

Gender (per cent men): 41.7%

Severity: PASI mean = 14.0

INCLUSION CRITERIA

  • Adults

  • Symmetrical chronic moderate chronic plaque psoriasis

EXCLUSION CRITERIA

  • Pregnancy

  • Lactation

  • Drugs affecting systemic calcium homeostasis

  • Recent systemic antipsoriatic or UVB therapy

Interventions

  • Calcitriol 3 mcg/g BD (CL)

  • Calcipotriol 50 mcg/g BD (C)

Outcomes

  1. PASI

Notes

Solvay‐Duphar Ltd sponsored the trial.

Risk of bias

Bias

Authors' judgement

Support for judgement

Allocation concealment (selection bias)

Unclear risk

The trial reported insufficient details.

Blinding (performance bias and detection bias)
All outcomes

Low risk

The trial was double‐blind (participant/assessor).

Randomisation method reported

Unclear risk

The trial did not report this.

Loss to follow up

Low risk

16.7%

Baseline assessments

Low risk

These were partially done.

Baseline comparability demonstrated

Unclear risk

This was partially demonstrated.

Brown 2005

Methods

DESIGN
Between‐patient
Participant delivery
ALLOCATION
Random
Method of randomisation: not stated
Concealment: unclear
BLINDING
Double‐blind (participant/investigator)
WITHDRAWAL/DROPOUT
Described

Participants

N: 30

Treatment duration: 12 wks; FU: 12 wks

LF: 6 (20%)

BC: unclear

Age: 55 (12.6SD); range = 20 to 75

Gender (per cent men): 50%

Ethnicity (% white): 46.7%

Severity: TSS (0 to 16) mean = 6.97

INCLUSION CRITERIA

  • People with mild stable plaque psoriasis

  • BSA affected < 15%

  • General good health

EXCLUSION CRITERIA

  • Pregnancy or risk thereof

  • Lactation

  • Phototherapy, topical therapy, or systemic therapy within previous 4 wks

  • Cancer

  • History of drug or alcohol abuse

  • Concomitant antipsoriatic therapy

Interventions

  • Kukui nut oil TD (K)

  • Placebo (mineral oil, vehicle) TD (P)

Outcomes

  1. Investigator assessment of PASI (scale unclear (0 to 64.8)) and Global Severity Score (5‐pt: 0 = none to 4 = very severe)

  2. Subject assessment of Global Severity Score (5‐pt: 0 = none to 4 = very severe)

  3. Total Severity Score (0 to 16; thickness + scaliness + erythema + itch)

  4. Compliance also assessed (bottles weighed)

Notes

Hawaii Community Foundation sponsored the study.

The trial author supplied unpublished data.

There was SD imputation (TSS).

Risk of bias

Bias

Authors' judgement

Support for judgement

Allocation concealment (selection bias)

Unclear risk

The trial reported insufficient details.

Blinding (performance bias and detection bias)
All outcomes

Low risk

The trial was double‐blind (participant/investigator).

Randomisation method reported

Unclear risk

The trial did not report this.

Loss to follow up

Unclear risk

20%

Baseline assessments

Unclear risk

The trial did not report these.

Baseline comparability demonstrated

Unclear risk

The trial did not report this.

Bruce 1994

Methods

DESIGN
Between‐patient
Participant delivery
ALLOCATION
Random
Method of randomisation: not reported
Concealment: unclear
BLINDING
Double‐blind (participant/investigator)

WITHDRAWAL/DROPOUT
Described

Participants

N: 114

Treatment duration: 6 wks; FU: 6 wks

LF: 15 (13.2%)

BC: yes

Age: 44.1 (14.6SD; range = 20 to 77)

Gender (per cent men): 60.2%

Severity: mean duration of current episode (days) = 142 (range = 0 to 601)

Overall severity score (mean): 4.5

INCLUSION CRITERIA

  • Stable plaque psoriasis

  • Adults

  • At least mild overall severity

  • At least moderately severe plaque elevation

EXCLUSION CRITERIA

  • Pregnancy

  • Lactation

  • Inadequate contraception

  • Sensitivity to test medications

  • Recent topical, UV, or systemic treatment

  • Recent involvement in other trials

  • Planned sun exposure

Interventions

  • Calcipotriol ointment 0.005% BD (C)

  • Fluocinonide ointment 0.05% BD (F)

Outcomes

  1. Sign: scaling, erythema, plaque elevation

  2. Overall severity (Total Sign Score and per cent involvement)

  3. Investigator Global Assessment

Notes

Westwood Squibb Pharmaceuticals Inc. sponsored the trial.
There was SD imputation (TSS).

Risk of bias

Bias

Authors' judgement

Support for judgement

Allocation concealment (selection bias)

Unclear risk

The trial reported insufficient details.

Blinding (performance bias and detection bias)
All outcomes

Low risk

The trial was double‐blind (participant/investigator).

Randomisation method reported

Unclear risk

The trial did not report this.

Loss to follow up

Low risk

13.2%

Baseline assessments

Low risk

Baseline comparability demonstrated

Low risk

Buckley 1978

Methods

DESIGN
Within‐patient
Participant delivery
ALLOCATION
Random
Method of randomisation: not reported
Concealment: unclear
BLINDING
Double‐blind (participant/investigator)
WITHDRAWAL/DROPOUT
Described

Participants

N: 10

Treatment duration: 3 wks; FU: 3 wks

LF: 2 (20%)

BC: not reported

Age: 21.4 (range = 9 to 41)

Gender (per cent men): 50%

Severity: not reported

INCLUSION CRITERIA

  • Active chronic psoriasis

  • Lesions approximately symmetrically distributed

EXCLUSION CRITERIA

  • Not reported

Interventions

  • Dead Sea salts emollient lotion 30% (frequency of application not reported) (D)

  • Base emollient lotion (placebo) (P)

Outcomes

  1. Jacoby assessment score (0 to 7 score transformed to per cent clinical improvement)

  2. Photographic evaluation

  3. Overall patient assessment (relative efficacy, speed of response, irritation, staining, ease of application)

Notes

The trial did not report sponsorship.

Risk of bias

Bias

Authors' judgement

Support for judgement

Allocation concealment (selection bias)

Unclear risk

The trial reported insufficient details.

Blinding (performance bias and detection bias)
All outcomes

Low risk

The trial was double‐blind (participant/investigator).

Randomisation method reported

Unclear risk

The trial did not report this.

Loss to follow up

Low risk

20.0%

Baseline assessments

Low risk

These were partially done.

Baseline comparability demonstrated

Unclear risk

The trial did not report this.

Buckley 2008

Methods

DESIGN
Between‐patient
Participant delivery
ALLOCATION
Random
Method of randomisation: not stated
Concealment: unclear
BLINDING
Double‐blind (participant/investigator)
WITHDRAWAL/DROPOUT
Described

Participants

N: 218

Treatment duration: 8 wks; FU: 10 wks

LF: 5 (2.3%)

BC: yes

Age: 48.4 (15.48SD)

Gender (per cent men): 45.0%

Ethnicity: 97.7%

Severity: TSS (0 to 12) = 6.80 (1.58SD)

Duration (yrs): 14.6 (13.87SD); range = 0 to 65

Extent of scalp psoriasis: 3.39 (1.36SD)

INCLUSION CRITERIA

  • People aged > = 18 with scalp psoriasis affecting > = 10% scalp

  • Amenable to topical treatment with < = 100 g medication/wk

  • TSS (0 to 12) > = 4

  • Each individual sign score (0 to 4) > = 1

  • IGA at least mild (> = 3)

EXCLUSION CRITERIA

  • Erythrodermic psoriasis

  • Pustular psoriasis

  • Systemic or PUVA therapy within previous 4 wks

  • UVB or grenz ray therapy on scalp, or topical scalp therapy within previous 2 wks

  • Severe renal impairment or severe hepatic disorders

Interventions

  • Combined gel: calcipotriol 50 mcg/g + betamethasone dipropionate 0.5 mg/g OD (C‐B)

  • Betamethasone dipropionate 0.5 mg/g gel OD (B)

Participants achieving absence of disease (IGA = 5) at weeks 2 to 5 could withdraw from the study.

Outcomes

  1. Signs: redness, thickness, scaliness (each sign scored on 5 pt scale 0 to 4)

  2. Total Sign Score (TSS; 13‐pt: 0 = none to 12 = very severe symptoms)

  3. Investigator's Global Assessment (IGA): 0 = absence of disease to 5 = very severe disease.

  4. Controlled disease: IGA < = 1

  5. Investigator assessment of extent of scalp psoriasis: 0% to 100% (score of 3 corresponds to 30% to 49% involvement)

  6. Patient's assessment of global improvement (PAGI): 7‐pt scale: 0 = worse to 6 = cleared. Reported as dichotomised treatment success: PAGI > = 4

  7. Treatment duration

  8. Compliance (medication usage)

Notes

Leo Pharma A/S, Ballerup, Denmark, sponsored the study.

Treatment duration (wks): C‐B: 6.1 (2.4 SD), N = 108; B: 6.8 (2.2 SD), N = 110

Compliance (missed < = 20% applications): C‐B: 93/108; B: 103/110

The sponsor supplied unpublished data.,

Risk of bias

Bias

Authors' judgement

Support for judgement

Allocation concealment (selection bias)

Unclear risk

The trial reported insufficient details.

Blinding (performance bias and detection bias)
All outcomes

Unclear risk

The trial was double‐blind (participant/investigator).

Randomisation method reported

Unclear risk

The trial did not report this.

Loss to follow up

Low risk

2.3%

Baseline assessments

Low risk

These were reported.

Baseline comparability demonstrated

Low risk

Camarasa 2003

Methods

DESIGN
Between‐patient
Participant delivery
ALLOCATION
Random
Method of randomisation: not reported
Conducted in 20 centres; stratification not reported
Concealment: unclear
BLINDING
Double‐blind (participant/investigator)
WITHDRAWAL/DROPOUT
Described

Participants

N: 258

Treatment duration: 6 wks; FU: 14 wks

LF: 15 (5.8%)

BC: yes

Age: 43.5 (14.3SD: range = 15 to 83)

Gender (per cent men): 64.3%

Severity: per cent BSA = 25.5 (22.9SD: range = 1 to 95); PASI = 15.4 (10.6SD)

Duration of psoriasis (mths) mean: 199.2 (157.5SD: range = 1 to 745)

INCLUSION CRITERIA

  • Adults

  • Moderate to severe chronic plaque psoriasis (≥ 2 on global severity score)

EXCLUSION CRITERIA

  • Systemic or intralesional therapy or photo(chemo)therapy in previous 2 mths

  • Medications or conditions that might interfere with the assessment of study drugs Concomitant bacterial, fungal, or viral skin conditions

  • Clinically relevant abnormalities in laboratory parameters (calcium homeostasis and renal function)

  • Pregnancy or lactation

  • Absence of adequate contraception, where appropriate

Interventions

  • Calcitriol 3 mcg/g ointment BD (C)

  • Betamethasone dipropionate 0.05% ointment BD (B)

Outcomes

  1. IAGI (6‐pt: worsening to clearance)

  2. PASI

  3. Overall global severity of lesions (5‐pt: 0 = none to 4 = very severe)

  4. Relapse rate

  5. Proportion remaining in remission (non‐randomised subgroup analysis)

Notes

There was a 1‐wk run‐in period without treatment, except tar shampoo and emollients.
Follow up was for responders only (defined as achieving clearance or considerable improvement).
The scalp was excluded.
Galderma Laboratories sponsored the trial.
There was SD imputation (TSS).

Risk of bias

Bias

Authors' judgement

Support for judgement

Allocation concealment (selection bias)

Unclear risk

The trial reported insufficient details.

Blinding (performance bias and detection bias)
All outcomes

Low risk

The trial was double‐blind (participant/investigator).

Randomisation method reported

Unclear risk

The trial did not report this.

Loss to follow up

Low risk

5.8%

Baseline assessments

Low risk

Baseline comparability demonstrated

Low risk

Cheesbrough 1992

Methods

DESIGN
Between‐patient
Participant delivery
ALLOCATION
Random
Method of randomisation: not reported
Concealment: unclear
BLINDING
Double‐blind (participant/investigator)
WITHDRAWAL/DROPOUT
Described

Participants

N: 24

Treatment duration: 12 wks; FU: 12 wks

LF: 5 (20.8 %)

BC: yes

Age (mean): 47

Gender (per cent men): 54.2%

Severity: PASI mean = 26

INCLUSION CRITERIA

  • Chronic stable plaque psoriasis

EXCLUSION CRITERIA

  • Not reported

Interventions

  • Dead sea salts emollient lotion 30% (frequency of application not reported) (D)

  • Base emollient lotion (placebo) (P)

Outcomes

  1. PASI

  2. Erythema, scaling, thickening, pruritus

  3. Adverse events

Notes

Finders Dead Sea Salt Co and Dead Sea Salt works supplied the study treatments.

Risk of bias

Bias

Authors' judgement

Support for judgement

Allocation concealment (selection bias)

Unclear risk

The trial reported insufficient details.

Blinding (performance bias and detection bias)
All outcomes

Low risk

The trial was double‐blind (participant/investigator).

Randomisation method reported

Unclear risk

The trial did not report this.

Loss to follow up

Unclear risk

20.8%

Baseline assessments

Low risk

These were reported.

Baseline comparability demonstrated

Low risk

Christensen 1999

Methods

DESIGN
Between‐patient
Participant delivery
ALLOCATION
Random
Method of randomisation: not reported
Concealment: unclear
BLINDING
Single‐blind at inclusion only (investigator)
WITHDRAWAL/DROPOUT
Described

Participants

N: 171

Treatment duration: 8 wks; FU: 16 wks (N = 95)

LF: 5 (2.9%)

BC: yes

Age: 47.4 (range = 17 to 88)

Gender (per cent men): 62.6%

Severity: mean TSS (0 to 9) = 6.24; mean duration of psoriasis = 18.5 (range = 1 to 58)

INCLUSION CRITERIA

  • Outpatients with mild to severe chronic stable chronic plaque psoriasis, not more than 10% BSA, Total Severity Score (0 to 9) ≥ 4, involving all 3 signs (erythema, scaling, infiltration)

EXCLUSION CRITERIA

  • Systemic treatment within previous 4 wks

  • Topical treatment within previous 2 wks; receipt of oral retinoids within previous 2 mths

Interventions

  • Short‐contact dithranol (30 min) 1% to 3%, OD (D)

  • Calcipotriol 50 mcg/g BD (C)

Outcomes

  1. Total Severity Score (0 to 9)

  2. Pruritus (0 to 3)

  3. Investigator's Global Assessment (7‐pt: worse to completely clear)

  4. Patient's Global Assessment (6‐pt: worse to completely clear)

  5. Adverse events

Notes

The study did not report sponsorship.
The study also included 16‐week follow‐up data for consenting participants who achieved at least 50% improvement from baseline (Investigator scale).
There was SD imputation (TSS).

Risk of bias

Bias

Authors' judgement

Support for judgement

Allocation concealment (selection bias)

Unclear risk

The trial reported insufficient details.

Blinding (performance bias and detection bias)
All outcomes

Low risk

The trial was single‐blind (investigator).

Randomisation method reported

Unclear risk

The trial did not report this.

Loss to follow up

Low risk

2.9%

Baseline assessments

Low risk

Baseline comparability demonstrated

Low risk

Cook‐Bolden 2010

Methods

DESIGN
Between‐patient
Participant delivery
ALLOCATION
Random
Method of randomisation: unclear
Concealment: unclear
BLINDING
Double‐blind (participant/investigator)
WITHDRAWAL/DROPOUT
Described

Participants

N: 81
Treatment duration: 4 wks; FU: 4 wks
LF: 3 (4%)
BC: yes
Age: 43.7 (14.69SD)
Ethnicity (% white): 78%
Gender (per cent men): 39.5%
Duration (yrs): 11.1 (10.5SD)

Severity: GSS = 3 (moderate) (67.9%); GSS = 4 (severe) (32.1%)

INCLUSION CRITERIA

  • People aged 18 or over with moderate to severe plaque psoriasis of the scalp (GSS = 3 or GSS = 4)

EXCLUSION CRITERIA

  • Use of chemical hair process, steroid medication, ultraviolet B (UVB) treatment, or both; calcipotriene; other vitamin D analogues; anthralin/tar; all other anti‐psoriasis medications (previous 2 wks)

  • Use of PUVA or other non‐biological systemic treatments (previous 4 wks)

  • Use of biological therapies (previous 12 wks)

  • Pregnancy or risk thereof

  • Lactation

Interventions

  • Clobetasol propionate spray 0.05% BD (CP)

  • Placebo (vehicle) spray BD (P)

Max usage/wk: 50 g

Participants achieving GSS = 0 at 2 wks completed ("withdrew" from) the study.

Outcomes

  1. Global Severity Score (GSS) (6‐pt: 0 = none to 5 = very severe), dichotomised as success (clear/almost clear) and failure

  2. Scalp psoriasis sign scores: erythema, scaling, elevation (0 to 4, where 0 = none)

  3. Pruritus (4‐pt: 0 = no itching to 3 = intense itching that disrupts sleep)

  4. Atrophy (0 to 3, where 0 = none)

  5. Telangiectasias (0 to 3, where 0 = none)

  6. Stinging/burning (0 to 3, where 0 = none)

  7. Patient satisfaction with applicator

  8. Scalpdex, a scalp dermatitis‐specific quality of life instrument; 23 questions, each scored 0 (never) to 100 (all the time)

  9. Compliance: yes if participant achieved 80% to 120% of expected applications

Notes

Galderma Laboratories, LP, sponsored the trial.

Galderma supplied safety data for this study.

Risk of bias

Bias

Authors' judgement

Support for judgement

Allocation concealment (selection bias)

Unclear risk

The trial reported insufficient details.

Blinding (performance bias and detection bias)
All outcomes

Low risk

The trial was double‐blind (participant/investigator).

Randomisation method reported

Unclear risk

The trial did not report this.

Loss to follow up

Low risk

4%

Baseline assessments

Low risk

These were made.

Baseline comparability demonstrated

Low risk

The trial demonstrated demographic and clinical comparability.

Crosti 1997

Methods

DESIGN
Between‐patient
Participant delivery
ALLOCATION
Random
Method of randomisation: not reported
Concealment: unclear
BLINDING
Unclear
WITHDRAWAL/DROPOUT
Described

Participants

N: 160

Treatment duration: 6 wks; FU: 10 wks

LF: 8 (5%)

BC: yes

Age: 49.9 (14.2SD)

Gender (per cent men): 68.1%

Severity: mean PASI = 7.6

INCLUSION CRITERIA

  • Mild stable chronic plaque psoriasis

  • Adult

EXCLUSION CRITERIA

  • Recent topical or systemic treatments

  • Pregnancy

  • Lactation

  • Concomitant vitamin D or systemic steroids

  • Hepatic or renal failure

Interventions

  • Calcipotriol ointment 50 mcg/g BD (C)

  • Betamethasone dipropionate + salicylic acid BD (B)

Outcomes

  1. PASI

  2. Investigator Global Assessment

  3. Patient Global Assessment of acceptability of treatment (5‐pt: nil to excellent)

Notes

The trial did not report sponsorship.
There was SD imputation (PASI).

Risk of bias

Bias

Authors' judgement

Support for judgement

Allocation concealment (selection bias)

Unclear risk

The trial reported insufficient details.

Blinding (performance bias and detection bias)
All outcomes

Unclear risk

The trial did not report this.

Randomisation method reported

Unclear risk

The trial did not report this.

Loss to follow up

Low risk

5.0%

Baseline assessments

Low risk

Baseline comparability demonstrated

Low risk

Cunliffe 1992

Methods

DESIGN
Between‐patient
Delivery unclear
ALLOCATION
Random
Method of randomisation: balanced blocks of 10 according to a computer‐generated random numbers table
Concealment: unclear
BLINDING
Double‐blind (participant/investigator)
WITHDRAWAL/DROPOUT
Described

Participants

N: 409

Treatment duration: 6 wks; FU: 6 wks

LF: 8 (2.0%)

BC: yes

Age: 44.9 (range = 17 to 83)

Gender (per cent men): 55.7%

Severity: mean PASI = 9.0 (range = 0.6 to 41.2); mean duration psoriasis = 16.2 (range = 0.2 to 57)

INCLUSION CRITERIA

  • Stable plaque psoriasis

  • Adults

  • Outpatients

EXCLUSION CRITERIA

  • Risk of pregnancy

  • Pregnancy

  • Lactation

  • Recent systemic antipsoriatic treatment

Interventions

  • Calcipotriol ointment 50 mcg/g BD (C)

  • Betamethasone 17‐valerate 1 mg/g BD (B)

Outcomes

  1. PASI

  2. Patient overall assessment (5 pt: worse to clear)

Notes

Leo Pharmaceuticals sponsored the trial.

Risk of bias

Bias

Authors' judgement

Support for judgement

Allocation concealment (selection bias)

Unclear risk

The trial reported insufficient details.

Blinding (performance bias and detection bias)
All outcomes

Low risk

The trial was double‐blind (participant/investigator).

Randomisation method reported

Low risk

A computer‐generated block list was used for randomisation.

Loss to follow up

Low risk

2.0%

Baseline assessments

Low risk

Baseline comparability demonstrated

Low risk

De Simone 1993

Methods

DESIGN
Between‐patient
Participant delivery
ALLOCATION
Random
Method of randomisation: not stated
Concealment: unclear
BLINDING
Blinding unclear
WITHDRAWAL/DROPOUT
Not described

Participants

N: 30

Treatment duration: 6 wks; FU: 10 wks

LF: 0 (0%)

BC: not reported

Age: range = 18 to 84

Gender (per cent men): 70.0%

Severity: PASI range = 2.7 to 24.3

INCLUSION CRITERIA

  • Chronic plaque psoriasis

EXCLUSION CRITERIA

  • Pregnancy

  • Lactation

  • Hepatic or renal disease

  • Recent systemic or topical therapy

  • High intake of vitamin D or calcium

Interventions

  • Calcipotriol ointment 50 mcg/g BD (C)

  • Coal tar 5% in Lassar's paste (T)

Outcomes

  1. Investigator Global Assessment (estimated from PASI score)

Notes

The trial did not report sponsorship.

Risk of bias

Bias

Authors' judgement

Support for judgement

Allocation concealment (selection bias)

Unclear risk

The trial reported insufficient details.

Blinding (performance bias and detection bias)
All outcomes

Unclear risk

The trial did not report this.

Randomisation method reported

Unclear risk

The trial did not report this.

Loss to follow up

Low risk

0.0%

Baseline assessments

Low risk

These were partially done.

Baseline comparability demonstrated

Unclear risk

The trial did not report this.

Decroix 2004

Methods

DESIGN
Between‐patient
Participant delivery
ALLOCATION
Random
Method of randomisation: not stated
Concealment: unclear
BLINDING
Single‐blind (investigator); as cream and lotion were compared, not possible to blind participants
WITHDRAWAL/DROPOUT
Described

Participants

N: 222

Treatment duration: 4 wks; FU: 4 wks

LF: 0 (0%)

BC: yes

Age: 48.4 (15.0SD)

Gender (per cent men): 55.9%

Ethnicity (% white): 100%

Severity: DSS (0 to 12) = 8.44 (1.45SD); atrophy (0 to 3) = 1.01; telangiectasia (0 to 3) = 0.01

INCLUSION CRITERIA

  • People aged > = 18 with stable moderate to severe plaque psoriasis

  • Target lesion diameter > 3 cm

  • Lesion not localised to scalp, face, hands, or feet

  • BSA > = 10%;

  • (Women participants only) negative pregnancy test

EXCLUSION CRITERIA

  • Use of topical treatments and phototherapy within previous 2 wks

  • Use of systemic therapies within previous 2 to 16 wks

  • Regular sun exposure within previous 2 wks

Interventions

  • Clobetasol propionate lotion/cream BD (CP)

  • Placebo (vehicle lotion) BD (P)

Participants were randomised to clobetasol propionate cream or lotion; results were aggregated for review purposes.

Outcomes

  1. Erythema, plaque elevation, scaling pruritus: each scored on 5‐pt scale (0 to 4)

  2. Dermatological Sum Score (DSS: erythema, elevation, scaling): 0 to 12

  3. Global severity (GSS): 0 (none) to 4 (severe)

  4. Dichotomised as success (GSS = 0, 0.5, or 1) or failure (GSS = 2 to 4)

  5. Investigator's Assessment of Global Improvement (IAGI): ‐1 (worse) to 5 (clear)

  6. Per cent BSA involvement: rule of nines

  7. Safety: telangiectasia (0 to 3), atrophy (0 to 3); adverse events

  8. Compliance (assessment method not reported)

  9. Cosmetic acceptability (questionnaire survey)

Notes

Galderma R&D, Sophia Antipolis, France, sponsored the trial.

There was SD imputation (TSS).

Risk of bias

Bias

Authors' judgement

Support for judgement

Allocation concealment (selection bias)

Unclear risk

The trial reported insufficient details.

Blinding (performance bias and detection bias)
All outcomes

Unclear risk

The study was single‐blind (investigator); as the cream and lotion were compared, it was not possible to blind participants.

Randomisation method reported

Unclear risk

The trial did not report this.

Loss to follow up

Low risk

0%

Baseline assessments

Low risk

These were reported.

Baseline comparability demonstrated

Low risk

This was demonstrated.

Douglas 2002

Methods

DESIGN
Between‐patient
Participant delivery
ALLOCATION
Random
Method of randomisation: computer‐generated randomisation schedule
Concealment: unclear
BLINDING
Double‐blind (participant/investigator)
WITHDRAWAL/DROPOUT
Described

Participants

N: 1106

Treatment duration: 4 wks; FU: 4 wks

LF: 86 (7.8%)

BC: yes

Age: mean = 47.1 (range = 18 to 89)

Gender (per cent men): 59.8%

Severity: PASI = 10.7 (range = 2.1 to 39.6)

Duration: mean = 18.4 (range = 0 to 65)

INCLUSION CRITERIA

  • Chronic plaque psoriasis

  • Aged at least 18 years

  • Use of systemic antipsoriatic treatment/phototherapy in previous 6 weeks

  • Treatment of lesions contraindicated for topical corticosteroid therapy

EXCLUSION CRITERIA

  • Pregnancy

  • Lactation

  • Current participation in other trial

  • Abnormality of calcium metabolism

  • Hypercalcaemia

Interventions

  • Calcipotriol (50 mcg/g)/betamethasone (0.5 mg/g) combination ointment (Daviobet®) BD (D)

  • Calcipotriol ointment (Daivonex®) 50 mcg/g BD (C)

  • Betamethasone dipropionate ointment (Diprosone®) 0.5 mg/g BD (B)

All groups then received 4 weeks of maintenance therapy with calcipotriol BD.

Outcomes

  1. PASI (modified) (0 to 64.8)

  2. Redness, thickness, scaling (0 to 8 each)

  3. Investigator Global Assessment (6‐pt: worse to cleared)

  4. Patient's assessment of treatment response (6‐pt: worse to cleared)

  5. Adverse events

Notes

Leo Pharmaceuticals sponsored the trial.
4‐week follow‐up study also reported (open design: all participants received calcipotriol).

Risk of bias

Bias

Authors' judgement

Support for judgement

Allocation concealment (selection bias)

Unclear risk

The trial reported insufficient details.

Blinding (performance bias and detection bias)
All outcomes

Low risk

The trial was double‐blind (participant/investigator).

Randomisation method reported

Low risk

Randomisation was computer‐generated.

Loss to follow up

Low risk

7.8%

Baseline assessments

Low risk

Baseline comparability demonstrated

Low risk

Dubertret 1992

Methods

DESIGN
Within‐patient
Participant delivery
ALLOCATION
Random
Method of randomisation: unclear
Concealment: unclear
BLINDING
Double‐blind (participant/investigator)
WITHDRAWAL/DROPOUT
Described

Participants

N: 66

Treatment duration: 4 wks; FU: 8 wks

LF: 6 (9.1%)

BC: yes

Age: 43 (range = 21 to 84)

Gender (per cent men): 69.7%

Severity: PASI mean = 14.15

Duration: 13.3 (range = 0.3 to 40.0)

INCLUSION CRITERIA

  • Bilateral stable symmetric chronic plaque psoriasis of the arms, limbs, or trunk

  • Adult

EXCLUSION CRITERIA

  • Guttate or pustular psoriasis

  • Psoriasis restricted to the scalp, face, elbows, or knees

  • Recent systemic or UV therapy in the previous 10 weeks

  • Calcium, vitamin D daily or other medications

  • Hepatic or renal impairment

  • Pplanned exposure to sun

Interventions

  • Calcipotriol ointment 50 mcg/gm BD (C)

  • Placebo (vehicle) (P)

Outcomes

  1. Severity [erythema, infiltration, desquamation]

  2. Modified PASI

  3. Preferred treatment

  4. Investigator Global Assessment (5‐pt: cleared to worse)

  5. Patient Global Assessment (5‐pt: cleared to worse)

Notes

Leo Pharmaceuticals sponsored the trial.
We contacted Leo for patient outcome data.

There was the SD imputation (TSS).

Risk of bias

Bias

Authors' judgement

Support for judgement

Allocation concealment (selection bias)

Unclear risk

The trial reported insufficient details.

Blinding (performance bias and detection bias)
All outcomes

Low risk

The trial was double‐blind (participant/investigator).

Randomisation method reported

Unclear risk

The trial did not report this.

Loss to follow up

Low risk

9.1%

Baseline assessments

Low risk

Baseline comparability demonstrated

Low risk

Durakovic 2001

Methods

DESIGN
Within‐patient
Participant delivery
ALLOCATION
Random
Method of randomisation: not stated
Concealment: unclear
BLINDING
Double‐blind (participant/investigator)
WITHDRAWAL/DROPOUT
Described

Participants

N: 15

Treatment duration: 12 wks; FU: 20 wks

LF: 0 (0%)

BC: yes

Age: 49 (range = 27 to 76)

Gender (per cent men): 80%

Severity: TSS (0 to 24) = 13.7 (14.7SD)

INCLUSION CRITERIA

  • Chronic plaque psoriasis involving at least 5% BSA

  • Bilateral lesions of approximately 25 cm²

EXCLUSION CRITERIA

  • Systemic treatment within previous 30 days

  • Topical treatment within previous 1 day

  • History of hepatic or renal failure

  • Nephrolithiasis; hypercalcaemia

  • Hypercalciuria

  • Pregnancy

  • Lactation

  • Unwillingness in women to use effective contraception

Interventions

  • Hexafluoro‐1,25‐dihydroxyvitamin D₃ 5 mcg/g in 0.1g of ointment BD (F6)

  • Placebo ointment BD (P)

Outcomes

  1. Total Severity Score (0 to 24)

  2. PASI (0 to 72)

  3. Investigator’s assessment of global improvement (5‐pt: worsening to excellent improvement)

Notes

National Institutes of Health and by Penederm Inc. sponsored the trial.
8‐week follow up (open design: all participants received study drug) study also reported.

Risk of bias

Bias

Authors' judgement

Support for judgement

Allocation concealment (selection bias)

Unclear risk

The trial reported insufficient details.

Blinding (performance bias and detection bias)
All outcomes

Low risk

The trial was double‐blind (participant/investigator).

Randomisation method reported

Unclear risk

The trial did not report this.

Loss to follow up

Low risk

0.0%

Baseline assessments

Low risk

Baseline comparability demonstrated

Low risk

Durakovic 2004

Methods

DESIGN
Within‐patient
Participant delivery
ALLOCATION
Random
Method of randomisation: not reported
Concealment: unclear
BLINDING
Double‐blind (participant/investigator)
WITHDRAWAL/DROPOUT
Described

Participants

N: 11
Treatment duration: 12 wks; FU: 12 wks
LF: 0 (0%)
BC: yes
Age: 46 (range = 29 to 65)
Gender (per cent men): 72.7%
Severity: TSS (0 to 12) = 9.30
INCLUSION CRITERIA

  • Moderate plaque psoriasis

  • BSA ≥ 5%; 2 target lesions with diameter ≥ 5cm

  • Severity score (0 to 4) ≥ 2 for each of plaque elevation, scaling, and erythema

EXCLUSION CRITERIA

  • Previous topical therapy within previous 2 wks

  • Systemic therapy within previous 4 wks

  • Pregnancy or risk thereof

  • Lactation

  • Hepatic failure

  • Renal failure

  • Hypercalcaemia

  • Hypercalciuria

  • Hyperphosphataemia

  • Concurrent calcium supplements or drugs influencing calcium metabolism

Interventions

  • Paricalcitol (19‐nor‐1 alpha,25‐dihydroxyvitamin D₂) ointment 15 mcg/g OD (PC)

  • Placebo ointment OD (P)

Outcomes

  1. Global severity score (0 to 12) (erythema, plaque elevation, scaling)

  2. Global treatment success rates (IAGI) (4‐pt: excellent, moderate, mild, or no improvement)

Notes

The trial was sponsored in part by grant from the National Institutes for Health. US Abbott Laboratories supplied the study drug.

Risk of bias

Bias

Authors' judgement

Support for judgement

Allocation concealment (selection bias)

Unclear risk

The trial reported insufficient details.

Blinding (performance bias and detection bias)
All outcomes

Low risk

The trial was double‐blind (participant/investigator).

Randomisation method reported

Unclear risk

The trial did not report this.

Loss to follow up

Low risk

0.0%

Baseline assessments

Low risk

Baseline comparability demonstrated

Low risk

Duweb 2000

Methods

DESIGN
Between‐patient
Participant delivery
ALLOCATION
Random
Method of randomisation: not reported
Concealment: unclear
BLINDING
Unclear
WITHDRAWAL/DROPOUT
Described

Participants

N: 42

Treatment duration: 6 wks; FU: unclear

LF: 0 (0%)

BC: clinical only

Age: 33.5 (range = 6 to 61)

Gender (per cent men): 69%

Severity: TSS (0 to 12) = 5.2

INCLUSION CRITERIA

  • Psoriasis of the scalp

EXCLUSION CRITERIA

  • Not reported

Interventions

  • Calcipotriol 50 mcg/g/ml solution BD (C)

  • Betamethasone valerate 1% lotion BD (B)

Outcomes

  1. Redness, thickness, scaliness (0 to 4)

  2. Total Severity Score (0 to 12)

  3. Adverse events

Notes

Leo Pharmaceuticals sponsored the trial.
There was SD imputation (TSS).

Risk of bias

Bias

Authors' judgement

Support for judgement

Allocation concealment (selection bias)

Unclear risk

The trial reported insufficient details.

Blinding (performance bias and detection bias)
All outcomes

Unclear risk

The trial did not report this.

Randomisation method reported

Unclear risk

The trial did not report this.

Loss to follow up

Low risk

0.0%

Baseline assessments

Low risk

Baseline comparability demonstrated

Low risk

This was partially demonstrated.

Elie 1983

Methods

DESIGN
Between‐patient
Participant delivery
ALLOCATION
Random
Method of randomisation: unclear
Concealment: unclear
BLINDING
Double‐blind (participant/investigator)
WITHDRAWAL/DROPOUT
Described

Participants

N: 40 (55% psoriasis)

Treatment duration: 3 wks; FU: 3 wks

LF: not reported

BC: yes

Age: 36.5 (range = 20 to 63)

Gender (per cent men): 40%

Severity: not reported

INCLUSION CRITERIA

  • Moderate to severe psoriasis, seborrhoeic dermatitis, or neurodermatitis of the scalp

  • Adult

EXCLUSION CRITERIA

  • None reported

Interventions

  • Betamethasone‐17,21‐dipropionate, 0.05% BD (B)

  • Salicylic acid 2% BD (S)

  • Betamethasone‐17,21‐dipropionate, 0.05% + Salicylic acid 2% BD (BS)

  • Placebo (vehicle) (P)

Outcomes

  1. Investigator Global Assessment (5‐pt: very severe to clear)

  2. Severity (redness; scaling; pruritis)

  3. Area of lesion (cm²)

Notes

Schering Canada Inc. sponsored the trial.
This was a scalp trial.
There was SD imputation (TSS/IAGI).

Risk of bias

Bias

Authors' judgement

Support for judgement

Allocation concealment (selection bias)

Unclear risk

The trial reported insufficient details.

Blinding (performance bias and detection bias)
All outcomes

Low risk

The trial was double‐blind (participant/investigator).

Randomisation method reported

Unclear risk

The trial did not report this.

Loss to follow up

Unclear risk

The trial did not report this.

Baseline assessments

Low risk

These were partially done.

Baseline comparability demonstrated

Low risk

Ellis 1988

Methods

DESIGN
Between‐patient
Participant delivery
ALLOCATION
Random
Method of randomisation: computer‐generated randomisation list (1:1)
Concealment: unclear
BLINDING
Double‐blind (participant/investigator)
WITHDRAWAL/DROPOUT
Described

Participants

N: 165

Treatment duration: 3 wks; FU: 3 wks

LF: 33 (20%)

BC: yes

Age: 49.1 (range = 19 to 82)

Gender (per cent men): 51.6%

Severity: not reported

INCLUSION CRITERIA

  • Psoriasis of the scalp

  • Adult

  • TSS (0 to 12) ≥ 6

  • Particpants required to have psoriatic lesions elsewhere

EXCLUSION CRITERIA

  • Acute systemic illness

  • Active skin infection

  • Concomitant antihistamine, topical, or systemic corticosteroid, antimetabolites, PUVA, or other dermatological treatment

  • Recalcitrant psoriasis

  • Intolerance or hypersensitivity to topical corticosteroids

  • Pregnant or lactating

Interventions

  • Amcinonide lotion 0.1% OD (A)

  • Placebo (vehicle) (P)

Outcomes

  1. Severity (erythema; excoriation; scaling; induration, pruritis)

  2. Total Sign Score (erythema; scaling; induration, pruritis)

  3. Investigator's Overall Evaluation (7‐pt: cleared to exacerbation)

  4. Patient's Overall Evaluation (4‐pt: poor to excellent)

  5. Patient Acceptability Evaluation

Notes

The trial did not report sponsorship.
Compliance was checked by counting returned bottles.
This was a scalp trial.
There was SD imputation (TSS).

Risk of bias

Bias

Authors' judgement

Support for judgement

Allocation concealment (selection bias)

Unclear risk

The trial reported insufficient details.

Blinding (performance bias and detection bias)
All outcomes

Low risk

The trial was double‐blind (participant/investigator).

Randomisation method reported

Low risk

Randomisation was computer‐generated.

Loss to follow up

Low risk

20.0%

Baseline assessments

Low risk

Baseline comparability demonstrated

Low risk

Escobar 1992

Methods

DESIGN
Within‐patient
Participant delivery
ALLOCATION
Random
Method of randomisation: 'randomised code'
Concealment: unclear
BLINDING
Single‐blind (investigator)
WITHDRAWAL/DROPOUT
Described

Participants

N: 25

Treatment duration: 4 wks; FU: 8 wks

LF: 0 (0%)

BC: yes

Age: 40.3 (14.1SD); range = 18 to 66

Gender (per cent men): 56.0%

Severity: mean TSS (0 to 12) = 7.83

INCLUSION CRITERIA

  • Clinical and histopathological diagnosis of psoriasis

EXCLUSION CRITERIA

  • Systemic cytostatic/corticosteroid therapy within previous year

  • Renal, hepatic, haematological disease

  • NSAIDs, beta adrenergic receptor blockers, antimalarial drugs

Interventions

  • Fish oil plus 6‐hour occlusion OD (FO)

  • Liquid paraffin plus 6‐hour occlusion OD (LP)

Outcomes

  1. Erythema, scaling, thickening (0 to 4)

  2. Pruritis (VAS)

  3. Patient acceptability

Notes

The trial did not report sponsorship.
There was SD imputation (TSS).

Risk of bias

Bias

Authors' judgement

Support for judgement

Allocation concealment (selection bias)

Unclear risk

The trial reported insufficient details.

Blinding (performance bias and detection bias)
All outcomes

Low risk

The trial was single‐blind (investigator).

Randomisation method reported

Unclear risk

The trial did not report this.

Loss to follow up

Low risk

0.0%

Baseline assessments

Low risk

Baseline comparability demonstrated

Low risk

Farkas 1999

Methods

DESIGN
Between‐patient
Delivery unclear
ALLOCATION
Random
Method of randomisation: computer programme randomised participants in blocks of 10
Concealment: unclear
BLINDING
Open
WITHDRAWAL/DROPOUT
Described

Participants

N: 84

Treatment duration: 8 wks; FU: 12 wks

LF: 0 (0%)

BC: yes

Age: 45.1 (range = 18 to 69)

Gender (per cent men): 60.7%

Severity: mean PASI = 13.2%; BSA (mean) = 16.5%

INCLUSION CRITERIA

  • Chronic stable plaque psoriasis

  • Adults

  • White participants = 30% BSA

  • mPASI > 10

  • In‐ and outpatients

EXCLUSION CRITERIA

  • Recent topical, systemic, or UV therapies

  • Sensitivity to study medications

  • Concurrent medication

  • Abnormal hepatic or renal function

  • Risk of pregnancy

  • Pregnancy

  • Lactation

Serious co‐morbidity

Interventions

  • Tacalcitol ointment 4 mcg/g OD (T)

  • Dithranol stick 1.5% or 3% OD (D)

Outcomes

  1. PASI (modified to exclude head)

  2. Total Sign Score (erythema, infiltration, and desquamation)

  3. Investigator Global Assessment

  4. Patients evaluation of benefit (10‐pt)

  5. Investigator evaluation of efficacy and tolerability (1 = very good to 4 = very bad)

  6. Patient evaluation of efficacy and tolerability (1 = very good to 4 = very bad)

Notes

Hermal sponsored the trial.

Risk of bias

Bias

Authors' judgement

Support for judgement

Allocation concealment (selection bias)

Unclear risk

The trial reported insufficient details.

Blinding (performance bias and detection bias)
All outcomes

High risk

The trial was open.

Randomisation method reported

Low risk

A computer‐generated block list was used for randomisation.

Loss to follow up

Low risk

0.0%

Baseline assessments

Low risk

Baseline comparability demonstrated

Low risk

Feldman 2010 (1)

Methods

DESIGN
Between‐patient
Participant delivery
ALLOCATION
Random
Method of randomisation: not stated
Concealment: unclear
BLINDING
Double‐blind (participant/investigator)
WITHDRAWAL/DROPOUT
Described

Participants

N: 323
Treatment duration: 8 wks; FU: 8 wks
LF: 7 (2.2%)
BC: yes
Age: 47.8 (15.2SD)
Gender (per cent men): 48.3%
Per cent white: 90.7%
Severity: ISGA = mild disease: 26.9%; ISGA = moderate disease: 73.1%; SGA = 3.69 (0.89SD); % BSA = 6.4% (4.9SD)

INCLUSION CRITERIA

  • People aged ≥12 with mild to moderate plaque psoriasis

  • BSA: 2% to 20%

  • ISGA: 2 to 3

EXCLUSION CRITERIA

  • Known allergy to any component of formulation

  • Hypercalcaemia or history thereof

  • Pregnancy or risk thereof

  • Topical or systemic therapy within previous 4 wks

  • Previous participation in trial of study medication

Interventions

  • Calcipotriol foam 0.005% BD (C)

  • Placebo foam BD (P)

Outcomes

  1. Investigator Static Global Assessment (IGSA): scale unclear

  2. Treatment success: ISGA < = 1 (clear/almost clear) and minimum improvement from baseline of 2 points.

  3. Subject Global Assessment (SGA) (6‐pt: 0 = clear to 5 = severe)

  4. Signs: erythema, scaling, thickness (0 to 4)

Notes

STUDY 1: nCT00689481

Stiefel Laboratories, a GSK Company, sponsored the trial.

Atrophy was not reported.

We sought data, but they were not received. No usable effectiveness data were reported or available from sponsor.

Risk of bias

Bias

Authors' judgement

Support for judgement

Allocation concealment (selection bias)

Unclear risk

The trial reported insufficient details.

Blinding (performance bias and detection bias)
All outcomes

Low risk

The trial was double‐blind (participant/investigator).

Randomisation method reported

Unclear risk

The trial did not report this.

Loss to follow up

Low risk

2.2%

Baseline assessments

Low risk

These were reported.

Baseline comparability demonstrated

Low risk

This was demonstrated.

Feldman 2010 (2)

Methods

DESIGN
Between‐patient
Participant delivery
ALLOCATION
Random
Method of randomisation: not stated
Concealment: unclear
BLINDING
Double‐blind (participant/investigator)
WITHDRAWAL/DROPOUT
Described

Participants

N: 336
Treatment duration: 8 wks; FU: 8 wks
LF: 6 (1.8%)
BC: yes
Age: 48.7 (14.4SD)
Gender (per cent men): 60.4%
% white: 86.0%
Severity: ISGA = mild disease: 31.8%; ISGA = moderate disease: 68.2%; SGA = 3.69 (0.83SD); % BSA = 6.2% (4.8SD)

INCLUSION CRITERIA

  • People aged ≥12 with mild to moderate plaque psoriasis

  • BSA: 2% to 20%

  • ISGA: 2 to 3

EXCLUSION CRITERIA

  • Known allergy to any component of formulation

  • Hypercalcaemia or history thereof

  • Pregnancy or risk thereof

  • Topical or systemic therapy within previous 4 wks

  • Previous participation in trial of study medication

Interventions

  • Calcipotriol foam 0.005% BD (C)

  • Placebo foam BD (P)

Outcomes

  1. Investigator Static Global Assessment (IGSA): scale unclear

  2. Treatment success: ISGA < = 1 (clear/almost clear) and minimum improvement from baseline of 2 points

  3. Subject Global Assessment (SGA) (6‐pt: 0 = clear to 5 = severe)

  4. Signs: erythema, scaling, thickness (0 to 4)

Notes

STUDY 2: nCT00688519

Stiefel Laboratories, a GSK Company, sponsored the trial.

Atrophy was not reported.

We sought data, but they were not received. No usable effectiveness data were reported or available from sponsor.

Risk of bias

Bias

Authors' judgement

Support for judgement

Allocation concealment (selection bias)

Unclear risk

The trial reported insufficient details.

Blinding (performance bias and detection bias)
All outcomes

Low risk

The trial was double‐blind (participant/investigator).

Randomisation method reported

Unclear risk

The trial did not report this.

Loss to follow up

Low risk

1.8%

Baseline assessments

Low risk

These were reported.

Baseline comparability demonstrated

Low risk

This was demonstrated.

Fleming 2010 (H)

Methods

DESIGN
Between‐patient
Participant delivery
ALLOCATION
Random
Method of randomisation: computer‐generated schedule
Concealment: unclear
BLINDING
Double‐blind (participant/investigator)
WITHDRAWAL/DROPOUT
Described

Participants

N: 364

Treatment duration: 8 wks; FU: 10 wks

LF: 2 (0.5%)

BC: yes

Age: 51.1 (14.7SD)

Gender (per cent men): 58.8%

Per cent white: 98.1%

Severity: PASI (0 to 64.8) = 7.8 (4.4SD), range = 1 to 25; IGA = 2.97 (0.66SD), range = mild (2) to very severe (5)

Duration (yrs): 18.9 (13.8SD)

INCLUSION CRITERIA

  • People aged > = 18 with psoriasis vulgaris affecting the trunk and or limbs, amenable to treatment with < = 100 g topical medication/w

  • IGA at least mild

EXCLUSION CRITERIA

  • Guttate, erythrodermic, exfoliative or pustular psoriasis

  • Use of biological therapy within previous 6 mths

  • Use of systemic antipsoriatic therapy, PUVA, or grenz ray therapy with previous 4 wks

  • Topical or UVB therapy within previous 2 wks

  • Concomitant use of emollients during study

Interventions

  • Calcipotriol gel 50 mcg/g plus betamethasone dipropionate gel 0.5 mg/g OD (C‐B)

  • Calcipotriol gel 50 mcg/g OD (C)

  • Betamethasone dipropionate gel 0.5 mg/g OD (B)

Concomitant use of corticosteroids (WHO group I or II), dithranol, tar, and retinoids on face, scalp, and flexures was permitted.

Outcomes

  1. Investigator's Global Assessment (IGA) of disease severity; 6‐pt (clear, minimal disease, mild, moderate, severe, very severe); rescaled as clear (0) to very severe (5)

  2. Responder (IGA): If IGA moderate at wk 0: clear/minimal at wk 4 or 8. If IGA mild at wk 0: clear at wk 4 or 8

  3. PASI (modified) (0 to 64.8): change from baseline

  4. Treatment success: PASI75

  5. Adverse events

  6. Compliance

Notes

Leo Pharma, Ballerup, Denmark, sponsored the trial.

Compliance: mean weekly us =: C‐B: 22.7 g; C: 22.4g; B: 25.9 g
Most participants (73.5% to 80%) were fully compliant and those non‐compliant missed < 10% applications.

Safety data were available for 362/364 participants.

Leo Pharmaceuticals supplied unpublished data.

Risk of bias

Bias

Authors' judgement

Support for judgement

Allocation concealment (selection bias)

Unclear risk

The trial reported insufficient details.

Blinding (performance bias and detection bias)
All outcomes

Low risk

The trial was double‐blind (participant/investigator).

Randomisation method reported

Low risk

A computer‐generated randomisation schedule was used.

Loss to follow up

Low risk

0.5%

Baseline assessments

Low risk

These were reported.

Baseline comparability demonstrated

Low risk

This was demonstrated.

Fleming 2010 (P)

Methods

DESIGN
Between‐patient
Participant delivery
ALLOCATION
Random
Method of randomisation: computer‐generated schedule
Concealment: unclear
BLINDING
Double‐blind (participant/investigator)
WITHDRAWAL/DROPOUT
Described

Participants

N: 364
Treatment duration: 8 wks; FU: 10 wks
LF: 2 (0.5%)
BC: yes
Age: 51.1 (14.7SD)
Gender (per cent men): 58.8%
Per cent white: 98.1%
Severity: PASI (0 to 64.8) = 7.8 (4.4SD), range = 1 to 25; IGA = 2.97 (0.66SD), range = mild (2) to very severe (5)

Duration (yrs): 18.9 (13.8SD)

INCLUSION CRITERIA

  • People aged > = 18 with psoriasis vulgaris affecting the trunk and or limbs, amenable to treatment with < = 100 g topical medication/w

  • IGA at least mild

EXCLUSION CRITERIA

  • Guttate, erythrodermic, exfoliative or pustular psoriasis

  • Use of biological therapy within previous 6 mths

  • Use of systemic antipsoriatic therapy, PUVA, or grenz ray therapy with previous 4 wks

  • Topical or UVB therapy within previous 2 wks

  • Concomitant use of emollients during study

Interventions

  • Calcipotriol gel 50 mcg/g plus betamethasone dipropionate gel 0.5 mg/g OD (C‐B)

  • Calcipotriol gel 50 mcg/g OD (C)

  • Betamethasone dipropionate gel 0.5 mg/g OD (B)

  • Placebo gel OD (P)

Concomitant use of corticosteroids (WHO group I or II), dithranol, tar, and retinoids on face, scalp, and flexures were permitted.

Outcomes

  1. Investigator's Global Assessment (IGA) of disease severity; 6‐pt (clear, minimal disease, mild, moderate, severe, very severe); rescaled as clear (0) to very severe (5)

  2. Responder (IGA): If IGA moderate at wk 0: clear/minimal at wk 4 or 8. If IGA mild at wk 0: clear at wk 4 or 8

  3. PASI (modified) (0 to 64.8): change from baseline

  4. Treatment success: PASI75

  5. Adverse events

  6. Compliance

Notes

Leo Pharma, Ballerup, Denmark, sponsored the trial.

Compliance: mean weekly us =: C‐B: 22.7 g; C: 22.4g; B: 25.9 g; P: 26.1 g
Most participants (73.5% to 80%) were fully compliant and those non‐compliant missed < 10% applications.

Safety data were available for 362/364 participants.

Leo Pharmaceuticals supplied unpublished data.

Risk of bias

Bias

Authors' judgement

Support for judgement

Allocation concealment (selection bias)

Unclear risk

The trial reported insufficient details.

Blinding (performance bias and detection bias)
All outcomes

Low risk

The trial was double‐blind (participant/investigator).

Randomisation method reported

Low risk

A computer‐generated randomisation schedule was used.

Loss to follow up

Low risk

0.5%

Baseline assessments

Low risk

These were reported.

Baseline comparability demonstrated

Low risk

This was demonstrated.

Franz 1999

Methods

DESIGN
Between‐patient
Participant delivery
ALLOCATION
Random
Method of randomisation: unclear
Concealment: unclear
BLINDING
Double‐blind (participant/investigator)
WITHDRAWAL/DROPOUT
Described

Participants

N: 190

Treatment duration: 2 wks; FU: 4 wks

LF: 18 (9.5%)

BC: yes

Age: 49.6

Gender (per cent men): 49.3%

Severity: mean TSS (0 to 12) = 7.92

INCLUSION CRITERIA

  • Moderate to severe scalp psoriasis (each of 3 primary signs ≥ 2)

  • Scalp involvement ≥10%

  • Adults

EXCLUSION CRITERIA

  • Systemic psoriatic therapy within previous 4 wks

  • Topical scalp preparations within previous 2 wks

Interventions

  • Betamethasone valerate foam 0.1% BD

  • Placebo foam BD

  • Betamethasone valerate lotion 0.1% BD

  • Placebo lotion BD

Findings reported for foam and lotion combined:

  • Betamethasone (B)

  • Placebo (P)

Outcomes

  1. Erythema, scaling, thickness, pruritis

  2. IAGI (7‐pt: worse to completely clear)

  3. PAGI (7‐pt: worse to completely clear)

Notes

Connectics Corporation sponsored by the trial.
This was a scalp trial.
There was SD imputation (TSS).

Risk of bias

Bias

Authors' judgement

Support for judgement

Allocation concealment (selection bias)

Unclear risk

The trial reported insufficient details.

Blinding (performance bias and detection bias)
All outcomes

Low risk

The trial was double‐blind (participant/investigator).

Randomisation method reported

Unclear risk

The trial did not report this.

Loss to follow up

Low risk

9.5%

Baseline assessments

Low risk

Baseline comparability demonstrated

Low risk

Franz 2000

Methods

DESIGN
Between‐patient
Participant delivery
ALLOCATION
Random
Method of randomisation: not reported
Concealment: unclear
BLINDING
Double‐blind (participant/investigator)
WITHDRAWAL/DROPOUT
Described

Participants

N: 188

Treatment duration: 2 wks; FU: 4 wks

LF: 0 (0%)

BC: unclear

Age: not reported

Gender (per cent men): 49.5%

Severity: mean TSS (0 to 12) = 7.25

INCLUSION CRITERIA

  • Moderate to severe scalp psoriasis (each of 3 primary signs ≥ 2)

  • Scalp involvement ≥10%

  • Adults

EXCLUSION CRITERIA

  • Not reported

Interventions

  • Clobetasol propionate foam 0.05% BD

  • Placebo foam BD

  • Clobetasol propionate lotion 0.05% BD

  • Placebo lotion BD

Findings reported for foam and lotion combined:

  • Clobetasol (C)

  • Placebo (P)

Outcomes

  1. Signs: erythema, scaling, thickness, pruritis

  2. TSS (0 to 12)

  3. IAGI (7‐pt: worse to completely clear)

  4. PAGI (7‐pt: worse to completely clear)

Notes

Connectics Corporation sponsored by the trial.
This was a scalp trial.
There was SD imputation (TSS).

Risk of bias

Bias

Authors' judgement

Support for judgement

Allocation concealment (selection bias)

Unclear risk

The trial reported insufficient details.

Blinding (performance bias and detection bias)
All outcomes

Low risk

The trial was double‐blind (participant/investigator).

Randomisation method reported

Unclear risk

The trial did not report this.

Loss to follow up

Low risk

0.0%

Baseline assessments

Low risk

These were partially done.

Baseline comparability demonstrated

Unclear risk

The trial did not report this.

Geilen 2000

Methods

DESIGN
Within‐patient
Nurse delivery
ALLOCATION
Random
Method of randomisation: not reported
Concealment: unclear
BLINDING
Double‐blind (participant/investigator)
WITHDRAWAL/DROPOUT
Described

Participants

N: 7

Treatment duration: 3 wks; FU: 3 wks

LF: 0 (0%)

BC: yes

Age: 36 to 67

Gender (per cent men): 100%

Severity: TSS (0 to 8) = 6.72 (0.76SD)

INCLUSION CRITERIA

  • Chronic plaque psoriasis

EXCLUSION CRITERIA

  • Not reported

Interventions

  • Mycophenolic acid ointment 1% plus occlusion OD (M)

  • Placebo ointment plus occlusion OD (P)

Outcomes

  1. TSS (erythema induration) (0 to 8)

Notes

The trial did not report sponsorship.

Risk of bias

Bias

Authors' judgement

Support for judgement

Allocation concealment (selection bias)

Unclear risk

The trial reported insufficient details.

Blinding (performance bias and detection bias)
All outcomes

Low risk

The trial was double‐blind (participant/investigator).

Randomisation method reported

Unclear risk

The trial did not report this.

Loss to follow up

Low risk

0.0%

Baseline assessments

Low risk

These were partially done.

Baseline comparability demonstrated

Low risk

Gottlieb 2003

Methods

DESIGN
Between‐patient
Participant delivery
ALLOCATION
Random
Method of randomisation: not reported
Conducted in 17 centres; stratification not reported
Concealment: unclear
BLINDING
Double‐blind (participant/investigator)
WITHDRAWAL/DROPOUT
Described

Participants

N: 279

Treatment duration: 2 wks; FU: 4 wks

LF: 8 (2.9%)

BC: yes (clinical only)

Age: 47 (range = 19 to 82)

Gender (per cent men): 57%

Severity: BSA = 6.7%

INCLUSION CRITERIA

  • Aged 18 to over

  • Mild to moderate chronic plaque psoriasis of non‐scalp regions

  • 2 > PSGA > 3; BSA < = 20%

  • Target lesion > 2 cm² on trunk or extremities with PGSA between 2 and 3 for each of erythema, scaling, and plaque thickness

EXCLUSION CRITERIA

  • Known allergy to study medications or other topical corticosteroids

  • Systemic therapy within previous 8 wks

  • Topical corticosteroid therapy or retinoids within previous 4 wks

  • Other topical therapy within previous 2 wks

  • Expected exposure to strong sunlight/UVB therapy during study period

  • Pregnancy or risk thereof

  • Lactation

Interventions

  • Clobetasol foam (OLUX®) 0.05% BD (C)

  • Placebo foam BD (P)

Limit of 50 g of medication/wk to non‐scalp sites only

Outcomes

  1. Signs and symptoms of psoriasis (6‐pt scale for each: induration, erythema, scaling, pruritis)

  2. Physician's Static Global Assessment (PGSA) (6‐pt: 0 = clear to 5 = majority of lesions have individual scores that average 5 on a 6‐pt scale)

  3. Proportion of patients with PSGA score < = 1 at 2 wks

  4. Mean change in Total Sign Scores (0 to 15)

  5. Patient Global Assessment (PGA) (6‐pt: 0 = no psoriasis; 5 = worst during current exacerbation)

  6. Patient assessment of likely compliance

  7. Patient assessment of cosmetic acceptability

Notes

Connetics Corporation sponsored the trial.
There was SD imputation (TSS).

Risk of bias

Bias

Authors' judgement

Support for judgement

Allocation concealment (selection bias)

Unclear risk

The trial reported insufficient details.

Blinding (performance bias and detection bias)
All outcomes

Low risk

The trial was double‐blind (participant/investigator).

Randomisation method reported

Unclear risk

The trial did not report this.

Loss to follow up

Low risk

Baseline assessments

Low risk

Baseline comparability demonstrated

Low risk

This was partially demonstrated.

Grattan 1997 (H)

Methods

DESIGN
Within‐patient
Delivery unclear
ALLOCATION
Random
Method of randomisation: pre‐determined randomisation schedule
Concealment: unclear
BLINDING
Open
WITHDRAWAL/DROPOUT
Described

Participants

N: 25

Treatment duration: 4 wks; FU: 16 weeks

LF: not reported

BC: yes

Age: 44.0 (range = 20 to 72)

Gender (per cent men): 52.0%)

Severity: BSA = 16.1% (range = 4.1% to 47.8%); TSS (target sites) = 6.3 (range = NR)

INCLUSION CRITERIA

  • Bilateral stable chronic plaque psoriasis

  • Adult

  • Hospitalised for routine dithranol treatment

EXCLUSION CRITERIA

  • Intolerance of dithranol

  • Unstable or pustular psoriasis

  • Calcium metabolism disorders

  • Systemic psoriasis treatment

  • Recent UVB or PUVA therapy

  • Pregnancy or lactation

Interventions

  • Calcipotriol ointment 0.005% BD (C)

  • Dithranol in aqueous gel (dose titration 0.1% to 2.0%) BD (D)

Outcomes

  1. Severity (erythema; scaling; palpability)

  2. Total Severity Score

  3. Patient assessment of irritation (VAS)

  4. Investigator assessment of skin staining (none, mild, moderate, or severe)

Notes

There was inpatient treatment to ensure high level of compliance.
Dermal Laboratories sponsored the trial.

Risk of bias

Bias

Authors' judgement

Support for judgement

Allocation concealment (selection bias)

Unclear risk

The trial reported insufficient details.

Blinding (performance bias and detection bias)
All outcomes

High risk

The trial was open.

Randomisation method reported

Unclear risk

The trial did not report this.

Loss to follow up

Unclear risk

The trial did not report this.

Baseline assessments

Low risk

These were reported.

Baseline comparability demonstrated

Low risk

This was demonstrated.

Grattan 1997 (P)

Methods

DESIGN
Within‐patient
Delivery unclear
ALLOCATION
Random
Method of randomisation: pre‐determined randomisation schedule
Concealment: unclear
BLINDING
Open
WITHDRAWAL/DROPOUT
Described

Participants

N: 12

Treatment duration: 4 wks: FU: 16 wks

LF: 0 (0%)

BC: yes

Age: 50.3 (range = 33 to 75)

Gender (per cent men): 33% (4/12)

Severity: BSA 17.1% (range = 4.7% to 45.7%); TSS = 6.3 (range = 5 to 7)

INCLUSION CRITERIA

  • Bilateral stable chronic plaque psoriasis

  • Adult

  • Hospitalised for routine dithranol treatment

EXCLUSION CRITERIA

  • Intolerance of dithranol

  • Unstable or pustular psoriasis

  • Calcium metabolism disorders

  • Systemic psoriasis treatment

  • Recent UVB or PUVA therapy

  • Pregnancy or lactation

Interventions

  • Dithranol in aqueous gel (dose titration 0.1 to 2.0%) BD (D)

  • Placebo (vehicle) (P)

Outcomes

  1. Severity (erythema; scaling; palpability)

  2. Total Severity Score, patient assessment of irritation (VAS)

  3. Investigator assessment of skin staining (none, mild, moderate, or severe)

Notes

There was inpatient treatment to ensure high level of compliance.
Dermal Laboratories sponsored the trial.

Risk of bias

Bias

Authors' judgement

Support for judgement

Allocation concealment (selection bias)

Unclear risk

The trial reported insufficient details.

Blinding (performance bias and detection bias)
All outcomes

High risk

The trial was open.

Randomisation method reported

Unclear risk

The trial did not report this.

Loss to follow up

Low risk

0.0%

Baseline assessments

Low risk

Baseline comparability demonstrated

Low risk

Green 1994

Methods

DESIGN
Between‐patient
Participant delivery
ALLOCATION
Random
Method of randomisation: not reported
Concealment: unclear
BLINDING
Double‐blind (participant/investigator)
WITHDRAWAL/DROPOUT
Described

Participants

N: 49

Treatment duration: 4 wks; FU: 4 wks

LF: 3 (6.1%)

BC: unclear

Age: not reported

Gender (per cent men): not reported

Severity: mean TSS (0 to 12) = 6.7

INCLUSION CRITERIA

  • Mild to moderate scalp psoriasis and a history of psoriasis elsewhere on the body

  • Adult

EXCLUSION CRITERIA

  • Excessively thick scalp psoriasis

  • Other scalp disease

  • Marked deterioration of scalp psoriasis at entry

  • Recent systemic or UV therapy

  • Concurrent topical corticosteroid use

  • Vitamin D or calcium supplement

  • Medications that could affect the course of the disease

  • Hypercalcaemia

  • Hepatic or renal disease

  • At risk of pregnancy

Interventions

  • Calcipotriol solution 50 mcg/ml BD (C)

  • Placebo (vehicle) (P)

Outcomes

  1. Signs (erythema; thickness; scaliness; flaking; itching)

  2. Total Sign Score (redness, thickness, scaliness)

  3. Investigator Global Assessment

  4. Patient Global Assessment

Notes

Leo Pharmaceutical Products sponsored the trial.
Compliance was assessed by unused medication returned at each visit. The compliance rate for participants in each group was > 90%.
This was a scalp trial.

Risk of bias

Bias

Authors' judgement

Support for judgement

Allocation concealment (selection bias)

Unclear risk

The trial reported insufficient details.

Blinding (performance bias and detection bias)
All outcomes

Low risk

The trial was double‐blind (participant/investigator).

Randomisation method reported

Unclear risk

The trial did not report this.

Loss to follow up

Low risk

6.1%

Baseline assessments

Low risk

These were partially done.

Baseline comparability demonstrated

Unclear risk

The trial did not report this.

Greenspan 1993

Methods

DESIGN
Between‐patient
Participant delivery
ALLOCATION
Random
Method of randomisation: not reported
Concealment: unclear
BLINDING
Double‐blind (participant/investigator)
WITHDRAWAL/DROPOUT
Described

Participants

N: 80

Treatment duration: 3 wks; FU: 3 wks

LF: 9 (11.3%)

BC: unclear

Age: 51.5 (range = 20 to 77)

Gender (per cent men): 43.8%

Severity: not reported

INCLUSION CRITERIA

  • Mild to moderate psoriasis

EXCLUSION CRITERIA

  • Recent systemic or topical treatment for psoriasis

  • Contraindication to low‐potency corticosteroids

  • Pregnant, nursing, or planning pregnancy

Interventions

  • Desonide lotion 0.05% TDS (DL)

  • Desonide cream 0.05% TDS (DC)

  • Placebo (vehicle lotion) (P)

Outcomes

  1. Severity (erythema; scaling; induration; pruritis)

  2. Investigator Global Assessment

Notes

The trial did not report sponsorship, but 3 of the authors were employed by Owen/Galderma laboratories.
There was SD imputation (IAGI).

Risk of bias

Bias

Authors' judgement

Support for judgement

Allocation concealment (selection bias)

Unclear risk

The trial reported insufficient details.

Blinding (performance bias and detection bias)
All outcomes

Low risk

The trial was double‐blind (participant/investigator).

Randomisation method reported

Unclear risk

The trial did not report this.

Loss to follow up

Low risk

11.3%

Baseline assessments

Low risk

These were partially done.

Baseline comparability demonstrated

Unclear risk

The trial did not report this.

Gribetz 2004

Methods

DESIGN
Between‐patient
Participant delivery
ALLOCATION
Random
Method of randomisation: 'validated system that automates the random assignment of treatment codes'
Concealment: adequate
BLINDING
Double‐blind (participant/investigator)
WITHDRAWAL/DROPOUT
Described

Participants

N: 57

Treatment duration: 8 wks; FU: 8 wks

LF: 6 (10.5%)

BC: yes

Age: 47.8 (range = 21 to 88)

Gender (per cent men): 50.9%

Severity: PGA, per cent moderate = 72%; PGA, per cent severe = 29.8%; TSS = 5.34 (range = 3.0 to 9.0)

INCLUSION CRITERIA

  • Stable chronic plaque psoriasis

  • Moderate to severe inverse psoriasis affecting axillae, inguinal, inframammary, or gluteal cleft regions (duration ≥ 6 mths)

  • PGA ≥ 3

  • Erythema ≥ 2

  • Aged ≥ 18

EXCLUSION CRITERIA

  • Clinically significant laboratory abnormalities

  • Hypersensitivity to study drug or vehicle

  • Systemic, phototherapy, or immuno‐modifying agents within previous 30 dys

  • Topical therapies within previous 14 dys

  • Unstable plaque psoriasis, pustular, drug associated or erythrodermic psoriasis

Interventions

  • Pimecrolimus cream (Elidel®) 1% BD (PM)

  • Placebo cream BD (P)

Outcomes

  1. Investigator's Global Assessment of overall severity (PGA) (5‐pt: clear to severe disease)

  2. Target Area Score (TSS) (erythema, induration, scaling) (0 to 9)

  3. Patient Self‐Assessment (control of psoriasis over previous 1 wk) (4‐pt: 0 = complete control; 3 = uncontrolled)

Notes

Novartis Pharmaceuticals Group sponsored the trial.
No instances of skin atrophy were reported.
This was an inverse psoriasis trial.

Risk of bias

Bias

Authors' judgement

Support for judgement

Allocation concealment (selection bias)

Low risk

Novartis supplied identical tubes identified only by randomisation number (participants and investigators blinded to tube contents).

Blinding (performance bias and detection bias)
All outcomes

Low risk

The trial was double‐blind (participant/investigator).

Randomisation method reported

Low risk

Randomisation was by a validated system that automated the random assignment of treatment codes.

Loss to follow up

Low risk

10.5%

Baseline assessments

Low risk

These were reported.

Baseline comparability demonstrated

Low risk

Guenther 2000

Methods

DESIGN
Between‐patient
Participant delivery
ALLOCATION
Random
Method of randomisation: not reported
Concealment: unclear
BLINDING
Single‐blind (investigator)
WITHDRAWAL/DROPOUT
Described

Participants

N: 120

Treatment duration: 8 wks; FU: 20 wks

LF: 14 (11.7%)

BC: yes

Age: 48.5

Gender (per cent men): 60.8%

Severity: not reported

INCLUSION CRITERIA

  • Stable chronic plaque psoriasis

  • BSA involvement between 5% and 20%

  • Adult

EXCLUSION CRITERIA

  • Pregnancy

  • Lactation

  • Unreliable contraception

  • Unstable plaque psoriasis

  • Other types of psoriasis or other concomitant dermatological disorder

  • Hypercalaemia

  • Uncontrolled systemic disease

  • Likelihood of prolonged UV exposure

  • Concomitant systemic or topical therapies that might affect psoriasis

  • Adherence to washout requirements

Interventions

  • Tazarotene gel, 0.1% ON, plus mometasone furoate cream 0.1% OM (TM)

  • Calcipotriol ointment 0.005% BD (C)

12 weeks' maintenance for both groups with emollient only.

Outcomes

  1. IAGI (0 to 6; exacerbation to complete clearance)

  2. Erythema, scaling, thickness (0 to 4 for each)

  3. BSA involvement

  4. Patient assessments (efficacy, comfort of skin; outlook for long‐term control; overall impression of treatment)

  5. Adverse events

Notes

Allergan Inc. sponsored the trial.

Risk of bias

Bias

Authors' judgement

Support for judgement

Allocation concealment (selection bias)

Unclear risk

The trial reported insufficient details.

Blinding (performance bias and detection bias)
All outcomes

Unclear risk

The trial was single‐blind (investigator).

Randomisation method reported

Unclear risk

The trial did not report this.

Loss to follow up

Low risk

11.7%

Baseline assessments

Low risk

Baseline comparability demonstrated

Low risk

Guenther 2002 (H)

Methods

DESIGN
Between‐patient
Participant delivery
ALLOCATION
Random
Method of randomisation: computer‐generated random numbers table
Concealment: adequate
BLINDING
Double‐blind (participant/investigator)
WITHDRAWAL/DROPOUT
Described

Participants

N: 828

Treatment duration: 4 wks; FU: 4 wks

LF: 10 (1.2%)

BC: yes

Age: 48.5 (14.3SD)

Gender (per cent men): 64.0%

Severity: mean PASI = 10.5; mean duration psoriasis = 18.3 yrs

INCLUSION CRITERIA

  • Aged 18 to 86

  • Chronic plaque psoriasis

  • BSA involvement ≥ 10%

EXCLUSION CRITERIA

  • Systemic therapy within previous 6 wks

  • Topical antipsoriatic therapy within previous 2 wks

  • Concurrent use of type III/IV topical corticosteroids

  • Recent UV exposure

  • Pregnancy

  • Lactation

  • Concurrent use of other medicines that could affect course of psoriasis

Interventions

  • Calcipotriol (50 mcg/g) and betamethasone dipropionate (0.5 mg/g) ointment ON, plus placebo OM (D1)

  • Calcipotriol (50 mcg/g) and betamethasone dipropionate (0.5 mg/g) ointment BD (D2)

  • Calcipotriol BD (C)

  • Placebo BD (P)

Outcomes

  1. PASI (head excluded)

  2. IAGI (6‐pt: worse to clearance)

  3. PAGI (6‐pt: worse to clearance)

  4. Percentage change in thickness score

  5. Speed of response (PASI) at 1 week

  6. Adverse events

  7. Quality of life: Psoriasis Disability Index; EQ‐5D and EQ‐VAS (reported in van de Kerkhof 2004)

Notes

Leo Pharmaceuticals sponsored the trial.
The trial was conducted across 57 centres in 8 countries.

Risk of bias

Bias

Authors' judgement

Support for judgement

Allocation concealment (selection bias)

Low risk

All study personnel and participants were blinded to treatment assignment for the duration of the study.

Blinding (performance bias and detection bias)
All outcomes

Low risk

The trial was double‐blind (participant/investigator).

Randomisation method reported

Low risk

Randomisation was computer‐generated.

Loss to follow up

Low risk

1.2%

Baseline assessments

Low risk

Baseline comparability demonstrated

Low risk

Guenther 2002 (P)

Methods

DESIGN
Between‐patient
Participant delivery
ALLOCATION
Random
Method of randomisation: computer‐generated random numbers table
Concealment: adequate
BLINDING
Double‐blind (participant/investigator)
WITHDRAWAL/DROPOUT
Described

Participants

N: 828
Treatment duration: 4 wks; FU: 4 wks
LF: 10 (1.2%)
BC: yes
Age: 48.5 (14.3SD)
Gender (per cent men): 64.0%
Severity: mean PASI = 10.5; mean duration psoriasis = 18.3 yrs

INCLUSION CRITERIA

  • Aged 18 to 86

  • Chronic plaque psoriasis

  • BSA involvement ≥ 10%

EXCLUSION CRITERIA

  • Systemic therapy within previous 6 wks

  • Topical antipsoriatic therapy within previous 2 wks

  • Concurrent use of type III/IV topical corticosteroids

  • Recent UV exposure

  • Pregnancy

  • Lactation

  • Concurrent use of other medicines that could affect course of psoriasis

Interventions

  • Calcipotriol (50 mcg/g) and betamethasone diproprionate (0.5 mg/g) ointment ON, plus placebo, OM (D1)

  • Calcipotriol (50 mcg/g) and betamethasone diproprionate (0.5 mg/g) ointment BD (D2)

  • Calcipotriol BD (C)

  • Placebo BD (P)

Outcomes

  1. PASI (head excluded)

  2. IAGI (6‐pt: worse to clearance)

  3. PAGI (6‐pt: worse to clearance)

  4. Percentage change in thickness score

  5. Speed of response (PASI) at 1 week

  6. Adverse events

  7. Quality of life: Psoriasis Disability Index; EQ‐5D and EQ‐VAS (reported in van de Kerkhof 2004)

Notes

Leo Pharmaceuticals sponsored the trial.
The trial was conducted across 57 centres in 8 countries.

Risk of bias

Bias

Authors' judgement

Support for judgement

Allocation concealment (selection bias)

Low risk

All study personnel and participants were blinded to treatment assignment for the duration of the study.

Blinding (performance bias and detection bias)
All outcomes

Low risk

The trial was double‐blind (participant/investigator).

Randomisation method reported

Low risk

Randomisation was computer‐generated.

Loss to follow up

Low risk

1.2%

Baseline assessments

Low risk

These were reported.

Baseline comparability demonstrated

Low risk

Han 2001

Methods

DESIGN
Between‐patient
Participant delivery
ALLOCATION
Random
Method of randomisation: not reported
Concealment: unclear
BLINDING
Open
WITHDRAWAL/DROPOUT
Described

Participants

N: 208

Treatment duration: 12 wks; FU: 12 wks

LF: 9 (4.3%)

BC: yes

Age: 40.4 (8.9SD)

Gender (per cent men): 59.8%

Severity: TSS (0 to 20) = 16.1 (11.0SD)

Duration (yrs): 9.4 (8.9SD)

INCLUSION CRITERIA

  • People with chronic plaque psoriasis

  • Aged between 18 and 65

  • BSA between 2% and 30%

EXCLUSION CRITERIA

  • Known allergy to study drug constituents

  • History of other skin diseases

  • Pustular or erythrodermic psoriasis

  • Topical treatments within previous 2 wks

  • PUVA within previous 4 wks

  • UVB within previous 2 wks

  • Alcohol or drug abuse

  • Renal, hepatic, or immunity disorder

  • Pregnancy or risk thereof

  • Lactation

  • Participation in another clinical trial within previous 4 wks

  • Other morbidity likely to affect outcome or raise safety issues

Interventions

  • Tazarotene gel 0.05% OD (T)

  • Calcipotriol ointment 5 mcg/g BD (C)

Outcomes

  1. TSS (0 to 20)

  2. Proportion of patients achieving effective response

  3. Curative rate

Notes

The trial did not report sponsorship.

Translation support was received for data extraction.

Risk of bias

Bias

Authors' judgement

Support for judgement

Allocation concealment (selection bias)

Unclear risk

The trial reported insufficient details.

Blinding (performance bias and detection bias)
All outcomes

High risk

The trial was open.

Randomisation method reported

Unclear risk

The trial did not report this.

Loss to follow up

Low risk

4.3%

Baseline assessments

Low risk

These were reported.

Baseline comparability demonstrated

Low risk

Harrington 1996a

Methods

DESIGN
Between‐patient
Participant delivery
ALLOCATION
Random
Method of randomisation: not reported
Concealment: unclear
BLINDING
Double‐blind (participant/investigator)
WITHDRAWAL/DROPOUT
Described

Participants

N: 413

Treatment duration: 8 wks; FU: 8 wks

LF: 47 (11.4%)

BC: yes, except average age in placebo group higher than for A and B (P = 0.02)

Age: 44.6

Gender (per cent men): 52.8%

Severity: PASI (modified) = 8.3 (range = 0.6 to 59.4)

Duration (yrs): 17.7 (range = 0.04 to 70)

INCLUSION CRITERIA

  • Stable chronic plaque psoriasis on trunk or limbs

  • Adult

EXCLUSION CRITERIA

  • Recent systemic medication or phototherapy for psoriasis

  • Hepatic or renal disease

  • Raised serum calcium

  • Calcium supplements or vitamin D

Interventions

  • Calcipotriol cream 50 mcg/g BD as follows:

    • Cream A (dissolved) (CA)

    • Cream B (suspended) (CB)

  • Placebo (vehicle of A) (P)

Outcomes

  1. PASI (modified to exclude head)

  2. Investigator Global Assessment

  3. Patient Global Assessment

Notes

Leo Pharmaceuticals sponsored the trial.

Risk of bias

Bias

Authors' judgement

Support for judgement

Allocation concealment (selection bias)

Unclear risk

The trial reported insufficient details.

Blinding (performance bias and detection bias)
All outcomes

Low risk

The trial was double‐blind (participant/investigator).

Randomisation method reported

Unclear risk

The trial did not report this.

Loss to follow up

Low risk

11.4%

Baseline assessments

Low risk

Baseline comparability demonstrated

Unclear risk

This was partially demonstrated.

Helfrich 2007

Methods

DESIGN
Between‐patient
Participant delivery
ALLOCATION
Random
Method of randomisation: unclear (method inadequately described)
Concealment: unclear (inadequately described)
BLINDING
Double‐blind (participant/investigator/assessor)
WITHDRAWAL/DROPOUT
Described

Participants

N: 185

Treatment duration:  8 wks; FU: 8 wks

LF: 3 (1.6%)

BC: yes

Age: 49.0 (range = 19 to 83)

Gender (per cent men): 56.8%

Severity: PGA = 3.2 (range = 3 to 4); PSS = 8.1 (range = 4.7 to 12)

Ethnicity (per cent white): NR

Duration: 17.3 (range = 0.5 to 65)

INCLUSION CRITERIA

  • People aged 18 and over with chronic plaque psoriasis affecting 2% to 10% BSA with severity "appropriate" for topical therapy

  • PGA score: > = 3

EXCLUSION CRITERIA

  • Topical therapies within previous 2 wks

  • Systemic/UV therapy within previous 4 wks

  • Biological within previous 6 mths

  • Oral vitamin D (> 400 IU/day), oral calcium (> 1200 mg/day) within previous 30 days

  • Pregnancy or risk thereof

  • Lactation

  • Significant medial comorbidity

  • Sensitivity to study drug

  • Concomitant antipsoriatics therapy, immunosuppressive drugs, lithium, hydoxycholoroquine, or biologicals

  • Non‐compliance with dosing of study medication

Interventions

  • Becocalcidiol ointment 75 mcg/g BD (B2)

  • Becocalcidiol ointment 75 mcg/g ON and placebo OM (B1)

  • Placebo ointment BD (P)

Max: 8 g ointment/day

Participants were permitted concurrent oral vitamin D (= < 400 IU/day), oral calcium (< = 1200 mg/day), or both; or tar shampoo for scalp psoriasis.

Outcomes

  1. Physician's Static Global Assessment of Overall Lesion Severity (PGA) (6‐point scale: clear to very severe)

  2. Psoriasis Symptom Severity  (PSS) score (0 to 12): sum of scores for erythema, scaling, induration (each scored 0 to 4)

  3. Adverse events

  4. Laboratory evaluations

  5. Compliance (participants who missed > 6 consecutive doses discontinued the study)

Notes

QuatRx Pharmaceuticals (product now owned by Deltanoid Pharmaceuticals) sponsored the trial.

The sponsor supplied unpublished data.

Risk of bias

Bias

Authors' judgement

Support for judgement

Allocation concealment (selection bias)

Unclear risk

The trial reported insufficient details.

Blinding (performance bias and detection bias)
All outcomes

Low risk

The trial was double‐blind (participant and investigator/assessor).

Randomisation method reported

Unclear risk

The trial did not report this.

Loss to follow up

Low risk

1.6%

Baseline assessments

Low risk

These were reported.

Baseline comparability demonstrated

Low risk

This was demonstrated (clinical and demographic).

Henneicke‐v. Z. 1993

Methods

DESIGN
Within‐patient (placebo)
Between‐patient (active)
Participant delivery
ALLOCATION
Random
Method of randomisation: not reported
Concealment: unclear
BLINDING
Double‐blind (participant/investigator)
WITHDRAWAL/DROPOUT
Described

Participants

N: 73

Treatment duration: 8 wks; FU: 8 wks

LF: 21 (28.8%)

BC: yes

Age: 40.5 (median); range = 18 to 71 (N = 52)

Gender (per cent men): 65.8% (N = 73)

Severity: TSS (0 to 12) = 7.4

INCLUSION CRITERIA

  • Aged 18 to 71

  • Moderate plaque psoriasis

  • 9 >TSS ≥ 4

EXCLUSION CRITERIA

  • Systemic antipsoriatic drugs within previous 4 wks

  • UV therapy within previous wk

  • Drug‐induced psoriasis

  • Cancer

  • Pregnancy

  • Lactation

  • Severe organ dysfunction

  • Metabolic disorders

  • Abuse of drugs or alcohol

Interventions

  • Omega‐3‐polyunsaturated fatty acids ointment 1% BD (O3(1))

  • Placebo (vehicle) 1% BD

  • Omega‐3‐polyunsaturated fatty acids ointment 10% BD (O3(10))

  • Placebo (vehicle) 10% BD (P)

Outcomes

  1. Local psoriasis severity index (TSS equivalent): erythema, induration, desquamation

  2. Area of indicator lesion

  3. Pruritis

  4. Investigator's subjective intra‐individual comparison (left side better than right side)

  5. Patient's subjective intra‐individual comparison (left side better than right side)

  6. Compliance: tube weight compared with expected use

Notes

The trial did not report sponsorship.

Risk of bias

Bias

Authors' judgement

Support for judgement

Allocation concealment (selection bias)

Unclear risk

The trial reported insufficient details.

Blinding (performance bias and detection bias)
All outcomes

Low risk

The trial was double‐blind (participant/investigator).

Randomisation method reported

Unclear risk

The trial did not report this.

Loss to follow up

High risk

28.8%

Baseline assessments

Low risk

These were reported.

Baseline comparability demonstrated

Low risk

Highton 1995

Methods

DESIGN
Between‐patient
Participant delivery
ALLOCATION
Random
Method of randomisation: not reported
Concealment: unclear
BLINDING
Double‐blind (participant/investigator)
WITHDRAWAL/DROPOUT
Described

Participants

N: 277

Treatment duration: 8 wks

LF: 30 (10.8%)

BC: clinical severity comparable, demographics unclear

Age: not reported

Gender (per cent men): not reported

Severity: TSS (0 to 8) = 3.90; BSA = 9.1%

INCLUSION CRITERIA

  • Moderately severe stable plaque psoriasis

  • Plaque elevation score greater than or equal to 4 (0 to 8)

  • Not pregnant or nursing during the duration of the study

EXCLUSION CRITERIA

  • Recent topical or systemic psoriasis treatment, prolonged exposure to sunlight, phototherapy

  • Photochemotherapy

  • Hypercalcemia

  • Erythrodermic or pustular psoriasis

  • Calcium, vitamin A or D supplements

Interventions

  • Calcipotriene ointment 0.005% BD (C)

  • Placebo (vehicle) (P)

Outcomes

  1. Severity (erythema; plaque elevation; scaling; overall disease severity)

  2. 75% improvement scores

  3. Investigator Global Assessment (7‐pt: worse to completely clear)

Notes

Bristol Myers Squibb sponsored the trial.
There was SD imputation (TSS).

Risk of bias

Bias

Authors' judgement

Support for judgement

Allocation concealment (selection bias)

Unclear risk

The trial reported insufficient details.

Blinding (performance bias and detection bias)
All outcomes

Low risk

The trial was double‐blind (participant/investigator).

Randomisation method reported

Unclear risk

The trial did not report this.

Loss to follow up

Low risk

10.8%

Baseline assessments

Low risk

These were partially done.

Baseline comparability demonstrated

Unclear risk

This was partially demonstrated.

Hindsén 2006 (H)

Methods

DESIGN
Between‐patient
Participant delivery
ALLOCATION
Random
Method of randomisation: not stated
Concealment: unclear
BLINDING
Double‐blind (participant/investigator)
WITHDRAWAL/DROPOUT
Not described

Participants

N: 360

Treatment duration: 2 or 6 wks; FU: 6 or 10 wks

LF: NR

BC: not demonstrated

Age: NR

Gender (per cent men): NR

Severity: NR

INCLUSION CRITERIA

  • People with moderately severe plaque psoriasis on elbows, knees, or both

EXCLUSION CRITERIA

  • Not stated

Interventions

  • Calcipotriol ointment 50 mcg/g BD (no occlusion) for 6 wks (C)

  • Calcipotriol ointment 50 mcg/g plus occlusion, once/week for 2 wks (CO)

[Placebo ointment plus occlusion, once/week for 2 wks (P)]

Outcomes

  1. Total Sign Score (redness, thickness, scaliness) (TSS): 0 to 24

Notes

Leo Pharma, Ballerup, sponsored the trial.

It was unclear how participants were blinded to treatment options where 2/3 involved occlusion.

The sponsor supplied unpublished data.

Risk of bias

Bias

Authors' judgement

Support for judgement

Allocation concealment (selection bias)

Unclear risk

The trial reported insufficient details.

Blinding (performance bias and detection bias)
All outcomes

Unclear risk

The trial was reported to be double‐blind (participant/investigator), but it was unclear how they blinded participants to treatment options where 2/3 involved occlusion.

Randomisation method reported

Unclear risk

The trial did not report this.

Loss to follow up

Unclear risk

The trial did not report this.

Baseline assessments

Unclear risk

The trial did not report these.

Baseline comparability demonstrated

Unclear risk

This was not demonstrated.

Hindsén 2006 (P)

Methods

DESIGN
Between‐patient
Participant delivery
ALLOCATION
Random
Method of randomisation: not stated
Concealment: unclear
BLINDING
Double‐blind (participant/investigator)
WITHDRAWAL/DROPOUT
Not described

Participants

N: 360
Treatment duration: 2 or 6 wks; FU: 6 or 10 wks
LF: NR
BC: not demonstrated
Age: NR
Gender (per cent men): NR
Severity: NR
INCLUSION CRITERIA

  • People with moderately severe plaque psoriasis on elbows, knees, or both

EXCLUSION CRITERIA

  • Not stated

Interventions

  • Calcipotriol ointment 50 mcg/g, BD (no occlusion) for 6 wks (C)

  • Calcipotriol ointment 50 mcg/g plus occlusion, once/week for 2 wks (CO)

  • Placebo ointment plus occlusion, once/week for 2 wks (P)

Outcomes

  1. Total Sign Score (redness, thickness, scaliness) (TSS): 0 to 24

Notes

Leo Pharma, Ballerup, sponsored the trial.

It was unclear how participants were blinded to treatment options where 2/3 involved occlusion.

The sponsor supplied unpublished data.

Risk of bias

Bias

Authors' judgement

Support for judgement

Allocation concealment (selection bias)

Unclear risk

The trial reported insufficient details.

Blinding (performance bias and detection bias)
All outcomes

Unclear risk

The trial was reported to be double‐blind (participant/investigator), but it was unclear how they blinded participants to treatment options where 2/3 involved occlusion.

Randomisation method reported

Unclear risk

The trial did not report this.

Loss to follow up

Unclear risk

The trial did not report this.

Baseline assessments

Unclear risk

The trial did not report these.

Baseline comparability demonstrated

Unclear risk

This was not demonstrated.

Holick 2003

Methods

DESIGN
Within‐patient
Participant delivery
ALLOCATION
Random
Method of randomisation: not reported
Concealment: unclear
BLINDING
Double‐blind (participant/investigator)
WITHDRAWAL/DROPOUT
Described

Participants

N: 15

Treatment duration: 8 wks; FU: 8 wks

LF: 0 (0%)

BC: not reported

Age: 56 (range = 25 to 74)

Gender (per cent men): 67 %

Severity: not reported

INCLUSION CRITERIA

  • Chronic plaque psoriasis

  • 2 symmetrically comparable plaques

  • Failure to respond to at least 1 standard treatment

EXCLUSION CRITERIA

  • Kidney disease, hypercalcaemia, hypercalciuria

  • Systemic therapy within previous 30 days

  • Topical therapy within previous 14 days

  • Concomitant medications that interfere with calcium metabolism

Interventions

  • Parathyroid hormone (PTH) (1 to 34) 20 mcg/g in Novasome A® liposomal cream BD (PTH)

  • Novasome A® liposomal cream BD (P)

Outcomes

  1. Global severity score (0 to 24)

  2. PASI (for open trial phase only)

Notes

The National Institutes for Health (Department of Health and Human Services) and the Department of Defense Small Business Innovation Research (SBIR) Program sponsored the trial through grants.
The trial also reported a uncontrolled open, large area, study for N = 10 (PTH applied OD for up to 11 months).

Risk of bias

Bias

Authors' judgement

Support for judgement

Allocation concealment (selection bias)

Unclear risk

The trial reported insufficient details.

Blinding (performance bias and detection bias)
All outcomes

Low risk

The trial was double‐blind (participant/investigator).

Randomisation method reported

Unclear risk

The trial did not report this.

Loss to follow up

Low risk

0.0%

Baseline assessments

Low risk

These were partially done.

Baseline comparability demonstrated

Unclear risk

The trial did not report this.

Huang 2009

Methods

DESIGN
Between‐patient
Participant delivery
ALLOCATION
Random
Method of randomisation: unclear
Concealment: unclear
BLINDING
Double‐blind (participant/investigator)
WITHDRAWAL/DROPOUT
Described

Participants

N: 320

Treatment duration: 4 wks; FU: 4 wks

LF: 0 (0%)

BC: stated no significant difference in clinical or demographic characteristics (data not shown)

Age: NR

Gender (per cent men): NR

Severity: NR

INCLUSION CRITERIA

  • Chinese people aged 18 to 65 with stable plaque psoriasis

  • At least 1 area (or arm, leg, body) with mPASI score > = 2 (i.e. % BSA > = 10% of affected area)

EXCLUSION CRITERIA

  • Psoriasis of the face

  • Severe disease requiring steroids or other systemic medication

  • % BSA > = 30%

  • Use of systemics during previous 4 weeks, topicals during previous 2 weeks

  • Participation in another trial during previous 3 months

  • Iodine deficiency, hypercalcaemia, Cushing's Syndrome, diabetes, or other metabolic disease

  • Heart disease, kidney disease, liver disease

  • Immunesuppression

  • Cancer

  • Mental disorder

  • Failure to consent

  • Pregnancy or risk thereof

  • Lactation

  • Investigator opinion of unsuitability

Interventions

  • Calcipotriol ointment BD (C)

  • Calcipotriol betamethasone ointment ON, placebo OM (C‐B)

Participant gave written consent to use < = 100 g/wk.

Outcomes

  1. mPASI (0 to 64.8)

  2. Treatment success: PASI75

  3. TSS (redness, thickness, scaliness) (0 to 12)

  4. DLQI

  5. Adverse events

  6. Laboratory tests: urine, blood, biochemistry, liver function, electrolytes, serum calcium

  7. Atrophy, telangiectasias

Notes

The trial did not report sponsorship.

We received translation support from native speaker.

Risk of bias

Bias

Authors' judgement

Support for judgement

Allocation concealment (selection bias)

Unclear risk

The trial reported insufficient details.

Blinding (performance bias and detection bias)
All outcomes

Low risk

The trial was double‐blind (participant/investigator).

Randomisation method reported

Unclear risk

The trial did not report this.

Loss to follow up

Low risk

0%

Baseline assessments

Unclear risk

The trial authors state these were undertaken.

Baseline comparability demonstrated

Unclear risk

The trial authors state that groups were comparable at baseline (not demonstrated).

Hutchinson 2000

Methods

DESIGN
Between‐patient
Participant delivery
ALLOCATION
Random
Method of randomisation: not reported
Concealment: unclear
BLINDING
Open
WITHDRAWAL/DROPOUT
Described

Participants

N: 114

Treatment duration: 8 wks; FU: 8 wks

LF: 28 (24.6%)

BC: yes

Age: 42.3

Gender (per cent men): 74.4%

Severity: PASI (mean) = 11.8

Duration of psoriasis (mths) (mean): 185.1 (range = 1 to 85)

INCLUSION CRITERIA

  • Chronic plaque psoriasis of at least moderate severity

  • Aged over 18

  • White or Asian origin

EXCLUSION CRITERIA

  • Systemic or intralesional therapy or photo‐chemotherapy within previous 2 mths

  • Topical antipsoriatics within previous wk or concomitant

  • Other medications that could affect psoriasis

  • Pregnancy

  • Inadequate contraception

Interventions

  • Calcitriol ointment 3 mcg/g BD (C)

  • Short contact dithranol 0.25 to 2% OD (D)

Outcomes

  1. PASI

  2. IAGI (6‐pt: worse to clearing)

  3. Overall global severity (5‐pt: none to very severe)

  4. Psoriasis Disability Index (quality of life) (scale NR)

  5. Cosmetic acceptability (1 = good/none to 3 = not acceptable): staining, irritation

  6. Adverse events

Notes

The trial did not report sponsorship.

Risk of bias

Bias

Authors' judgement

Support for judgement

Allocation concealment (selection bias)

Unclear risk

The trial reported insufficient details.

Blinding (performance bias and detection bias)
All outcomes

High risk

The trial was open.

Randomisation method reported

Unclear risk

The trial did not report this.

Loss to follow up

Unclear risk

24.6%

Baseline assessments

Low risk

These were reported.

Baseline comparability demonstrated

Low risk

This was demonstrated.

Jarratt 2004

Methods

DESIGN
Between‐patient
Participant delivery
ALLOCATION
Random
Method of randomisation: computer‐generated list
Concealment: unclear
BLINDING
Double‐blind (participant/investigator)
WITHDRAWAL/DROPOUT
Unclear

Participants

N: 142

Treatment duration: 4 wks; FU: 6 wks

LF: 1 (0.7%)

BC: yes

Age: 45.1 (15.37SD)

Gender (per cent men): 42.3%

Severity: TSS (0 to 9) = 6.6; GSS (6‐pt (rescaled: 0 = very severe to 5 = clear) = 1.65 (0.61SD), N = 142

INCLUSION CRITERIA

  • Aged 12 or over

  • Moderate to severe scalp psoriasis (global severity score ≥ 3)

  • Compliance with wash‐out periods for systemic therapies (details not reported)

EXCLUSION CRITERIA

  • Pregnancy or risk thereof

  • Known allergy to test products

  • Need for systemic therapy or other concomitant antipsoriatics

  • Excessive UV exposure

Interventions

  • Clobetasol propionate shampoo 0.05% OLUX® OD (C)

  • Placebo shampoo OD (P)

  • Treatments applied OD, left to dry for 15 minutes, then washed out

  • Placebo represented by vehicle for clobetasol propionate

Outcomes

  1. Global severity score (GSS) (6‐pt: 0 = clear to 5 = very severe)

  2. Total Severity Score (erythema, thickening, scaling) (TSS) (0 to 9)

  3. Individual sign scores for erythema, thickening, scaling pruritis, per cent scalp involvement (4‐pt: 0 = none to 3 = severe)

  4. IAGI (5‐pt: worse to clear)

  5. PAGI (5‐pt: worse to clear)

Notes

Galderma R&D Inc sponsored the trial.
Missing data imputed using last observation carried forward.
No cases of skin atrophy, teleangiectasia, or acne were reported.
This was a scalp trial.
There was SD imputation (TSS).

Risk of bias

Bias

Authors' judgement

Support for judgement

Allocation concealment (selection bias)

Unclear risk

The trial reported insufficient details.

Blinding (performance bias and detection bias)
All outcomes

Low risk

The trial was double‐blind (participant/investigator).

Randomisation method reported

Low risk

Loss to follow up

Low risk

0.7%

Baseline assessments

Low risk

Baseline comparability demonstrated

Low risk

Jarratt 2006

Methods

DESIGN
Between‐patient
Participant delivery
ALLOCATION
Random
Method of randomisation: not stated
Concealment: unclear
BLINDING
Double‐blind (participant/investigator)
WITHDRAWAL/DROPOUT
Described

Participants

N: 120

Treatment duration: 4 wks; FU: 8 wks

LF: 0 (0%)

BC: yes

Age: 48.0 (12.9SD)

Gender (per cent men): 60.0%

Severity: % BSA = 7.69% (6.17%SD); ODS (moderate) = 90.8%; ODS (severe/very severe) = 9.2%

Ethnicity (per cent white): 94.2%

Duration: NR

INCLUSION CRITERIA

  • People aged 18 and over with moderate to severe chronic plaque psoriasis

  • BSA > = 2% (excluding face, scalp, groin, axillae, and other intertriginous areas)

  • Overall disease severity score (0 to 4) > = 3

EXCLUSION CRITERIA

  • Non‐compliance with treatment specific wash‐out periods on topical and systemic treatments or phototherapy or natural UV light (periods NS)

  • Pregnancy or risk thereof

Interventions

  • Clobetasol propionate 0.05% spray BD (CP)

  • Placebo spray BD (P)

Then 4‐week treatment‐free follow‐up period.

There was 8 hrs between applications, and the treated area was unwashed for 4 hours after application.

Outcomes

  1. Scaling, erythema, plaque elevation, pruritus, overall disease severity (ODS) each scored on 5‐pt scale (0 = clear to 4 = severe/very severe)

  2. Success rate: ODS < = 2 at wk 2 and ODS < = 1 at wk 4

  3. ODS at wk 1 and wk 8

  4. Signs at wk 1 and wk 8

  5. ODS < = 1 at wk 8

  6. Adverse events (atrophy, telangiectasia, burning/stinging, folliculitis); HPA axis suppression

Notes

Galderma Pharmaceuticals sponsored the trial.

The trial also reported CIC data on a safety RCT (2 or 4 wks with clobetasol propionate 0.05% spray, < = 50 g/wk): 8/36 had HPA suppression; all returned to normal within 2 wks of end of treatment (EOT).

The trialist supplied unpublished data.

Risk of bias

Bias

Authors' judgement

Support for judgement

Allocation concealment (selection bias)

Unclear risk

The trial reported insufficient details.

Blinding (performance bias and detection bias)
All outcomes

Low risk

The trial was double‐blind (participant/investigator).

Randomisation method reported

Unclear risk

The trial did not report this.

Loss to follow up

Low risk

0%

Baseline assessments

Low risk

The trial reported these.

Baseline comparability demonstrated

Low risk

This was demonstrated.

Jekler 1992

Methods

DESIGN
Within‐patient
Participant delivery
ALLOCATION
Random
Method of randomisation: not reported
Concealment: unclear
BLINDING
Double‐blind (participant/investigator)
WITHDRAWAL/DROPOUT
Described

Participants

N: 30

Treatment duration: 8 wks

LF: 3 (10%)

BC: not reported

Age: 45.2 (14.0SD; N = 27)

Gender (per cent men): 77.8%; N = 27

Severity: severity (mean score, 0 to 3) = 1.9; N = 27

Duration disease (years): 20.5 (14.8SD; N = 27)

Duration exacerbation (mths): 5.1 (6.4SD; N = 27)

INCLUSION CRITERIA

  • Chronic plaque‐type psoriasis with bilateral lesions of equal clinical severity

  • Adult.

EXCLUSION CRITERIA

  • Topical or systemic corticosteroids

  • Recent phototherapy

Interventions

  • Dithranol 2% ointment 1 minute therapy OD (D)

  • Placebo (vehicle) (P)

Outcomes

  1. Severity (pruritis; erythema; scaling; infiltration; overall result)

  2. Investigator's assessment of degree of clearing

  3. Patient's assessment of degree of clearing

Notes

E Merck AB sponsored the trial.

Risk of bias

Bias

Authors' judgement

Support for judgement

Allocation concealment (selection bias)

Unclear risk

The trial reported insufficient details.

Blinding (performance bias and detection bias)
All outcomes

Low risk

The trial was double‐blind (participant/investigator).

Randomisation method reported

Unclear risk

The trial did not report this.

Loss to follow up

Low risk

10.0%

Baseline assessments

Low risk

Baseline comparability demonstrated

Unclear risk

The trial did not report this.

Jemec 2008 (H)

Methods

DESIGN
Between‐patient
Participant delivery
ALLOCATION
Random
Method of randomisation: pre‐planned computer‐generated randomisation code list (2:4:4:1)
Concealment: unclear
BLINDING
Double‐blind (participant/investigator)
WITHDRAWAL/DROPOUT
Described

Participants

N: 1505

Treatment duration: 8 wks; FU: 8 wks

LF: 32 (2.1%)

BC: yes

Age: 49.0 (15.8SD); range = 17 to 97

Gender (per cent men): 44.8%

Ethnicity (per cent white): 96.3%

Severity: IGA mild disease = 6.5%; IGA moderate disease = 56.2%; IGA severe disease = 31.6%; IGA very severe disease = 5.7%; TSS (0 to 12) = 6.82 (1.85SD)

Duration (yrs): 16.5 (13.6SD)

INCLUSION CRITERIA

  • People aged > = 18 with scalp plaque psoriasis involving > = 10% scalp

  • Amenable to topical treatment with < = 100 g medication/wk

  • Diagnosis of psoriasis vulgaris on trunk/limbs

  • Score at least moderate in 1 sign (erythema, thickness, scaliness) and at least slight for other signs

  • IGA mild to very severe

EXCLUSION CRITERIA

  • PUVA or grenz ray or relevant systemic therapy within previous 4 wks

  • UVB or topical scalp antipsoriatic therapy or topical very potent (WHO group IV) corticosteroid on face/body within previous 2 wks

  • Biological therapy within previous 6 mths

  • Planned initiation of/changes to concomitant medication that could affect scalp psoriasis

  • Planned exposure to sun

  • Erythrodermic, exfoliative, or postural psoriasis

  • Viral lesions

  • Skin infections

  • Parasitic infections

  • Atrophic skin on scalp

  • Known/suspected abnormality of calcium homeostasis

  • Severe renal insufficiency

  • Severe hepatic disorder

Interventions

  • Calcipotriol 50 mcg/g gel OD (C)

  • Betamethasone dipropionate 0.5 mg/g gel OD (B)

  • Combined gel: calcipotriol 50 mcg/g + betamethasone dipropionate 0.5 mg/g OD (C‐B)

  • Placebo gel OD (P)

Outcomes

  1. Total Sign Score (0 to 12)

  2. Investigator's Global Assessment of Disease Severity of the scalp (IGA): 6‐pt: absence of disease to very severe disease

  3. Treatment success: IGA absence of disease or very mild disease

  4. Patient overall assessment of treatment response on a 7‐pt scale (worse, unchanged, slight improvement, moderate improvement, marked improvement, almost clear, cleared)

  5. Compliance (self‐report)

  6. Adverse events

  7. Laboratory tests (serum calcium, serum albumin)

Notes

Leo Pharma A/S, Ballerup, Denmark, sponsored the trial.

The sponsor supplied unpublished data.

Risk of bias

Bias

Authors' judgement

Support for judgement

Allocation concealment (selection bias)

Unclear risk

The trial reported insufficient details.

Blinding (performance bias and detection bias)
All outcomes

Low risk

The trial was double‐blind (participant/investigator).

Randomisation method reported

Low risk

A preplanned computer‐generated randomisation code list was used.

Loss to follow up

Low risk

2.1%

Baseline assessments

Low risk

These were reported.

Baseline comparability demonstrated

Low risk

This was demonstrated.

Jemec 2008 (P)

Methods

DESIGN
Between‐patient
Participant delivery
ALLOCATION
Random
Method of randomisation: pre‐planned computer‐generated randomisation code list (2:4:4:1)
Concealment: unclear
BLINDING
Double‐blind (participant/investigator)
WITHDRAWAL/DROPOUT
Described

Participants

N: 1505
Treatment duration: 8 wks; FU: 8 wks
LF: 32 (2.1%)
BC: yes
Age: 49.0 (15.8SD); range = 17 to 97
Gender (per cent men): 44.8%
Ethnicity (% white): 96.3%
Severity: IGA mild disease = 6.5%; IGA moderate disease = 56.2%; IGA severe disease = 31.6%; IGA very severe disease = 5.7%; TSS (0 to 12) = 6.82 (1.85SD)

Duration (yrs): 16.5 (13.6SD)

INCLUSION CRITERIA

  • People aged > = 18 with scalp plaque psoriasis involving > = 10% scalp

  • Amenable to topical treatment with < = 100 g medication/wk

  • Diagnosis of psoriasis vulgaris on trunk/limbs

  • Score at least moderate in 1 sign (erythema, thickness, scaliness) and at least slight for other signs

  • IGA mild to very severe

EXCLUSION CRITERIA

  • PUVA or grenz ray or relevant systemic therapy within previous 4 wks

  • UVB or topical scalp antipsoriatic therapy or topical very potent (WHO group IV) corticosteroid on face/body within previous 2 wks

  • Biological therapy within previous 6 mths

  • Planned initiation of/changes to concomitant medication that could affect scalp psoriasis

  • Planned exposure to sun

  • Erythrodermic, exfoliative, or postural psoriasis

  • Viral lesions

  • Skin infections

  • Parasitic infections

  • Atrophic skin on scalp

  • Known/suspected abnormality of calcium homeostasis

  • Severe renal insufficiency

  • Severe hepatic disorder

Interventions

  • Calcipotriol 50 mcg/g gel OD (C)

  • Betamethasone dipropionate 0.5 mg/g gel OD (B)

  • Combined gel: calcipotriol 50 mcg/g + betamethasone dipropionate 0.5 mg/g OD (C‐B)

  • Placebo gel OD (P)

Outcomes

  1. Total Sign Score (0 to 12)

  2. Investigator's Global Assessment of Disease Severity of the scalp (IGA): 6‐pt: absence of disease to very severe disease

  3. Treatment success: IGA absence of disease or very mild disease

  4. Patient overall assessment of treatment response on a 7‐pt scale (worse, unchanged, slight improvement, moderate improvement, marked improvement, almost clear, cleared)

  5. Compliance (self‐report)

  6. Adverse events

  7. Laboratory tests (serum calcium, serum albumin)

Notes

Leo Pharma A/S, Ballerup, Denmark, sponsored the trial.

The sponsor supplied unpublished data.

Risk of bias

Bias

Authors' judgement

Support for judgement

Allocation concealment (selection bias)

Unclear risk

The trial reported insufficient details.

Blinding (performance bias and detection bias)
All outcomes

Low risk

The trial was double‐blind (participant/investigator).

Randomisation method reported

Low risk

A preplanned computer‐generated randomisation code list was used.

Loss to follow up

Low risk

2.1%

Baseline assessments

Low risk

These were reported.

Baseline comparability demonstrated

Low risk

This was demonstrated.

Ji 2008

Methods

DESIGN
Between‐patient
Participant delivery
ALLOCATION
Random
Method of randomisation: not stated
Concealment: unclear
BLINDING
Single‐blind (investigator)
WITHDRAWAL/DROPOUT
Described

Participants

N: 250
Treatment duration: 12 wks; FU: 12 wks
LF: 7 (2.8%)
BC: yes
Age: 41.7 (12.2SD)
Gender (per cent men): 65.6%
Ethnicity (per cent Asian): 100%
Severity: per cent BSA = 18%, range = 1% to 35%; DSS (0 to 12) = 8.12 (1.97SD), range = 3 to 12

INCLUSION CRITERIA

  • People aged 18 to 65 with stable mild to moderate plaque psoriasis

  • BSA < = 35%

  • Diameter of target lesions > = 3 cm

EXCLUSION CRITERIA

  • Pregnancy or risk thereof

  • Acute guttate psoriasis

  • Erythrodermic, pustular, arthropathic psoriasis

  • Hypercalcaemia

  • Renal dysfunction

  • Calcium nephrolithiasis

  • Use of topical antipsoriatic therapy within previous 2 wks

  • Use of systemic antipsoriatic therapy within previous 8 wks

Interventions

  • Calcipotriol 50 mcg/g ointment BD (C1)

  • Calcitriol 3 mcg/g BD (C2)

Usage restrictions:

    • < = 210 g/wk calcitriol

    • < = 100 g/wk calcipotriol

Outcomes

  1. Investigator's Assessment of Global Improvement (IAGI; 4‐pt: 0 = worse/no change to 3 = clear/almost clear)

  2. Subject's Assessment of Global Improvement (PAGI) (4‐pt: 0 = worse/no change to 3 = clear/almost clear)

  3. Dermatological Sum Score (DSS): erythema, plaque elevation, scaling: 0 to 12

  4. Local: cutaneous safety (investigator): 5‐pt: 0 (none) to 4 (very severe); cutaneous discomfort (subject): 5‐pt: 0 (none) to 4 (very severe)

  5. Adverse events

  6. Systemic: routine blood and urine safety parameters, albumin‐adjusted serum total calcium

  7. Compliance (medication usage)

Notes

Galderma Laboratories LP sponsored the trial.

The trial was set in China.

We received translation support for data extraction.

Risk of bias

Bias

Authors' judgement

Support for judgement

Allocation concealment (selection bias)

Unclear risk

The trial reported insufficient details.

Blinding (performance bias and detection bias)
All outcomes

High risk

The study was single‐blind (investigator).

Randomisation method reported

Unclear risk

The trial did not report this.

Loss to follow up

Low risk

2.8%

Baseline assessments

Low risk

These were reported.

Baseline comparability demonstrated

Low risk

This was demonstrated.

Jin 2001

Methods

DESIGN
Between‐patient
Participant delivery
ALLOCATION
Random
Method of randomisation:
Not stated
Concealment: unclear
BLINDING
Double‐blind (participant/investigator)
WITHDRAWAL/DROPOUT
Described

Participants

N: 96

Treatment duration: 6 wks; FU: 6 wks

LF: 7 (7.3%)

BC: yes

Age: 35.8 (range = 18 to 65)

Gender (per cent men): 57.3%

Severity: TSS (0 to 20) = 9.4

INCLUSION CRITERIA

  • Chronic plaque psoriasis

  • Aged over 18? (cannot translate)

EXCLUSION CRITERIA

  • (cannot translate)

Interventions

  • Anti‐IL‐8 monoclonal antibody cream (M)

  • Placebo (P)

Outcomes

  1. Efficacy rate

  2. Cure rate

  3. Erythema, infiltration, scaling, pruritis

  4. TSS (skin damage, erythema, infiltration, thickness, scaling)

  5. IAGI (4‐pt: failure to cure)

Notes

Biological Technical Medical Trade Limited sponsored the trial.

We received translation support for data extraction.

Risk of bias

Bias

Authors' judgement

Support for judgement

Allocation concealment (selection bias)

Unclear risk

The trial reported insufficient details.

Blinding (performance bias and detection bias)
All outcomes

Low risk

The trial was double‐blind (participant/investigator).

Randomisation method reported

Unclear risk

The trial did not report this.

Loss to follow up

Low risk

7.3%

Baseline assessments

Low risk

These were reported.

Baseline comparability demonstrated

Low risk

Jorizzo 1997

Methods

DESIGN
Between‐patient
Participant delivery
ALLOCATION
Random
Method of randomisation: not reported
Concealment: unclear
BLINDING
Double‐blind (participant/investigator)
WITHDRAWAL/DROPOUT
Described

Participants

N: 89

Treatment duration: 4 wks; FU: 6 wks

LF: Unclear

BC: yes

Age: 49.7 (range = 21 to 84)

Gender (per cent men): 65%

Severity: per cent BSA affected = 8.1%

Duration of psoriasis (range, years): 1 to 57

Duration of exacerbation (range, wks): 3 to 2080

INCLUSION CRITERIA

  • Moderate to severe plaque type psoriasis

  • Non‐hospitalised men or non‐pregnant; non‐lactating women ≥ 12 yrs

  • Baseline morning serum cortisol concentration of 5 to 18 mcg/100 mL

EXCLUSION CRITERIA

  • Recent topical antipsoriatic medication or other drug that could alter psoriatic status

Interventions

  • Clobetasol propionate emollient 0.05% BD (C)

  • Placebo (vehicle) (P)

Outcomes

  1. Severity (erythema; skin thickening; scaling; pruritis)

  2. Total Severity Score (0 to 12)

  3. Investigator Global Assessment of improvement (6‐pt: worse to cleared)

  4. Patient Global Assessment of improvement (5‐pt: worse to excellent)

Notes

Glaxo Wellcome Inc. sponsored the trial.
There was SD imputation (TSS).

Risk of bias

Bias

Authors' judgement

Support for judgement

Allocation concealment (selection bias)

Unclear risk

The trial reported insufficient details.

Blinding (performance bias and detection bias)
All outcomes

Low risk

The trial was double‐blind (participant/investigator).

Randomisation method reported

Unclear risk

The trial did not report this.

Loss to follow up

Unclear risk

The trial did not report this.

Baseline assessments

Low risk

These were reported.

Baseline comparability demonstrated

Low risk

Jorizzo 2007

Methods

DESIGN
Between‐patient
Participant delivery
ALLOCATION
Random
Method of randomisation: not stated
Concealment: unclear
BLINDING
Double‐blind (participant/investigator)
WITHDRAWAL/DROPOUT
Not described

Participants

N: 379

Treatment duration: 6 wks; FU: 6 wks

LF: NR

BC: yes (only clinical comparability demonstrated)

Age: NR

Gender (per cent men): NR

Severity: PASI = 7.9 (5.3SD); IGA moderate = 76.2%; IGA severe = 22.2%

INCLUSION CRITERIA

  • People with moderate to severe plaque psoriasis

EXCLUSION CRITERIA

  • Not stated

Interventions

  • Calcipotriene 0.005% ointment (C)

  • Calcipotriene 0.005% plus betamethasone dipropionate 0.064% ointment (C‐B)

< = 100 g/wk ‐ the daily dose was not specified.

Outcomes

  1. PASI

  2. Investigator Global Assessment (IGA)

  3. Controlled disease (IGA: absence. very mild disease)

  4. Patient Global Assessment of Improvement (PAGI)

  5. Treatment success (PAGI marked improvement/cleared)

Notes

Warner‐Chilcott sponsored the trial.

This was a conference abstract only.

We sought data but received no response.

There was SD imputation (PASI).

Risk of bias

Bias

Authors' judgement

Support for judgement

Allocation concealment (selection bias)

Unclear risk

The trial reported insufficient details.

Blinding (performance bias and detection bias)
All outcomes

Low risk

The trial was double‐blind (participant/investigator).

Randomisation method reported

Unclear risk

The trial did not report this.

Loss to follow up

Unclear risk

The trial did not report this.

Baseline assessments

Unclear risk

The trial only reported clinical assessments (demographic characteristics not reported).

Baseline comparability demonstrated

Unclear risk

This was partially demonstrated (demographic characteristics not assessed).

Kang 1998

Methods

DESIGN
Between‐patient
Participant delivery
ALLOCATION
Random
Method of randomisation: identical tubes with computer‐generated codes
Concealment: adequate
BLINDING
Double‐blind (participant/investigator)
WITHDRAWAL/DROPOUT
Described

Participants

N: 30

Treatment duration: 6 wks

LF: 0 (0%)

BC: psoriasis comparable, demographics unclear

Age: 41 (range = 18 to 66)

Gender (per cent men): 66.7%

Severity: TSS (0 to 24) = 12.27

INCLUSION CRITERIA

  • Mild to moderate stable plaque‐type psoriasis

  • Adult

EXCLUSION CRITERIA

  • Recent systemic therapy, UV, or topical therapy for psoriasis (excluding emollient) 

  • Pregnant or breast‐feeding women

Interventions

  • Calcipotriene ointment 0.005% BD (C)

  • Placebo (vehicle) (P)

Outcomes

  1. Signs (erythema; thickness; scaling)

  2. TSS (0 to 24)

  3. Investigator Global Assessment (7‐pt: worse to clear)

Notes

Bristol‐Myers Squibb Corporation and from Babcock Dermatologic Endowment (University of Michigan) sponsored the trial through grants.

Risk of bias

Bias

Authors' judgement

Support for judgement

Allocation concealment (selection bias)

Low risk

Participants were assigned by computer‐generated code.

Blinding (performance bias and detection bias)
All outcomes

Low risk

The trial was double‐blind (participant/investigator).

Randomisation method reported

Low risk

Randomisation was computer‐generated.

Loss to follow up

Low risk

0.0%

Baseline assessments

Low risk

Baseline comparability demonstrated

Unclear risk

This was partially demonstrated.

Kanzler 1993

Methods

DESIGN
Within‐patient
Participant delivery
ALLOCATION
Random
Method of randomisation: identical containers labelled right and left; labelling method not reported
Concealment: unclear
BLINDING
Double‐blind (participant/investigator)
WITHDRAWAL/DROPOUT
Not described

Participants

N: 18

Treatment duration: 4 wks; FU: 4 wks

LF: 0 (0%)

BC: not reported

Age: 45.4 (range = 21 to 66)

Gender (per cent men): 55.6%

Severity: not reported

INCLUSION CRITERIA

  • Bilaterally similar chronic stable plaque psoriasis

EXCLUSION CRITERIA

  • Recent topical or systemic therapy

Interventions

  • Tar (liquor carbonis detergens) 5% BD (T)

  • Placebo (vehicle) (P)

Outcomes

  1. Severity (erythema; induration; scaling; pruritis)

  2. Total Severity Score (0 to 12)

  3. Investigator Global Assessment: per cent improvement from baseline, based on TSS

Notes

The trial did not report sponsorship.

Compliance was assessed by unused medication returned at each visit. The compliance rate for participants in each group was > 90%.
This was a scalp trial.

Risk of bias

Bias

Authors' judgement

Support for judgement

Allocation concealment (selection bias)

Unclear risk

The trial reported insufficient details.

Blinding (performance bias and detection bias)
All outcomes

Low risk

The trial was double‐blind (participant/investigator).

Randomisation method reported

Unclear risk

The trial did not report this.

Loss to follow up

Low risk

0.0%

Baseline assessments

Low risk

These were partially done.

Baseline comparability demonstrated

Unclear risk

The trial did not report this.

Katz 1987a

Methods

DESIGN
Between‐patient
Participant delivery
ALLOCATION
Random
Method of randomisation: not reported
Concealment: unclear
BLINDING
Double‐blind (participant/investigator)
WITHDRAWAL/DROPOUT
Described

Participants

N: 40

Treatment duration: 12 wks; FU: 12 wks

LF: 2 (5%)

BC: yes

Age: 46.7

Gender (per cent men): 60%

Severity: per cent participants with BSA affected < 10% = 68%

Duration (years): 20.8

INCLUSION CRITERIA

  • Plaques psoriasis in remission (> 85% resolution) after 2 to 3 weeks treatment with Betamethasone dipropionate

Note: 38/59 (64%) achieved remission during the acute phase

EXCLUSION CRITERIA

  • Not achieving remission during acute phase treatment

Interventions

  • Betamethasone dipropionate, intermittent maintenance (3 doses at 12‐hour intervals each weekend) (B)

  • Placebo (vehicle) (P)

Outcomes

  1. Signs (erythema; induration; scaling)

  2. Area adjusted clinical score

  3. Relapse (adjusted clinical score > 35% of baseline score)

Notes

The trial was supported in part by a grant from Schering Plough Corporation.
There was SD imputation (TSS).

Risk of bias

Bias

Authors' judgement

Support for judgement

Allocation concealment (selection bias)

Unclear risk

The trial reported insufficient details.

Blinding (performance bias and detection bias)
All outcomes

Low risk

The trial was double‐blind (participant/investigator).

Randomisation method reported

Unclear risk

The trial did not report this.

Loss to follow up

Low risk

5.0%

Baseline assessments

Low risk

Baseline comparability demonstrated

Low risk

Katz 1991a

Methods

DESIGN
Between‐patient
Participant delivery
ALLOCATION
Random
Method of randomisation: computer‐generated code
Concealment unclear
BLINDING
Double‐blind (participant/investigator)
WITHDRAWAL/DROPOUT
Described

Participants

N: 94

Treatment duration: 24 wks; FU: 24 wks

LF: 4 (4.3%)

BC: yes

Age: 46.0 (range = 21 to 86)

Gender (per cent men): 67.8%

Severity: overall score not reported

INCLUSION CRITERIA

  • Plaques psoriasis in remission after 3 to 4 weeks treatment with Betamethasone dipropionate (erythema score = 1; induration = 0.5; scaling = 0)

Note: 94/123 (76%) achieved remission during acute phase

EXCLUSION CRITERIA

  • Recent topical or systemic treatment

  • Pregnant

  • Nursing

  • Intent to conceive

  • Not achieving remission during acute phase treatment

Interventions

  • Betamethasone dipropionate, intermittent maintenance (3 doses at 12‐hour intervals once a week) (B)

  • Placebo (vehicle) (P)

Outcomes

  1. Signs (erythema; induration; scaling)

  2. TSS (0 to 9)

  3. Area adjusted clinical score

  4. Treatment failure (adjusted clinical score ≥ 2.5, or overall disease status moderate or severe)

  5. Overall disease status

  6. Patient evaluation of effectiveness.

  7. Time to relapse

Notes

The trial did not report sponsorship, but the Schering Corporation employed the corresponding author.

Risk of bias

Bias

Authors' judgement

Support for judgement

Allocation concealment (selection bias)

Unclear risk

The trial reported insufficient details.

Blinding (performance bias and detection bias)
All outcomes

Low risk

The trial was double‐blind (participant/investigator).

Randomisation method reported

Low risk

Randomisation was computer‐generated.

Loss to follow up

Low risk

4.3%

Baseline assessments

Low risk

These were reported.

Baseline comparability demonstrated

Low risk

Katz 1991b

Methods

DESIGN
Within‐patient
Participant delivery
ALLOCATION
Random
Method of randomisation: identical tubes labelled by computer‐generated code
Concealment: unclear
BLINDING
Double‐blind (participant/investigator)
WITHDRAWAL/DROPOUT
Described

Participants

N: 110

Treatment duration: 2 wks

LF: 2 (1.8%)

BC: inadequately reported

Age: 51.7 (range = 19 to 84)

Gender (per cent men): 80.6%

Severity: Total Severity Score (0 to 12) (median) = 8

Duration of disease (years): 21 (range 1 to 57)

Duration of exacerbation (years): 15.4 (range < 1 to 57)

INCLUSION CRITERIA

  • Comparable bilateral lesions of moderate or greater severity of plaque psoriasis

  • Adult

  • At least 2 signs or symptoms of at least moderate severity

  • Lesions ≥10 cm²

EXCLUSION CRITERIA

  • Pustular or erythodermic psoriasis

  • Recent topical or systemic medication

  • Women at risk of pregnancy

Interventions

  • Halobetasol propionate cream 0.05% BD (H)

  • Placebo (vehicle) (P)

Outcomes

  1. Severity (0 to 3) (erythema; plaque elevation; scaling pruritis)

  2. Total Severity Score (0 to 12)

  3. Patient Global Assessments of effectiveness and overall rating (5‐pt: poor to excellent)

Notes

The trial was supported by an educational grant from Westwood‐Squibb Pharmaceuticals, a Bristol‐Myers Squibb company.

Risk of bias

Bias

Authors' judgement

Support for judgement

Allocation concealment (selection bias)

Unclear risk

The trial reported insufficient details.

Blinding (performance bias and detection bias)
All outcomes

Low risk

The trial was double‐blind (participant/investigator).

Randomisation method reported

Low risk

Randomisation was computer‐generated.

Loss to follow up

Low risk

1.8%

Baseline assessments

Low risk

Baseline comparability demonstrated

Unclear risk

The trial did not report this.

Kaufmann 2002 (H)

Methods

DESIGN
Between‐patient
Participant delivery
ALLOCATION
Random
Method of randomisation: computer‐generated randomisation schedule
Concealment: unclear
BLINDING
Double‐blind (participant/assessor)
WITHDRAWAL/DROPOUT
Described

Participants

N: 1603

Treatment duration: 4 wks; FU: 4 wks

LF: 0 (0%)

BC: yes

Age: 48.4 (range = 17 to 90)

Gender (per cent men): 60.5%

Severity: PASI mean = 10.0 (range = 1.2 to 49.5)

Duration: 19.2 (range = 0 to 75)

INCLUSION CRITERIA

  • People aged 18 and over with chronic plaque psoriasis

  • BSA at least 10%

EXCLUSION CRITERIA

  • Unstable psoriasis in treatment areas

  • Other skin diseases that could confound treatment assessments

  • Concomitant antipsoriatic therapy

  • Hypercalcaemia

  • Application of study corticosteroid to untargeted lesion

  • Pregnancy

  • Lactation

Interventions

  • Calcipotriol 50 mcg/g + betamethasone dipropionate 0.5 mg/g combination ointment OD (D)

  • Calcipotriol 50 mcg/g, in combination vehicle ointment OD (C)

  • Betamethasone dipropionate 0.5 mg/g, in combination vehicle ointment OD (B)

  • Placebo (combination vehicle) ointment OD (P)

Outcomes

  1. PASI, modified (change score)

  2. Investigator's Global Assessment of Disease Severity (6‐pt: disease absent to very severe)

  3. Patient's global assessment of disease severity (6‐pt: worse to cleared)

Notes

Leo Pharmaceuticals sponsored the trial.
Compliance rates were reported for each regimen.

Risk of bias

Bias

Authors' judgement

Support for judgement

Allocation concealment (selection bias)

Unclear risk

The trial reported insufficient details.

Blinding (performance bias and detection bias)
All outcomes

Low risk

The trial was double‐blind (participant/assessor).

Randomisation method reported

Low risk

Randomisation was computer‐generated.

Loss to follow up

Low risk

0.0%

Baseline assessments

Low risk

These were reported.

Baseline comparability demonstrated

Low risk

Kaufmann 2002 (P)

Methods

DESIGN
Between‐patient
Participant delivery
ALLOCATION
Random
Method of randomisation: computer‐generated randomisation schedule
Concealment: unclear
BLINDING
Double‐blind (participant/assessor)
WITHDRAWAL/DROPOUT
Described

Participants

N: 1603
Treatment duration: 4 wks; FU: 4 wks
LF: 0 (0%)
BC: yes
Age: 48.4 (range = 17 to 90)
Gender (per cent men): 60.5%
Severity: PASI mean = 10.0 (range = 1.2 to 49.5)
Duration: 19.2 (range = 0 to 75)

INCLUSION CRITERIA

  • People aged 18 and over with chronic plaque psoriasis

  • BSA at least 10%

EXCLUSION CRITERIA

  • Unstable psoriasis in treatment areas

  • Other skin diseases that could confound treatment assessments

  • Concomitant antipsoriatic therapy

  • Hypercalcaemia

  • Application of study corticosteroid to untargeted lesion

  • Pregnancy

  • Lactation

Interventions

  • Calcipotriol 50 mcg/g + betamethasone dipropionate 0.5 mg/g combination ointment, OD (D)

  • Calcipotriol 50 mcg/g, in combination vehicle ointment OD (C)

  • Betamethasone dipropionate 0.5 mg/g, in combination vehicle ointment OD (B)

  • Placebo (combination vehicle) ointment OD (P)

Outcomes

  1. PASI, modified (change score)

  2. Investigator's Global Assessment of Disease Severity (6‐pt: disease absent to very severe)

  3. Patient's global assessment of disease severity (6‐pt: worse to cleared)

Notes

Leo Pharmaceuticals sponsored the trial.
Compliance were rates reported for each regimen.

Risk of bias

Bias

Authors' judgement

Support for judgement

Allocation concealment (selection bias)

Unclear risk

The trial reported insufficient details.

Blinding (performance bias and detection bias)
All outcomes

Low risk

The trial was double‐blind (participant/assessor).

Randomisation method reported

Low risk

Randomisation was computer‐generated.

Loss to follow up

Low risk

0.0%

Baseline assessments

Low risk

These were reported.

Baseline comparability demonstrated

Low risk

Kim 1994

Methods

DESIGN
Within‐patient
Participant delivery
ALLOCATION
Random
Method of randomisation: unclear
Concealment: unclear
BLINDING
Double‐blind (unclear who was blinded)
WITHDRAWAL/DROPOUT
Not described

Participants

N: 10

Treatment duration: 8 wks; FU: 8 wks

LF: 0 (0%)

BC: yes

Age: 32.1 (range 20 to 52)

Gender (per cent men): 60%

Severity: PASI = 10.49 (1.60SD)

Duration: 6.7 years (range 0.2 to 15)

INCLUSION CRITERIA

  • Psoriasis

EXCLUSION CRITERIA

  • Not identifiable

Interventions

  • Calcipotriol ointment 50 mcg/g BD (C)

  • Desoxymethasone ointment 2.5 mg/g BD (D)

Outcomes

  1. PASI

  2. Erythema, infiltration, desquamation (0 to 9)

Notes

The trial did not report sponsorship.

Risk of bias

Bias

Authors' judgement

Support for judgement

Allocation concealment (selection bias)

Unclear risk

The trial reported insufficient details.

Blinding (performance bias and detection bias)
All outcomes

Low risk

The trial was double‐blind (unclear who was blinded).

Randomisation method reported

Unclear risk

The trial did not report this.

Loss to follow up

Low risk

0.0%

Baseline assessments

Low risk

These were reported.

Baseline comparability demonstrated

Low risk

Kiss 1996

Methods

DESIGN
Between‐patient
Participant delivery
ALLOCATION
Random
Method of randomisation: not reported
Concealment: unclear
BLINDING
Double‐blind (participant/investigator)
WITHDRAWAL/DROPOUT
Described

Participants

N: 239

Treatment duration: 8 wks

LF: 29 (12.1%)

BC: not reported

Age: not reported

Gender (per cent men): not reported

Severity: not reported

INCLUSION CRITERIA

  • Moderate scalp psoriasis

  • Adult

  • Overall disease severity ≥ 4

EXCLUSION CRITERIA

  • None reported

Interventions

  • Calcipotriene solution 0.0025% and 0.005% BD (C)

  • Placebo (vehicle) (P)

Outcomes

  1. Severity (scaling; erythema; plaque elevation; pruritis)

  2. Overall severity (9‐pt: none to very severe)

  3. Investigator Global Assessment (4‐pt: worsened to cleared)

Notes

Bristol Myers Squibb Pharmaceuticals sponsored the trial.
Carder 1996 reports finding for subgroup (N = 29).
This was a scalp trial.

Risk of bias

Bias

Authors' judgement

Support for judgement

Allocation concealment (selection bias)

Unclear risk

The trial reported insufficient details.

Blinding (performance bias and detection bias)
All outcomes

Low risk

The trial was double‐blind (participant/investigator).

Randomisation method reported

Unclear risk

The trial did not report this.

Loss to follow up

Low risk

12.1%

Baseline assessments

Unclear risk

The trial did not report these.

Baseline comparability demonstrated

Unclear risk

The trial did not report this.

Klaber 1994

Methods

DESIGN
Between‐patient
Participant delivery
ALLOCATION
Random
Method of randomisation:
Concealment: unclear
BLINDING
Double‐blind (participant/assessor)
WITHDRAWAL/DROPOUT
Described

Participants

N: 474

Treatment duration: 4 wks

LF: assessment = 6 (1.3%)

TSS: 29 (6.1%)

BC: yes

Age: 44.1 (range = 18 to 90)

Gender (per cent men): 51.5%

Severity: TSS (0 to 12) = 6.5 (range = 2 to 12)

Duration of scalp psoriasis (yrs): 13.1 (range = 0.1 to 67.0)

INCLUSION CRITERIA

  • Adults

  • Stable, mild‐to‐moderate scalp psoriasis

  • History of psoriasis on body

EXCLUSION CRITERIA

  • More extensive, severe, or infected psoriasis

  • Recent systemic antipsoriatic treatment or UV

  • Concurrent vitamin D, calcium, or other relevant medication

  • Significant hepatic or renal disease

  • Hypercalcaemia

  • Risk of pregnancy

  • Pregnancy

  • Lactation

Interventions

  • Calcipotriol solution 50 mcg/ml BD (C)

  • Betamethasone 17‐valerate solution 1 mg/ml BD (B)

Outcomes

  1. Investigator Global Assessment (5‐pt: worse to cleared)

  2. Patient Global Assessment (5‐pt: worse to cleared)

  3. Total Sign Score (erythema, thickness, scaliness) (0 to 12)

  4. Assessment of extent of scalp psoriasis

  5. Assessment of acceptability

Notes

Leo Pharmaceutical Products sponsored the trial.
This was a scalp trial.

Risk of bias

Bias

Authors' judgement

Support for judgement

Allocation concealment (selection bias)

Unclear risk

The trial reported insufficient details.

Blinding (performance bias and detection bias)
All outcomes

Low risk

The trial was double‐blind (participant/assessor).

Randomisation method reported

Unclear risk

The trial did not report this.

Loss to follow up

Low risk

1.3%

Baseline assessments

Low risk

reported

Baseline comparability demonstrated

Low risk

Klaber 2000b

Methods

DESIGN
Between‐patient
Participant delivery
ALLOCATION
Random
Method of randomisation: not reported
Concealment: unclear
BLINDING
Open
WITHDRAWAL/DROPOUT
Described

Participants

N: 475

Treatment duration: 8 wks; FU: 24 wks (N = 166)

LF: 52 (10.9%)

BC: yes

Age: 45.3

Gender (per cent men): 52.0%

Severity: Total Severity Score (0 to 12) = 5.1

INCLUSION CRITERIA

  • Mild or moderate scalp psoriasis

EXCLUSION CRITERIA

  • Other forms of psoriasis

  • Topical antipsoriatic treatment within previous 2 wks

  • Systemic antipsoriatic treatment or UV therapy within previous 4 wks

  • Concomitant vitamins, calcium, or other medications that could affect the course of psoriasis

  • Known hypersensitivity to study medications

  • Pregnancy

  • Inadequate contraception

  • Lactation

  • Hypercalaemia

  • Significant renal or hepatic disease

Interventions

  • Calcipotriol solution 50 mcg/g (Dovonex®) BD (C)

  • Coal tar 1%, coconut oil 1%, salicylic acid 0.5%, shampoo (Capasal ®) OD (T)

Outcomes

  1. IAGI (6‐pt: worse to cleared)

  2. TSS (0 to 12)

  3. Patients global assessment of disease severity (VAS)

Notes

Leo Pharmaceuticals sponsored the trial.
All participants who achieved at least a slight improvement in scalp psoriasis then received 16 weeks of treatment with calcipotriol BD.
This was a scalp trial.

Risk of bias

Bias

Authors' judgement

Support for judgement

Allocation concealment (selection bias)

Unclear risk

The trial reported insufficient details.

Blinding (performance bias and detection bias)
All outcomes

High risk

The trial was open.

Randomisation method reported

Unclear risk

The trial did not report this.

Loss to follow up

Low risk

10.9%

Baseline assessments

Low risk

These were reported.

Baseline comparability demonstrated

Low risk

Koo 2006

Methods

DESIGN
Between‐patient
Participant delivery
ALLOCATION
Random
Method of randomisation: not stated (1:1:2)
Concealment: unclear
BLINDING
Double‐blind (participant/investigator)
WITHDRAWAL/DROPOUT
Described

Participants

N: 86

Treatment duration: 2 wks; FU: 2 wks

LF: 0 (0%)

BC: not demonstrated

Age: NR

Gender (per cent men): NR

Severity: NR

INCLUSION CRITERIA

  • People aged > = 18 with plaque psoriasis

  • Good general health

  • Target lesions on trunk and extremities with severity score > = 2 for each sign (erythema, induration, scaling; 0 to 4)

EXCLUSION CRITERIA

  • Pregnancy or risk thereof

  • Lactation

  • Use of investigational drug within previous 30 dys

  • Systemic or phototherapy within previous 30 dys

  • Use of topical or intralesional therapies (other than emollients) within previous 2 wks

  • Guttate, erythrodermic, pustular psoriasis

  • BSA > 20% (excluding face/scalp)

  • Known hypersensitivity to study medications

  • Concomitant topical/systemic medication that might affect target lesions Concomitant phototherapy

Interventions

Part 1

  • Calcipotriene 0.005% ointment BD (C)

  • Clobetasol propionate foam 0.05% BD (CP)

  • Calcipotriene 0.005% ointment plus clobetasol propionate foam 0.05% BD (CC)

Part 2

  • Follow‐up maintenance study based on responders from combination group (CC)

Outcomes

  1. Total Severity Score, based on Psoriasis Grading Scale (erythema, induration, scaling, each 0 to 4) (TSS; 0 to 12). Scores adjusted for baseline differences. TSS reported separately for trunk and extremity lesions

  2. Remission: per cent reduction in TSS > = 50%, IGA reduction of 3 points, or PGA reduction of 3 points

  3. Investigator Global Severity Assessment (IGA); 7‐pt: 0 (clear) to 6 (severe)

  4. Subject Global Severity Assessment (PGA); 7‐pt: 0 (clear) to 6 (severe)

  5. Adverse events

  6. Skin atrophy

  7. Safety

Notes

Connetics Corporation, Palo Alto, California, US, sponsored the trial.

We sought data, but we received no response.

There was SD imputation (IGA/PGA).

Risk of bias

Bias

Authors' judgement

Support for judgement

Allocation concealment (selection bias)

Unclear risk

The trial reported insufficient details.

Blinding (performance bias and detection bias)
All outcomes

Low risk

The trial was double‐blind (participant/investigator).

Randomisation method reported

Unclear risk

The trial did not report this.

Loss to follow up

Low risk

0%

Baseline assessments

Unclear risk

The trial did not report these.

Baseline comparability demonstrated

Unclear risk

This was not demonstrated.

Kragballe 1988b

Methods

DESIGN
Within‐patient
Participant delivery
ALLOCATION
Random
Method of randomisation: not reported
Concealment: unclear
BLINDING
Double‐blind (participant/investigator)
WITHDRAWAL/DROPOUT
Not described

Participants

N: 30

Treatment duration: 6 wks

LF: 3 (10%)

BC: yes

Age: 39 (range = 18 to 65)

Gender (per cent men): 30.0%

Severity: TSS (0 to 9) = 6.9; per cent BSA = 18.7% (range = 12% to 50%)

Duration (yrs): 15.3 (range = 1 to 35)

INCLUSION CRITERIA

  • Stable symmetrically distributed moderate

  • Chronic plaque‐type psoriasis

  • Outpatients

  • Adult

  • Women above child bearing age or using adequate contraception

EXCLUSION CRITERIA

  • Recent topical, systemic, intralesional, or UV radiation therapy (excluding bland emollients)

  • Non‐normal serum levels of calcium and creatinine

  • Taking calcium tablets

Interventions

  • Calcipotriol cream 10 mcg/g, 33 mcg/g, or 100 mcg/g BD C (10); C (33); C (100)

  • Placebo (vehicle) (P)

Outcomes

  1. Severity (erythema; thickness; scaling)

  2. TSS (0 to 9)

  3. Investigator Global Assessment (5‐pt: worse to clear)

  4. Patient Global Assessment (5‐pt: worse to clear)

Notes

The trial did not report sponsorship.

Risk of bias

Bias

Authors' judgement

Support for judgement

Allocation concealment (selection bias)

Unclear risk

The trial reported insufficient details.

Blinding (performance bias and detection bias)
All outcomes

Low risk

The trial was double‐blind (participant/investigator).

Randomisation method reported

Unclear risk

The trial did not report this.

Loss to follow up

Low risk

10.0%

Baseline assessments

Low risk

Baseline comparability demonstrated

Low risk

Kragballe 1991a

Methods

DESIGN
Within‐patient
Participant delivery
ALLOCATION
Random
Method of randomisation: not stated
Concealment: unclear
BLINDING
Double‐blind (participant/assessor)
WITHDRAWAL/DROPOUT
Described

Participants

N: 345

Treatment duration: 6 wks

LF: 3 (0.9%)

BC: yes

Age: 45.2 (range = 18 to 90)

Gender (per cent men): 58.8%

Severity: PASI = 8.35 (range = 0.60 to 48.5)

Duration (yrs): 19.5 (range = 0.5 to 76)

INCLUSION CRITERIA

  • Adult

  • Symmetrical chronic plaque psoriasis

  • Inpatients and outpatients

EXCLUSION CRITERIA

  • Unstable psoriasis

  • Recent systemic or UV therapy

  • Hypercalcaemia

  • Impaired renal/hepatic function

  • High dose calcium/Vitamin D intake

  • Unresponsive to corticosteroids

  • Concomitant medication

Interventions

  • Calcipotriol ointment 50 mcg/g BD (C)

  • Betamethasone valerate ointment 0.1% BD (B)

Outcomes

  1. PASI

  2. Total Sign Score (erythema, thickness, scaliness) (0 to 12)

  3. Patient assessment of response

Notes

Leo Pharmaceuticals sponsored the trial
Trial participants were inpatients and outpatients.
There was SD imputation (TSS).

Risk of bias

Bias

Authors' judgement

Support for judgement

Allocation concealment (selection bias)

Unclear risk

The trial reported insufficient details.

Blinding (performance bias and detection bias)
All outcomes

Low risk

The trial was double‐blind (participant/assessor).

Randomisation method reported

Unclear risk

The trial did not report this.

Loss to follow up

Low risk

0.9%

Baseline assessments

Low risk

Baseline comparability demonstrated

Low risk

Kragballe 1998b

Methods

DESIGN
Between‐patient
Participant delivery
ALLOCATION
Random
Method of randomisation: not stated
Concealment: not stated
BLINDING
Double‐blind (participant/assessor)
WITHDRAWAL/DROPOUT
Described

Participants

N: 699

Treatment duration: 8 wks; FU: 8 wks

LF: 8 (1.1%)

BC: psoriasis comparable, demographics unclear

Age: not stated

Gender (per cent men): not stated

Severity: not stated

INCLUSION CRITERIA

  • Adult

  • Stable chronic plaque psoriasis on trunk and limbs

EXCLUSION CRITERIA

  • Pregnancy

  • Risk of pregnancy

  • Lactation

  • Recent systemic or UV therapy

  • Concomitant medication

  • Hypercalcaemia or renal disease

  • Planned exposure to sun

Interventions

  • Calcipotriol cream 50 mcg/g BD (C2)

  • Calcipotriol cream 50 mcg/g OM, plus clobetasone17‐butyrate cream,0.5 mg/g ON (CL)

  • Calcipotriol cream 50 mcg/g OM, plus betamethasone 17‐valerate cream 1 mg/g ON (CB)

  • Calcipotriol cream 50 mcg/g OM, plus vehicle ON (C1)

Outcomes

  1. PASI

  2. Investigator overall assessment of response (6‐pt: worse to clearance)

  3. Patient overall assessment of response (6‐pt: worse to clearance)

Notes

Leo Pharmaceuticals sponsored the trial

Risk of bias

Bias

Authors' judgement

Support for judgement

Allocation concealment (selection bias)

Unclear risk

The trial reported insufficient details.

Blinding (performance bias and detection bias)
All outcomes

Low risk

The study was double‐blind (participant/assessor).

Randomisation method reported

Unclear risk

The trial did not report this.

Loss to follow up

Low risk

1.1%

Baseline assessments

Unclear risk

The trial did not report these.

Baseline comparability demonstrated

Unclear risk

This was partially demonstrated.

Kragballe 2004

Methods

DESIGN
Between‐patient
Participant delivery
ALLOCATION
Random
Method of randomisation: computer‐generated randomisation schedule, using centralised telephone voice response system
Concealment: adequate
BLINDING
Double‐blind (participant/investigator) (Groups A and B)
Single‐blind (investigator) (Group C)
WITHDRAWAL/DROPOUT
Described

Participants

N: 972

Treatment duration: 8 wk; FU: 12 wks

LF: 99 (10.2%)

BC: yes

Age: 47.7 (range = 18 to 97)

Gender (per cent men): 63.8%

Severity: PASI = 10.5 (range = 2 to 49); per cent with moderate disease = 64.3%

Duration (yrs): 18.5 (range = 0 to 70)

INCLUSION CRITERIA

  • Aged 18 and over

  • Chronic plaque psoriasis amenable to topical treatment

  • BSA ≥ 10% of at least 1 body region (arms, trunk, legs)

EXCLUSION CRITERIA

  • Pregnancy or risk thereof

  • Lactation

  • Unstable psoriasis or other inflammatory skin disease

  • Concurrent systemic or UV therapy

  • Concurrent topical therapy for  trunk or limbs

  • Abnormal calcium homeostasis

Interventions

  • TCP OD for 8 wks then calcipotriol ointment 50 mcg/g OD for 4 wks (A)

  • TCP OD for 4 wks then calcipotriol ointment 50 mcg/g OD (weekdays) and TCP OD (weekends) for 8 wks (B)

  • Calcipotriol ointment 50 mcg/g BD for 12 wks (C)

  • TCP: calcipotriol ointment 50 mcg/g, plus betamethasone dipropionate 0.5 mg/g ointment

Outcomes

  1. PASI

  2. Investigator's global assessment of severity (PGA) (6‐pt: absence of disease to very severe disease)

  3. Self‐reported compliance with trial medication

Notes

Leo Pharmaceuticals sponsored the trial.
Request data: none supplied
Reversible skin atrophy: A: 1/322; B: 0/322; C: 0/327

Risk of bias

Bias

Authors' judgement

Support for judgement

Allocation concealment (selection bias)

Low risk

A centralised telephone voice response system was used for the participant assignment, and this removed the opportunity for investigator bias during randomisation.

Blinding (performance bias and detection bias)
All outcomes

Low risk

Groups A and B were double‐blind (participant/investigator); group C was single‐blind (investigator).

Randomisation method reported

Low risk

Randomisation was computer‐generated.

Loss to follow up

Low risk

10.2%

Baseline assessments

Low risk

Baseline comparability demonstrated

Low risk

Kragballe 2006

Methods

DESIGN
Between‐patient
Participant delivery
ALLOCATION
Random
Method of randomisation: computer‐generated randomisation schedule (1:1:1)
Concealment: unclear
BLINDING
Double‐blind (participant/investigator)
WITHDRAWAL/DROPOUT
Described

Participants

N: 634
Treatment duration: 52 wks; FU: 52 wks
LF: 8 (1.3%)
BC: yes
Age: 48.7 (14.2SD)
Gender (per cent men): 61.0%
Ethnicity (per cent white): 97.3%
Severity: per cent IGA moderate = 69.1%; per cent IGA severe = 27.9%; per cent IGA very severe = 3.0%
Duration (yrs): mean = 19.7; median = 17.0; range = 1 to 65
Use of topical corticosteroids during last decade (mths): 33.8

INCLUSION CRITERIA

  • Outpatients aged > = 18 with plaque psoriasis of trunk and limbs

  • IGA at least moderate.

EXCLUSION CRITERIA

  • Erythrodermic, exfoliative, and pustular psoriasis

  • Skin infection, use of systemic or topical antipsoriatic therapy

  • Use of PUVA or UVB

  • BSA > = 30% (and requiring treatment)

  • Calcium metabolic disorder

  • Pregnancy

  • Lactation

Interventions

  1. Calcipotriol ointment 50 mcg/g plus betamethasone dipropionate ointment 0.5 mg/g OD (C‐B)

  2. Alternating every 4 weeks: calcipotriol ointment 50 mcg/g plus betamethasone dipropionate ointment 0.5 mg/g OD (4 wks) then calcipotriol 50 mcg/g (4 wks) (A)

  3. Calcipotriol ointment 50 mcg/g plus betamethasone dipropionate ointment 0.5 mg/g, OD (4 wks) then calcipotriol ointment 50 mcg/g (48 wks) (C)

< = 100 g/wk

Outcomes

  1. Investigator's Global Assessment (IGA): 6‐pt (absent, very mild, mild, moderate, severe, very severe)

  2. Treatment success: IGA absent, very mild,  or mild

  3. Independent assessment of adverse events by non‐investigator clinicians: adjudicated corticosteroid reactions

  4. Patient Global Assessment (PGA): 3‐pt (satisfactory, not satisfactory, not applicable (not used))

  5. Compliance (medication usage)

  6. HPA assessed in subgroup of 19 participants

Notes

Leo Pharma A/S sponsored the trial.

The sponsor supplied unpublished data.

Risk of bias

Bias

Authors' judgement

Support for judgement

Allocation concealment (selection bias)

Unclear risk

The trial reported insufficient details.

Blinding (performance bias and detection bias)
All outcomes

Low risk

The trial was double‐blind (participant/investigator).

Randomisation method reported

Low risk

A computer‐generated randomisation schedule was used (1:1:1).

Loss to follow up

Low risk

1.3%

Baseline assessments

Low risk

These were reported.

Baseline comparability demonstrated

Unclear risk

The trial only reported mean values (no measure of spread). They described groups as "well balanced".

Kragballe 2009

Methods

DESIGN
Between‐patient
Participant delivery
ALLOCATION
Random
Method of randomisation: computer‐generated schedule (1:2)
Concealment: unclear
BLINDING
Single‐blind (investigator)
WITHDRAWAL/DROPOUT
Described

Participants

N: 312

Treatment duration: 8 wks; FU: 16 wks

LF: 2 (0.6%)

BC: yes

Age: 51.0 (15.4SD); range = 18 to 91

Gender (per cent men): 43.0%

Ethnicity (per cent white): 99.0%

Severity: IGA moderate = 56.7%; IGA severe = 35.9%; IGA very severe = 7.4%; TSS (0 to 12) = 7.3 (1.7SD)

Duration (yrs): 18.7 (14.6SD); range = 0 to 70

INCLUSION CRITERIA

  • People with moderately severe scalp psoriasis amenable to treatment with < = 100 g medication/wk (combined product) or 60 mL solution/wk (calcipotriol)

  • Psoriasis of trunk/limbs

  • Scalp involvement > = 10%

  • Clinical signs > = moderate for > = 1 sign and > = slight for remaining signs

  • IGA > = moderate

EXCLUSION CRITERIA

  • PUVA or grenz ray therapy within previous 4 wks

  • Topical scalp treatments or UVB therapy or very potent (WHO group IV) corticosteroids on body within previous 2 wks

  • Biologicals within previous 6 mths

  • Systemic therapies within previous 4 wks

  • Current diagnosis of unstable forms of psoriasis or other skin diseases confounding psoriasis assessment

  • Skin infections

  • Atrophy of the scalp

  • Calcium homeostasis abnormality

  • Severe renal or hepatic disorder

  • Concomitant use of medications that could affect scalp psoriasis

  • Pregnancy

  • Lactation

Interventions

  • Calcipotriol solution 50 mcg/g BD (C)

  • Calcipotriol gel 50 mcg/g plus betamethasone dipropionate "scalp formulation" (gel) 0.5 mg/g OD (C‐B)

There was no concomitant topical treatment, emollient, or medicated shampoo or conditioner.

Outcomes

  1. Investigator's Global Assessment (IGA): 6‐pt (absent (0), very mild, mild, moderate, severe, very severe (5))

  2. Treatment success: IGA clear or minimal

  3. Total Sign Score (TSS): 0 to 12

  4. Patient Global Assessment of Disease Severity (PGA). 5‐pt scale (clear, very mild, mild, moderate, severe)

  5. Patient assessment of itching (4‐pt: none, mild, moderate, severe)

  6. Compliance: self‐report; use of study medication

Notes

Leo Pharma A/S, Ballerup, Denmark, sponsored the trial.

The sponsor supplied unpublished data.

Risk of bias

Bias

Authors' judgement

Support for judgement

Allocation concealment (selection bias)

Unclear risk

The trial reported insufficient details.

Blinding (performance bias and detection bias)
All outcomes

Low risk

The trial was double‐blind (participant/investigator).

Randomisation method reported

Low risk

A computer‐generated randomisation schedule was used (1:2).

Loss to follow up

Low risk

0.6%

Baseline assessments

Low risk

These were reported.

Baseline comparability demonstrated

Low risk

This was demonstrated.

Kreuter 2006 (H)

Methods

DESIGN
Between‐patient
Participant delivery
ALLOCATION
Random
Method of randomisation: computer‐generated randomisation lists
Concealment: unclear
BLINDING
Double‐blind (participant/investigator)
WITHDRAWAL/DROPOUT
Described

Participants

N: 80

Treatment duration: 4 wks; FU: 10 wks

LF: 2 (2.5%)

BC: yes

Age: 52.4 (14.3SD); range = 28 to 87

Gender (per cent men): 61.3%

Ethnicity: NR

Severity: mPASI = 21.2 (13.4SD); range = 3 to 54; VAS (0 to 10) = 4.8 (2.7SD); range = 1 to 10

INCLUSION CRITERIA

  • People aged > = 18 with inverse psoriasis that had been present for at least 6 mths

  • Good general health

EXCLUSION CRITERIA

  • Systemic or phototherapies within previous 4 wks

  • Topical therapies within previous 2 wks

  • Acute guttate or pustular psoriasis

  • Pregnancy

  • Lactation

  • Severe concurrent infectious diseases

  • Diseases associated with immunesuppression or malignancy

  • Drug dependency

  • Mental dysfunction or other factors limiting compliance

Interventions

  • Calcipotriol 0.005% ointment OD (C)

  • Betamethasone valerate 0.1% OD (B)

  • Pimecrolimus 1% cream OD (PM)

  • Placebo (vehicle for pimecrolimus) OD (P)

No concomitant therapies were permitted (including emollients).

Outcomes

  1. mPASI (0 to 72): assessment confined to body area affected. Each sign scored 0 to 4 and then multiplied by area affects (0 (0%) to 6 (90% to 100%))

  2. VAS (itching): 0 = absence to 10 = maximum

  3. Adverse events

Notes

Novartis Pharma GmbH sponsored the trial.

Atrophy was not reported.

We sought unpublished data, but it was reported to be unavailable.

There was SD imputation (PASI).

Risk of bias

Bias

Authors' judgement

Support for judgement

Allocation concealment (selection bias)

Unclear risk

The trial reported insufficient details.

Blinding (performance bias and detection bias)
All outcomes

Low risk

The trial was double‐blind (participant/investigator).

Randomisation method reported

Low risk

Computer‐generated randomisation lists were used.

Loss to follow up

Low risk

2.5%

Baseline assessments

Low risk

These were reported.

Baseline comparability demonstrated

Low risk

This was demonstrated.

Kreuter 2006 (P)

Methods

DESIGN
Between‐patient
Participant delivery
ALLOCATION
Random
Method of randomisation: computer‐generated randomisation lists
Concealment: unclear
BLINDING
Double‐blind (participant/investigator)
WITHDRAWAL/DROPOUT
Described

Participants

N: 80
Treatment duration: 4 wks; FU: 10 wks
LF: 2 (2.5%)
BC: yes
Age: 52.4 (14.3SD); range = 28 to 87
Gender (per cent men): 61.3%
Ethnicity: NR
Severity: mPASI = 21.2 (13.4SD), range = 3 to 54; VAS (0 to 10) = 4.8 (2.7SD), range = 1 to 10

INCLUSION CRITERIA

  • People aged > = 18 with inverse psoriasis that had been present for at least 6 mths

  • Good general health

EXCLUSION CRITERIA

  • Systemic or phototherapies within previous 4 wks

  • Topical therapies within previous 2 wks

  • Acute guttate or pustular psoriasis

  • Pregnancy

  • Lactation

  • Severe concurrent infectious diseases

  • Diseases associated with immunesuppression or malignancy

  • Drug dependency

  • Mental dysfunction or other factors limiting compliance

Interventions

  • Calcipotriol 0.005% ointment OD (C)

  • Betamethasone valerate 0.1% OD (B)

  • Pimecrolimus 1% cream OD (PM)

  • Placebo (vehicle for pimecrolimus) OD (P)

No concomitant therapies were permitted (including emollients).

Outcomes

  1. mPASI (0 to 72): assessment confined to body area affected. Each sign scored 0 to 4 and then multiplied by area affects (0 (0%) to 6 (90% to 100%))

  2. VAS (itching): 0 = absence to 10 = maximum

  3. Adverse events

Notes

Novartis Pharma GmbH sponsored the trial.

Atrophy was not reported.

We sought unpublished data, but it was reported to be unavailable.

There was SD imputation (PASI).

Risk of bias

Bias

Authors' judgement

Support for judgement

Allocation concealment (selection bias)

Unclear risk

The trial reported insufficient details.

Blinding (performance bias and detection bias)
All outcomes

Low risk

The trial was double‐blind (participant/investigator).

Randomisation method reported

Low risk

Computer‐generated randomisation lists were used.

Loss to follow up

Low risk

2.5%

Baseline assessments

Low risk

These were reported.

Baseline comparability demonstrated

Low risk

This was demonstrated.

Krueger 1998

Methods

DESIGN
Within‐patient
Participant delivery
ALLOCATION
Random
Method of randomisation: not reported
Concealment: unclear
BLINDING
Double‐blind (participant/investigator)
WITHDRAWAL/DROPOUT
Described

Participants

N: 45

Treatment duration: 6 wks

LF: 0 (0%)

BC: reported to be similar

Age: 50 (range = 23 to 83)

Gender (per cent men): 84%

Severity: not reported

INCLUSION CRITERIA

  • Mild to moderate bilateral psoriatic plaques

  • Adult

  • Total Severity Score less than or equal to 6.

EXCLUSION CRITERIA

  • Pregnant

  • Nursing or of likely to conceive

  • Recent use of certain topical agents

  • Recent systemic retinoids, UV phototherapy, or systemic antipsoriasis drugs

Interventions

  • Tazarotene gel 0.01% or 0.05% BD (T)

  • Placebo (vehicle) (P)

Outcomes

  1. Severity (erythema; plaque elevation; scaling)

  2. TSS (0 to 12)

  3. Investigator Global Assessment (6‐pt: no change/worse to completely clear)

Notes

Allergan, Inc, California, sponsored the trial.

Risk of bias

Bias

Authors' judgement

Support for judgement

Allocation concealment (selection bias)

Unclear risk

The trial reported insufficient details.

Blinding (performance bias and detection bias)
All outcomes

Low risk

The trial was double‐blind (participant/investigator).

Randomisation method reported

Unclear risk

The trial did not report this.

Loss to follow up

Low risk

0.0%

Baseline assessments

Unclear risk

These were partially done.

Baseline comparability demonstrated

Unclear risk

These were stated to be similar; comparability was not demonstrated.

Köse 1997

Methods

DESIGN
Between‐patient
Delivery unclear
ALLOCATION
Random
Method of randomisation: not stated
Concealment: unclear
BLINDING
Unclear
WITHDRAWAL/DROPOUT
Described

Participants

N: 43

Treatment duration: 10 days FU: 20 days

LF: 0 (0%)

BC: yes

Age: not stated

Gender (per cent men): not stated

Severity: not stated

INCLUSION CRITERIA

  • Psoriasis of the scalp

EXCLUSION CRITERIA

  • Not reported

Interventions

  • Calcipotriol ointment 50 mcg/g occluded ON (CO)

  • Clobetasol 17‐propionate solution BD (CP)

Outcomes

  1. TSS (0 to 9)

Notes

The trial did not report sponsorship.

This was a scalp trial.

Risk of bias

Bias

Authors' judgement

Support for judgement

Allocation concealment (selection bias)

Unclear risk

The trial reported insufficient details.

Blinding (performance bias and detection bias)
All outcomes

Unclear risk

The trial did not report this.

Randomisation method reported

Unclear risk

The trial did not report this.

Loss to follow up

Low risk

0.0%

Baseline assessments

Unclear risk

The trial did not report these.

Baseline comparability demonstrated

Unclear risk

The trial reported baseline comparability (demographic/clinical), but it was not demonstrated.

Lahfa 2003

Methods

DESIGN
Between‐patient
Participant delivery
ALLOCATION
Random
Method of randomisation: not stated
Concealment: unclear
BLINDING
Single‐blind (investigator)
WITHDRAWAL/DROPOUT
Described

Participants

N: 125

Treatment duration: 12 wks; FU: 12 wks

LF: 5 (4.0%)

BC: yes

Age: 49.5 (15.1SD)

Gender (per cent men): 55.2%

Ethnicity (per cent white/Caucasoid): 97.6%

Severity: PASI = 6.8; per cent BSA = 13.2 (7.4SD)

Duration (yrs): 16.7

INCLUSION CRITERIA

  • People with mild to moderate plaque psoriasis

  • BSA < 30%

EXCLUSION CRITERIA

  • Skin conditions interfering with assessment

  • Co‐morbidities that put participant at risk

  • Severe psoriasis, including erythrodermic

  • Pregnancy or risk thereof

  • Lactation

  • Topical/UVB therapy within previous 2 wks

  • PUVA within previous 4 wks

  • Systemic therapy, beta blockers, or lithium within previous 8 wks

Interventions

  • Calcipotriol 50 mcg/g ointment ON, plus clobetasol propionate 0.05% cream OM (2 to 4 wks), then calcipotriol ointment BD (to wk 12) (C1)

  • Calcitriol 3 mcg/g ointment ON, plus clobetasol propionate 0.05% cream OM (2 to 4 wks), then calcitriol ointment BD (to wk 12) (C2)

In the initial phase, the participant applied dual therapy until achieving clearance or marked improvement or until 4 wks elapsed, then switched to monotherapy maintenance phase.

Outcomes

  1. PASI, based on scores from 3 lesions, 1 each on trunk, and upper and lower limbs

  2. Investigator's Assessment of Global Improvement (IAGI): 7‐pt (worse to clear, rescaled 0 to 6)

  3. Clinical success: IAGI > = marked improved

  4. Relapse (maintenance phase): IAGI < = moderate improvement

  5. Patient Assessment of Global Improvement: 7‐pt (worse to clear)

  6. Adverse events: cutaneous safety including signs and soreness (all scored 0 to 3); investigator assessment of global safety (poor, good, excellent); patient self report

Notes

Galderma Laboratories sponsored the trial.

We sought unpublished data, but it was reported to be unavailable.

There was SD imputation (PASI).

Risk of bias

Bias

Authors' judgement

Support for judgement

Allocation concealment (selection bias)

Unclear risk

The trial reported insufficient details.

Blinding (performance bias and detection bias)
All outcomes

Unclear risk

The study was single‐blind (investigator).

Randomisation method reported

Unclear risk

The trial did not report this.

Loss to follow up

Low risk

4.0%

Baseline assessments

Low risk

These were reported.

Baseline comparability demonstrated

Low risk

This was demonstrated.

Landi 1993

Methods

DESIGN
Between‐patient
Delivery unclear
ALLOCATION
Random
Method of randomisation: not stated
Concealment: unclear
BLINDING
Unclear
WITHDRAWAL/DROPOUT
Described

Participants

N: 40

Treatment duration: 6 wks; FU: 10 wks

LF: 0 (0%)

BC: psoriasis comparable, demographics unclear

Age: range = 17 to 84

Gender (per cent men): not stated

Severity: PASI (mean) = 11.6 (range = 3.0 to 35.1)

INCLUSION CRITERIA

  • Adult

  • Mild and moderate psoriasis

EXCLUSION CRITERIA

  • Not reported

Interventions

  • Calcipotriol ointment 50 mcg/g BD (C)

  • Clobetasol propionate 0.05% ointment BD (CP)

Outcomes

  1. PASI

Notes

Leo Pharmaceuticals sponsored the trial.
Landi 1993 reported the findings of a single centre, 1 of 3 centres reported in Landi 1993 (N = 120).

Risk of bias

Bias

Authors' judgement

Support for judgement

Allocation concealment (selection bias)

Unclear risk

The trial reported insufficient details.

Blinding (performance bias and detection bias)
All outcomes

Unclear risk

The trial did not report this.

Randomisation method reported

Unclear risk

The trial did not report this.

Loss to follow up

Low risk

0.0%

Baseline assessments

Unclear risk

These were partially done.

Baseline comparability demonstrated

Unclear risk

This was partially demonstrated.

Lane 1983

Methods

DESIGN
Between‐patient
Participant delivery
ALLOCATION
Random
Method of randomisation: not reported
Concealment: unclear
BLINDING
Double‐blind (participant/investigator)
WITHDRAWAL/DROPOUT
Not described

Participants

N: 157

Treatment duration: 3 wks; FU: 3 wks

LF: 18 (11.5%)

BC: yes

Age: 39.6

Gender (per cent men): 52.5%

Severity: TSS (0 to 20) = 10.6

INCLUSION CRITERIA

  • History and physical finding compatible with psoriasis including scaling erythema, epidermal thickening, crusting, or both

  • All ages > 1 year

  • Stable disease.

EXCLUSION CRITERIA

  • Recent topical or systemic corticosteroid treatment

  • Oral antihistamine

  • Antipruritic therapy, UV, or X‐ray therapy or any medication affecting the study

  • Pregnant

Interventions

  • Betamethasone dipropionate ointment 0.05% OD (B)

  • Diflorasone diacetate ointment 0.05% OD (D)

  • Placebo (vehicle) (P)

Outcomes

  1. Severity (scaling; erythema; pruritis; thickening; crusting; overall condition)

  2. Total Severity Score (0 to 20)

Notes

The trial did not report sponsorship.

There was SD imputation (TSS).

Risk of bias

Bias

Authors' judgement

Support for judgement

Allocation concealment (selection bias)

Unclear risk

The trial reported insufficient details.

Blinding (performance bias and detection bias)
All outcomes

Low risk

The trial was double‐blind (participant/investigator).

Randomisation method reported

Unclear risk

The trial did not report this.

Loss to follow up

Low risk

11.5%

Baseline assessments

Low risk

Baseline comparability demonstrated

Low risk

Langley 2011 (H)

Methods

DESIGN
Between‐patient
Participant delivery
ALLOCATION
Random
Method of randomisation: not stated (2:2:1)
Concealment: adequate: treatments dispensed by non‐study staff
BLINDING
Single‐blind (investigator)
WITHDRAWAL/DROPOUT
Described

Participants

N: 458

Treatment duration: 8 wks; FU: 16 wks

LF: 0 (0%)

BC: yes

Age: 51.6 (14SD)

Gender (per cent men): 62.2%

Ethnicity (per cent white): 93.9%

Severity: mPASI = 9.39, range = 2.4 to 59.4; IGA moderate = 68.3%; IGA severe = 29.5%; IGA very severe = 2.2%; per cent BSA = 9.3 (8.2SD)

Duration (yrs): 19.8 (13.3SD)

INCLUSION CRITERIA

  • Participants with moderately severe plaque psoriasis involving trunk, limbs, or both

  • BSA > = 10% on arms, trunk, limbs, or a mixture of the aforementioned

  • Amendable to maximum weekly dose of 100 g of gel or 70 g of ointment

EXCLUSION CRITERIA

  • Systemic biological therapy within previous 3 mths

  • Other systemic treatment within previous 4 wks

  • Concurrent oral vitamin D > 500 IU/day

  • UVA or grenz ray therapy within previous 4 wks

  • UVB within previous 2 wks

  • Pregnancy

  • Lactation

Interventions

  • Tacalcitol ointment 4 mcg/g OD (T)

  • Calcipotriol gel 50 mcg/g plus betamethasone dipropionate gel 0.5 mg/g OD (C‐B)

  • Placebo (gel vehicle) OD (P)

Participants achieving clear IGA stopped treatment and restarted if psoriasis reappeared.

There was follow up of responders only (IGA clear or almost clear).

Outcomes

  1. Investigator's Global Assessment of Disease Severity: 6‐pt (clear to very severe)

  2. Treatment responder (controlled disease): IGA clear or almost clear at wk 8

  3. mPASI (0 to 64.8)

  4. PASI 50, PASI 75

  5. Patient Global Assessment (PGA) of disease severity: 5‐pt (clear to severe)

  6. Adverse events

  7. Relapse (treatment responders only): > = 50% reduction in PASI improvement achieved (wk0 to wk8)

  8. Time to relapse

  9. Rebound (treatment responders only): > 125% reduction in PASI at wk 0

  10. Compliance (wk 2 to wk 6): self‐report and medication usage

  11. Adverse events

Notes

Leo Pharma A/S, Ballerup, Denmark, sponsored the trial.

Participants could not be completely blinded to treatment allocation because of differences in formulation and packaging (bottles for gel vs. tubes for ointments).

Atrophy was not assessed.

The sponsor supplied unpublished data.

Risk of bias

Bias

Authors' judgement

Support for judgement

Allocation concealment (selection bias)

Low risk

A designated third person performed allocation of the investigational products at all 18 centres.

Blinding (performance bias and detection bias)
All outcomes

Unclear risk

The study was single‐blind (investigator); it was not possible to blind participants to treatments because of differences in vehicle formulations.

Randomisation method reported

Unclear risk

The trial did not report this.

Loss to follow up

Low risk

0%

Baseline assessments

Low risk

These were reported.

Baseline comparability demonstrated

Low risk

This was demonstrated.

Langley 2011 (P)

Methods

DESIGN
Between‐patient
Participant delivery
ALLOCATION
Random
Method of randomisation: not stated (2:2:1)
Concealment: adequate: treatments dispensed by non‐study staff.
BLINDING
Single‐blind (investigator)
WITHDRAWAL/DROPOUT
Described

Participants

N: 458
Treatment duration: 8 wks; FU: 16 wks
LF: 0 (0%)
BC: yes
Age: 51.6 (14SD)
Gender (per cent men): 62.2%
Ethnicity (per cent white): 93.9%

Severity: mPASI = 9.39, range = 2.4 to 59.4; IGA moderate = 68.3%; IGA severe = 29.5%; IGA very severe = 2.2%; per cent BSA = 9.3 (8.2SD)

Duration (yrs): 19.8 (13.3SD)

INCLUSION CRITERIA

  • Participants with moderately severe plaque psoriasis involving trunk, limbs, or both

  • BSA > = 10% on arms, trunk, limbs, or a mixture of the aforementioned

  • Amendable to maximum weekly dose of 100 g of gel or 70 g of ointment

EXCLUSION CRITERIA

  • Systemic biological therapy within previous 3 mths

  • Other systemic treatment within previous 4 wks

  • Concurrent oral vitamin D > 500 IU/day

  • UVA or grenz ray therapy within previous 4 wks

  • UVB within previous 2 wks

  • Pregnancy

  • Lactation

Interventions

  • Tacalcitol ointment 4 mcg/g OD (T)

  • Calcipotriol gel 50 mcg/g plus betamethasone dipropionate gel 0.5 mg/g OD (C‐B)

  • Placebo (gel vehicle) OD (P)

Participants achieving clear IGA stopped treatment and restarted if psoriasis reappeared.

There was follow up of responders only (IGA clear or almost clear).

Outcomes

  1. Investigator's Global Assessment of Disease Severity: 6‐pt (clear to very severe)

  2. Treatment responder (controlled disease): IGA clear or almost clear at wk 8

  3. mPASI (0 to 64.8)

  4. PASI 50, PASI 75

  5. Patient Global Assessment (PGA) of disease severity: 5‐pt (clear to severe)

  6. Adverse events

  7. Relapse (treatment responders only): > = 50% reduction in PASI improvement achieved (wk0 to wk8)

  8. Time to relapse

  9. Rebound (treatment responders only): > 125% reduction in PASI at wk 0

  10. Compliance (wk 2 to wk 6): self‐report and medication usage

  11. Adverse events

Notes

Leo Pharma A/S, Ballerup, Denmark, sponsored the trial.

Participants could not be completely blinded to treatment allocation because of differences in formulation and packaging (bottles for gel vs. tubes for ointments).

Atrophy was not assessed.

The sponsor supplied unpublished data.

Risk of bias

Bias

Authors' judgement

Support for judgement

Allocation concealment (selection bias)

Low risk

A designated third person performed allocation of the investigational products at all 18 centres.

Blinding (performance bias and detection bias)
All outcomes

Unclear risk

The study was single‐blind (investigator); it was not possible to blind participants to treatments because of differences in vehicle formulations.

Randomisation method reported

Unclear risk

The trial did not report this.

Loss to follow up

Low risk

0%

Baseline assessments

Low risk

These were reported.

Baseline comparability demonstrated

Low risk

This was demonstrated.

Langner 1992

Methods

DESIGN
Within‐patient
Participant delivery
ALLOCATION
Random
Method of randomisation: unclear
Concealment: unclear
BLINDING
Double‐blind (participant/investigator)
WITHDRAWAL/DROPOUT
Described

Participants

N: 29

Treatment duration: 6 wks; FU: 6 wks

LF: 0 (0%)

BC: yes

Age: mean: 40.5 (range = 16‐77)

Gender (per cent men): 69.0%

Severity: not reported

INCLUSION CRITERIA

  • Severe chronic psoriasis

  • Symmetrical lesions

  • Adult

  • Outpatients

EXCLUSION CRITERIA

  • Pregnancy or inadequate contraception

Interventions

  • Calcitriol ointment 3 mcg/g BD (C)

  • Placebo (vehicle) (P)

Outcomes

  1. Severity (erythema; pustules, desquamation, encrustation, vesiculation and pruritis)

  2. Investigator Global Assessment (6‐pt: worse to clear)

Notes

The trial did not report sponsorship.

All participants received 2 weeks' pre‐treatment with vehicle BD.

Risk of bias

Bias

Authors' judgement

Support for judgement

Allocation concealment (selection bias)

Unclear risk

The trial reported insufficient details.

Blinding (performance bias and detection bias)
All outcomes

Low risk

The trial was double‐blind (participant/investigator).

Randomisation method reported

Unclear risk

The trial did not report this.

Loss to follow up

Low risk

0.0%

Baseline assessments

Low risk

These were partially done.

Baseline comparability demonstrated

Low risk

This was demonstrated.

Langner 1993

Methods

DESIGN
Within‐patient
Participant delivery
ALLOCATION
Random
Method of randomisation: unclear
Concealment: unclear
BLINDING
Double‐blind (participant/investigator)
WITHDRAWAL/DROPOUT
Described

Participants

N: 32

Treatment duration: 6 wks; FU: 6 wks

LF: 2 (6.3%)

BC: yes

Age: mean: 42.4 (range = 16 to 77)

Gender (per cent men): 62.5%

Severity: global severity score (0 to 4) = 3.5

INCLUSION CRITERIA

  • Bilateral

  • Symmetrical

  • Severe chronic plaque psoriasis

  • Outpatients.

EXCLUSION CRITERIA

  • Pregnancy or inadequate contraception

  • Use of calcium

  • Vitamin D or analogues

  • Calcium‐containing antacids

  • Digitalis

  • Thiazide diuretics or glucocorticosteroids

Interventions

  • Calcitriol ointment 15 mcg/g BD (C)

  • Placebo (vehicle) (P)

Outcomes

  1. Severity (erythema; scaling; induration; pruritis)

  2. PASI

  3. Investigator Global Assessment (6‐pt: worse to clear)

Notes

The trial did not report sponsorship.
All participants received 2 weeks' pre‐treatment with vehicle BD.

Risk of bias

Bias

Authors' judgement

Support for judgement

Allocation concealment (selection bias)

Unclear risk

The trial reported insufficient details.

Blinding (performance bias and detection bias)
All outcomes

Low risk

The trial was double‐blind (participant/investigator).

Randomisation method reported

Unclear risk

The trial did not report this.

Loss to follow up

Low risk

6.3%

Baseline assessments

Low risk

Baseline comparability demonstrated

Low risk

Langner 2001 (H)

Methods

DESIGN
Between‐patient
Participant delivery
ALLOCATION
Random
Method of randomisation: unclear
Concealment: unclear
BLINDING
Double‐blind (participant/investigator)
WITHDRAWAL/DROPOUT
Described 

Participants

N: 44

Treatment duration: 6 wks; FU: 6 wks (14 wks for responders)

LF: 4 (9.1%)

BC: not reported

Age: not reported

Gender (per cent men): 54.5%

Severity: not reported

INCLUSION CRITERIA

  • Adults with chronic plaque psoriasis

  • BSA = 20%

EXCLUSION CRITERIA

  • Pregnancy

  • Inadequate contraception

Interventions

  • Calcitriol ointment 3 mcg/g BD (C)

  • Betamethasone valerate ointment 0.1% BD (B)

Outcomes

  1. IAGI (5‐pt: worse to clearance)

Notes

The trial did not report sponsorship.
All participants received 2 weeks' pre‐treatment with vehicle BD.

Risk of bias

Bias

Authors' judgement

Support for judgement

Allocation concealment (selection bias)

Unclear risk

The trial reported insufficient details.

Blinding (performance bias and detection bias)
All outcomes

Low risk

The trial was double‐blind (participant/investigator).

Randomisation method reported

Unclear risk

The trial did not report this.

Loss to follow up

Low risk

9.1%

Baseline assessments

Low risk

These were partially done.

Baseline comparability demonstrated

Unclear risk

The trial did not report this.

Langner 2001 (P)

Methods

DESIGN
Between‐patient
Participant delivery
ALLOCATION
Random
Method of randomisation: unclear
Concealment: unclear
BLINDING
Double‐blind (participant/investigator)
WITHDRAWAL/DROPOUT
Described 

Participants

N: 44

Treatment duration: 6 wks; FU: 6 wks (14 wks for responders)

LF: 4 (9.1%)

BC: not reported

Age: not reported

Gender (per cent men): 54.5%

Severity: not reported

INCLUSION CRITERIA

  • Adults with chronic plaque psoriasis

  • BSA = 20%

EXCLUSION CRITERIA

  • Pregnancy

  • Inadequate contraception

Interventions

  • Calcitriol ointment 3 mcg/g BD (C)

  • Placebo ointment BD (P)

Outcomes

  1. IAGI (5‐pt: worse to clearance)

Notes

The trial did not report sponsorship.
All participants received 2 weeks' pre‐treatment with vehicle BD.

Risk of bias

Bias

Authors' judgement

Support for judgement

Allocation concealment (selection bias)

Unclear risk

The trial reported insufficient details.

Blinding (performance bias and detection bias)
All outcomes

Low risk

The trial was double‐blind (participant/investigator).

Randomisation method reported

Unclear risk

The trial did not report this.

Loss to follow up

Low risk

9.1%

Baseline assessments

Low risk

These were partially done.

Baseline comparability demonstrated

Unclear risk

The trial did not report this.

Lassus 1991

Methods

DESIGN
Between‐patient
Participant delivery
ALLOCATION
Random
Method of randomisation: block randomisation
Concealment: unclear
BLINDING
Double‐blind (participant/investigator)
WITHDRAWAL/DROPOUT
Described

Participants

N: 50

Treatment duration: 12 wks; FU: 12 wks

LF:  8 (16%)

BC: yes

Age: 42.8 (range = 22 to 50; N = 42)

Gender (per cent men): 45.2% (N = 42)

Severity: TSS (0 to 12) = 7.72

INCLUSION CRITERIA

  • Stable psoriasis of at least 1 years' duration

  • Mild to moderate plaque psoriasis

  • Nummular, discoid, or guttate psoriasis

  • Stable aged 18 to 50

  • Localised lesions

EXCLUSION CRITERIA

  • Pregnancy

  • Lactation

  • Antipsoriatic therapy within previous 2 wks

  • People declining to abstain from alcohol during treatment period

Interventions

  • Oleum horwathiensis (Psoricur®) OD  (O)

  • Placebo OD (P)

Outcomes

  1. TSS (0 to 12)

  2. Severity (scaling, pruritis, erythema, induration)

  3. IAGI (5‐pt: poor to healed)

Notes

The trial did not report sponsorship.
There was SD imputation (TSS).

Risk of bias

Bias

Authors' judgement

Support for judgement

Allocation concealment (selection bias)

Unclear risk

The trial reported insufficient details.

Blinding (performance bias and detection bias)
All outcomes

Low risk

The trial was double‐blind (participant/investigator).

Randomisation method reported

Low risk

Block randomisation was used.

Loss to follow up

Low risk

16.0%

Baseline assessments

Low risk

Baseline comparability demonstrated

Low risk

Lebwohl 2002

Methods

DESIGN
Between‐patient
Participant delivery
ALLOCATION
Random
Method of randomisation: not reported (but ratio 3:1 used)
Concealment: unclear
BLINDING
Double‐blind (participant/investigator)
WITHDRAWAL/DROPOUT
Described

Participants

N: 81

Treatment duration: 2 wks; FU: 4 wks

LF: 5 (6.2%)

BC: yes

Age: not reported

Gender (per cent men): not reported

Severity: pruritis (0 to 4) = 2.11

INCLUSION CRITERIA

  • Mild to moderate plaque type psoriasis

  • Aged at least 18

  • TSS (0 to 12) ≥ 3

  • Target lesions in at least 1 of 5 anatomical regions

  • BSA ≤ 20%

EXCLUSION CRITERIA

  • Investigational medication within previous 4 wks

  • Topical antipsoriatic treatment within previous 2 wks

  • Systemic antipsoriatic treatment within previous 4 wks

  • Concurrent UV treatment or sunbathing

  • Pregnancy

  • Lactation

  • Inadequate contraception

  • Men wishing to father children during the study

  • Concurrent drug or alcohol abuse

Interventions

  • Clobetasol propionate foam 0.05% BD (maximum of 50 g/wk) (C)

  • Placebo foam BD (P)

Outcomes

  1. IAGI (7‐pt: worse to completely clear)

  2. PAGI (7‐pt: worse to completely clear)

  3. Total Severity Score: erythema, scaling, thickness, pruritis (0 to 4)

  4. Adverse events

  5. Medicines consumption (compliance)

Notes

Connetics Corporation sponsored the trial.
Only non‐scalp sites were treated.

Risk of bias

Bias

Authors' judgement

Support for judgement

Allocation concealment (selection bias)

Unclear risk

The trial reported insufficient details.

Blinding (performance bias and detection bias)
All outcomes

Low risk

The trial was double‐blind (participant/investigator).

Randomisation method reported

Unclear risk

The trial did not report this.

Loss to follow up

Low risk

6.2%

Baseline assessments

Low risk

These were partially done.

Baseline comparability demonstrated

Low risk

Lebwohl 2004

Methods

DESIGN
Between‐patient
Participant delivery
ALLOCATION
Random
Method of randomisation: not reported
Concealment: unclear
BLINDING
Double‐blind (participant/investigator)
WITHDRAWAL/DROPOUT
Described

Participants

N: 167

Treatment duration: 8 wks; FU: 8 wks

LF: 30 (18%)

BC: yes

Age: 48.0

Gender (per cent men): 58.7%

Severity: Static Severity Score (SSS) (0 to 6) (median) = 3 (range = 1.5 to 5.0); per cent with concurrent plaque‐type lesions = 85%

INCLUSION CRITERIA

  • Age limit unclear (stated as ≥ 2 and ≥ 16)

  • Chronic plaque psoriasis affecting intertriginous and facial skin

  • Disease stable or slowly worsening for ≥ 1 wk

  • Target lesion of moderate erythema and TSS (0 to 12) ≥ 4

EXCLUSION CRITERIA

  • Systemic therapy or phototherapy within previous 4 wks

  • Topical therapy within previous 2 wks

  • Inhaled/intranasal corticosteroids within previous 2 wks

  • Other topical agents (excluding sunscreen) within previous 1 dy

  • Recently diagnosed (< 6 mths) or recent exacerbation of inverse psoriasis

  • Uncontrolled chronic co‐morbidity

  • Pregnancy

  • Lactation

  • Previous use of tacrolimus ointment for facial or intertriginous psoriasis

Interventions

  • Tacrolimus ointment 0.1% BD

  • Placebo ointment BD

Outcomes

  1. Inverse psoriasis severity score (Static Severity Score) (SSS) (6‐pt: clear to very severe)

  2. IAGI ('PGA') (7‐pt: exacerbation to clear)

  3. Signs (0 to 3 each) (erythema, induration, desquamation; overall severity)

  4. Patient satisfaction (per cent agreeing with range of statements)

Notes

Fujisawa Healthcare Inc sponsored the trial.
Loss to follow up was reported as 11/167.
Non‐study body sites received usual topical treatment.
No adequate effectiveness data were reported or available from the sponsor.
This was an inverse psoriasis trial.

Risk of bias

Bias

Authors' judgement

Support for judgement

Allocation concealment (selection bias)

Unclear risk

The trial reported insufficient details.

Blinding (performance bias and detection bias)
All outcomes

Low risk

The trial was double‐blind (participant/investigator).

Randomisation method reported

Unclear risk

The trial did not report this.

Loss to follow up

Low risk

18.0%

Baseline assessments

Low risk

Baseline comparability demonstrated

Low risk

Lebwohl 2007

Methods

DESIGN
Between‐patient
Participant delivery
ALLOCATION
Random
Method of randomisation: not stated
Concealment: unclear
BLINDING
Double‐blind (participant/investigator)
WITHDRAWAL/DROPOUT
Not described

Participants

N: 418

Treatment duration: 8 wks; FU: 8 wks

LF: 0 (0%)

BC: NR separately (see notes)

Age: NR

Gender (per cent men): NR

Severity: GSS (0 to 5) = 2.81 (0.40SD); DSS (0 to 12) (bony areas) = 6.4 (1.24SD); (non‐bony areas) = 6.4 (1.33SD)

INCLUSION CRITERIA

  • People aged > = 12 with mild to moderate plaque psoriasis

  • BSA < = 35%

EXCLUSION CRITERIA

  • Not stated

Interventions

  • Calcitriol 3 mcg/g ointment BD (C)

  • Placebo ointment BD (P)

Outcomes

  1. Global Severity Score (GSS) on a 6‐pt scale (0 = clear, 1 = almost clear, 2 = mild, 3 = moderate, 4 = severe, 5 = very severe)

  2. Dermatological sum score (DSS) (0 to 12): reported separately for bony and non‐bony areas

  3. Investigator Assessment of Global Improvement (IAGI) on a 7‐pt scale (clear to worse)

  4. Subject Global Assessment (PAGI), 7‐pt (clear to worse)

  5. Routine clinical and safety laboratory parameters including calcium homeostasis (> 10% above upper limit of normal range)

Notes

Galderma R&D Inc, Princeton, New Jersey, sponsored the trial.

The main publication reports only pooled results and baseline statistics from 2 studies (Lebwohl 2007; Powers 2005).

The sponsor supplied unpublished data.

Risk of bias

Bias

Authors' judgement

Support for judgement

Allocation concealment (selection bias)

Unclear risk

The trial reported insufficient details.

Blinding (performance bias and detection bias)
All outcomes

Low risk

The trial was double‐blind (participant/investigator).

Randomisation method reported

Unclear risk

The trial did not report this.

Loss to follow up

Low risk

0%

Baseline assessments

Unclear risk

The trial did not report these.

Baseline comparability demonstrated

Unclear risk

This was not demonstrated.

Lee 2007

Methods

DESIGN
Between‐patient
Participant delivery
ALLOCATION
Random
Method of randomisation: not stated
Concealment: unclear
BLINDING
Single‐blind (investigator)
WITHDRAWAL/DROPOUT
Described

Participants

N: 142

Treatment duration: 6 wks; FU: 14 wks

LF: 11 (7.7%)

BC: yes (clinical only)

Age: NR

Gender (per cent men): NR

Severity: PASI = 3.75 (2.90SD)

INCLUSION CRITERIA

  • People with mild to moderate psoriasis

EXCLUSION CRITERIA

  • NR

Interventions

  • Calcitriol ointment BD (C)

  • Diflucortolone valerate OM, plus calcitriol ointment ON (C‐D)

Outcomes

  1. PASI (scale NR)

Notes

Sponsor: NR

The trial was set in Korea.

Risk of bias

Bias

Authors' judgement

Support for judgement

Allocation concealment (selection bias)

Unclear risk

The trial reported insufficient details.

Blinding (performance bias and detection bias)
All outcomes

Unclear risk

The study was single‐blind (investigator).

Randomisation method reported

Unclear risk

The trial did not report this.

Loss to follow up

Low risk

7.7%

Baseline assessments

Unclear risk

Clinical assessments were reported; demographics were unclear.

Baseline comparability demonstrated

Unclear risk

Only clinical comparability was demonstrated.

Lepaw 1978

Methods

DESIGN
Within‐patient
Participant delivery
ALLOCATION
Random
Method of randomisation: predetermined schedule using identical containers coded with participant number
Concealment: unclear
BLINDING
Double‐blind (participant/investigator)
WITHDRAWAL/DROPOUT
Described

Participants

N: 29

Treatment duration: 2 wks; FU: 2 wks

LF: 2 (6.9%)

BC: inadequately reported

Age: 14 to 75

Gender (per cent men): 55.2%

Severity: not reported

INCLUSION CRITERIA

  • Bilaterally similar psoriatic lesions of the scalp

  • Adults or adolescents

EXCLUSION CRITERIA

  • Systemic therapy, topical scalp treatments

Interventions

  • Halcinonide solution 0.1% TDS (H)

  • Placebo (vehicle) TDS (P)

Outcomes

  1. Overall therapeutic response

  2. Overall comparative response

Notes

The trial did not report sponsorship.
This was a scalp trial.

Risk of bias

Bias

Authors' judgement

Support for judgement

Allocation concealment (selection bias)

Unclear risk

The trial reported insufficient details.

Blinding (performance bias and detection bias)
All outcomes

Low risk

The trial was double‐blind (participant/investigator).

Randomisation method reported

Unclear risk

The trial did not report this.

Loss to follow up

Low risk

6.9%

Baseline assessments

Low risk

These were partially done.

Baseline comparability demonstrated

Unclear risk

The trial did not report this.

Levine 2010 (H)

Methods

DESIGN
Within‐patient
Participant delivery
ALLOCATION
Random
Method of randomisation: computer‐generated randomisation table
Concealment: adequate
BLINDING
Double‐blind (participant/investigator)
WITHDRAWAL/DROPOUT
Described

Participants

N: 168

Treatment duration: 12 wks; FU: 12 wks

LF: 4 (2.4%)

BC: stated, not demonstrated

Age: not reported

Gender (per cent men): not reported

Severity: TLPSS = 6.69 (1.38 SD)

INCLUSION CRITERIA

  • People aged 18 and over with moderate plaque psoriasis

  • Bilateral plaques or 2 plaques > = 5 cm distant on same side

  • 15 x 15 cm>plaque size > 2 x 2 cm

EXCLUSION CRITERIA

  • BSA > 15%

  • Participants with only scalp, nail, flexural, palmoplantar, or pustular psoriasis

  • Participation in trial within previous 3 mths

  • Topical antipsoriatic therapy within previous 2 wks

  • Systemic antipsoriatic therapy within previous 1 mth

  • Use of systemic niacin or multivitamins within previous 2 wks

  • Concomitant use of carbamazepine or primidone

  • People starting or modifying treatment with betablockers within previous 1 mth

  • Significant hematologic, renal, or liver disease

  • Relevant psychiatric or medical illness or surgery

  • Hemoglobin < 10.0 g/dL, hematocrit < 30%, white blood cell count < 3000/mcg/L, platelets < 100,000/mcg/L, aspartate aminotransferase or alanine aminotransferase > 3 x upper limit of normal

  • Pregnancy

Interventions

Participants were randomised to 2 of 7 treatments:

  • calcipotriene 0.005% ointment BD (C)

  • placebo ointment BD (P)]

  • nicotinamide 1.4% BD (NI)

  • calcipotriene 0.005% ointment BD + nicotinamide 0.05% BD (NC005)

  • calcipotriene 0.005% ointment BD + nicotinamide 0.1% BD (NC010)

  • calcipotriene 0.005% ointment BD + nicotinamide 0.7% BD (NC070)

  • calcipotriene 0.005% ointment BD + nicotinamide 1.4% BD (NC140)

Outcomes

  1. Total Local Psoriasis Severity Score (0 to 12): sum of erythema, plaque elevation, scaling (each scored 0 to 4)

  2. Efficacy end‐point: per cent patients 'clear to almost clear' (TLPSS = 0 to 2):

    • 'clear': no elevation above normal skin, no scaling, and no erythema

    • 'almost clear': no elevation above normal skin, surface dryness with some white coloration, and slight to moderate red colouration

Notes

Dermipsor Ltd sponsored the trial.
Compliance rates (medicine usage) were reported for each regimen.

The trial author supplied unpublished data.

As participants were randomised to 2 of 7 treatments, some comparisons were within‐patient and others between‐patient.

Risk of bias

Bias

Authors' judgement

Support for judgement

Allocation concealment (selection bias)

Low risk

The participants, investigators, study site personnel, sponsor, and laboratories were unaware of the treatment assignments; throughout the study, the study investigator retained a set of code envelopes that were to be opened by the investigator only if deemed necessary after a serious adverse event.

Blinding (performance bias and detection bias)
All outcomes

Low risk

The trial was double‐blind (participant/investigator).

Randomisation method reported

Low risk

A computer‐generated randomisation table was used.

Loss to follow up

Low risk

2.4%

Baseline assessments

Unclear risk

The trial did not report these.

Baseline comparability demonstrated

Unclear risk

Clinical comparability was stated (not demonstrated).

Levine 2010 (P)

Methods

DESIGN
Within‐patient
Participant delivery
ALLOCATION
Random
Method of randomisation: computer‐generated randomisation table
Concealment: adequate
BLINDING
Double‐blind (participant/investigator)
WITHDRAWAL/DROPOUT
Described

Participants

N: 168
Treatment duration: 12 wks; FU: 12 wks
LF: 4 (2.4%)
BC: stated, not demonstrated
Age: not reported
Gender (per cent men): not reported
Severity: TLPSS = 6.69 (1.38SD)

INCLUSION CRITERIA

  • People aged 18 and over with moderate plaque psoriasis

  • Bilateral plaques or 2 plaques > = 5 cm distant on same side

  • 15 x 15 cm>plaque size > 2 x 2 cm

EXCLUSION CRITERIA

  • BSA > 15%

  • Participants with only scalp, nail, flexural, palmoplantar, or pustular psoriasis

  • Participation in trial within previous 3 mths

  • Topical antipsoriatic therapy within previous 2 wks

  • Systemic antipsoriatic therapy within previous 1 mth

  • Use of systemic niacin or multivitamins within previous 2 wks

  • Concomitant use of carbamazepine or primidone

  • People starting or modifying treatment with betablockers within previous 1 mth

  • Significant hematologic, renal, or liver disease

  • Relevant psychiatric or medical illness or surgery

  • Hemoglobin < 10.0 g/dL, hematocrit < 30%, white blood cell count < 3000/mcg/L, platelets < 100,000/mcg/L, aspartate aminotransferase or alanine aminotransferase > 3 x upper limit of normal

  • Pregnancy

Interventions

Participants were randomised to 2 of 7 treatments:

  • calcipotriene 0.005% ointment BD (C)

  • placebo ointment BD (P)]

  • nicotinamide 1.4% BD (NI)

  • calcipotriene 0.005% ointment BD + nicotinamide 0.05% BD (NC005)

  • calcipotriene 0.005% ointment BD + nicotinamide 0.1% BD (NC010)

  • calcipotriene 0.005% ointment BD + nicotinamide 0.7% BD (NC070)

  • calcipotriene 0.005% ointment BD + nicotinamide 1.4% BD (NC140)

Outcomes

  1. Total Local Psoriasis Severity Score (0 to 12): sum of erythema, plaque elevation, scaling (each scored 0 to 4)

  2. Efficacy end‐point: per cent patients 'clear to almost clear' (TLPSS = 0 to 2):

    • 'clear': no elevation above normal skin, no scaling, and no erythema

    • 'almost clear': no elevation above normal skin, surface dryness with some white coloration, and slight to moderate red colouration

Notes

Dermipsor Ltd sponsored the trial.
Compliance rates (medicine usage) were reported for each regimen.

The trial author supplied unpublished data.

As participants were randomised to 2 of 7 treatments, some comparisons were within‐patient and others between‐patient.

Risk of bias

Bias

Authors' judgement

Support for judgement

Allocation concealment (selection bias)

Low risk

The participants, investigators, study site personnel, sponsor, and laboratories were unaware of the treatment assignments; throughout the study, the study investigator retained a set of code envelopes that were to be opened by the investigator only if deemed necessary after a serious adverse event.

Blinding (performance bias and detection bias)
All outcomes

Low risk

The trial was double‐blind (participant/investigator).

Randomisation method reported

Low risk

A computer‐generated randomisation table was used.

Loss to follow up

Low risk

2.4%

Baseline assessments

Unclear risk

The trial did not report these.

Baseline comparability demonstrated

Unclear risk

Clinical comparability was stated (not demonstrated).

Liao 2007

Methods

DESIGN

Between‐patient
Participant delivery
ALLOCATION
Random
Method of randomisation: not stated
Concealment: unclear
BLINDING
Double‐blind (participant/investigator)
WITHDRAWAL/DROPOUT
Described

Participants

N: 50

Treatment duration: 6 wks; FU: 6 wks

LF: 1 (2.0%)

BC: yes

Age: 39.6 (12.8SD); range 21 to 69

Gender (per cent men): 73.5%

Target lesion: face (89.8%); genitofemoral (10.2%)

Severity: TAS (0 to 12) = 6.2 (3.32SD)

INCLUSION CRITERIA

  • People aged 18 to 70 with chronic plaque psoriasis affecting facial and genitofemoral areas

EXCLUSION CRITERIA

  • Topical therapies within previous 1 wk

  • UV therapy or sunbathing within previous 2 wks

  • Systemic therapy within previous 4 wks

  • Concurrent use of oral calcium or Vitamin D supplements, or lithium, beta‐blockers, or ACE inhibitors

Interventions

  • Calcitriol 3 mcg/g ointment BD (C)

  • Tacrolimus 0.3 mg/g ointment BD (T)

No concomitant topical therapies or emollients were permitted. Dosing frequency could be reduced or medication discontinued depending on level of irritancy.

Outcomes

  1. Target Area Score (TAS): 0 to 12 (erythema, plaque elevation, scaling)

  2. Physician Global Assessment of improvement (PGA) on a 7‐pt scale (worse to clear)

  3. Safety: erythema (0 to 4), perilesional oedema (0 to 4), stinging/burning (0 to 4), hot sensation (0 to 4), folliculitis/acne (0 to 1)

Notes

Galderma, Taiwan, sponsored the trial.

Individual safety measures were reported, but the total number of participants experiencing any adverse event were not reported.

The trial author supplied unpublished data.

Risk of bias

Bias

Authors' judgement

Support for judgement

Allocation concealment (selection bias)

Unclear risk

The trial reported insufficient details.

Blinding (performance bias and detection bias)
All outcomes

Low risk

The trial was double‐blind (participant/investigator).

Randomisation method reported

Unclear risk

The trial did not report this.

Loss to follow up

Low risk

2.0%

Baseline assessments

Low risk

These were reported.

Baseline comparability demonstrated

Low risk

This was demonstrated.

Lin 2007

Methods

DESIGN
Within‐patient
Participant delivery
ALLOCATION
Random
Method of randomisation: not stated
Concealment: unclear
BLINDING
Single‐blind (investigator)
WITHDRAWAL/DROPOUT
Described

Participants

N: 14

Treatment duration: 8 wks; FU: 8 wks

LF: 4 (28.6%)

BC: yes

Age: 35.8 (10.4SD), range = 21 to 54

Gender (per cent men): 78.6%

Severity: PSI (0 to 12) = 9.9 (1.2SD); PASI = 11.7 (4.8SD), range = 5.5 to 19.2; per cent BSA = 13.6 (6.1SD), range = 3% to 20%

Duration (yrs): 110.8 (9.4SD); range = 2 to 30

INCLUSION CRITERIA

  • Adult people with recalcitrant, bilateral chronic plaque psoriasis affecting 5% to 20% of BSA

  • Plaques 3 to 20 cm diameter

  • Disease duration > = 2 yrs

  • Resistant to > = 1 topical therapy

  • No other significant medical problem

EXCLUSION CRITERIA

  • Systemic therapy within previous 30 days

  • Topical therapy within previous 14 days

  • Tests positive for HIV, hepatitis B, or hepatitis C

  • Known sensitivity to Chinese herbs

  • Pregnancy or risk thereof

  • Lactation

  • Clinically significant laboratory abnormality

Interventions

  • Indigo naturalis 1.4% ointment,OD (I)

  • Placebo ointment (olive oil, yellow wax, petroleum jelly) OD (P)

Outcomes

  1. Clearing per cent area of target lesions affected

  2. Psoriasis severity Index (TSS, 0 to 12)

  3. PASI (range not stated)

  4. Safety (immunohistochemical analysis of skin biopsies and blood tests)

Notes

The sponsor was not reported.

Assessments were conducted by 2 blinded investigators.

A 3‐month uncontrolled follow‐study also conducted.

The trial author supplied unpublished data.

Risk of bias

Bias

Authors' judgement

Support for judgement

Allocation concealment (selection bias)

Unclear risk

The trial reported insufficient details.

Blinding (performance bias and detection bias)
All outcomes

Unclear risk

The study was single‐blind (investigator).

Randomisation method reported

Unclear risk

The trial did not report this.

Loss to follow up

High risk

28.6%

Baseline assessments

Unclear risk

These were reported.

Baseline comparability demonstrated

Unclear risk

This was demonstrated.

Lin 2008

Methods

DESIGN
Within‐patient
Participant delivery
ALLOCATION
Random
Method of randomisation: not stated
Concealment: unclear
BLINDING
Single‐blind (investigator)
WITHDRAWAL/DROPOUT
Described

Participants

N: 42

Treatment duration: 12 wks; FU: 12 wks

LF: 0 (0%)

BC: Yes

Age: 34.6 (11.SD); range = 18 to 58

Gender (per cent men): 76.2%

Severity: PASI (median) = 14.7; per cent BSA (median) = 18%; TSS (0 to 24) = 18.8 (3.03SD)

Duration (yrs): 10 (median); range = 2 to 41

INCLUSION CRITERIA

  • People aged 18 to 75 with mild to moderate bilateral symmetric plaque psoriasis

  • Disease duration > = 2 yrs

  • Resistant to > = 2 topical therapies

  • Good general health (no abnormality in blood, renal, and liver function tests)

EXCLUSION CRITERIA

  • BSA > 60%

  • Pustular or generalised erythrodermic psoriasis

  • Concomitant use of medications that could affect psoriasis

  • Systemic therapy within previous 30 days

  • UV therapy within previous 21 days

  • Topical therapy within previous 2 wks

  • Tests positive for HIV, hepatitis B, or hepatitis C

  • History of alcohol/drug misuse

  • History of hepatitis

  • Known sensitivity to Chinese herbs or vehicle ingredients

  • Pregnancy or risk thereof

  • Lactation

  • Trial participation within previous 30 days

Interventions

  • Indigo naturalis 1.4% ointment OD (I)

  • Placebo ointment (olive oil, yellow wax, petroleum jelly) OD (P)

Participants achieving clearance before study end point could stop treatment.

Outcomes

  1. Global improvement (IAGI); 6‐pt: worse to clearance

  2. Signs (erythema, induration, scaling), each scored 0 (none) to 8 (very severe)

  3. Total sum score (0 to 24)

  4. PASI (range unclear): baseline median used to explore response by group

  5. Compliance (medication use)

  6. Safety

Notes

The trial was supported by a grant: CMRPG33024 from Chang Gung Memorial Hospital.

Participants were instructed to wash skin thoroughly before visits; assessments were based on photographs.

Risk of bias

Bias

Authors' judgement

Support for judgement

Allocation concealment (selection bias)

Unclear risk

The trial reported insufficient details.

Blinding (performance bias and detection bias)
All outcomes

Unclear risk

The study was single‐blind (investigator).

Randomisation method reported

Unclear risk

The trial did not report this.

Loss to follow up

Low risk

0.0%

Baseline assessments

Unclear risk

These were reported.

Baseline comparability demonstrated

Unclear risk

This was demonstrated.

Lister 1997

Methods

DESIGN
Between‐patient
Participant delivery
ALLOCATION
Random
Method of randomisation: not stated
Concealment: unclear
BLINDING
Single‐blind (investigator)
WITHDRAWAL/DROPOUT
Described

Participants

N: 171

Treatment duration: 8 wks; FU: 16 wks

LF: not reported

BC: psoriasis comparable, demographics unclear

Age: not stated

Gender (per cent men):  not stated

Severity: TSS (scale NR) = 6.24

INCLUSION CRITERIA

  • Chronic plaque psoriasis

EXCLUSION CRITERIA

  • Unclear

Interventions

  • Dithranol cream 1 to 3% OD (D)

  • Calcipotriol BD (C)

Outcomes

  1. Total Sign Score (erythema, scaling, induration) (scale NR)

  2. Investigator and Patient Global Assessments (scales NR)

  3. Relapse rates

Notes

Bioglan Laboratories sponsored the trial.

Risk of bias

Bias

Authors' judgement

Support for judgement

Allocation concealment (selection bias)

Unclear risk

The trial reported insufficient detail.

Blinding (performance bias and detection bias)
All outcomes

Low risk

The trial was single‐blind (investigator).

Randomisation method reported

Unclear risk

The trial did not report this.

Loss to follow up

Unclear risk

The trial did not report this.

Baseline assessments

Low risk

These were partially done.

Baseline comparability demonstrated

Unclear risk

This was partially demonstrated.

Lowe 2005

Methods

DESIGN
Between‐patient
Participant delivery
ALLOCATION
Random
Method of randomisation: consecutive balanced blocks of 7 (3:3:1)
Concealment: unclear
BLINDING
Single‐blind (investigator); as cream and lotion were compared, not possible to blind patients
WITHDRAWAL/DROPOUT
Described

Participants

N: 192

Treatment duration: 4 wks; FU: 8 wks

LF: 0 (0%)

BC: yes

Age: 48.65; range = 19 to 79

Gender (per cent men): 65.6%

Ethnicity (per cent white): 82.8%

Severity: DSS (0 to 12) = 7.60 (1.55SD)

INCLUSION CRITERIA

  • People aged > = 18 with stable moderate to severe plaque psoriasis

  • DSS (0 to 12) > = 6

  • Target lesion diameter > 3 cm, lesion not located on face, axillae, groin, scalp, hands, or feet

EXCLUSION CRITERIA

  • Contravention of wash‐out periods for topicals and systemics (duration not stated)

Interventions

  • Clobetasol propionate lotion/cream BD (CP)

  • Placebo lotion BD (P)

Participants were randomised to clobetasol propionate cream or lotion; results were aggregated for review purposes.

Other affected areas could also be treated.

There was a 4‐wk treatment‐ free follow‐up period.

Outcomes

  1. Signs: erythema, plaque elevation, scaling, pruritus (0 (none) to 4 (very severe))

  2. Dermatological sum score (DSS) (erythema, plaque elevation, scaling): 0 to 12

  3. Investigator's Assessment of Global improvement (IAGI): 7‐pt (worse to clear)

  4. Global severity score (GSS): dichotomised as success (GSS = 0, 0.5 or 1) or failure (GSS > = 2)

  5. BSA

Notes

Galderma R&D, Sophia Antipolis, France, sponsored the trial.

We sought unpublished data, but it was reported to be unavailable.

Risk of bias

Bias

Authors' judgement

Support for judgement

Allocation concealment (selection bias)

Unclear risk

The trial reported insufficient details.

Blinding (performance bias and detection bias)
All outcomes

Unclear risk

The study was single‐blind (investigator); as the cream and lotion were compared, it was not possible to blind participants.

Randomisation method reported

Low risk

Participants allocated in consecutive balanced blocks of 7 using the following ratios: 3:3:1.

Loss to follow up

Low risk

0%

Baseline assessments

Low risk

These were reported.

Baseline comparability demonstrated

Low risk

This was demonstrated.

Luger 2008

Methods

DESIGN
Between‐patient
Participant delivery
ALLOCATION
Random
Method of randomisation: not stated
Concealment: unclear
BLINDING
Double‐blind (participant/investigator)
WITHDRAWAL/DROPOUT
Described

Participants

N: 869

Treatment duration: 52 wks; FU: 52 wks

LF: 55 (6.3%)

BC: yes

Age: 48.7 (15.0SD), range = 18 to 86

Gender (per cent men): 44.0%

Ethnicity (per cent white): 96.7%

Severity: IGA moderate = 55.5%; IGA severe = 37.8%; IGA very severe = 6.7%

Duration (yrs): 17.6 (14.2SD)

INCLUSION CRITERIA

  • Hospital outpatients aged > = 18 with moderate to severe scalp psoriasis

  • Amendable to topical treatment with < = 100 g/wk

  • Psoriasis vulgaris on trunk or limbs;

  • Area of scalp affected > 10%

  • IGA at least moderate severity

EXCLUSION CRITERIA

  • Use within previous 28 days of PUVA or grenz ray therapy

  • Systemics with a potential impact on scalp psoriasis, or biological therapies; UVB; topical therapies; calcium metabolism disorders associated with hypercalcaemia. Unclear if concurrent use permitted during the trial

Interventions

  • Calcipotriol 50 mcg/g in scalp formulation (gel) OD PRN (C)

  • Calcipotriol gel 50 mcg/g plus betamethasone dipropionate "scalp formulation" (gel) 0.5 mg/g OD (C‐B)

Participants achieving clearance could stop treatment, but remained in the trial, and restart as needed. The regimen was intended to reflect usual clinical practice.

Outcomes

  1. Adverse drug reactions

  2. Adverse events associated with long‐term corticosteroid use

  3. Investigator's Global Assessment of disease severity (IGA) (6‐pt: absence of disease (0) to very severe disease (5))

  4. Controlled disease: IGA < = 2

  5. Compliance (self‐report; failure to use treatment for any reason other than no treatment required) (tube weight also assessed)

Notes

Leo Pharma, Ballerup, Denmark,sponsored the trial.

Adverse events were recorded by investigators and reviewed by an adjudication committee (Data Safety Monitoring Board) comprising of 3 dermatologists blinded to treatment assignment.

The sponsor supplied unpublished data.

Risk of bias

Bias

Authors' judgement

Support for judgement

Allocation concealment (selection bias)

Unclear risk

The trial reported insufficient details.

Blinding (performance bias and detection bias)
All outcomes

Low risk

The trial was double‐blind (participant/investigator).

Randomisation method reported

Unclear risk

This was not stated.

Loss to follow up

Low risk

6.3%

Baseline assessments

Low risk

These were reported.

Baseline comparability demonstrated

Low risk

This was demonstrated.

Maier 2004

Methods

DESIGN
Between‐patient
Participant delivery
ALLOCATION
Random
Method of randomisation: not stated
Concealment: unclear
BLINDING
Double‐blind (participant/investigator)
WITHDRAWAL/DROPOUT
Not described

Participants

N: 34

Treatment duration: 8 wks; FU: 8 wks

LF: 10 (29.4%)

BC: yes (clinical only)

Age: NR

Gender (per cent men): 55.9%

Severity: mPASI = 6.3 (2.2SD)

INCLUSION CRITERIA

  • People with stable mild to moderate plaque psoriasis

EXCLUSION CRITERIA

  • Concomitant antipsoriatic therapy or use within previous 2 wks

Interventions

  • Herbal skincare products (Dr Michaels® cleansing gel, ointment, and skin conditioner) BD (H)

  • 3 fatty skin care products (not vehicle) BD (P)

Outcomes

  1. mPASI (0 to 64.8)

Notes

The trial did not state the sponsor.

This was an abstract only.

Risk of bias

Bias

Authors' judgement

Support for judgement

Allocation concealment (selection bias)

Unclear risk

The trial reported insufficient details.

Blinding (performance bias and detection bias)
All outcomes

Low risk

The trial was double‐blind (participant/investigator).

Randomisation method reported

Unclear risk

The trial did not report this.

Loss to follow up

High risk

29.4%

Baseline assessments

Unclear risk

Clinical assessments were reported.

Baseline comparability demonstrated

Unclear risk

Clinical comparability was demonstrated.

Medansky 1987

Methods

DESIGN
Between‐patient
Participant delivery
ALLOCATION
Random
Method of randomisation: not reported
Concealment: unclear
BLINDING
Double‐blind (participant/investigator)
WITHDRAWAL/DROPOUT
Described

Participants

N: 121

Treatment duration: 3 wks; FU: 3 wks

LF: 6 (5.0%)

BC: yes, except duration of disease (P = 0.04)

Age: 53.8 (range = 16 to 80)

Gender (per cent men): 67.8%

Severity: TSS (0 to 9) = 6.6

Duration (yrs): 17.9 (range = 1 to 52)

INCLUSION CRITERIA

  • Aged ≥12; chronic plaque psoriasis, stable, or worsening

  • Duration ≥ 1 year

  • Total Sign Score ≥ 6

EXCLUSION CRITERIA

  • Concomitant medication

  • Recent systemic corticosteroids or antimetabolites

  • Recent topical corticosteroids

  • Pregnancy

  • Lactation

  • Those needing > 90 g/wk topical steroid

  • Other forms of psoriasis

Interventions

  • Mometasone furoate ointment 0.1% OD (M)

  • Vehicle OD (P)

Outcomes

  1. Signs (erythema; induration; scaling)

  2. Total Sign Score (0 to 9)

  3. Investigator Global Assessment (6‐pt: no change or worse to cleared or marked improvement)

Notes

The trial was supported in part by a grant from Schering Corporation.
There was SD imputation (TSS).

Risk of bias

Bias

Authors' judgement

Support for judgement

Allocation concealment (selection bias)

Unclear risk

The trial reported insufficient details.

Blinding (performance bias and detection bias)
All outcomes

Low risk

The trial was double‐blind (participant/investigator).

Randomisation method reported

Unclear risk

The trial did not report this.

Loss to follow up

Low risk

67.8%

Baseline assessments

Low risk

Baseline comparability demonstrated

Low risk

Baseline comparability was demonstrated (only significant difference: duration of disease).

Medansky 1996

Methods

DESIGN
Within‐patient
Participant delivery
ALLOCATION
Random
Method of randomisation: "schedule"
Concealment: unclear
BLINDING
Double‐blind (participant/assessor)
WITHDRAWAL/DROPOUT
Described

Participants

N: 134

Treatment duration: 3 wks; FU: 3 wks

LF: 6 (4.5%)

BC: unclear

Age: 47 (range = 20 to 81)

Gender (per cent men): not stated

Severity: TSS (0 to 9) = 6.5; per cent unstable psoriasis = 28%

INCLUSION CRITERIA

  • Mild‐to‐moderate symmetrical chronic plaque psoriasis

  • Adult

  • TSS (0 to 9) ≥ 6

EXCLUSION CRITERIA

  • Recent topical or systemic antipsoriatic therapy

  • Recent lithium, NSAIDs, or beta‐blockers

Interventions

  • Diflorasone diacetate ointment, 0.05% BD (D)

  • Calcipotriene ointment 0.005% BD (C)

Outcomes

  1. Signs (erythema, scaling, induration)

  2. Total Sign Score (0 to 9)

  3. Physician overall evaluation (7 pt: worse to clear)

  4. Physician comparative evaluation

  5. Patient comparative evaluation

Notes

Dermik Laboratories Inc. sponsored the trial.
Adverse events: itching and burning
There was SD imputation (TSS/IAGI).

Risk of bias

Bias

Authors' judgement

Support for judgement

Allocation concealment (selection bias)

Unclear risk

The trial reported insufficient details.

Blinding (performance bias and detection bias)
All outcomes

Low risk

The trial was double‐blind (participant/assessor).

Randomisation method reported

Unclear risk

The trial did not report this.

Loss to follow up

Low risk

4.5%

Baseline assessments

Low risk

These were partially done.

Baseline comparability demonstrated

Unclear risk

The trial did not report this.

Menter 2009

Methods

DESIGN
Between‐patient
Participant delivery
ALLOCATION
Random
Method of randomisation: not reported
Concealment: unclear
BLINDING
Open (blinding NS but product vehicles differ)
WITHDRAWAL/DROPOUT
Described

Participants

N: 122
Treatment duration: 4 wks; FU: 8 wks
LF: 0 (0%)
BC: yes
Age: 46.5 (14.2SD)
Gender (per cent men): 61.1%
Duration (yrs): 16.4 (11.50SD)
Severity: ODS = 3.06 (0.43SD)
(participant demographics based on per‐protocol sample).

INCLUSION CRITERIA

  • People aged 18 to 80 with moderate to severe stable plaque psoriasis

  • BSA: 3 to 20%

EXCLUSION CRITERIA

  • Known allergy to study ingredients

  • Psoriasis affecting scalp, face, or groin only

  • Area affected required weekly treatment with > 50 g CP spray or > 100 g C‐BD ointment

Interventions

  • Calcipotriol 50 mcg/g + betamethasone dipropionate 0.5 mg/g combination ointment OD (C‐BD)

  • Clobetasol propionate 0.05% spray (CP)

Outcomes

  1. Overall disease severity (ODS) on a 5‐pt scale: clear (0), almost clear, mild, moderate, severe/very severe (4)

  2. Based on erythema, scaling, and elevation

  3. Investigator Global Assessment (IGA) on a 4‐pt scale (0 to 3): clear (0), mild, moderate, severe (3). Based on per cent BSA affected (extent) rather than signs

Notes

Galderma Laboratories, LP, sponsored the trial.

Atrophy was not assessed.

Telangiectasia was not assessed.

29 participants were 'non‐compliant' with treatment, but intention‐to‐treat (ITT) analysis included all enrolled participants.

The sponsor supplied unpublished data.

Risk of bias

Bias

Authors' judgement

Support for judgement

Allocation concealment (selection bias)

Unclear risk

The trial reported insufficient details.

Blinding (performance bias and detection bias)
All outcomes

High risk

The trial was open (blinding not reported, but product vehicles differ).

Randomisation method reported

Unclear risk

The trial did not report this.

Loss to follow up

Low risk

0%

Baseline assessments

Low risk

These were reported.

Baseline comparability demonstrated

Low risk

This was demonstrated.

Molin 1997

Methods

DESIGN
Between‐patient
Participant delivery
ALLOCATION
Random
Method of randomisation: not stated
Concealment: unclear
BLINDING
Double‐blind (participant/assessor)
WITHDRAWAL/DROPOUT
Described

Participants

N: 421

Treatment duration: 8 wks; FU: 8 wks

LF: 4 (1%)

BC: Psoriasis comparable, demographics not reported

Age: not stated

Gender (per cent men): not stated

Severity: no summary measure reported

INCLUSION CRITERIA

  • Adult outpatients

  • Mild‐to‐moderate stable and chronic plaque psoriasis of limbs and trunk

EXCLUSION CRITERIA

  • None reported

Interventions

  • Calcipotriol cream 50 mcg/g BD (C)

  • Betamethasone 17‐valerate cream 1 mg/g BD (B)

Outcomes

  1. PASI (0 to 64.8)

  2. Severity scores

  3. Investigator Global Assessment of response (5‐pt: worse to cleared)

  4. Patient Global Assessments of response (5‐pt: worse to cleared)

Notes

Leo Pharmaceutical Products sponsored the trial.

Risk of bias

Bias

Authors' judgement

Support for judgement

Allocation concealment (selection bias)

Unclear risk

The trial reported insufficient details.

Blinding (performance bias and detection bias)
All outcomes

Low risk

The trial was double‐blind (participant/assessor).

Randomisation method reported

Unclear risk

The trial did not report this.

Loss to follow up

Low risk

1.0%

Baseline assessments

Unclear risk

The trial did not report these.

Baseline comparability demonstrated

Unclear risk

This was partially demonstrated.

Monastirli 2000

Methods

DESIGN
Between‐patient
Delivery unclear
ALLOCATION
Random
Method of randomisation: not stated
Concealment: unclear
BLINDING
Open
WITHDRAWAL/DROPOUT
Described

Participants

N: 70

Treatment duration: 10 wks; FU: 10 wks

LF: not reported

BC: yes

Age: 45.7

Gender (per cent men): 57.1%

Severity: PASI =

    • D: 7.31 (1.79SD, N = 35)

    • C: 6.29 (1.63SD, N = 35)

Duration (yrs): 17

INCLUSION CRITERIA

  • Inpatients with chronic plaque psoriasis

EXCLUSION CRITERIA

  • Pregnancy

  • Lactation

  • Ineffective contraception

  • Systemic treatment within previous 2 mths

  • Hepatic or renal disease

  • Hypercalcaemia

  • Known hypersensitivity to study medications

Interventions

  • Dithranol 2% 30 minutes OD (D)

  • Calcipotriol ointment 50 mcg/g BD (C)

Outcomes

  1. PASI (excluding head)

Notes

The trial did not report sponsorship.
Treatment was delivered in an inpatient setting.

Risk of bias

Bias

Authors' judgement

Support for judgement

Allocation concealment (selection bias)

Unclear risk

The trial reported insufficient details.

Blinding (performance bias and detection bias)
All outcomes

High risk

The trial was open.

Randomisation method reported

Unclear risk

The trial did not report this.

Loss to follow up

Unclear risk

The trial did not report this.

Baseline assessments

Low risk

Baseline comparability demonstrated

Low risk

Mortensen 1993b

Methods

DESIGN
Between‐patient
Participant delivery
ALLOCATION
Random
Method of randomisation: not reported
Concealment: unclear
BLINDING
Double‐blind (participant/investigator)
WITHDRAWAL/DROPOUT
Described

Participants

N: 34

Treatment duration: 3 wks; FU: 4 wks

LF: 0 (0%)

BC: psoriasis comparable, demographics inadequately reported.

Age: 43 (range = 26 to 75)

Gender (per cent men): 58.8%

Severity: PASI = 12.2

INCLUSION CRITERIA

  • Stable plaque‐type psoriasis

  • Adult outpatients

  • Normal hepatic and renal function

EXCLUSION CRITERIA

  • Recent UV or other psoriasis treatments

  • Disease or medication influencing calcium or bone metabolism

Interventions

  • Calcipotriol ointment 50 mcg/g BD (C) [max 100 g/wk]

  • Placebo (vehicle) (P)

Outcomes

  1. PASI

  2. Investigator Global Assessment: per cent improvement from baseline, based on PASI

  3. Patient Global Assessment : per cent improvement from baseline, based on PASI

Notes

Leo Pharmaceuticals, Denmark Duration (yrs) sponsored the trial.

Risk of bias

Bias

Authors' judgement

Support for judgement

Allocation concealment (selection bias)

Unclear risk

The trial reported insufficient details.

Blinding (performance bias and detection bias)
All outcomes

Low risk

The trial was double‐blind (participant/investigator).

Randomisation method reported

Unclear risk

The trial did not report this.

Loss to follow up

Low risk

0.0%

Baseline assessments

Low risk

Baseline comparability demonstrated

Unclear risk

This was partially demonstrated.

Olsen 1991

Methods

DESIGN
Between‐patient
Participant delivery
ALLOCATION
Random
Method of randomisation: not reported
Concealment: unclear
BLINDING
Double‐blind (participant/investigator)
WITHDRAWAL/DROPOUT
Described 

Participants

N: 378

Treatment duration: 2 wks; FU: 3 wks

LF: 1 (0.3%)

BC: yes

Age: 46 (range = 18 to 88)

Gender (per cent men): 45%

Severity: 80% moderate (6 ≤ TSS < 7.5), 20% severe (TSS > 7.5)

Duration (yr): 12.0 (9.7SD, N = 377); range = 0.4 to 55.0

INCLUSION CRITERIA

  • Moderate to severe scalp psoriasis (TSS (0 to 9) ≥ 6)

  • Stable or worsening

  • Adult

EXCLUSION CRITERIA

  • Recent systemic, topical, or UV treatment for psoriasis.

Interventions

  • Clobetasol propionate 0.05% BD (C)

  • Placebo (vehicle) (P)

Outcomes

  1. Severity (erythema; induration; scaling, pruritis)

  2. TSS (0 to12)

  3. Investigator Global Assessment (6‐pt: worse to cleared)

  4. Patient Global Assessment (4‐pt: poor to excellent)

Notes

In part, Glaxo Inc. sponsored the trial.
This was a scalp trial.
There was SD imputation (TSS).

Risk of bias

Bias

Authors' judgement

Support for judgement

Allocation concealment (selection bias)

Unclear risk

The trial reported insufficient details.

Blinding (performance bias and detection bias)
All outcomes

Low risk

The trial was double‐blind (participant/investigator).

Randomisation method reported

Unclear risk

The trial did not report this.

Loss to follow up

Low risk

0.3%

Baseline assessments

Low risk

Baseline comparability demonstrated

Low risk

Olsen 1996 (1)

Methods

DESIGN
Between‐patient
Participant delivery
ALLOCATION
Random
Method of randomisation: not reported
Concealment: unclear
BLINDING
Double‐blind (participant/investigator)
WITHDRAWAL/DROPOUT
Described (for both trials together)

Participants

N: 181
Treatment duration: 4 wks; FU: 4 wks
LF: 3 (1.7%)
BC: yes
Age: 49 (range = 15 to 76)
Gender (per cent men): 68.0%
Severity: per cent BSA affected = 12.0% (range = 1% to 80%); per cent BSA treated = 11% (range = 1% to 80%)
Duration (yrs): 19 (range = 1 to 60)

Interventions

  • Fluticasone propionate 0.005% ointment (F) (max 100 g/wk)

  • Placebo (vehicle) (P)

Outcomes

  1. Investigator Global Assessment (6‐pt: cleared to worse)

  2. Severity (erythema; induration; scaling; pruritis)

  3. Patient subjective assessment (treatment effect: 1 = excellent to 4 = poor)

Notes

The trial did not report sponsorship.

Risk of bias

Bias

Authors' judgement

Support for judgement

Allocation concealment (selection bias)

Unclear risk

The trial reported insufficient details.

Blinding (performance bias and detection bias)
All outcomes

Low risk

The trial was double‐blind (participant/investigator).

Randomisation method reported

Unclear risk

The trial did not report this.

Loss to follow up

Low risk

1.7%

Baseline assessments

Low risk

Baseline comparability demonstrated

Low risk

Olsen 1996 (2)

Methods

DESIGN
Between‐patient
Participant delivery
ALLOCATION
Random
Method of randomisation: not reported
Concealment: unclear
BLINDING
Double‐blind (participant/investigator)
WITHDRAWAL/DROPOUT
Described (for both trials together)

Participants

N: 207
Treatment duration: 4 wks; FU: 4 wks
LF: 2 (1.0%)
BC: yes
Age: 45 (range = 12 to 87)
Gender (per cent men): 52.7%
Severity: per cent BSA affected = 12.5% (range = 1% to 80%); per cent BSA treated = 12% (range = 1% to 80%)
Duration (yrs): 16 (range = 0.8 to 52)

Interventions

  • Fluticasone propionate 0.005% ointment (F) (max 100 g/wk)

  • Placebo (vehicle) (P)

Outcomes

  1. Investigator Global Assessment (6‐pt: cleared to worse)

  2. Severity (erythema; induration; scaling; pruritis)

  3. Patient subjective assessment (treatment effect: 1 = excellent to 4 = poor)

Notes

The trial did not report sponsorship.

Risk of bias

Bias

Authors' judgement

Support for judgement

Allocation concealment (selection bias)

Unclear risk

The trial reported insufficient details.

Blinding (performance bias and detection bias)
All outcomes

Low risk

The trial was double‐blind (participant/investigator).

Randomisation method reported

Unclear risk

The trial did not report this.

Loss to follow up

Low risk

1.0%

Baseline assessments

Low risk

Baseline comparability demonstrated

Low risk

Oranje 1997

Methods

DESIGN
Between‐patient
Patient/parent delivery
ALLOCATION
Random
Method of randomisation: computer‐generated random number table used by 7/14 centres to randomly select ≤ 3 participants
Concealment: unclear
BLINDING
Double‐blind (participant/investigator)
WITHDRAWAL/DROPOUT
Described

Participants

N: 77

Treatment duration: 8 wks; FU: 8 wks

LF: 0 (0%)

BC: yes

Age: 10 (range = 2 to 14)

Gender (per cent men): 46.8%

Severity: not reported

INCLUSION CRITERIA

  • Mild to moderate chronic plaque psoriasis

  • Children aged 2 to 14

EXCLUSION CRITERIA

  • Acute guttate, pustular, erythrodermic, or worsening psoriasis

  • Psoriasis mainly on the face, scalp, or diaper area

  • Systemic treatment

  • Recent phototherapy

  • Concurrent Vitamin D, calcium, or other intercurrent medication

  • Renal, hepatic, or osteoarthritic disease

Interventions

  • Calcipotriol ointment 50 mcg/g BD (C)

  • Placebo (vehicle) (P)

Outcomes

  1. PASI: severity (redness; thickness; scaliness, area)

  2. Extent of disease

  3. Investigator Global Assessment

  4. Patient Global Assessment (by parent/guardian for those aged < 8)

  5. Compliance

Notes

Leo Pharmaceutical Products, Denmark, sponsored the trial.
The trial participants were children.

Risk of bias

Bias

Authors' judgement

Support for judgement

Allocation concealment (selection bias)

Unclear risk

The trial reported insufficient details.

Blinding (performance bias and detection bias)
All outcomes

Low risk

The trial was double‐blind (participant/investigator).

Randomisation method reported

Low risk

Randomisation was computer‐generated.

Loss to follow up

Low risk

0.0%

Baseline assessments

Low risk

These were partially done.

Baseline comparability demonstrated

Low risk

Ormerod 1997

Methods

DESIGN
Within‐patient
Participant delivery
ALLOCATION
Random
Method of randomisation: not reported
Concealment: unclear
BLINDING
Double‐blind (participant/investigator)
WITHDRAWAL/DROPOUT
Not described

Participants

N: 12

Treatment duration: 2 wks; FU: 2 wks

LF: unclear

BC: unclear

Age: not reported

Gender (per cent men): not reported

Severity: TSS (0 to 24) =12.2

INCLUSION CRITERIA

  • Bilaterally similar chronic

  • Stable plaque psoriasis.

EXCLUSION CRITERIA

  • Recent systemic or UV therapy

Interventions

  • Betamethasone valerate ointment 0.1% BD (B)

  • White soft paraffin BD (P)

Outcomes

  1. Signs (erythema; elevation; scaling)

  2. Total Sign Score (0 to 24)

Notes

Wyeth‐Ayerst Research and Glaxo Dermatology sponsored the trial.

Risk of bias

Bias

Authors' judgement

Support for judgement

Allocation concealment (selection bias)

Unclear risk

The trial reported insufficient details.

Blinding (performance bias and detection bias)
All outcomes

Low risk

The trial was double‐blind (participant/investigator).

Randomisation method reported

Unclear risk

The trial did not report this.

Loss to follow up

Unclear risk

The trial did not report this.

Baseline assessments

Low risk

These were partially done.

Baseline comparability demonstrated

Unclear risk

The trial did not report this.

Ormerod 2000

Methods

DESIGN
Within‐patient
Participant delivery
ALLOCATION
Random
Method of randomisation: not reported
Concealment: unclear
BLINDING
Double‐blind (participant/investigator)
WITHDRAWAL/DROPOUT
Described

Participants

N: 17

Treatment duration: 4 wks; FU: 4 wks

LF: 0 (0%)

BC: not reported

Age: not reported

Gender (per cent men): not reported

Severity: TSS (0 to 24) = 15.5 (SD: 3.7; N = 17)

INCLUSION CRITERIA

  • Stable plaque psoriasis

EXCLUSION CRITERIA

  • Pregnancy

  • Ineffective contraception

  • Lactation

Interventions

  • NG‐monomethyl‐L‐arginine (L‐NMMA) cream 25% BD

  • NG‐monomethyl‐L‐arginine (L‐NMMA) cream 5% BD

  • Placebo (P)

Outcomes

  1. TSS (elevation, erythema, scaling) (0 to 24)

Notes

The trial did not report sponsorship.

Risk of bias

Bias

Authors' judgement

Support for judgement

Allocation concealment (selection bias)

Unclear risk

The trial reported insufficient details.

Blinding (performance bias and detection bias)
All outcomes

Low risk

The trial was double‐blind (participant/investigator).

Randomisation method reported

Unclear risk

The trial did not report this.

Loss to follow up

Low risk

0.0%

Baseline assessments

Low risk

These were partially done.

Baseline comparability demonstrated

Unclear risk

The trial did not report this.

Ormerod 2005

Methods

DESIGN
Within‐patient
Participant delivery
ALLOCATION
Random
Method of randomisation: randomised in blocks of 4 by the pharmacy department using 'Minitab'
Concealment: unclear
BLINDING
Double‐blind (participant/investigator)
WITHDRAWAL/DROPOUT
Unclear

Participants

N: 24

Treatment duration: 12 wks; FU: 12 wks

LF: 2 (8.3%)

BC: yes

Age: 47.5 (range = 28 to 78)

Gender (per cent men): 75.0%

Severity: TSS (0 to 24) = 17.0 (3.3SD, N = 22)

INCLUSION CRITERIA

  • Chronic plaque psoriasis

  • Aged 18 and over

  • No significant co morbidity

  • Transminase levels within double normal upper limit

EXCLUSION CRITERIA

  • Planned exposure to sunlight over trial duration

  • Pregnancy or risk thereof

  • Lactation; systemic or UV therapy within previous 4 wks

  • Topical therapy within previous 2 wks

  • Known allergy to macrolide drugs

  • Renal or hepatic disease

  • Renal malignancy within previous 5 yrs

Interventions

  • Topical sirolimus 2.2% for 6 wks then 8% for a further 6 wks (S)

  • Placebo (P)

Dosing frequency was not reported.

Outcomes

  1. Total Sign Score (TSS) of target plaque (erythema, thickening, scaling) (0 to 24)

Notes

Wyeth Research, Philadelphia, sponsored the trial.
No systemic adverse event was considered clinically significant.
The daily dosing frequency was unclear.

Risk of bias

Bias

Authors' judgement

Support for judgement

Allocation concealment (selection bias)

Unclear risk

The trial reported insufficient details.

Blinding (performance bias and detection bias)
All outcomes

Low risk

The trial was double‐blind (participant/investigator).

Randomisation method reported

Low risk

Block randomisation was used.

Loss to follow up

Low risk

9.3%

Baseline assessments

Low risk

Baseline comparability demonstrated

Low risk

Ortonne 1994

Methods

DESIGN
Between‐patient
Participant delivery
ALLOCATION
Random
Method of randomisation: participants allocated sequentially upon inclusion
Concealment: unclear
BLINDING
Double‐blind (participant/assessor)
WITHDRAWAL/DROPOUT
Described

Participants

N: 188

Treatment duration: 6 wks; FU: 6 wks

LF: 32 (17.0%)

BC: yes

Age: 46.0 (range = 20 to 85)

Gender (per cent men) 67.3%

Severity: per cent BSA = 18.9%; PASI = 11.67; per cent unstable psoriasis = 40%

Duration (yrs): 14.9

INCLUSION CRITERIA

  • Chronic plaque psoriasis

  • Stable or worsening

  • BSA 10% to 40%

  • PASI 1 to 30; outpatients

EXCLUSION CRITERIA

  • Pregnancy

  • Lactation

  • Concurrent disease

  • Concomitant therapy

  • Hypersensitivity to Vitamin D or analogues

  • Planned exposure to sun

Interventions

  • Calcipotriol ointment BD (C)

  • Calcipotriol ointment OM, plus betamethasone dipropionate ointment ON (CB)

Outcomes

  1. PASI

  2. Investigator Global Assessment

Notes

Leo Pharmaceuticals sponsored the trial.

Risk of bias

Bias

Authors' judgement

Support for judgement

Allocation concealment (selection bias)

Unclear risk

The trial reported insufficient details.

Blinding (performance bias and detection bias)
All outcomes

Low risk

The trial was double‐blind (participant/assessor).

Randomisation method reported

Low risk

Randomisation was sequential.

Loss to follow up

Low risk

17.0%

Baseline assessments

Low risk

Baseline comparability demonstrated

Low risk

Ortonne 2003

Methods

DESIGN
Within‐patient
Participant delivery
ALLOCATION
Random
Method of randomisation: computer‐generated randomisation by blocks of 4 using RANUNI routine of the SAS system
Concealment: unclear
BLINDING
Single‐blind (investigator)
WITHDRAWAL/DROPOUT
Described

Participants

N: 75

Treatment duration: 6 wks; FU: 6 wks

LF: 10 (13.3%)

BC: yes, within‐patient design but comparability of lesions at baseline not reported

Age: 44.5 (14.5SD: range = 18.8 to 70.7)

Gender (per cent men): 53%

Severity: not reported

INCLUSION CRITERIA

  • People with stable chronic plaque psoriasis, localised on 'sensitive areas': face, hairline, retro‐auricular, and flexural areas

  • Aged 18 to 70

  • 1 to 4 bilateral lesions of similar severity

EXCLUSION CRITERIA

  • Pregnancy or risk thereof

  • Lactation

  • Concomitant disease

  • Acute guttate, pustular, erythrodermic, or arthropathic psoriasis

  • History of hypercalcaemia, renal dysfunction

  • Calcium‐based calculi

  • Conditions requiring systemic supplements of vitamin D or calcium

  • Previous topical therapy within previous 2 wks (4 wks for retinoids)

  • Previous systemic therapy within previous 4 wks (16 wks for retinoids)

Interventions

  • Calcitriol ointment 3 mcg/g BD (C1)

  • Calcipotriol ointment 50 mcg/g BD (C2)

Outcomes

  1. Investigator's Global Assessment of local safety for each lesion (3‐pt: 0 = poor to 2 = excellent)

  2. Mean of worst sign scores (0 to 9) (signs: perilesional erythema; perilesional oedema; stinging/burning)

  3. Investigator's Global Assessment of Improvement (IAGI) (7‐pt: worse to clear)

  4. Patient's preference for tolerance, efficacy, and global preference (5‐pt: right‐hand side (RHS) > left‐hand side (LHS): ‐2 to LHS > RHS: 2)

Notes

The trial did not report sponsorship, but 2 authors worked for Galderma, France
This was an inverse psoriasis trial.
There was SD imputation (TSS).

Risk of bias

Bias

Authors' judgement

Support for judgement

Allocation concealment (selection bias)

Unclear risk

The trial reported insufficient details.

Blinding (performance bias and detection bias)
All outcomes

Low risk

The trial was single‐blind (investigator).

Randomisation method reported

Low risk

A computer‐generated block list was used for randomisation.

Loss to follow up

Low risk

13.3%

Baseline assessments

Low risk

These were partially done.

Baseline comparability demonstrated

Unclear risk

This was partially demonstrated.

Ortonne 2004

Methods

DESIGN
Between‐patient
Participant delivery
ALLOCATION
Random
Method of randomisation: computer‐generated randomisation schedule
Concealment: unclear
BLINDING
Double‐blind (participant/investigator)
WITHDRAWAL/DROPOUT
Described

Participants

N: 501

Treatment duration: 8 wks; FU: 8 wks

LF: 21 (4.2%)

BC: yes

Age: 51.2 (15.0SD, N = 501)

Gender (per cent men): 54.9%

Severity: PASI = 9.8 (6.1SD, N = 501)

Duration (yrs): 19.4 (14.6SD, N = 501)

INCLUSION CRITERIA

  • Stable chronic plaque psoriasis amenable to topical treatment

  • Aged 18 and over

EXCLUSION CRITERIA

  • Pregnancy or risk thereof

  • Lactation

  • Unstable psoriasis or other inflammatory diseases

  • Abnormality of calcium metabolism or hypercalcaemia

  • Systemic or phototherapy within previous 4 wks

  • Topical therapy within previous 2 wks

  • Other topical therapy for trunk or limbs during study period

  • Corticosteroid treatment of scalp (WHO: class IV) or facial area (WHO: class III/IV) during study period

Interventions

  • TCP ointment ON for 4 wks then calcipotriol ointment 50 mcg/g ON for 4 wks (A)

  • Tacalcitol ointment 4 mcg/g ON for 8 wks (T)

  • TCP: calcipotriol 50 mcg/g, plus betamethasone dipropionate 0.5 mg/g ointment

Outcomes

  1. PASI: mean % reduction

  2. IAGI (6‐pt: worse to clearance)

  3. PAGI (6‐pt: worse to clearance)

Notes

Leo Pharmaceutical Products sponsored the trial.

Risk of bias

Bias

Authors' judgement

Support for judgement

Allocation concealment (selection bias)

Unclear risk

The trial reported insufficient details.

Blinding (performance bias and detection bias)
All outcomes

Low risk

The trial was double‐blind (participant/investigator).

Randomisation method reported

Low risk

Randomisation was computer‐generated.

Loss to follow up

Low risk

4.2%

Baseline assessments

Low risk

Baseline comparability demonstrated

Low risk

Ortonne 2006

Methods

DESIGN
Between‐patient
Participant delivery
ALLOCATION
Random
Method of randomisation: generated by sponsor; stratified by centre (N = 16);
Concealment: unclear
BLINDING
Single‐blind (investigator); as cream and gel were compared, it was not possible to blind participants
WITHDRAWAL/DROPOUT
Described

Participants

N: 124

Treatment duration: 12 wks; FU: 14 wks

LF: 0 (0%)

BC: yes

Age: 48.2 (14.8SD); range = 18 to 82

Gender (per cent men): 68.5%

Ethnicity (per cent white): 96.0%

Severity: per cent BSA = 6.3 ((2.2SD), range = 1% to 10%; LPSI (0 to 12) = 7.2 (1.7SD), range = 4 to 12; PASI (range NS) = 7.1 (3.7SD), range = 1.4 to 21.8

Duration (yrs): 18.9 (13.9SD); range = 0.7 to 69.3

INCLUSION CRITERIA

  • People aged > = 18 with mild to moderate stable plaque psoriasis

  • Per cent BSA < = 10%

  • Target lesion on extremities or trunk between 40 and 200 cm^2

  • LPSI > = 5

EXCLUSION CRITERIA

  • Intranasal or inhaled corticosteroids, systemic, and topic corticosteroids, phototherapy, topical antipsoriatic therapies

  • Immunosuppriessive drugs, chemotherapy agents, systemic drugs with potential to alter tacrolimus concentrations, lithium, beta blockers, antimalarials, other medicated topical agents

Interventions

  • Calcipotriol 0.005% ointment BD (C)

  • Tacrolimus 0.3% gel BD or 0.5% tacrolimus cream BD (T)

There were10 to 14 hours between applications; lesions were treated for 7 days following clearance.

Participants were randomised to tacrolimus cream or gel; results were aggregated for review purposes.

Outcomes

  1. Local Psoriasis Severity Index (LPSI) (erythema, induration, scaling): 0 to 12

  2. Physician assessment of clinical response of target lesion: IAGI: 5‐pt = 0 (worse) to 4 (much better)

  3. Subject's assessment of clinical response of target lesion: PAGI: 5‐pt = 0 (worse) to 4 (much better)

  4. Compliance (median daily medication usage)

  5. Cosmetic acceptability (participant)

  6. Adverse events and clinical laboratory evaluations

Notes

Fujisawa GmbH, Munich, Germany, sponsored the trial.

Vissers 2008 (secondary reference under Ortonne 2006) reports immunohistochemistry findings for subgroup (N = 18).

Risk of bias

Bias

Authors' judgement

Support for judgement

Allocation concealment (selection bias)

Unclear risk

The trial reported insufficient details.

Blinding (performance bias and detection bias)
All outcomes

Unclear risk

The study was single‐blind (investigator); as the cream and gel were compared, it was not possible to blind participants.

Randomisation method reported

Low risk

Randomisation was generated by the sponsor and stratified by centre.

Loss to follow up

Low risk

0%

Baseline assessments

Low risk

These were reported.

Baseline comparability demonstrated

Low risk

This was demonstrated.

Ortonne 2010

Methods

DESIGN
Between‐patient
Participant delivery
ALLOCATION
Random
Method of randomisation: pre‐planned computer‐generated schedule
Concealment: unclear
BLINDING
Double‐blind (participant/investigator)
WITHDRAWAL/DROPOUT
Described

Participants

N: 408

Treatment duration: 8 wks; FU: 8 wks

LF: 9 (2.2%)

BC: yes

Age: 45.6; range = 18 to 86

Gender (per cent men): 54.7%

Ethnicity (per cent white): 97.8%

Severity: PASI = 9.6, range = 0.9 to 32.7; IGA moderate = 68.6%

Duration (yrs): 17.7; range = 0 to 70

INCLUSION CRITERIA

  • People aged > = 18 with chronic plaque psoriasis amenable to topical treatment

  • % face affected >10%

  • % 1 of more body areas affected > = 10%

  • IGA at least mild

EXCLUSION CRITERIA

  • Pregnancy or risk thereof

  • Lactation

  • Unstable forms of psoriasis in treatment areas

  • Other skin condition that could affect assessment

  • PUVA or systemic therapy within previous 4 wks

  • UVB or topical therapy on trunk, limbs, or face within previous 2 wks

  • Treatment of scalp psoriasis with very potent (WHO group IV) corticosteroids or vitamin D analogues

  • Known or suspected abnormality in calcium homeostasis

Interventions

  • Calcipotriol 25 mcg/g ointment OD (C25)

  • Calcipotriol 25 mcg/g ointment plus hydrocortisone 10 mg/g ointment, OD (C25H)

  • Calcipotriol 50 mcg/g ointment OD (C50)

  • Calcipotriol 50 mcg/g ointment plus hydrocortisone 10 mg/g ointment OD (C50H)

Outcomes

Outcomes were assessed for the face and body overall and for the face only:

  1. PASI (per cent change from baseline to EOT): face = 0 to 3.6; face + body = 0 to 68.4 [1]

  2. Investigator's Global Assessment of Disease Severity (IGA): 6‐pt = absence of disease to very severe disease

  3. Adverse events

  4. Compliance (self‐report)

Notes

Leo Pharma A/S sponsored the trial.

The sponsor supplied unpublished data.

Risk of bias

Bias

Authors' judgement

Support for judgement

Allocation concealment (selection bias)

Unclear risk

The trial reported insufficient details.

Blinding (performance bias and detection bias)
All outcomes

Low risk

The trial was double‐blind (participant/investigator).

Randomisation method reported

Low risk

A preplanned computer‐generated schedule was used.

Loss to follow up

Low risk

2.2%

Baseline assessments

Low risk

These were reported.

Baseline comparability demonstrated

Low risk

This was demonstrated.

Papakostantinou 2005

Methods

DESIGN
Between‐patient
Participant delivery
ALLOCATION
Random
Method of randomisation: not stated
Concealment: unclear
BLINDING
Double‐blind (participant/investigator)
WITHDRAWAL/DROPOUT
Described

Participants

N: 22

Treatment duration: 2 wks; FU: 2 wks

LF: 0 (0%)

BC: no

Age: 41.3 (3.94SD)

Gender (per cent men): 45.5%

Severity: NS

INCLUSION CRITERIA

  • People with mild or moderate plaque psoriasis

  • PASI (0 to 72) < = 10

  • Elbow lesions for treatment > = 5 cm diameter

EXCLUSION CRITERIA

  • Antipsoriatic therapy within previous 4 wks

Interventions

  • Theophylline 1% ointment BD (T)

  • Vehicle ointment (20% transcutol, 10% oleic acid) BD (P)

Outcomes

  1. PASI (0 to 72)

Notes

The sponsor was not stated.

Risk of bias

Bias

Authors' judgement

Support for judgement

Allocation concealment (selection bias)

Unclear risk

The trial reported insufficient details (abstract only).

Blinding (performance bias and detection bias)
All outcomes

Low risk

The trial was double‐blind (participant/investigator).

Randomisation method reported

Unclear risk

The trial did not report this.

Loss to follow up

Low risk

0%

Baseline assessments

Unclear risk

The trial did not report this (but this was a within‐patient study, so demographics will be comparable by definition).

Baseline comparability demonstrated

Unclear risk

This was not demonstrated (see comment above).

Papp 2003 (H)

Methods

DESIGN
Between‐patient
Participant delivery
ALLOCATION
Random
Method of randomisation: computer‐generated random code
Concealment: adequate
BLINDING
Double‐blind (participant/assessor)
WITHDRAWAL/DROPOUT
Described

Participants

N: 1043

Treatment duration: 4 wks; FU: 4 wks

LF: 15 (1.4%)

BC: yes

Age: 47.1

Gender (per cent men): 58.4%

Severity: mean PASI = 10.8 (range = 1 to 36)

Duration: 18.7 years

INCLUSION CRITERIA

  • Chronic plaque psoriasis

  • Aged at least 18

  • BSA ≥10%

EXCLUSION CRITERIA

  • Other types of psoriasis or skin diseases

  • Hypercalcaemia

  • Systemic antipsoriatic treatment or UV therapy within previous 6 wks

  • Topical antipsoriatic therapy within previous 2 wks

  • Other concomitant medication that might affect psoriasis

  • Contraindications for corticosteroid treatment

  • Planned exposure to UV light

  • Pregnancy

  • Lactation

Interventions

  • Calcipotriol 50 mcg/g + betamethasone dipropionate 0.5 mg/g combination ointment BD (D)

  • Calcipotriol 50 mcg/g in combination vehicle ointment BD (C)

  • Betamethasone dipropionate 0.5 mg/g in combination vehicle ointment BD (B)

  • Placebo (combination vehicle) ointment BD (P)

Outcomes

  1. PASI (head excluded)

  2. Total Severity Score (9‐pt, absent to very severe)

  3. IAGI (6‐pt: worse to clearance)

  4. PAGI (6‐pt: worse to clearance)

Notes

Leo Pharmaceuticals sponsored the trial.

Risk of bias

Bias

Authors' judgement

Support for judgement

Allocation concealment (selection bias)

Low risk

Treatments were assigned by computer‐generated code and assigned chronologically at each centre.

Blinding (performance bias and detection bias)
All outcomes

Low risk

The trial was double‐blind (participant/investigator). Treatments were identifiable only by a code number.

Randomisation method reported

Low risk

Randomisation was computer‐generated. (3:3:3:1)

Loss to follow up

Low risk

1.4%

Baseline assessments

Low risk

Baseline comparability demonstrated

Low risk

Papp 2003 (P)

Methods

DESIGN
Between‐patient
Participant delivery
ALLOCATION
Random
Method of randomisation: computer‐generated random code
Concealment: adequate
BLINDING
Double‐blind (participant/investigator)
WITHDRAWAL/DROPOUT
Described

Participants

N: 1043
Treatment duration: 4 wks; FU: 4 wks
LF: 15 (1.4%)
BC: yes
Age: 47.1
Gender (per cent men): 58.4%
Severity: mean PASI = 10.8 (range = 1 to 36)
Duration: 18.7 years

INCLUSION CRITERIA

  • Chronic plaque psoriasis

  • Aged at least 18

  • BSA ≥10%

EXCLUSION CRITERIA

  • Other types of psoriasis or skin diseases

  • Hypercalcaemia

  • Systemic antipsoriatic treatment or UV therapy within previous 6 wks

  • Topical antipsoriatic therapy within previous 2 wks

  • Other concomitant medication that might affect psoriasis

  • Contraindications for corticosteroid treatment

  • Planned exposure to UV light

  • Pregnancy

  • Lactation

Interventions

  • Calcipotriol 50 mcg/g + betamethasone dipropionate 0.5 mg/g combination ointment BD (D)

  • Calcipotriol 50 mcg/g in combination vehicle ointment BD (C)

  • Betamethasone dipropionate 0.5 mg/g in combination vehicle ointment BD (B)

  • Placebo (combination vehicle) ointment BD (P)

Outcomes

  1. PASI (head excluded)

  2. Total Severity Score (9‐pt, absent to very severe)

  3. IAGI (6‐pt: worse to clearance)

  4. PAGI (6‐pt: worse to clearance)

Notes

Leo Pharmaceuticals sponsored the trial.

Risk of bias

Bias

Authors' judgement

Support for judgement

Allocation concealment (selection bias)

Low risk

Treatments were assigned by computer‐generated code and assigned chronologically at each centre.

Blinding (performance bias and detection bias)
All outcomes

Low risk

The trial was double‐blind (participant/investigator), and treatments were identifiable only by a code number.

Randomisation method reported

Low risk

Randomisation was computer‐generated. (3:3:3:1)

Loss to follow up

Low risk

1.4%

Baseline assessments

Low risk

Baseline comparability demonstrated

Low risk

Pariser 1996

Methods

DESIGN
Between‐patient
Participant delivery
ALLOCATION
Random
Method of randomisation: not reported
Concealment: unclear
BLINDING
Double‐blind (participant/assessor)
WITHDRAWAL/DROPOUT
Not described

Participants

N: 235

Treatment duration: 8 wks; FU: 8 wks

LF: Unclear

BC: psoriasis comparable, demographics not reported.

Age: 45.1 (range = 18 to 86)

Gender (per cent men): not reported

Severity: TSS (0 to 9) = 4.75

INCLUSION CRITERIA

  • Stable plaque‐type psoriasis; otherwise healthy, non‐pregnant people

  • At least 4/9 for plaque elevation

  • BSA range = 5% to 20%

EXCLUSION CRITERIA

  • None reported

Interventions

  • Calcipotriene ointment 0.005% OD (C)

  • Placebo (vehicle) (P)

Outcomes

  1. Severity (scaling; erythema; plaque elevation)

  2. TSS (0 to 9)

  3. Investigator Global Assessment (10‐pt)

Notes

Bristol‐Myers Squibb Pharmaceutical Research Institute sponsored the trial.
There was SD imputation (TSS).

Risk of bias

Bias

Authors' judgement

Support for judgement

Allocation concealment (selection bias)

Unclear risk

The trial reported insufficient details.

Blinding (performance bias and detection bias)
All outcomes

Low risk

The trial was double‐blind (participant/assessor).

Randomisation method reported

Unclear risk

The trial did not report this.

Loss to follow up

Unclear risk

The trial did not report this.

Baseline assessments

Low risk

These were partially done.

Baseline comparability demonstrated

Unclear risk

This was partially demonstrated.

Pauporte 2004

Methods

DESIGN
Between‐patient
Participant delivery
ALLOCATION
Random
Method of randomisation: not reported
Concealment: unclear
BLINDING
Double‐blind (participant/investigator)
WITHDRAWAL/DROPOUT
Described

Participants

N: 89

Treatment duration: 3 wks; FU: 4 wks

LF: 4 (4.5%)

BC: yes

Age: 46 (15SD)

Gender (per cent men): 44.8%

Severity: TSS (0 to 9) = 7.15

INCLUSION CRITERIA

  • Moderate to severe scalp psoriasis, stable, or slowly exacerbating > 1 wk

  • Aged ≥12

  • Good general health

  • Scalp involvement ≥ 20%

  • TSS (0 to 9) ≥ 6

EXCLUSION CRITERIA

  • Pregnancy or risk thereof

  • Lactation

  • People requiring topical or systemic treatments that could affect psoriasis

  • Systemic corticosteroids within previous 4 wks

  • Topical therapies within previous 1 wk

  • Concomitant use of other scalp therapies

Interventions

  • Fluocinolone acetonide 0.01% topical oil (Derma‐Smoothe/FS), plus occlusion ON or for at least 4 hours (F)

  • Placebo oil, plus occlusion ON or for at least 4 hours (P)

Participants washed their hair with a non‐medicated shampoo after treatment.

Outcomes

  1. Total Severity Score (0 to 9) (erythema, thickening, scaling)

  2. Investigator's Assessment of Global Improvement (IAGI) (7‐pt: cleared to exacerbation)

Notes

The trial did not report sponsorship, but the corresponding author worked for Hill Dermaceuticals Inc, US.
To be eligible for inclusion in the efficacy analysis, participants were permitted to deviate from the treatment plan < = 2 consecutive days and < = 4/10 days.
No case of skin atrophy or telangiectasia were reported.
This was a scalp trial.

Risk of bias

Bias

Authors' judgement

Support for judgement

Allocation concealment (selection bias)

Unclear risk

The trial reported insufficient details.

Blinding (performance bias and detection bias)
All outcomes

Low risk

The trial was double‐blind (participant/investigator).

Randomisation method reported

Unclear risk

The trial did not report this.

Loss to follow up

Low risk

4.5%

Baseline assessments

Low risk

Baseline comparability demonstrated

Low risk

Perez 1996

Methods

DESIGN
Within‐patient
Participant delivery
ALLOCATION
Random
Method of randomisation: not reported
Concealment: unclear
BLINDING
Double‐blind (participant/investigator)
WITHDRAWAL/DROPOUT
Described

Participants

N: 84

Treatment duration: 10 wks: FU: 52 wks

LF: 0 (0%)

BC: yes

Age: 46 (range = 19 to 76)

Gender (per cent men): 65.5%

Severity: TSS (0 to 9) = 7.6 (range = 5 to 9)

INCLUSION CRITERIA

  • Stable plaque or erythrodermic psoriasis

  • Unsatisfactory response to at least 1 previous treatment (topical steroids/UVB/PUVA/MTX)

  • Adult

  • BSA ≥10%

EXCLUSION CRITERIA

  • Pregnant, nursing, or inadequate contraception

  • Hepatic or renal impairment

  • Recent systemic therapy or phototherapy or topical medications (excluding emollients)

Interventions

  • Calcitriol 1.5 mcg/g OD (C)

  • Placebo (vehicle) (P)

Outcomes

  • Severity (erythema; plaque thickness; scaling)

  • Total Severity Score (0 to 9)

  • Investigator Global Assessment (5‐pt, worse to excellent improvement)

  • PASI (reported only for participants participating in follow‐up study)

Notes

The NIH General Clinical Research Center supported the trial.
There was also an uncontrolled follow up study (N = 22) involving large‐area administration of calcitriol; 12‐month results were based on results from 6 participants.

Risk of bias

Bias

Authors' judgement

Support for judgement

Allocation concealment (selection bias)

Unclear risk

The trial reported insufficient details.

Blinding (performance bias and detection bias)
All outcomes

Low risk

The trial was double‐blind (participant/investigator).

Randomisation method reported

Unclear risk

The trial did not report this.

Loss to follow up

Low risk

0.0%

Baseline assessments

Low risk

Baseline comparability demonstrated

Low risk

Pinheiro 1997

Methods

DESIGN
Between‐patient
Participant delivery
ALLOCATION
Random
Method of randomisation: not reported
Concealment: unclear
BLINDING
Open
WITHDRAWAL/DROPOUT
Described

Participants

N: 132

Treatment duration: 8 wks; FU: 8 wks

LF: 10 (7.6%)

BC: yes

Age: 48.2 (range = 17 to 90)

Gender (per cent men): 59.1%

Severity: per cent severe = 13.6%

Duration (yrs): 16.9 (range = 0.5 to 60)

INCLUSION CRITERIA

  • Chronic plaque psoriasis

  • Adult

  • BSA ≥100 cm²

EXCLUSION CRITERIA

  • Hypersensitivity to trial medications

  • Concomitant treatment with Vitamin D/calcium/other relevant agent

  • Pregnancy

  • Risk of pregnancy

  • Lactation

  • Unable to comply with protocol

Interventions

  • Calcipotriol ointment 50 mcg/g BD (C)

  • Coal tar 5%/allantoin 2%/hydrocortisone cream 0.5% BD (T)

Outcomes

  1. Signs (redness; thickness; scaliness)

  2. Total Sign Score (0 to 12)

  3. Investigator Global Assessment (5‐pt: worse to cleared)

  4. Area of affected skin (area scales)

  5. Patient evaluation of overall response (VAS)

Notes

Leo Pharmaceuticals sponsored the trial.
There was SD imputation (TSS).

Risk of bias

Bias

Authors' judgement

Support for judgement

Allocation concealment (selection bias)

Unclear risk

The trial reported insufficient details.

Blinding (performance bias and detection bias)
All outcomes

High risk

The trial was open.

Randomisation method reported

Unclear risk

The trial did not report this.

Loss to follow up

Low risk

7.6%

Baseline assessments

Low risk

Baseline comparability demonstrated

Low risk

Poulin 2010

Methods

DESIGN
Between‐patient
Participant delivery
ALLOCATION
Random
Method of randomisation: not stated
Concealment: unclear
BLINDING
Double‐blind (participant/investigator)
WITHDRAWAL/DROPOUT
Described

Participants

N: 217
Treatment duration: 6 mths; FU: 6 mths
LF: 45 (20.7%)
BC: yes
Age: 50.4; range = 18 to 82
Gender (per cent men): 44.7%
Ethnicity (per cent white): 91.2%
Severity: GSS = 0 (clear): 10.1%; GSS = 0 (very mild): 33.7%; GSS = 0 (mild): 56.2%; < 20% scalp affected = 76.5%; mPASI = 4.2 (4.2SD)

INCLUSION CRITERIA

  • People aged > = 18 with moderate to severe scalp psoriasis (GSS = 3 or 4) eligible for initial phase (4 wks)

  • Responders (GSS < = 2) eligible for maintenance phase (6 mths)

  • Topical and systemic wash‐out periods required but not specified

EXCLUSION CRITERIA

  • Pregnancy or risk thereof

  • Lactation

  • Use of superpotent steroids on body

  • Body psoriasis requiring systemic therapy.

Interventions

  • Open‐label initial treatment phase with clobetasol propionate 0.05% shampoo OD for up to 4 wks (N = 288), then participants with GSS < = 2 were randomised to maintenance therapy:

    • clobetasol propionate 0.05% shampoo, 2 x/wk for 6 mths (CP)

    • placebo (vehicle) shampoo, 2 x/wk for 6 mths (P)

  • Participants evaluated every 4 wks for relapse (GSS > 2): relapses received clobetasol propionate 0.05% shampoo OD for 4 wks

    • GSS < = 2: participants re‐initiated maintenance therapy

    • GSS > 2: participants exited the study

Outcomes

  1. Global Severity Score (GSS) (6‐pt: 0 = clear to 5 = very severe)

  2. Extent of disease (6‐pt, 0 (none) to 5 (80% to 100%)) (investigator)

  3. Signs (investigator): erythema, scaling, thickness (each scored 0 to 4)

  4. MPASI (0 to 7.2)

  5. Per cent with rebound at first relapse (mPASI > = 125% of baseline score)

  6. Pruritis (subject) (0 to 3)

  7. No. relapses

  8. Atrophy (0 to 2)

  9. Telangiectasia (0 to 2)

  10. Burning (0 to 2)

  11. adverse events

  12. HPA axis activity

  13. Patient satisfaction

Notes

Galderma Laboratories, LP, sponsored the trial.

The trial (JDT) reported findings for a subset with moderate scalp psoriasis.

The sponsor supplied unpublished safety data. No useable efficacy data were available.

Risk of bias

Bias

Authors' judgement

Support for judgement

Allocation concealment (selection bias)

Unclear risk

The trial reported insufficient details.

Blinding (performance bias and detection bias)
All outcomes

Low risk

The trial was double‐blind (participant/investigator).

Randomisation method reported

Unclear risk

The trial did not report this.

Loss to follow up

Unclear risk

20.7%

Baseline assessments

Low risk

These were reported (clinical and demographic).

Baseline comparability demonstrated

Low risk

This was demonstrated.

Powers 2005

Methods

DESIGN
Between‐patient
Participant delivery
ALLOCATION
Random
Method of randomisation: unclear
Concealment: unclear
BLINDING
Double‐blind (participant/investigator)
WITHDRAWAL/DROPOUT
Not described

Participants

N: 421
Treatment duration: 8 wks; FU: 8 wks
LF: 0 (0%)
BC: yes (clinically), demographics NR (abstract)
Age: NR
Gender (per cent men): NR
Per cent white: NR
Severity: GSS (0 to 5) = 2.71 (0.45SD)

INCLUSION CRITERIA

  • People aged > = 12 with mild to moderate plaque psoriasis

  • BSA < = 35%

EXCLUSION CRITERIA

  • Not reported

Interventions

  • Calcitriol 3 mcg/g ointment BD (C)

  • Placebo ointment BD (P)

Max 30 g/day

Outcomes

  1. Global Severity Score (GSS) (6‐pt: 0 = none to 5 = very severe), dichotomised as success (clear/almost clear) and failure

  2. Signs: erythema, scaling, thickness (each scored 0 = absent to 4 = severe)

  3. Dermatological Sum Score (DSS) (0 to 12)

  4. Pruritus (0 to 4)

  5. Investigator Global Improvement score (7‐pt: worse to clear)

  6. Subject Global Improvement score (7‐pt: worse to clear)

  7. Routine clinical and safety laboratory parameters including calcium homeostasis (> 10% above upper limit of normal range)

Notes

Galderma Laboratories, LP, sponsored the trial.

The sponsor supplied unpublished data.

This was an abstract only.

Risk of bias

Bias

Authors' judgement

Support for judgement

Allocation concealment (selection bias)

Unclear risk

The trial reported insufficient details.

Blinding (performance bias and detection bias)
All outcomes

Low risk

The trial was double‐blind (participant/investigator).

Randomisation method reported

Unclear risk

The trial did not report this.

Loss to follow up

Low risk

0%

Baseline assessments

Unclear risk

Clinical assessments were reported (demographic characteristics was unclear).

Baseline comparability demonstrated

Unclear risk

Clinical comparability was demonstrated (demographic comparability was unclear).

Reygagne 2005

Methods

DESIGN
Between‐patient
Participant delivery
ALLOCATION
Random
Method of randomisation: computer‐generated randomisation list
Concealment: unclear
BLINDING
Single‐blind (investigator)
WITHDRAWAL/DROPOUT
Described

Participants

N: 151
Treatment duration: 4 wks; FU: 4 wks
LF: 0 (0%)
BC: yes
Age: 45.3 (17.1SD)(range = 10 to 89)
Gender (per cent men): 47.0%
Per cent white: 98.7%
Severity: TSS (0 to 9) = 4.90 (1.74SD); GSS (0 to 5) = 1.50 (0.60SD)
Per cent scalp affected: 45% (SD28%)

INCLUSION CRITERIA

  • People aged at least 12 with moderate to severe scalp psoriasis (GSS (0 to 5) > = 3

  • Affected area on scalp > = 2 cm^2

EXCLUSION CRITERIA

  • Very severe scalp psoriasis requiring systemic treatment

  • Known allergy to study medications

  • Immuno‐compromised

  • History of adverse response to topical or systemic steroid therapy

  • Use of concomitant antipsoriatic therapy, betablockers, lithium, antimalarials or NSAIDs

Interventions

  • calcipotriol 0.005% solution BD (C)

  • clobetasol propionate 0.05% shampoo OD (CP)

Outcomes

  1. Global Severity Score (GSS) (6‐pt: 0 = none to 5 = very severe)

  2. Total Severity Score (10‐pt: 0 = none to 9 = severe)

  3. Pruritus (0 to 3)

  4. Per cent scalp area affected

  5. Investigator's Global Assessment of Improvement (7‐pt: worse to cleared)

  6. Subject's Global Assessment of Improvement (7‐pt: worse to cleared)

  7. Atrophy, telangiectasia; burning sensation (scalp/neck/face) (0 to 3), burning/stinging sensation (eyes) (0 to 3)

  8. Adverse events

Notes

Galderma Laboratories, LP, sponsored the trial.

The sponsor supplied unpublished data.

Risk of bias

Bias

Authors' judgement

Support for judgement

Allocation concealment (selection bias)

Unclear risk

The trial reported insufficient details.

Blinding (performance bias and detection bias)
All outcomes

Unclear risk

The study was single‐blind (investigator).

Randomisation method reported

Low risk

A computer‐generated randomisation list was used.

Loss to follow up

Low risk

0%

Baseline assessments

Low risk

These were reported.

Baseline comparability demonstrated

Low risk

This was demonstrated.

Ruzicka 1998

Methods

DESIGN
Between‐patient
Participant delivery
ALLOCATION
Random
Method of randomisation: not stated
Concealment: unclear
BLINDING
Double‐blind (participant/assessor)
WITHDRAWAL/DROPOUT
Described

Participants

N: 178

Treatment duration: 2 + 4 wks; FU: 14 wks

LF: 7 (3.9%)

BC: psoriasis comparable, demographics not reported

Age: 42 (range = 18 to 80)

Gender (per cent men): 55.6%

Severity: PASI = 6.0

INCLUSION CRITERIA

  • Adults

  • Chronic plaque‐type psoriasis

  • BSA ≥ 30%

  • Calcium levels, renal, and liver function within normal range

EXCLUSION CRITERIA

  • Pregnancy

  • Lactation

  • Recent systemic or UV therapy

Interventions

  1. Calcipotriol 0.005% ointment BD 6 weeks (C)

  2. Calcipotriol 0.005% ointment BD 2 weeks, then calcipotriol ointment 0.005% OM plus Betamethasone valerate ointment ON 4 weeks (CB)

Outcomes

  1. PASI

  2. Investigator Global Assessment (6‐pt: deterioration to complete healing)

  3. Patient evaluation of overall response (5‐pt: scale NR)

Notes

The trial did not state sponsorship.
Schering AG employed 1 author.

Risk of bias

Bias

Authors' judgement

Support for judgement

Allocation concealment (selection bias)

Unclear risk

The trial reported insufficient details.

Blinding (performance bias and detection bias)
All outcomes

Low risk

The trial was double‐blind (participant/investigator).

Randomisation method reported

Unclear risk

The trial did not report this.

Loss to follow up

Low risk

3.9%

Baseline assessments

Low risk

These were partially done.

Baseline comparability demonstrated

Unclear risk

This was partially demonstrated.

Salmhofer 2000

Methods

DESIGN
Within‐patient
Participant delivery
ALLOCATION
Random
Method of randomisation: not reported
Concealment: NR
BLINDING
Double‐blind (participant/assessor)
WITHDRAWAL/DROPOUT
Described

Participants

N: 63

Treatment duration: 4 wks; FU: 8 wks

LF: 5 (7.9%)

BC: yes

Age: 47 (15.4SD, range = 19 to 83)

Gender (per cent men): 54.0%

Severity: PASI = 5.5 (2.65SD)

Duration (months): 141 (124SD)

INCLUSION CRITERIA

  • Stable chronic plaque psoriasis

  • Aged over 19

  • Symmetrical lesions

EXCLUSION CRITERIA

  • Other types of psoriasis

  • BSA affected > 30%

  • Concurrent systemic antipsoriatic therapy

  • Pregnancy

  • Lactation

  • Concurrent infectious disease

  • Other concurrent dematoses

  • Hypercalcaemia

  • Severe hepatic/renal disease

Interventions

  • Calcipotriol ointment 5 mcg/g BD (C)

  • Calcipotriol ointment 5 mcg/g OM plus diflucortolone valerate ointment 0.1%, ON (D)

Outcomes

  1. PASI

  2. IAGI (7‐pt: extreme deterioration to complete healing)

  3. PAGI (7‐pt: extreme deterioration to complete healing)

Notes

Schering Wien GmbH sponsored the trial.

Risk of bias

Bias

Authors' judgement

Support for judgement

Allocation concealment (selection bias)

Unclear risk

The trial reported insufficient details.

Blinding (performance bias and detection bias)
All outcomes

Low risk

The trial was double‐blind (participant/assessor).

Randomisation method reported

Unclear risk

The trial did not report this.

Loss to follow up

Low risk

7.9%

Baseline assessments

Low risk

Baseline comparability demonstrated

Low risk

Sanchez 2001

Methods

DESIGN
Between‐patient
Participant delivery
ALLOCATION
Random
Method of randomisation: not reported
Concealment: unclear
BLINDING
Unclear
WITHDRAWAL/DROPOUT
Described

Participants

N: 28

Treatment duration: 8 wks; FU: 8 wks

LF: 3 (10.7%)

BC: yes

Age: 49.5 (range = 22 to 73)

Gender (per cent men): 50%

Severity: PASI = 7.7 (range = 4 to 10)

INCLUSION CRITERIA

  • People with plaque type psoriasis

EXCLUSION CRITERIA

  • Systemic treatment within previous 4 wks

  • Topical treatment within previous 2 wks

  • Known hypersensitivity to sulphides

  • Hypothyroidism

  • Lactation

Interventions

  • Propylthiouracil cream 5% TD

  • Calcipotriol ointment 50 mcg/g BD

Outcomes

  1. PASI

Notes

The trial did not report sponsorship.

Risk of bias

Bias

Authors' judgement

Support for judgement

Allocation concealment (selection bias)

Unclear risk

The trial reported insufficient details.

Blinding (performance bias and detection bias)
All outcomes

Unclear risk

The trial did not report this.

Randomisation method reported

Unclear risk

The trial did not report this.

Loss to follow up

Low risk

10.7%

Baseline assessments

Low risk

Baseline comparability demonstrated

Low risk

Santoianni 2001

Methods

DESIGN
Between‐patient
Participant delivery
ALLOCATION
Random
Method of randomisation: computer‐generated list using block randomisation; pharmacy‐dispensed treatments in identical tubes
Concealment: unclear
BLINDING
Double‐blind (participant/investigator)
WITHDRAWAL/DROPOUT
Described

Participants

N: 85

Treatment duration: 3 wks; FU: 3 wks

LF: 4 (4.7%)

BC: clinical only

Age: 51.9 (range = 18.8 to 88.5)

Gender (per cent men): 55.3%

Severity: PASI = 6.2

INCLUSION CRITERIA

  • Outpatients with disseminated keratotic plaque psoriasis

  • Aged over 18

EXCLUSION CRITERIA

  • Not reported

Interventions

  • Betamethasone 17‐valerate 21‐acetate plus tretinoine plus salicylic acid OD

  • Placebo OD

Outcomes

  1. PASI

  2. IAGI (5‐pt: worse to cured)

  3. PAGI (5‐pt: no change to  excellent)

  4. Adverse events

Notes

IDI Farmaceuticia SpA sponsored the trial.

Risk of bias

Bias

Authors' judgement

Support for judgement

Allocation concealment (selection bias)

Unclear risk

The trial reported insufficient details.

Blinding (performance bias and detection bias)
All outcomes

Low risk

The trial was double‐blind (participant/investigator).

Randomisation method reported

Low risk

Randomisation was computer‐generated.

Loss to follow up

Low risk

4.7%

Baseline assessments

Low risk

Baseline comparability demonstrated

Unclear risk

This was partially demonstrated.

Saraceno 2007

Methods

DESIGN
Between‐patient
Participant delivery
ALLOCATION
Random
Method of randomisation: computer‐generated randomisation schedule; boxes dispensed sequentially
Concealment: inadequate
BLINDING
Open
WITHDRAWAL/DROPOUT
Described

Participants

N: 150

Treatment duration: 12 wks; FU: 12 wks

LF: 3 (2.0%)

BC: yes

Age: 47.7 (16.5SD); range = 18 to 83

Gender (per cent men): 66.0%

Severity: per cent BSA = 18.6 (7.6SD), range 2 to 30; PASI = 9.2 (4.8SD), range = 1.6 to 33.0

Duration (yrs): 13.8 (13.4SD); range = 0 to 60.1

INCLUSION CRITERIA

  • People aged > = 18 with mild to moderate plaque psoriasis

EXCLUSION CRITERIA

  • Topical therapy within previous 2 wks

  • Systemic therapy within previous 4 wks

  • Severe forms of plaque psoriasis

  • Guttate, erythrodermic, and pustular psoriasis

  • Cutaneous atrophy

  • Suspected abnormality in calcium homeostasis

  • Pregnancy

  • Lactation

Interventions

  • Calcipotriol 50 mcg/g cream BD (C)

  • Calcipotriol 50 mcg/g plus betamethasone dipropionate 0.5 mg/g formulation (4 weeks) OD then calcipotriol 50 mcg/g cream (8 weeks) BD (C‐B)

Outcomes

  1. PASI (scale NR)

  2. Skindex‐29: burden of symptoms; social functioning; quality of life

Notes

Prodotti Formenti Srl, Milano, Italy, sponsored the trial.

Risk of bias

Bias

Authors' judgement

Support for judgement

Allocation concealment (selection bias)

High risk

Consecutive coded treatment boxes were assigned to participants in a 1:1 ratio. It was unclear if boxes were of identical appearance.

Blinding (performance bias and detection bias)
All outcomes

High risk

The trial was open.

Randomisation method reported

Low risk

A computer‐generated randomisation schedule was used.

Loss to follow up

Low risk

2.0%

Baseline assessments

Low risk

These were reported (clinical and demographic).

Baseline comparability demonstrated

Low risk

This was demonstrated (clinical and demographic).

Scarpa 1994

Methods

DESIGN
Between‐patient
Delivery unclear
ALLOCATION
Random
Method of randomisation: not reported
Concealment: unclear
BLINDING
Blinding unclear
WITHDRAWAL/DROPOUT
Not described

Participants

N: 160

Treatment duration: 6 wks; FU: 10 wks

LF: not reported

BC: demographics comparable, severity not reported

Age: 50

Gender (per cent men): 68.1%

Severity: not reported

INCLUSION CRITERIA

  • Plaque‐type psoriasis

EXCLUSION CRITERIA

  • Not reported

Interventions

  • Calcipotriol ointment 50 mg/g BD (C)

  • Betamethasone dipropionate ointment 0.05% + salicylic acid 3% BD (B)

Outcomes

  1. Investigator Global Assessment (5‐pt: null to excellent)

  2. Patient's overall acceptance (5‐pt: null to excellent)

Notes

The trial did not report sponsorship.

Risk of bias

Bias

Authors' judgement

Support for judgement

Allocation concealment (selection bias)

Unclear risk

The trial reported insufficient details.

Blinding (performance bias and detection bias)
All outcomes

Unclear risk

The trial did not report this.

Randomisation method reported

Unclear risk

The trial did not report this.

Loss to follow up

Unclear risk

The trial did not report this.

Baseline assessments

Unclear risk

These were partially done.

Baseline comparability demonstrated

Unclear risk

This was partially demonstrated.

Scarpa 1996

Methods

DESIGN
Within‐patient
Delivery unclear
ALLOCATION
Random
Method of randomisation: block randomisation (6 participants)
Concealment: unclear
BLINDING
Double‐blind (participant/investigator)
WITHDRAWAL/DROPOUT
Described

Participants

N: 76

Treatment duration: 6 wks; FU: 8 wks

LF: 13 (17.1%)

BC: yes

Age: not reported

Gender (per cent men): not reported

Severity: TSS (0 to 12) = 7.92

INCLUSION CRITERIA

  • Chronic plaque psoriasis

EXCLUSION CRITERIA

  • Concomitant medications (except emollients, tar shampoo, and salicylic acid)

  • Topical or systemic steroids

  • Calcium or vitamin D intake

  • Antipsoriatic medications

Interventions

  • Tacalcitol ointment 4 mcg/g OD (T)

  • Betamethasone‐17‐valerate ointment 0.1% OD (B)

Outcomes

  1. Severity (erythema; thickness; scaling)

  2. Total Severity Score (0 to 12)

  3. Comparison of lesions, based on difference in TSS

  4. Investigator Global Assessment (6‐pt: worsening to healing)

  5. Patient assessment of difference 

Notes

The trial did not report sponsorship.
There was SD imputation (TSS).

Risk of bias

Bias

Authors' judgement

Support for judgement

Allocation concealment (selection bias)

Unclear risk

The trial reported insufficient details.

Blinding (performance bias and detection bias)
All outcomes

Low risk

The trial was double‐blind (participant/investigator).

Randomisation method reported

Low risk

Block randomisation was used.

Loss to follow up

Low risk

17.1%

Baseline assessments

Low risk

These were partially done.

Baseline comparability demonstrated

Low risk

Scarpa 1997

Methods

DESIGN
Within‐patient
Participant delivery
ALLOCATION
Random
Method of randomisation: not reported; tubes labelled left or right and with participant ID number and tube ID number
Concealment: unclear
BLINDING
Double‐blind (participant/investigator)
WITHDRAWAL/DROPOUT
Described

Participants

N: 157

Treatment duration: 6 wks; FU: 7 wks

LF: 23 (14.6%)

BC: yes

Age: 49 (15SD; N = 134)

Gender (per cent men): 65.6% (N = 157)

Severity: TSS (0 to 12) = 7.7

INCLUSION CRITERIA

  • Stable chronic plaque psoriasis

  • Symmetrical lesions

  • In‐ and outpatients

EXCLUSION CRITERIA

  • Pregnancy

  • Lactation

  • Inadequate contraception

  • Recent systemic, light, or topical therapy

  • Severe renal failure

  • Liver and cardiac dysfunction

  • Hypercalcemia

  • Hyperphosphoremia

  • AIDS

  • Drug addiction

Interventions

  • Tacalcitol ointment 4 mcg/g OD (T)

  • Placebo (vehicle) OD (P)

Outcomes

  1. Signs: scaling; erythema; scaling

  2. TSS (0 to 12)

  3. Patient compliance (tube count; tube contents)

Notes

The trial did not report sponsorship, but Istituto Gentili SpA provided medications and appeared to have undertaken the randomisation.
There was SD imputation (TSS).

Risk of bias

Bias

Authors' judgement

Support for judgement

Allocation concealment (selection bias)

Unclear risk

The trial reported insufficient details.

Blinding (performance bias and detection bias)
All outcomes

Low risk

The trial was double‐blind (participant/investigator).

Randomisation method reported

Unclear risk

The trial did not report this.

Loss to follow up

Low risk

14.6%

Baseline assessments

Low risk

Baseline comparability demonstrated

Low risk

Sears 1997

Methods

DESIGN
Between‐patient
Participant delivery
ALLOCATION
Random
Method of randomisation: not reported
Concealment: unclear
BLINDING
Double‐blind (participant/investigator)
WITHDRAWAL/DROPOUT
Described

Participants

N: 190 participants

Treatment duration: 3 wks; FU: 3 wks

LF: 21 (11%)

BC: yes

Age: 44 (range = 19 to 73)

Gender (per cent men): 47.9%

Severity: TSS (0 to 9) = 6.0

Duration (yrs): 17 (range = 1 to 56)

INCLUSION CRITERIA

  • Mild or moderate psoriasis not spontaneously remitting

  • Adults aged 18 to 70

  • Total Sign Score 3 to 8

EXCLUSION CRITERIA

  • Acute systemic illness

  • Hypothamic‐pituitary‐adrenal system disorder, severe hepatic or renal disorder

  • Psoriatic infection

  • Lactation, pregnancy, or inadequate contraception

  • Recent use of any corticosteroid, long‐acting antihistamines, retinoids

  • Drugs exacerbating or influencing psoriasis

  • Antimetabolic therapy

  • PUVA

  • ACE inhibitor

  • Intolerant of topical corticosteroids or study medication

Interventions

  • Hydrocortisone buteprate 0.1% cream BD (H)

  • Placebo (vehicle) (P)

Outcomes

  1. Signs (erythema; skin thickening; scaling)

  2. Total Sign Score (0 to 9)

  3. Pruritis

  4. Investigator and patient evaluations of efficacy (4‐pt: poor to excellent)

  5. Investigator Global Assessment (7‐pt: exacerbation to cleared)

  6. Compliance (actual vs. expected usage)

Notes

The trial did not report sponsorship.

Risk of bias

Bias

Authors' judgement

Support for judgement

Allocation concealment (selection bias)

Unclear risk

The trial reported insufficient details.

Blinding (performance bias and detection bias)
All outcomes

Unclear risk

The trial was double‐blind (participant/investigator).

Randomisation method reported

Unclear risk

The trial did not report this.

Loss to follow up

Low risk

11%

Baseline assessments

Low risk

These were reported.

Baseline comparability demonstrated

Low risk

Seidenari 1997 (H)

Methods

DESIGN
Within‐patient
Participant delivery
ALLOCATION
Random
Method of randomisation: not reported
Concealment: unclear
BLINDING
Double‐blind (participant/assessor)
WITHDRAWAL/DROPOUT
Described

Participants

N: 14

Treatment duration: 6 wks; FU: 8 wks

LF: 3 (21.4%)

BC: yes

Age: 46 (range 23 to 69, N = 26)

Gender (per cent men): 46.2% (N = 26)

Severity: TSS = 6.31 (1.25SD, N = 11)

INCLUSION CRITERIA

  • Symmetrical, stable psoriatic plaques

  • Adult

  • Inpatient or outpatients

EXCLUSION CRITERIA

  • Recent topical, UV, or systemic therapy

  • Inadequate contraception

Interventions

  • Tacalcitol ointment 4 mcg/g OD (T)

  • Betamethasone valerate ointment 0.1% OD (B)

Outcomes

  1. Signs: erythema; thickening; scaling

  2. Total Sign Score (0 to 12)

Notes

Demographic characteristics were summarised over both studies, placebo and active controls (N = 26).

Risk of bias

Bias

Authors' judgement

Support for judgement

Allocation concealment (selection bias)

Unclear risk

The trial reported insufficient details.

Blinding (performance bias and detection bias)
All outcomes

Low risk

The trial was double‐blind (participant/assessor).

Randomisation method reported

Unclear risk

The trial did not report this.

Loss to follow up

Unclear risk

21.4%

Baseline assessments

Low risk

These were reported.

Baseline comparability demonstrated

Low risk

Seidenari 1997 (P)

Methods

DESIGN
Within‐patient
Participant delivery
ALLOCATION
Random
Method of randomisation: not reported
Concealment: unclear
BLINDING
Double‐blind (participant/assessor)
WITHDRAWAL/DROPOUT
Described

Participants

N: 12
Treatment duration: 6 wks; FU: 8 wks
LF: 1 (8%)
BC: yes
Age: 46 (range 23 to 69, N = 26)
Gender (per cent men): 46.2% (N = 26)
Severity: TSS = 6.50 (0.76SD, N = 11)

INCLUSION CRITERIA

  • Symmetrical, stable psoriatic plaques

  • Adult

  • Inpatient or outpatients

EXCLUSION CRITERIA

  • Recent topical, UV, or systemic therapy

  • Inadequate contraception

Interventions

  • Tacalcitol ointment 4 mcg/g OD (T)

  • Placebo (vehicle) (P)

Outcomes

  1. Signs: erythema; thickening; scaling

  2. Total Sign Score (0 to 12)

Notes

Demographic characteristics were summarised over both studies, placebo and active controls (N = 26).

Risk of bias

Bias

Authors' judgement

Support for judgement

Allocation concealment (selection bias)

Unclear risk

The trial reported insufficient details.

Blinding (performance bias and detection bias)
All outcomes

Low risk

The trial was double‐blind (participant/assessor).

Randomisation method reported

Unclear risk

The trial did not report this.

Loss to follow up

Low risk

8.0%

Baseline assessments

Low risk

These were reported.

Baseline comparability demonstrated

Low risk

Shuttleworth 1998

Methods

DESIGN
Between‐patient
Participant delivery
ALLOCATION
Random
Method of randomisation: predetermined randomisation schedule in blocks of 10
Concealment: unclear
BLINDING
Double‐blind (participant/investigator)
WITHDRAWAL/DROPOUT
Described

Participants

N: 40

Treatment duration: 4 wks; FU: 4 wks

LF: 3 (7.5%)

BC: yes

Age: 41.4 (12.0SD)

Gender (per cent men):60.0%

Severity: investigator's overall assessment (0 to 9) = 4.85; patient's overall assessment (0 to 4) = 2.43

INCLUSION CRITERIA

  • Scalp psoriasis

  • Aged 18 to 70

EXCLUSION CRITERIA

  • Pregnancy

  • Lactation

  • Inadequate contraception

  • Known hypersensitivity to study medication

  • Participation in other study within previous month

  • Concurrent systemic medication likely to affect psoriasis

  • Photosensitivity; PUVA within previous 2 wks

  • 'helmet' (diffuse) psoriasis

  • Concurrent topical antipsoriatics

  • Eye disease

Interventions

  • Ciclopirox olamine shampoo 1.5% 3 times/wk

  • Placebo shampoo 3 times/wk

Outcomes

  1. IAGI (7‐pt: very much worse to completely cleared)

  2. Area affected

  3. Investigator's overall assessment (extent of scalp psoriasis) (10‐pt: normal to ≥ 75% scaling)

  4. Scaling (0 to 4.5)

  5. Pruritis

  6. Patient overall assessment (5‐pt: poor to excellent)

  7. Adverse events

Notes

Stiefel Laboratories sponsored the trial.
The study was underpowered to detect a statistically significant difference due to recruitment difficulties.
This was a scalp trial.

Risk of bias

Bias

Authors' judgement

Support for judgement

Allocation concealment (selection bias)

Unclear risk

The trial reported insufficient details.

Blinding (performance bias and detection bias)
All outcomes

Low risk

The trial was double‐blind (participant/investigator).

Randomisation method reported

Low risk

Block randomisation was used.

Loss to follow up

Low risk

7.5%

Baseline assessments

Low risk

Baseline comparability demonstrated

Low risk

Staberg 1989

Methods

DESIGN
Within‐patient
Delivery unclear
ALLOCATION
Random
Method of randomisation: not reported
Concealment: unclear
BLINDING
Double‐blind (participant/investigator)
WITHDRAWAL/DROPOUT
Described

Participants

N: 10

Treatment duration: 6 wks; FU: 6 wks

LF: 1 (10%)

BC: yes

Age: 50 (26 to 76)

Gender (per cent men): not reported

Severity: TSS (0 to 9) = 7.3

INCLUSION CRITERIA

  • Symmetrical chronic plaque psoriasis

  • Inpatients

  • Adult

EXCLUSION CRITERIA

  • None reported

Interventions

  • Calcipotriol cream 1200 mcg/g BD (C)

  • Placebo cream (P)

Outcomes

  1. Signs: infiltration; erythema; scaling

  2. Total Sign Score (0 to 9)

Notes

Leo Pharmaceutical Products supplied the drugs and undertook the statistical analysis.

Risk of bias

Bias

Authors' judgement

Support for judgement

Allocation concealment (selection bias)

Unclear risk

The trial reported insufficient details.

Blinding (performance bias and detection bias)
All outcomes

Low risk

The trial was double‐blind (participant/investigator).

Randomisation method reported

Unclear risk

The trial did not report this.

Loss to follow up

Low risk

10.0%

Baseline assessments

Low risk

These were partially done.

Baseline comparability demonstrated

Low risk

Stein 2001

Methods

DESIGN
Within‐patient
Participant delivery
ALLOCATION
Random
Method of randomisation: investigator undertook randomisation
Concealment: inadequate
BLINDING
Double‐blind (participant/investigator)
WITHDRAWAL/DROPOUT
Described

Participants

N: 40

Treatment duration: 12 wks; FU: 12 wks

LF: 3 (7.5%)

BC: unclear

Age: range = 20 to 70 +

Gender (per cent men): not reported

Severity: TSS (elbows) (0 to 12) = 7.0

INCLUSION CRITERIA

  • Mild to moderate symmetrical plaque psoriasis

  • Aged at least 18

EXCLUSION CRITERIA

  • Systemic treatment within previous 4 wks

  • Topical treatment within previous 2 wks

  • Investigational medication within previous 4 wks

Interventions

  • Betamethasone valerate foam 0.12% (Luxiq®) BD (B)

  • Placebo foam BD (P)

Outcomes

  1. IAGI (7‐pt: worse to completely clear)

  2. Composite severity score (sum of change scores in erythema, scaling, thickness) (0 to 12)

  3. Pruritis

  4. BSA involvement

  5. Compliance (weight of containers)

Notes

The Connetics Corporation sponsored the trial.
There was SD imputation (IAGI).

Risk of bias

Bias

Authors' judgement

Support for judgement

Allocation concealment (selection bias)

High risk

Allocation concealment was inadequate: The investigator undertook randomisation.

Blinding (performance bias and detection bias)
All outcomes

Unclear risk

The trial was double‐blind (participant/investigator).

Randomisation method reported

Unclear risk

The trial did not report this.

Loss to follow up

Low risk

7.5%

Baseline assessments

Low risk

These were partially done.

Baseline comparability demonstrated

Unclear risk

The trial did not report this.

Stuecker 2001

Methods

DESIGN
Within‐patient
Participant delivery
ALLOCATION
Random
Method of randomisation: not reported
Concealment: unclear
BLINDING
Blinding unclear
WITHDRAWAL/DROPOUT
Described

Participants

N: 13

Treatment duration: 12 wks; FU: 12 wks

LF: 2 (15.4%)

BC: yes

Age: 52.9 (12.2SD, range = 38 to 67)

Gender (per cent men): 76.9%

Severity: PASI = 9.11 (4.88SD, range = 2.20 to 18.70)

Duration: 20.8 (12.7SD)

INCLUSION CRITERIA

  • Stable psoriasis vulgaris

  • Aged 18 to 70

EXCLUSION CRITERIA

  • Topical treatment within previous wk

  • Modification of systemic treatment within previous 3 mths

  • Pototherapy within previous 6 wks

  • Known hypersensitivity to study medications

  • Avocado oil allergy

  • BSA ≥ 60%

Interventions

  • Calcipotriol cream BD

  • Vitamin B₁₂ cream (with avocado oil) BD

Outcomes

  1. PASI (modified to exclude head and neck; each side given weighting of 50%)

  2. IAGI (4‐pt: poor to very good)

  3. PAGI (4‐pt: poor to very good)

  4. Tolerability

Notes

Regeneratio Pharma AG sponsored the trial.

Risk of bias

Bias

Authors' judgement

Support for judgement

Allocation concealment (selection bias)

Unclear risk

The trial reported insufficient details.

Blinding (performance bias and detection bias)
All outcomes

Unclear risk

The trial did not report this.

Randomisation method reported

Unclear risk

The trial did not report this.

Loss to follow up

Low risk

15.4%

Baseline assessments

Low risk

Baseline comparability demonstrated

Low risk

Stutz 1996

Methods

DESIGN
Within‐patient
Participant delivery
ALLOCATION
Random
Method of randomisation: computer‐generated randomisation code to allocate sides
Concealment: adequate
BLINDING
Double‐blind (participant/investigator)
WITHDRAWAL/DROPOUT
Not described

Participants

N: 15

Treatment duration: 3 wks; FU: 3 wks

LF: 2 (13.3%)

BC: not reported

Age: range = 21 to 68

Gender (per cent men): The trial did not report this.

Severity: TSS (scale not reported) = 2.8 (0.3SD)

INCLUSION CRITERIA

  • Mild plaque psoriasis

EXCLUSION CRITERIA

  • Prescription treatments within previous 2 wks

Interventions

  • Polymyxin B cream 200,000 U/g TD

  • Placebo cream TD

Outcomes

  1. Total severity

  2. Erythema, scaling, thickness

Notes

Babcock Dermatologic Endowment and the alumni of the Department of Dermatology, University of Michigan Medical Center, MI, sponsored the trial.

Risk of bias

Bias

Authors' judgement

Support for judgement

Allocation concealment (selection bias)

Low risk

Body sites were selected then assigned a computer‐generated randomisation code that was concealed from both investigators and participants.

Blinding (performance bias and detection bias)
All outcomes

Low risk

The trial was double‐blind (participant/investigator).

Randomisation method reported

Low risk

Randomisation was computer‐generated.

Loss to follow up

Low risk

13.3%

Baseline assessments

Low risk

These were partially done.

Baseline comparability demonstrated

Unclear risk

The trial did not report this.

Sudilovsky 1981

Methods

DESIGN
Within‐patient 
Participant delivery
ALLOCATION
Random
Method of randomisation: identical tubes allocated by random numbers table
Concealment: adequate
BLINDING
Double‐blind (participant/investigator)
WITHDRAWAL/DROPOUT
Described

Participants

N: 78 (57% psoriasis)

Treatment duration: 3 wks; FU: 3 wks

LF: 0%

BC: Inadequately reported

Age: not reported

Gender (per cent men): not reported

Severity: not reported

INCLUSION CRITERIA

  • Bilateral lesions of similar severity and duration

EXCLUSION CRITERIA

  • Recent corticosteroid medication

  • History of poor response to corticosteroids

  • Concomitant local or systemic therapy that could affect psoriasis

Interventions

  • Halcinonide cream 0.1% OD + vehicle cream BD (H)

  • Placebo (vehicle) treatment durations (P)

Outcomes

  1. Comparative therapeutic response (3‐pt: equal response to markedly superior response)

  2. Absolute therapeutic response (4‐pt: poor (< 25% improvement) to excellent (75% to 100% improvement))

  3. Investigator Global Assessment: reflects comparative and absolute responses (methodology unclear)

Notes

The Squibb Institute for Medical Research sponsored the trial.
Part of a larger study involving participants with atopic dermatitis and trialling other dosages; aggregated demographics were reported.

Risk of bias

Bias

Authors' judgement

Support for judgement

Allocation concealment (selection bias)

Low risk

The part of the study (I or II) and side of the body chosen for treatment were concealed from investigators and determined by random numbers table.

Blinding (performance bias and detection bias)
All outcomes

Low risk

The trial was double‐blind (participant/investigator).

Randomisation method reported

Unclear risk

The trial did not report this.

Loss to follow up

Low risk

0.0%

Baseline assessments

Unclear risk

The trial did not report these.

Baseline comparability demonstrated

Unclear risk

The trial did not report this.

Sutton 2001

Methods

DESIGN
Within‐patient
Participant delivery
ALLOCATION
Random
Method of randomisation: not reported
Concealment: unclear
BLINDING
Double‐blind (participant/investigator)
WITHDRAWAL/DROPOUT
Described

Participants

N: 53 participants

Treatment duration: 8 wks; FU: 12 wks

LF:  5 (9.4%)

BC: yes

Age: range = 26 to 67

Gender (per cent men): 58.5%

Severity: duration (yrs) = 2 to 50

INCLUSION CRITERIA

  • Psoriasis

  • Good general health

EXCLUSION CRITERIA

  • Women of childbearing potential

  • Systemic retinoids within previous 6 mths

  • NSAIDs, cytostatic agents, or folic acid‐containing vitamin preparations within previous mth

  • Topical or UV treatments within previous 2 wks

Interventions

  • Methotrexate gel (Azone®) 1% OD

  • Placebo gel OD

Outcomes

  1. IAGI (6‐pt: worse to cleared)

  2. Total Severity Score (erythema, thickness, scaling, pruritis) (0 to 20)

  3. Adverse events

Notes

Cato Research Ltd and Durham Pharmaceuticals LLC, NC, sponsored the trial.
They treated lesions < = 20% BSA.

Risk of bias

Bias

Authors' judgement

Support for judgement

Allocation concealment (selection bias)

Unclear risk

The trial reported insufficient details.

Blinding (performance bias and detection bias)
All outcomes

Low risk

The trial was double‐blind (participant/investigator).

Randomisation method reported

Unclear risk

The trial did not report this.

Loss to follow up

Low risk

9.4%

Baseline assessments

Low risk

These were partially done.

Baseline comparability demonstrated

Low risk

Syed 1996

Methods

DESIGN
Between‐patient
Participant delivery
ALLOCATION
Random
Method of randomisation: not reported
Concealment: unclear
BLINDING
Double‐blind (participant/investigator)
WITHDRAWAL/DROPOUT
Described

Participants

N: 60

Treatment duration: 4 wks; FU: 52 wks

LF: 0 (0%)

BC: yes

Age: 25.6 (range = 18 to 50)

Gender (per cent men): 60.0%

Severity: PASI = 9.3 (range = 4.8 to 16.7)

Duration (yrs): 8.5 (range = 1 to 21)

INCLUSION CRITERIA

  • Mild‐to‐moderate chronic plaque‐type psoriasis

EXCLUSION CRITERIA

  • Pregnancy

  • Lactation

  • Cytotoxic drugs

  • Beta‐blockers

  • Recent systemic medication, UV therapy

  • Epilepsy

Interventions

  • Aloe vera extract 0.5% hydrophilic cream TDS (5 days/wk)

  • Placebo cream TDS (5 days/wk)

Outcomes

  1. PASI

  2. Cure rate

  3. Significant clearing

Notes

The trial did not report sponsorship.
Concomitant water soluble emollients were permitted.
SDs were imputed (PASI).

Risk of bias

Bias

Authors' judgement

Support for judgement

Allocation concealment (selection bias)

Unclear risk

The trial reported insufficient details.

Blinding (performance bias and detection bias)
All outcomes

Low risk

The trial was double‐blind (participant/investigator).

Randomisation method reported

Unclear risk

The trial did not report this.

Loss to follow up

Low risk

0.0%

Baseline assessments

Low risk

Baseline comparability demonstrated

Low risk

Syed 2001b

Methods

DESIGN
Between‐patient
Participant delivery
ALLOCATION
Random
Method of randomisation: not reported
Concealment: unclear
BLINDING
Double‐blind (participant/investigator)
WITHDRAWAL/DROPOUT
Described

Participants

N: 60 participants

Treatment duration: 4 wks; FU: 8 wks

LF:  0 (0%)

BC: yes

Age: 29.3 (range = 18 to 70)

Gender (per cent men): 61.7%

Severity: PASI = 9.8 (range = 5.3 to 17.5)

Duration (yrs): 9.6 (range = 1 to 24)

INCLUSION CRITERIA

  • Chronic, mild to moderate, plaque type psoriasis

  • Outpatients

  • PASI > 4 or BSA > 20%

EXCLUSION CRITERIA

  • Topical or systemic corticosteroids or cytotoxic drugs or beta‐blockers or phototherapy within previous 3 mths

  • Pregnancy

  • Lactation

  • Alcoholic problems

  • Concurrent renal, hepatic, or haematological abnormalities

Interventions

  • Methotrexate gel (Azone ®) 0.25% BD (5 days/wk)

  • Placebo gel BD (5 days/wk)

Outcomes

  1. PASI

  2. Plaques cleared

  3. Adverse events

  4. Compliance (≤ 40 topical applications during 4‐wk period)

Notes

The trial did not report sponsorship.
SDs were imputation (PASI).

Risk of bias

Bias

Authors' judgement

Support for judgement

Allocation concealment (selection bias)

Unclear risk

The trial reported insufficient details.

Blinding (performance bias and detection bias)
All outcomes

Low risk

The trial was double‐blind (participant/investigator).

Randomisation method reported

Unclear risk

The trial did not report this.

Loss to follow up

Low risk

0.0%

Baseline assessments

Low risk

Baseline comparability demonstrated

Low risk

Tham 1994

Methods

DESIGN
Within‐patient
Participant delivery
ALLOCATION
Random
Method of randomisation: computer‐generated random numbers
Concealment: unclear
BLINDING
Single‐blind (investigator)
WITHDRAWAL/DROPOUT
Described

Participants

N: 30

Treatment duration: 6 wks; FU: 6 wks

LF: 3 (10%)

BC: yes

Age: 40 (range = 20 to 74)

Gender (per cent men): 56.7%

Ethnicity: Chinese (70.0%), Indian (16.7%), Malay (10.0%), and Sikh (3.3%)

Severity: PASI = 6.65

Duration (years): 9.7 (range = 2 to 20)

INCLUSION CRITERIA

  • Stable symmetrical chronic plaque‐type psoriasis

  • Adult

EXCLUSION CRITERIA

  • Recent systemic or UV therapy

  • Hypercalcaemia

  • High calcium or vitamin D intake

  • Impaired renal or hepatic function

  • Previous poor response to tar

  • Concomitant medications

Interventions

  • Calcipotriol ointment 50 mcg/g BD (C)

  • White soft paraffin OM plus coal tar solution BP in aqueous cream 15% ON (T)

Outcomes

  1. PASI (modified to exclude head)

  2. Severity (erythema; infiltration; desquamation)

  3. Investigator Global Assessment (5‐pt: worse to cleared)

  4. Patient Global Assessment (5‐pt: worse to cleared)

Notes

Leo Pharmaceutical Products sponsored the trial.

Risk of bias

Bias

Authors' judgement

Support for judgement

Allocation concealment (selection bias)

Unclear risk

The trial reported insufficient details.

Blinding (performance bias and detection bias)
All outcomes

Low risk

The trial was single‐blind (investigator).

Randomisation method reported

Low risk

Randomisation was computer‐generated.

Loss to follow up

Low risk

10.0%

Baseline assessments

Low risk

Baseline comparability demonstrated

Low risk

Tyring 2010

Methods

DESIGN
Between‐patient
Participant delivery
ALLOCATION
Random
Method of randomisation: computer‐generated schedule (3:1), stratified by ethnicity;
Concealment: adequate
BLINDING
Double‐blind (participant/investigator)
WITHDRAWAL/DROPOUT
Described

Participants

N: 177

Treatment duration: 8 wks; FU: 52 wks

LF: 0 (0%) (at 8 wks)

BC: yes

Age: 44.7 (range = 18 to 76)

Gender (per cent men): 63.3%

Ethnicity: per cent white = 0%; per cent Hispanic/Latino: 56%; per cent black/African American = 44%

Severity: scalp IGA (moderate) = 80.2%; scalp IGA (severe/very severe) = 19.8%; TSS (0 to 12) = 6.3, range = 4 to 11

Duration (yrs): 10.8, range = 1 to 50

INCLUSION CRITERIA

  • People aged > = 18 with plaque psoriasis affecting the scalp and limbs/trunk

  • > = 10% scalp affected

  • IGA scalp psoriasis at least moderate

  • Ethnicity: Hispanic/Latino/black/African American

EXCLUSION CRITERIA

  • Topical or UV therapy within previous 2 wks

  • Biological within previous 12 wks

  • Systemic therapies within previous 4 wks

  • Erythrodermic, exfoliative, or pustular psoriasis

  • Skin infections

  • Skin diseases confounding evaluation of psoriasis

  • Calcium metabolic disorder or hypercalcaemia

  • Pregnancy

  • Lactation

Interventions

  • Calcipotriene 50 mcg/g plus betamethasone 0.5 mg/g scalp formulation (gel) OD (C‐B)

  • Placebo gel OD (P) (8 wks) then C‐B (44 wks)

 

Maximum of 40 g/wk. Treatment was stopped if scalp psoriasis cleared.

Concurrent (scalp) antipsoriatics and 'chemical treatments of the hair' were not permitted.

All participants received C‐B ointment for trunk/limbs.

Outcomes

  1. Investigator Global Assessment of Disease Severity (IGA): 6‐pt = clear (0) to very severe (5). Based on written definitions for plaque thickness, scaling, and erythema.

  2. Success: IGA < = 1

  3. Signs (investigator assessment): plaque thickness, scaling and erythema (each scored 0 (none) to 4 (very severe).

  4. Total Sign Score (0 to 12)

  5. Response criteria: TSS < = 1; PGA < = 1

  6. Signs (each): absent

  7. Patient Global Assessment of Disease Severity (PGA): 6‐pt = clear (0) to very severe (5). Based overall severity and impact on daily life

  8. Adverse events

  9. Blood pressure

  10. Laboratory tests: serum calcium, albumin, blood urea nitrogen, creatinine.

  11. Compliance (medication usage)

Notes

Leo Pharma A/S sponsored the trial

This was part of a 52‐wk study: Following 8 wks of double‐blind treatment, all participants received C‐B scalp formulation for 44 wks. Data were reported only for the 8‐wk end point.

The sponsor supplied unpublished data.

Risk of bias

Bias

Authors' judgement

Support for judgement

Allocation concealment (selection bias)

Low risk

Participants were assigned the next consecutive randomisation number available at the site for his/her ethnic category.

Blinding (performance bias and detection bias)
All outcomes

Unclear risk

The trial was double‐blind (participant/investigator).

Randomisation method reported

Unclear risk

Randomisation was preplanned according to a computer‐generated randomisation schedule in a ratio of 3:1, stratified by ethnicity.

Loss to follow up

Unclear risk

0%

Baseline assessments

Low risk

These were reported.

Baseline comparability demonstrated

Unclear risk

This was partially demonstrated (reported means, but not standard, deviations; proportions reported).

Tzung 2005

Methods

DESIGN
Within‐patient
Participant delivery
ALLOCATION
Random
Method of randomisation: not stated
Concealment: unclear
BLINDING
Single‐blind (investigator)
WITHDRAWAL/DROPOUT
Described

Participants

N: 23

Treatment duration: 12 wks; FU: 16 wks

LF: 4 (17.4%)

BC: yes

Age: 60.2; range = 12 to 80

Gender (per cent men): 91.3%

Severity: Signs = mean baseline scores ranged from 2.1 to 2.3 (SD range = 0.71 to 0.80)

INCLUSION CRITERIA

  • People with plaque psoriasis attending study centre (veteran’s hospital)

  • Ethnicity: Chinese

  • Target lesions of at least moderate severity

EXCLUSION CRITERIA

  • Topical within previous 2 wks

  • Oral systemic therapies within previous 6 wks

  • Phototherapy or sun exposure within previous 4 wks

  • Unstable psoriasis

  • Pregnancy

  • Lactation

  • Uncontrolled systemic disease

Interventions

  • Calcipotriol 0.005% ointment BD (C)

  • Tazarotene 0.1% gel ON placebo petrolatum ointment OM (T)

Outcomes

  1. Adverse events

  2. Scaling, plaque elevation, erythema (8 pt: 0 = none to 4 = very severe; 0.5 increments)

  3. Patient Assessment of Overall Improvement (PAGI): 5‐pt = deterioration to excellent improvement (> 75%)

Notes

The trial did not state the sponsor.

The number of adverse events was described, but the number of participants experiencing ADRs was not reported.

Risk of bias

Bias

Authors' judgement

Support for judgement

Allocation concealment (selection bias)

Unclear risk

The trial reported insufficient details.

Blinding (performance bias and detection bias)
All outcomes

Unclear risk

The study was single‐blind (investigator).

Randomisation method reported

Unclear risk

The trial did not report this.

Loss to follow up

Unclear risk

17.4%

Baseline assessments

Low risk

Clinical assessments were reported (within‐patient study, so demographics comparable).

Baseline comparability demonstrated

Low risk

Clinical comparability was demonstrated.

Vali 2005

Methods

DESIGN
Within‐patient
Participant delivery
ALLOCATION
Random
Method of randomisation: flip of coin
Concealment: unclear
BLINDING
Double‐blind (participant/investigator)
WITHDRAWAL/DROPOUT
Described

Participants

N: 42

Treatment duration: 8 wks; FU: 8 wks

LF: 3 (7.1%)

BC: yes

Age: 32 (12.22SD)

Gender (per cent men): 66.7%

Severity: PASI = 10.86 (5.15SD)

INCLUSION CRITERIA

  • People with symmetrical plaque psoriasis

  • BSA < 20%

EXCLUSION CRITERIA

  • Systemic or topical antipsoriatic therapy within previous 4 wks

  • Pregnancy

  • Lactation

  • Use of medications that could affect course of psoriasis

Interventions

  • Topical caffeine 10% in Plastibase® TD (C)

  • Placebo (Plastibase®) TD (P)

Outcomes

  1. modified PASI ('regional PASI'): range unclear

  2. Adverse events

Notes

The trial did not state the sponsor.

Risk of bias

Bias

Authors' judgement

Support for judgement

Allocation concealment (selection bias)

Unclear risk

The trial reported insufficient details.

Blinding (performance bias and detection bias)
All outcomes

Low risk

The trial was double‐blind (participant/investigator).

Randomisation method reported

Low risk

Randomisation was by the flip of a coin.

Loss to follow up

Low risk

7.1%

Baseline assessments

Low risk

These were reported.

Baseline comparability demonstrated

Low risk

This was demonstrated.

Van de Kerkhof 1989

Methods

DESIGN
Within‐patient
Participant delivery
ALLOCATION
Random
Method of randomisation: not reported
Concealment: adequate
BLINDING
Double‐blind (participant/investigator)
WITHDRAWAL/DROPOUT
Described

Participants

N: 10

Treatment duration: 4 wks; FU: 4 wks

LF: 0 (0%)

BC: yes

Age: range = 28 to 72

Gender (per cent men): 70%

Severity: TSS (0 to 9) = 7.2

INCLUSION CRITERIA

  • People with symmetrical chronic stable plaque psoriasis

EXCLUSION CRITERIA

  • Topical antipsoriatic therapy within previous 2 wks

  • Systemic antipsoriatic therapy within previous 1 mth

  • BSA affected < = 15%

Interventions

  • Calcitriol solution 2 mcg/ml BD (C)

  • Placebo (vehicle) (P)

Outcomes

  1. Severity (erythema; thickness; scaling)

  2. TSS (0 to 9)

Notes

The trial did not report sponsorship, but Hoffmann‐La Roche, Switzerland , employed 1 of the authors.
The authors stated that allocation was concealed to the investigator, but provided no justification.
Treatment was given at subtherapeutic dose.
There was SD imputation (TSS).

Risk of bias

Bias

Authors' judgement

Support for judgement

Allocation concealment (selection bias)

Low risk

A randomisation code was generated centrally and concealed from the investigator until after trial completion.

Blinding (performance bias and detection bias)
All outcomes

Low risk

The trial was double‐blind (participant/investigator).

Randomisation method reported

Unclear risk

The trial did not report this.

Loss to follow up

Low risk

0.0%

Baseline assessments

Low risk

These were partially done.

Baseline comparability demonstrated

Low risk

Van de Kerkhof 1996a

Methods

DESIGN
Within‐patient
Participant delivery
ALLOCATION
Random
Method of randomisation: not reported
Concealment: unclear
BLINDING
Double‐blind (participant/investigator)
WITHDRAWAL/DROPOUT
Described

Participants

N: 122

Treatment duration: 8 wks; FU: 12 wks

LF: 19 (15.6%)

BC: inadequately reported

Age: 44.8 (13.69SD)

Gender (per cent men): 62.3%

Severity: BSA = 5.6%

Duration (mths): 233.5 (175.9SD)

INCLUSION CRITERIA

  • Stable plaque psoriasis

  • Not localised on the scalp

  • BSA: 5.6%

  • Score ≥ 2 for erythema and desquamation and Score sum > 5

  • White adults and adolescents

EXCLUSION CRITERIA

  • Increased serum calcium or serum phosphate level

  • Recent systemic or topical antipsoriatic treatment

  • Serious disease

  • Known allergy to study medication

  • Recent participation in another clinical trial

  • Expected poor compliance

  • Calcium supplements

  • Drugs influencing calcium metabolism

  • Corticosteroids

  • Barbiturates

  • Phenytoin

  • NSAIDs

  • Pregnancy

Interventions

  • Tacalcitol 4 mcg/g OD (T)

  • Placebo (vehicle) (P)

Outcomes

  1. Signs: erythema; infiltration; desquamation

  2. Total Sign Score (0 to 12)

  3. Severity

  4. Preference assessment

  5. Area of test lesions

  6. Investigator Global Assessment (4‐pt: poor to very good)

  7. Patient Global Assessment (4‐pt: poor to very good)

  8. Assessment of benefit

  9. Post‐treatment relapse

Notes

Hermal Kurt Herrmann sponsored the trial.
Maximum treatment area: 10% BSA
There was SD imputation (TSS).

Risk of bias

Bias

Authors' judgement

Support for judgement

Allocation concealment (selection bias)

Unclear risk

The trial reported insufficient details.

Blinding (performance bias and detection bias)
All outcomes

Low risk

The trial was double‐blind (participant/investigator).

Randomisation method reported

Unclear risk

The trial did not report this.

Loss to follow up

Low risk

15.6%

Baseline assessments

Low risk

Baseline comparability demonstrated

Unclear risk

The trial did not report this.

Van de Kerkhof 2002a

Methods

DESIGN
Between‐patient
Participant delivery
ALLOCATION
Random
Method of randomisation: not reported
Concealment: unclear
BLINDING
Open
WITHDRAWAL/DROPOUT
Described

Participants

N: 88 participants

Treatment duration: 4 wks; FU: 5 wks

LF: 7 (8.0%)

BC: yes

Age: not reported

Gender (per cent men): not reported

Severity: PASI = 16.9 (range = 4.3 to 48.0)

INCLUSION CRITERIA

  • Inpatients or outpatients

  • Aged 18 or over; chronic plaque psoriasis

  • Scalp involvement

EXCLUSION CRITERIA

  • Other forms of psoriasis

  • Systemic antipsoriatic treatment within previous 6 wks

  • UV treatment within previous 6 wks

  • Impaired renal or hepatic function

  • History of urolithiasis or hypercalciurea

  • Arthritis

  • Immobilisation

  • Hypo‐ or hyperthyroidism

  • Heavy exposure to sunlight

  • Pregnancy

  • Lactation

  • Planning of pregnancy

Interventions

  • Calcipotriol ointment 50 mcg/g (80 to 100 g/wk) and calcipotriol scalp solution 50 mg/ml (30 to 50 ml/wk) (C)

  • Dithranol/tar regimen (D)

Outcomes

  1. PASI (scalp assessed separately)

  2. TSS (SCALP: erythema, thickness, scaling) (0 to 12)

  3. IAGI (6‐pt: worse to clearance)

  4. PAGI (6‐pt: worse to clearance)

  5. Adverse events

Notes

Leo Pharmaceutical Products sponsored the trial.

The trial included inpatients.

The trial reported medication quantities used: "patients complied well".

'High dose' calcipotriol was given (above recommended dosage).

IAGI/PAGI: combined scalp/body
TSS: scalp only
PASI: body only

Risk of bias

Bias

Authors' judgement

Support for judgement

Allocation concealment (selection bias)

Unclear risk

The trial reported insufficient details.

Blinding (performance bias and detection bias)
All outcomes

High risk

The trial was open.

Randomisation method reported

Unclear risk

The trial did not report this.

Loss to follow up

Low risk

8.0%

Baseline assessments

Low risk

These were partially done.

Baseline comparability demonstrated

Low risk

Van de Kerkhof 2006

Methods

DESIGN
Between‐patient
Nurse and participant delivery
ALLOCATION
Random
Method of randomisation: computer‐generated system using telephone response
Concealment: adequate
BLINDING
Open
WITHDRAWAL/DROPOUT
Described

Participants

N: 106

Treatment duration: 12 wks; FU: 12 wks

LF: 0 (0%)

BC: yes

Age (mean): 51.2; range = 25 to 83

Gender (per cent men): 59/100 (reported by de Korte 2008 ‐ this is a secondary reference under Van de Kerkhof 2006); 6 participants missing)

Ethnicity: NR

Severity: mPASI (mean) = 9.9, range = 2.7 to 27.0

INCLUSION CRITERIA

  • Outpatients aged > = 18 with plaque psoriasis involving arms, trunk, legs, or a combination of the aforementioned

  • Condition amendable to topical treatment

  • Target area treatable with < = 100 g calcipotriol/wk

  • PASI extent score > = 2 (i.e. BSA (body region) > = 10%)

  • Willing/able to comply with study protocol

EXCLUSION CRITERIA

  • Acute guttate, generalised pustular, or erythrodermic exfoliative psoriasis

  • Atopic dermatitis, seborrhoeic dermatitis, or other inflammatory skin diseases

  • Systemic antipsoriatic therapy (including corticosteroids) or phototherapy within previous 6 wks

  • Topical antipsoriatic therapy (body) within previous 2 wks

  • Planned changes in concurrent medication that could affect psoriasis (e.g. beta‐blockers, lithium, etc)

  • Pregnancy or risk thereof

  • Lactation

  • Known or suspected hypercalcaemia

  • Hypersensitivity to components of study medication

  • Treatment with an investigational drug within previous 3 mths

  • Current participation in other clinical trial

  • Planned exposure to excessive levels of sun/UV radiation

  • Known treatment resistance to study medication

Interventions

  • Calcipotriol 50 mcg/g ointment BD (C)

  • Short‐contact dithranol cream (dose titration from 0.1% to 5%; application time 15 to 45 mins) OD; class II or III corticosteroids for treatment of severe skin irritation (D)

    • wk1: 5 (daily) visits to outpatient clinic

    • wk2 onwards: twice‐weekly visits PRN

Participants intolerant of 0.1% dithranol used 0.05% dose.

Cases of extensive hyperkeratosis, scales of participants in both treatment groups could be removed with salicylic acid (5%) in petrolatum before wk 0.

Participants achieving clearance exited the study.

Outcomes

PRIMARY OUTCOMES

  1. mPASI (scalp excluded)

SECONDARY OUTCOMES

  1. IAGI: Investigator’s overall assessment of treatment response: 6‐pt (worse to clearance)

  2. PAGI: Patient's overall assessment of treatment response: 6‐pt (worse to clearance)

  3. Quality of life

  4. Adverse events

  5. Compliance (per cent using study medication as prescribed)

Notes

Leo Pharma sponsored the trial.

Secondary response criteria did not demonstrate a statistically significant difference between treatments.

The sponsor supplied unpublished data.

Risk of bias

Bias

Authors' judgement

Support for judgement

Allocation concealment (selection bias)

Low risk

The treatment was assignment using a telephone voice response system, to ensure that the investigators' decision to randomise the participant preceded knowledge of the randomised treatment.

Blinding (performance bias and detection bias)
All outcomes

High risk

The trial was open.

Randomisation method reported

Low risk

Randomisation was through a computer‐generated system using telephone response.

Loss to follow up

Low risk

0%

Baseline assessments

Low risk

These were reported.

Baseline comparability demonstrated

Unclear risk

This was partially demonstrated (de Korte 2008). There were significantly more men in the dithranol group (72% versus 46%). However, de Korte does not provide data on 6 participants. If all these participants are assumed to be of the gender that minimises between group differences, the difference is almost statistically significant at the 5% level (= 0.0502; Fisher's exact test). This may indicate a flawed randomisation process, or it may be chance. The primary reference does not report variance around mean PASI baseline estimates, so comparability was unclear.

Van de Kerkhof 2009

Methods

DESIGN
Between‐patient
Participant delivery
ALLOCATION
Random
Method of randomisation: computer‐generated schedule (1:2:2)
Concealment: unclear
BLINDING
Double‐blind (participant/investigator)
WITHDRAWAL/DROPOUT
Described

Participants

N: 1417

Treatment duration: 8 wks; FU: 8 wks

LF: 2 (0.1%)

BC: yes

Age: 48.3 (16.4SD); range = 18 to 92

Gender (per cent men): 44.8%

Ethnicity (per cent white): 97.2%

Severity: IGA (0 to 5) = 3.32 (0.71SD), range = 2 to 5; TSS (0 to 12) = 6.8 (1.8SD)

Duration (yrs): 15.9 (13.4SD)

INCLUSION CRITERIA

  • People aged > = 18 with scalp psoriasis involving > 10% of the scalp, amenable to treatment with < = 100 g medication/wk

EXCLUSION CRITERIA

  • Concomitant topical scalp therapy (except medicated shampoos and emollients)

  • Planned initiation of/changes to concomitant medication that could affect scalp psoriasis

  • Use of topical treatment of the face, trunk or limbs with very potent (WHO group IV) corticosteroids or UVB within previous 2 wks

  • PUVA or grenz ray therapy, planned exposure to the sun, systemic therapy within previous 4 wks

  • Biological therapy within previous 6 mths

  • Erythrodermic, exfoliative, or pustular psoriasis

  • Presence of viral lesions, fungal, or bacterial skin infections, parasitic infections, or atrophic skin on the scalp, known/suspected abnormality of calcium homeostasis associated with clinically significant hypercalcaemia

  • Severe renal insufficiency

  • Severe hepatic disorders

Interventions

  • Calcipotriol 50 mcg/g gel OD (C)

  • Betamethasone dipropionate 0.5 mg/g gel OD (B)

  • Calcipotriol 50 mcg/g plus betamethasone dipropionate 0. 5 mg/g gel (scalp formulation) OD (C‐B)

Participants achieving IGA = 0 could stop medication during the study.

Outcomes

  1. Investigator's Global Assessment of severity of scalp psoriasis (IGA); 6‐pt (0 = absence of disease to 5 = very severe disease)

  2. Responder: IGA absence or very mild

  3. Total Sign Score (erythema, thickness, scaliness): 13‐pt (0 to 12)

  4. Patient assessment of overall response: 7‐pt (worse to clear)

  5. Adverse events (local)

  6. Laboratory tests for calcium and albumin.

  7. Compliance (self report and weight medication used)

Notes

Leo Pharma A/S, Ballerup, Denmark, sponsored the trial.

The sponsor supplied unpublished data.

Risk of bias

Bias

Authors' judgement

Support for judgement

Allocation concealment (selection bias)

Unclear risk

The trial reported insufficient details.

Blinding (performance bias and detection bias)
All outcomes

Low risk

The trial was double‐blind (participant/investigator).

Randomisation method reported

Low risk

A computer‐generated randomisation schedule was used (1:2:2).

Loss to follow up

Low risk

0.1%

Baseline assessments

Low risk

These were reported.

Baseline comparability demonstrated

Low risk

This was demonstrated.

Van der Vleuten 1995

Methods

DESIGN
Within‐patient
Delivery unclear
ALLOCATION
Random
Method of randomisation: not reported
Concealment: unclear
BLINDING
Open
WITHDRAWAL/DROPOUT
Described

Participants

N: 10

Treatment duration: 2 wks; FU: 2 wks

LF: 0 (0%)

BC: inadequately reported

Age: range = 20 to 72

Gender (per cent men): 40%

Severity: PASI (modified) = 17.1 (2.1SEM)

Duration (yrs): 3 to 53

INCLUSION CRITERIA

  • Adult

  • Inpatient

  • Severe, disabling psoriasis

  • Resistant to topical therapy

EXCLUSION CRITERIA

  • Recent or concomitant oral antipsoriatic therapy, no topical or systemic treatments except corticosteroids for the scalp and face

Interventions

  • Calcipotriol ointment 50 mcg/g BD

  • Dithranol in paste or petroleum 0.05% to 4%, 24‐hour application on alternate days

Outcomes

  1. PASI (excludes scalp)

Notes

The trial did not report sponsorship.
Treatment was delivered in an inpatient setting.

Risk of bias

Bias

Authors' judgement

Support for judgement

Allocation concealment (selection bias)

Unclear risk

The trial reported insufficient details.

Blinding (performance bias and detection bias)
All outcomes

High risk

The trial was open.

Randomisation method reported

Unclear risk

The trial did not report this.

Loss to follow up

Low risk

0.0%

Baseline assessments

Low risk

These were partially done.

Baseline comparability demonstrated

Unclear risk

The trial did not report this.

Vanderploeg 1976

Methods

DESIGN
Between‐patient
Participant delivery
ALLOCATION
Random
Method of randomisation: identical tubes allocated by sequential admission number, corresponding to a standard randomisation schedule using a double‐blind code
Concealment: adequate
BLINDING
Double‐blind (participant/investigator)
WITHDRAWAL/DROPOUT
Described

Participants

N: 36

Treatment duration: 3 wks; FU: 3 wks

LF: 3 of 36 (8.3%)

BC: yes

Age: 45.7 (range = 10 to 66; N = 33)

Gender (per cent men): 48.5% (N = 33)

Severity: TSS (0 to 20) = 9.9

INCLUSION CRITERIA

  • Psoriasis or atopic dermatitis

EXCLUSION CRITERIA

  • Recent systemic or topical steroids

  • Concomitant medications

Interventions

  • Betamethasone dipropionate ointment 0.05% BD (B)

  • Vehicle BD (P)

Outcomes

  1. Signs: scale; erythema; pruritis; thickness; crusting

  2. Total Sign Score (0 to 20)

  3. Investigator Global Assessment (5 pt: exacerbation to excellent improvement)

Notes

The trial did not report sponsorship.
This was part of a larger trial that included participants with atopic dermatitis (50% psoriasis).
There was SD imputation (TSS).

Risk of bias

Bias

Authors' judgement

Support for judgement

Allocation concealment (selection bias)

Low risk

The sequential trial admission number corresponded to the randomisation schedule; the randomisation code was 'double blind'.

Blinding (performance bias and detection bias)
All outcomes

Low risk

The trial was double‐blind (participant/investigator).

Randomisation method reported

Low risk

Randomisation was sequential.

Loss to follow up

Low risk

8.3%

Baseline assessments

Low risk

Baseline comparability demonstrated

Low risk

Veien 1997

Methods

DESIGN
Between‐patient
Participant delivery
ALLOCATION
Random
Method of randomisation: block
Concealment: unclear
BLINDING
Double‐blind (participant/investigator)
WITHDRAWAL/DROPOUT
Described

Participants

N: 287

Treatment duration: 8 wks; FU: 12 wks

LF: 0 (0%)

BC: psoriasis comparable, demographics inadequately reported

Age: 45.0

Gender (per cent men): 53.7%

Severity: BSA = 7.9% (range = 1% to 75%); TSS (0 to 12) = 7.59

INCLUSION CRITERIA

  • Adult

  • Stable plaque psoriasis

  • TSS > 5

  • Erythema ≥ 2, scaling ≥ 2

EXCLUSION CRITERIA

  • Pregnancy

  • Lactation

  • High serum calcium, serum phosphate, serum creatinine

  • Unresponsive to calcipotriol

  • Intolerant to study ingredients

  • Serious co‐morbidity

Interventions

  • Tacalcitol ointment 4 mcg/g OD plus Tacalcitol vehicle OD (T)

  • Calcipotriol ointment 50 mcg/g BD (C)

Outcomes

  1. Severity: erythema; infiltration; scaling; pruritus

  2. Total Sign Score (TSS): 0 to12

  3. Investigator Global Assessment (6‐pt: worse to clear)

  4. Patient Global Assessment (scale "virtually identical" to IAGI; details not reported)

  5. Patient evaluation of global usefulness (VAS)

  6. Patient evaluation of cosmetic acceptability

  7. Quantity of medication used

  8. Rebound (aggravation equal to or worse than pre‐treatment severity)

Notes

Nycomed Pharma sponsored the trial.

Risk of bias

Bias

Authors' judgement

Support for judgement

Allocation concealment (selection bias)

Unclear risk

The trial reported insufficient details.

Blinding (performance bias and detection bias)
All outcomes

Low risk

The trial was double‐blind (participant/investigator).

Randomisation method reported

Low risk

Block randomisation was used.

Loss to follow up

Low risk

0.0%

Baseline assessments

Low risk

Baseline comparability demonstrated

Unclear risk

The trial did not report this.

Vladimirov 1994

Methods

DESIGN
Between‐patient
Participant delivery
ALLOCATION
Random
Method of randomisation: not reported
Concealment: unclear
BLINDING
Double‐blind (participant/investigator)
WITHDRAWAL/DROPOUT
Not described

Participants

N: 60

Treatment duration: 6 wks; FU: 6 wks

LF: 0 (0%)

BC: inadequately reported

Age: range = 18 to 70

Gender (per cent men): not reported

Severity: PASI = 2.92

Duration (yrs): range = 0.2 to 30

INCLUSION CRITERIA

  • Adult

  • Mild to moderate psoriasis

EXCLUSION CRITERIA

  • None reported

Interventions

  • Calcipotriol cream 50 mcg/g BD (C)

  • Betamethasone17‐valerate ointment 0.1% BD (B)

Outcomes

  1. PASI (range unclear)

  2. Investigator Global Assessment (scale NR)

Notes

Leo Pharmaceuticals sponsored the trial.
There was SD imputation (PASI).

Risk of bias

Bias

Authors' judgement

Support for judgement

Allocation concealment (selection bias)

Unclear risk

The trial reported insufficient details.

Blinding (performance bias and detection bias)
All outcomes

Low risk

The trial was double‐blind (participant/investigator).

Randomisation method reported

Unclear risk

The trial did not report this.

Loss to follow up

Low risk

0.0%

Baseline assessments

Low risk

These were partially done.

Baseline comparability demonstrated

Unclear risk

The trial did not report this.

Volden 1992

Methods

DESIGN
Within‐patient 
Participant delivery
ALLOCATION
Random
Method of randomisation: not reported
Concealment: unclear
BLINDING
Double‐blind (participant/investigator)
WITHDRAWAL/DROPOUT
Described

Participants

N: 10

Treatment duration: 4 wks; FU: 4 wks

LF: 1 (10%)

BC: yes

Age: not reported

Gender (per cent men): not reported

Severity: BSA = 5% to 15%

Duration (mean years): 20

INCLUSION CRITERIA

  • Symmetrical plaque‐type psoriasis

  • Adult outpatients

EXCLUSION CRITERIA

  • Recent active treatment for psoriasis

Interventions

  • Dithranol 1% in petrolatum (D)

  • Placebo (vehicle) (P)

Outcomes

  1. Signs: erythema; infiltration; scaling

  2. Total Sign Score (0 to 12)

Notes

The trial did not report sponsorship, but Hydro Pharma, Swedenone, employed 1 of the authors.

Risk of bias

Bias

Authors' judgement

Support for judgement

Allocation concealment (selection bias)

Unclear risk

The trial reported insufficient details.

Blinding (performance bias and detection bias)
All outcomes

Low risk

The trial was double‐blind (participant/investigator).

Randomisation method reported

Unclear risk

The trial did not report this.

Loss to follow up

Low risk

10.0%

Baseline assessments

Low risk

These were partially done.

Baseline comparability demonstrated

Low risk

Wall 1998

Methods

DESIGN
Between‐patient
Participant delivery
ALLOCATION
Random
Method of randomisation: not reported
Concealment: unclear
BLINDING
Open
WITHDRAWAL/DROPOUT
Not described

Participants

N: 306

Treatment duration: 3 mths

LF: 28 (7.2%)

BC: yes

Age: 46.7

Gender (per cent men): 47.1%

Severity: duration (yrs) = 18.7

Signs and extent reported, but not by summary measure

INCLUSION CRITERIA

  • Adult

  • Stable mild‐to‐moderate chronic plaque psoriasis

  • BSA ≥100 cm² but < 40%

  • Recent GP visit

EXCLUSION CRITERIA

  • Acute guttate or pustular psoriasis

  • Psoriasis of scalp or face only

  • Recent topical or systemic antipsoriatic therapy

  • Pregnancy

  • Lactation; concomitant vitamin D or calcium intake

  • Hypersensitivity to study medication

  • Unlikely to comply with protocol

Interventions

  • Calcipotriol ointment 50 mcg/g BD (C)

  • Dithranol 0.1 to 2% OD (D)

Outcomes

  1. Investigator assessment of overall clinical response (5‐pt: worse to clear)

  2. Patient assessment of overall clinical response (5‐pt: worse to clear)

  3. Quality of Life:

    • Psoriasis Disability Index (PDI)

    • Sickness Impact Profile (SIP)

Notes

Leo Pharmaceuticals sponsored the trial.

Risk of bias

Bias

Authors' judgement

Support for judgement

Allocation concealment (selection bias)

Unclear risk

The trial reported insufficient details.

Blinding (performance bias and detection bias)
All outcomes

High risk

The trial was open.

Randomisation method reported

Unclear risk

The trial did not report this.

Loss to follow up

Low risk

7.2%

Baseline assessments

Low risk

These were partially done.

Baseline comparability demonstrated

Low risk

Weinstein 1996

Methods

DESIGN
Between‐patient
Participant delivery
ALLOCATION
Random
Method of randomisation: not reported
Concealment: unclear
BLINDING
Double‐blind (participant/investigator)
WITHDRAWAL/DROPOUT
Described

Participants

N: 324

Treatment duration: 12 wks; FU: 24 wks

LF: 6 (1.9%)

BC: yes

Age: 46.8 (range = 12 to 83)

Gender (per cent men): 67%

Severity: per cent BSA = 6.9 (5.2SD); TSS (0 to 12) = 7.3

Duration (yrs): 17.5 (12.7SD)

INCLUSION CRITERIA

  • Stable plaque psoriasis

  • BSA ≤ 20%

  • 2 target lesions with plaque elevation ≥ 2 and ≥ 2 cm in diameter: 1 on elbow/knee and 1 on trunk/limbs

EXCLUSION CRITERIA

  • Pustular or exfoliative psoriasis

  • Sensitivity to study medication

  • Other confounding skin conditions

  • Recent use of tar shampoos

  • Topical/systemic/light therapies

  • Topical corticosteroids/UVB

  • PUVA/systemic therapy

  • Oral retinoids

  • Uncontrolled systemic disease

  • Pregnant

  • Lactating

  • Inadequate contraception

Interventions

  • Tazarotene gel 0.1% OD

  • Tazarotene gel 0.05% OD

  • Placebo (vehicle) (P)

Outcomes

  1. Signs: plaque elevation; scaling; erythema

  2. Total Sign Score (0 to 12)

  3. Per cent clearance

  4. Patient assessment of cosmetic acceptability

Notes

Allergan Inc. sponsored the trial.
The authors stated that concealment of treatment allocation was achieved for participants and clinicians, as tubes were identical.
There was SD imputation (TSS).

Risk of bias

Bias

Authors' judgement

Support for judgement

Allocation concealment (selection bias)

Unclear risk

The trial reported insufficient details.

Blinding (performance bias and detection bias)
All outcomes

Low risk

The trial was double‐blind (participant/investigator).

Randomisation method reported

Unclear risk

The trial did not report this.

Loss to follow up

Low risk

1.9%

Baseline assessments

Low risk

Baseline comparability demonstrated

Low risk

Weinstein 2003

Methods

DESIGN
Between‐patient
Participant delivery
ALLOCATION
Random
Method of randomisation: randomised in blocks of 6
Concealment: unclear
BLINDING
Double‐blind (participant/investigator)
WITHDRAWAL/DROPOUT
Described

Participants

N: 1303

Treatment duration: 12 wks; FU: 24 wks

LF: 411 (31.5%)

BC: yes

Age: 48.2 (range = 18 to 84)

Gender (per cent men): 62.6%

Severity: OLA (0 to 5) (mean) = 3.6; BSA affected (mean) = 10.5%

Duration (mean yrs): 18.4

INCLUSION CRITERIA

  • Aged ≥18

  • BSA ≥ 2%; OLA (0 to 5) ≥ 3

  • Acceptable blood or urinary test results

EXCLUSION CRITERIA

  • Pregnancy or risk thereof

  • Lactation

  • UV or topical therapies within previous 2 wks

  • PUVA or systemic therapies within previous 4 wks

  • Oral retinoid therapy within previous 8 wks

  • Expected prolonged exposure to UV light

Interventions

  • Tazarotene cream 0.05% OD (T1)

  • Tazarotene cream 0.1% OD (T2)

  • Placebo (P)

Outcomes

  1. Overall lesion assessment (OLA) (0 = none to 5 = very severe), as applied to all treated lesions

  2. Clinical success (OLA ≤ 2 at 12 wks)

  3. Effectiveness (improvement in OLA from baseline of ≥ 15% relative to placebo improvement score)

  4. Overall plaque elevation, scaling and erythema (each scored 0 = none to 4 = severe)

  5. Overall global response to treatment (7‐pt: completely cleared to worsened)

  6. Target lesion response (7‐pt: completely cleared to worsened)

Notes

Allergan Inc. sponsored the trial.
The paper reported 2 trials; only study A reported follow‐up data after 12 weeks (N = 108).

Risk of bias

Bias

Authors' judgement

Support for judgement

Allocation concealment (selection bias)

Unclear risk

The trial reported insufficient details.

Blinding (performance bias and detection bias)
All outcomes

Low risk

The trial was double‐blind (participant/investigator).

Randomisation method reported

Low risk

Block randomisation was used.

Loss to follow up

High risk

31.5%

Baseline assessments

Low risk

Baseline comparability demonstrated

Low risk

White 2006 (H)

Methods

DESIGN
Between‐patient
Participant delivery
ALLOCATION
Random
Method of randomisation: computer‐generated schedule
Concealment: unclear
BLINDING
Open (acute phase and maintenance phase for CB‐W); double‐blind (participant/investigator) (maintenance phase for CB‐C and CB‐P)
WITHDRAWAL/DROPOUT
Described

Participants

N: 1136

Treatment duration: 12 wks; FU: 12 wks

LF: 0 (0%)

BC: yes

Age: 50.7; range = 18 to 89

Gender (per cent men): 60.7%

Ethnicity (per cent white): 96.9%

Severity: per cent BSA = 12.1%; mPASI = 8.9 (3.8SD), range = 2.4 to 30.9; IGA moderate = 76%; IGA severe = 24%

Duration (yrs): 0 to 75

INCLUSION CRITERIA

  • People aged > = 18 with plaque psoriasis affecting at least 10% arms, 10% trunk, 10% legs, or a combination of the aforementioned

  • IGA at least moderate

EXCLUSION CRITERIA

  • Erythrodermic, exfoliative, pustular, or guttate psoriasis

  • Skin infections

  • Other confounding inflammatory skin disease

  • Calcium metabolic disorder

  • Pregnancy

  • Lactation

  • Concurrent antipsoriatic therapy

Interventions

  • Calcipotriol 50 mcg/g plus betamethasone dipropionate 0.5 mg/g ointment OD (4 wks), then calcipotriol cream 50 mcg/g OD [8 wks] (CB‐C)

  • Calcipotriol 50 mcg/g plus betamethasone dipropionate 0.5 mg/g ointment OD (4 wks), then calcipotriol cream 50 mcg/g OD weekdays, CB ointment OD weekends (8 wks) (CB‐W)

  • Calcipotriol 50 mcg/g plus betamethasone dipropionate 0.5 mg/g ointment OD (4 wks), then placebo cream (calcipotriol vehicle), OD (8 wks) (CB‐P)]

Use < = 100 g/wk

Outcomes

  1. mPASI (0 to 64.8) ‐ per cent change from baseline: rebound: > 125% of baseline; relapse: > 50% reduction in maximum improvement from baseline

  2. Investigator's Assessment of disease severity (IGA); 6‐pt (absent to very severe)

  3. Patient's assessment of overall response (PAGI); 7‐pt (worse to clear)

  4. Adverse events

  5. Compliance (medication usage; self‐reported compliance)

Notes

Leo Pharma A/S sponsored the trial.

Atrophy was not assessed.

Risk of bias

Bias

Authors' judgement

Support for judgement

Allocation concealment (selection bias)

Unclear risk

The trial reported insufficient details.

Blinding (performance bias and detection bias)
All outcomes

High risk

The trial was open in the acute phase and maintenance phase for CB‐W and double‐blind (participant/investigator) in the maintenance phase for CB‐C and CB‐P. It was not possible to blind the alternating group (CB‐W), as the vehicles were different.

Randomisation method reported

Low risk

A preplanned computer‐generated randomisation schedule was used (1:1:1).

Loss to follow up

Low risk

0%

Baseline assessments

Low risk

These were reported.

Baseline comparability demonstrated

Unclear risk

This was partially demonstrated (reported means, but not standard, deviations; proportions reported).

White 2006 (P)

Methods

DESIGN
Between‐patient
Participant delivery
ALLOCATION
Random
Method of randomisation: computer‐generated schedule
Concealment: unclear
BLINDING
Open (acute phase and maintenance phase for CB‐W); double‐blind (participant/investigator) (maintenance phase for CB‐C and CB‐P)
WITHDRAWAL/DROPOUT
Described

Participants

N: 1136

Treatment duration: 12 wks; FU: 12 wks

LF: 0 (0%)

BC: yes

Age: 50.7; range = 18 to 89

Gender (per cent men): 60.7%

Ethnicity (per cent white): 96.9%

Severity: per cent BSA = 12.1%; mPASI = 8.9 (3.8SD), range = 2.4 to 30.9; IGA moderate = 76%; IGA severe = 24%

Duration (yrs): 0 to 75

INCLUSION CRITERIA

  • People aged > = 18 with plaque psoriasis affecting at least 10% arms, 10% trunk, 10% legs, or a combination of the aforementioned

  • IGA at least moderate

EXCLUSION CRITERIA

  • Erythrodermic, exfoliative, pustular, or guttate psoriasis

  • Skin infections

  • Other confounding inflammatory skin disease

  • Calcium metabolic disorder

  • Pregnancy

  • Lactation

  • Concurrent antipsoriatic therapy

Interventions

  • Calcipotriol 50 mcg/g plus betamethasone dipropionate 0.5 mg/g ointment OD (4 wks), then calcipotriol cream 50 mcg/g OD [8 wks] (CB‐C)

  • Calcipotriol 50 mcg/g plus betamethasone dipropionate 0.5 mg/g ointment OD (4 wks), then calcipotriol cream 50 mcg/g OD weekdays, CB ointment OD weekends (8 wks) (CB‐W)

  • Calcipotriol 50 mcg/g plus betamethasone dipropionate 0.5 mg/g ointment OD (4 wks), then placebo cream (calcipotriol vehicle), OD (8 wks) (CB‐P)]

Use < = 100 g/wk

Outcomes

  1. mPASI (0 to 64.8) ‐ per cent change from baseline: rebound: > 125% of baseline; relapse: > 50% reduction in maximum improvement from baseline

  2. Investigator's Assessment of disease severity (IGA); 6‐pt (absent to very severe)

  3. Patient's assessment of overall response (PAGI); 7‐pt (worse to clear)

  4. Adverse events

  5. Compliance (medication usage; self‐reported compliance)

Notes

Leo Pharma A/S sponsored the trial.

Atrophy was not assessed.

Risk of bias

Bias

Authors' judgement

Support for judgement

Allocation concealment (selection bias)

Unclear risk

The trial reported insufficient details.

Blinding (performance bias and detection bias)
All outcomes

High risk

The trial was open in the acute phase and maintenance phase for CB‐W and double‐blind (participant/investigator) in the maintenance phase for CB‐C and CB‐P. It was not possible to blind the alternating group (CB‐W), as the vehicles were different.

Randomisation method reported

Low risk

A preplanned computer‐generated randomisation schedule was used (1:1:1).

Loss to follow up

Low risk

0%

Baseline assessments

Low risk

These were reported.

Baseline comparability demonstrated

Unclear risk

This was partially demonstrated (reported means, but not standard, deviations; proportions reported).

Wolska 1995

Methods

DESIGN
Within‐patient
Participant delivery
ALLOCATION
Random
Method of randomisation: not reported
Concealment: unclear
BLINDING
Double‐blind (participant/investigator)
WITHDRAWAL/DROPOUT
Described

Participants

N: 52

Treatment duration: 4 wks; FU: 4 wks

LF: 12 (23.1%)

BC: yes

Age: 44.7 (range = 18 to 77; N = 40)

Gender (per cent men): 70%; N = 40

Severity: TSS (0 to 9) (median) = 7.1 (range = 6.0 to 9.0)

INCLUSION CRITERIA

  • Plaque type psoriasis

  • At least 2 symmetrical lesions, excluding those on neck, head, feet, and hands

  • TSS ≥ 6

  • Between‐plaque TSS scores ≤ 1

  • Lesions clinically stable ≥ 1wk

EXCLUSION CRITERIA

  • Topical antipsoriatic treatment (tar/dithranol/steroids) within previous 2 wks

  • Systemic antipsoriatic treatment (steroids/retinoids/methotrexate/cyclosporin) within previous 4 wks

  • UV treatment within previous 4 wks

  • Pregnancy

  • Lactation;

  • Inadequate contraception

  • Impaired renal or hepatic function

Interventions

  • Platelet aggregation activating factor (PAF) (Ro 24 to 0238) 10% solution BD

  • Placebo solution BD

Outcomes

  1. TSS (erythema, desquamation, infiltration) (0 to 9)

  2. IAGI (6‐pt: marked worsening to total clearing)

  3. Adverse events

Notes

The trial did not report sponsorship.
Inpatients PLS CAN YOU PUT THIS IN A SENTENCE?]

Risk of bias

Bias

Authors' judgement

Support for judgement

Allocation concealment (selection bias)

Unclear risk

The trial reported insufficient details.

Blinding (performance bias and detection bias)
All outcomes

Low risk

The trial was double‐blind (participant/investigator).

Randomisation method reported

Unclear risk

The trial did not report this.

Loss to follow up

Unclear risk

23.1%

Baseline assessments

Low risk

Baseline comparability demonstrated

Low risk

Wortzel 1975 (1)

Methods

DESIGN
Between‐patient
Delivery unclear
ALLOCATION
Random
Method of randomisation: sequential admission number
Concealment: adequate
BLINDING
Double‐blind (participant/physician)
WITHDRAWAL/DROPOUT
Not described

Participants

N: 76

Treatment duration: 3 wks; FU: 3 wks

LF: 0 (0%)

BC: not reported

Age: not reported

Gender (per cent men): not reported

Severity: not reported

INCLUSION CRITERIA

  • Moderately severe to very severe psoriasis and atopic dermatitis

  • Outpatients

EXCLUSION CRITERIA

  • Not reported

Interventions

  • Betamethasone dipropionate ointment 0.05 BD (B)

  • Placebo BD (P)

Outcomes

  1. IAGI (5‐pt: worse to excellent)

  2. Physician opinion of drug effect (scale unclear, results not reported)

Notes

Leo Pharmaceuticals sponsored the trial.

Risk of bias

Bias

Authors' judgement

Support for judgement

Allocation concealment (selection bias)

Low risk

The sequential trial admission number corresponded to a treatment unit on a randomisation schedule.

Blinding (performance bias and detection bias)
All outcomes

Low risk

The trial was double‐blind (participant/physician).

Randomisation method reported

Low risk

Randomisation was sequential.

Loss to follow up

Low risk

0.0%

Baseline assessments

Unclear risk

The trial did not report these.

Baseline comparability demonstrated

Unclear risk

The trial did not report this.

Wortzel 1975 (2)

Methods

DESIGN
Between‐patient
Delivery unclear
ALLOCATION
Random
Method of randomisation: sequential admission number
Concealment: adequate
BLINDING
Double‐blind (participant/physician)
WITHDRAWAL/DROPOUT
Not described

Participants

N: 9

Treatment duration: 3 wks; FU: 3 wks

LF: 0 (0%)

BC: The trial did not report this.

Age: not reported

Gender (per cent men): not reported

Severity: not reported

INCLUSION CRITERIA

  • Moderately severe to very severe psoriasis and atopic dermatitis

  • Inpatients

EXCLUSION CRITERIA

  • Not reported

Interventions

  • Betamethasone dipropionate ointment 0.05 BD (B)

  • Placebo BD (P)

Outcomes

  1. IAGI (5‐pt: worse to excellent)

  2. Physician opinion of drug effect (scale unclear, results not reported)

Notes

The trial did not report sponsorship.
Concomitant water soluble emollients were permitted.
There was SD imputation (PASI).

Risk of bias

Bias

Authors' judgement

Support for judgement

Allocation concealment (selection bias)

Low risk

The sequential trial admission number corresponded to a treatment unit on a randomisation schedule.

Blinding (performance bias and detection bias)
All outcomes

Low risk

The trial was double‐blind (participant/physician).

Randomisation method reported

Low risk

Randomisation was sequential.

Loss to follow up

Low risk

0.0%

Baseline assessments

Unclear risk

The trial did not report these.

Baseline comparability demonstrated

Unclear risk

The trial did not report this.

Wozel 2001

Methods

DESIGN
Between‐patient
Participant delivery
ALLOCATION
Random
Method of randomisation: not reported
Concealment: unclear
BLINDING
Double‐blind (unclear)
WITHDRAWAL/DROPOUT
Described

Participants

N: 38

Treatment duration: 2 wks; FU: 6 wks

LF: 0 (0%)

BC: yes (statistical significance not reported)

Age: not reported

Gender (per cent men): not reported

Severity: not reported

INCLUSION CRITERIA

  • Chronic plaque psoriasis

EXCLUSION CRITERIA

  • Not reported

Interventions

  • Calcipotriol ointment OM plus fluocinolone acetonide ointment 0.025% ON (CF)

  • Calcipotriol ointment OM plus vehicle ointment ON (CP)

  • 4 weeks' maintenance for both groups with calcipotriol ointment BD

Outcomes

  1. PASI

Notes

The trial did not report sponsorship.

Risk of bias

Bias

Authors' judgement

Support for judgement

Allocation concealment (selection bias)

Unclear risk

The trial reported insufficient detail.

Blinding (performance bias and detection bias)
All outcomes

Low risk

The trial was double‐blind (it was unclear who was blinded).

Randomisation method reported

Unclear risk

The trial did not report this.

Loss to follow up

Low risk

0.0%

Baseline assessments

Unclear risk

The trial did not report these.

Baseline comparability demonstrated

Low risk

Yang 2009

Methods

DESIGN
Between‐patient
Participant delivery
ALLOCATION
Random
Method of randomisation: not stated
Concealment: unclear
BLINDING
Not stated
WITHDRAWAL/DROPOUT
Described

Participants

N: 76

Treatment duration: 6 wks; FU: 6 wks

LF: 0 (0%)

BC: yes

Age: range = 18 to 65

Gender (per cent men): 68.4%

Severity: PASI = 14.3 (5.5SD), range = 4.2 to 19.6

Duration (yrs): range = 0.5 to 34

INCLUSION CRITERIA

  • People aged 18 to 65 with plaque psoriasis affecting limbs and body

  • PASI < 25

EXCLUSION CRITERIA

  • Systemic antipsoriatic therapy within previous 4 wks

  • Topical therapy within previous 2 wks

  • Use of corticosteroids or vitamin D3 derivatives

  • Concurrent infection

  • Pregnancy

  • Heart, liver, kidney, or mental disorder

  • Known sensitivity to study medication

  • External injury

Interventions

  • Calcipotriol cream BD (C)

  • Halometasone cream (OM), calcipotriol cream (ON) (2 wks); calcipotriol cream BD (weekdays), halometasone cream BD (weekends) (2 wks); calcipotriol cream BD (2 wks) (CH)

Treatments were stopped when 90% improvement achieved.

Outcomes

  1. mPASI (0 to 64.8)

  2. Improvement score (based on change in PASI score x 100%) (IAGI):

    • Complete recovery: > 90%

    • Marked improvement: 60% to 89%

    • Some improvement: 25% to 59%

    • No effect: <25%

Notes

The trial did not state the sponsor.

There was 1 case of skin atrophy in the monotherapy group.

We received translation support for data extraction.

Risk of bias

Bias

Authors' judgement

Support for judgement

Allocation concealment (selection bias)

Unclear risk

The trial reported insufficient details.

Blinding (performance bias and detection bias)
All outcomes

Unclear risk

The trial did not report this.

Randomisation method reported

Unclear risk

The trial did not report this.

Loss to follow up

Low risk

0%

Baseline assessments

Low risk

These were reported.

Baseline comparability demonstrated

Low risk

This was demonstrated.

Zonneveld 1998 (H)

Methods

DESIGN
Between‐patient
Delivery unclear
ALLOCATION
Random
Method of randomisation: not reported
Concealment: unclear
BLINDING
Double‐blind (but unmatched regimens) (participant/assessor)
WITHDRAWAL/DROPOUT
Not described

Participants

N: 70

Treatment duration: 6 wks; FU: 6 wks

LF: not reported

BC: Yes (clinical); demographics not reported

Age: not reported

Gender (per cent men): not reported

Severity: median LPSI ranged from 7.0 (C;T) to 8.0 (P)

INCLUSION CRITERIA

  • Chronic plaque psoriasis

  • LPSI ≥ 6

EXCLUSION CRITERIA

  • Not reported

Interventions

  • Calcipotriol ointment 0.005% BD (C)

  • Tacrolimus ointment 0.3% OD (T)

  • Placebo ointment BD (P)

Outcomes

  1. Local psoriasis severity index (scale NR)

Notes

The study was double‐blind (but unmatched regimens).
Fujisawa GmbH sponsored the trial.
There was SD imputation (TSS).

Risk of bias

Bias

Authors' judgement

Support for judgement

Allocation concealment (selection bias)

Unclear risk

The trial reported insufficient details.

Blinding (performance bias and detection bias)
All outcomes

Low risk

The trial was double‐blind (but unmatched regimens) (participant/assessor).

Randomisation method reported

Unclear risk

The trial did not report this.

Loss to follow up

Unclear risk

The trial did not report this.

Baseline assessments

Low risk

These were partially done.

Baseline comparability demonstrated

Unclear risk

This was partially demonstrated.

Zonneveld 1998 (P)

Methods

DESIGN
Between‐patient
Delivery unclear
ALLOCATION
Random
Method of randomisation: not reported
Concealment: unclear
BLINDING
Double‐blind (but unmatched regimens) (participant/assessor)
WITHDRAWAL/DROPOUT
Not described

Participants

N: 70

Treatment duration: 6 wks; FU: 6 wks

LF: not reported

BC: yes (clinical), demographics not reported

Age: not reported

Gender (per cent men): not reported

Severity: median LPSI ranged from 7.0 (C;T) to 8.0 (P)

INCLUSION CRITERIA

  • Chronic plaque psoriasis

  • LPSI ≥ 6

EXCLUSION CRITERIA

  • Not reported

Interventions

  • Calcipotriol ointment 0.005% BD (C)

  • Tacrolimus ointment 0.3% OD (T)

  • Placebo ointment BD (P)

Outcomes

  1. Local psoriasis severity index (scale NR)

Notes

The study was double‐blind (but unmatched regimens).
Fujisawa GmbH sponsored the trial.
There was SD imputation (TSS).

Risk of bias

Bias

Authors' judgement

Support for judgement

Allocation concealment (selection bias)

Unclear risk

The trial reported insufficient details.

Blinding (performance bias and detection bias)
All outcomes

Low risk

The trial was double‐blind (but unmatched regimens) (participant/assessor).

Randomisation method reported

Unclear risk

The trial did not report this.

Loss to follow up

Unclear risk

The trial did not report this.

Baseline assessments

Low risk

Baseline comparability demonstrated

Unclear risk

This was partially demonstrated.

Characteristics of excluded studies [ordered by study ID]

Study

Reason for exclusion

Agrawal 2010

The study did not provide a comparison of interest (compared acitretin gel in 2 formulations).

Akerman 2009

The trialists did not report or make available adequate data.

Ambroziak 2002

The study compared steroid against no treatment (rather than against placebo).

Baadsgaard 1995

The study was within‐patient, but did not adopt clear left‐right design and assessed multiple plaques for each participant.

Baran 1999

The trialists did not report or make available adequate data.

Bianchi 2003

The study compared steroid against no treatment (rather than against placebo).

Brodell 2011a

The sponsor did not report or make available adequate data.

Buder 2010

The study assessed multiple plaques for each participant (7 per participant).

Callen 1996

The trialists or sponsor did not report or make available adequate data.

Cannavo 2003

This was a nail psoriasis trial, which was removed in the 2011 update.

Carroll 2005

The comparator was not strictly placebo (salicylic acid in vehicle).

De Jong 1999

The comparator was not strictly placebo (urea in vehicle).

Elias 1994

It was unclear if it was a valid randomised controlled trial.

Esposito 2009

The study did not provide a comparison of interest.

Friedrich 2004

The sponsors did not report or make available adequate data.

Hsia 2010

The study did not assess patient outcomes/tolerability

Insa 2009

The study did not assess patient outcomes/tolerability.

Iraji 2010

The trialists did not report or make available adequate data.

Ito 2005

The study was not randomised.

Jansen 1986

No adequate data were reported.

Kaur 2004

The study was not randomised.

Kleyn 2005

The study did not provide a comparison of interest.

Kragballe 1989

Participants were randomised to the 2 substudies, but within the substudies, treatments were applied without randomisation.

Kragballe 1994

This was a dose‐ranging study of an unlicensed product not subsequently marketed.

Lebwohl 1998b

The study did not provide a simple comparison against a vitamin D₃ derivative treatment.

Lebwohl 2001

The trialists or sponsor did not report or make available adequate data.

Levin 2003

The trialists or sponsor did not report or make available adequate data.

Meyrat 1996

The study did not provide a comparison of interest.

Palazon 2005

The study did not provide a comparison of interest.

Reygagne 2002a

The trialists or sponsor did not report or make available adequate data.

Rhemus 2006

The study did not provide a comparison of interest (product unlicensed).

Ruzicka 2004

The trialists or sponsor did not report or make available adequate data.

Sander 1998

The study did not provide a simple comparison against a vitamin D₃ derivative treatment.

Saraswat 2007

The study did not provide a simple comparison against a vitamin D₃ derivative treatment.

Scher 2001

This was a nail psoriasis trial, which was removed in the 2011 update.

Sefton 1984

The trialists or sponsor did not report or make available adequate data.

Sharma 2003

The study used concomitant UV light.

Syed 2001a

The trialists did not report or make available adequate data.

Tokura 2004

No translation was available.

Tosti 1998

This was a nail psoriasis trial, which was removed in the 2011 update.

Tzaneva 2003

The study used concomitant UV light.

van de Kerkhof 1996b

The trialists did not report or make available adequate data.

Vena 2005

The study was not a randomised controlled trial.

Characteristics of studies awaiting assessment [ordered by study ID]

Bissonnette 2011

Methods

DESIGN
Between‐patient
Participant delivery
ALLOCATION
Random
Method of randomisation: computer‐generated code
Concealment: unclear
BLINDING
Double‐blind (participant/investigator)
WITHDRAWAL/DROPOUT
Described

Participants

N: 61

Treatment duration: 12 wks; FU: 12 wks

LF: 0 (0%)

BC: yes

Age: 50.6 (22 to 65)

Gender (per cent men): 83.6%

Severity: PGA = 3.3 (0.6SD); PASI = 6.0 (2.5SD); BSA = 3.2% (2.0SD)

INCLUSION CRITERIA

  • Participants aged 18 to 65 with mild to moderate plaque psoriasis

  • BSA: 1% to 15%

  • PGA: 2 to 4

  • Good general health

EXCLUSION CRITERIA

  • Concomitant serious illness/medical condition

  • Systemic therapy within previous 12 to 24 wks (depending on drug)

  • Phototherapy within previous 4 wks

  • Topical antipsoriatic therapy within previous 2 wks

  • Other non‐plaque forms of psoriasis

Interventions

  • 1% WBI‐1001 in a cream formulation twice daily

  • Placebo vehicle twice daily

Outcomes

  1. Physician's Global Assessment (PGA), 6‐pt (0 = clear to 5 = very severe)

  2. Body surface area (BSA)

  3. Psoriasis Area and Severity Index (PASI)

Notes

Welichem Biotech Inc. sponsored the trial.

Callis Duffin 2010

Methods

DESIGN
Between‐patient
Participant delivery
ALLOCATION
Random
Method of randomisation: not stated
Concealment: unclear
BLINDING
Double‐blind (participant/investigator)
WITHDRAWAL/DROPOUT
Not described

Participants

N: 200
Treatment duration: 12 wks; FU: 12 wks
LF: NS
BC: NS
Age: NS
Gender (per cent men): NS
Severity: NS

INCLUSION CRITERIA

  • Participants aged 18 to 75 with mild to moderate plaque psoriasis

  • BSA: 2% to 20%

EXCLUSION CRITERIA

  • Lesions solely involving intertriginious areas, the scalp, or the face

  • Pustular psoriasis or erythroderma

  • Concurrent systemic therapy, topical agents, or UVB therapy within 2 weeks of the first dose of study medication

  • Systemic triazole antifungals except fluconazole

Interventions

  • INCB018424: Ruxolitinib phosphate cream QD

  • Placebo cream QD

Outcomes

  1. Total Lesion Score (sum of erythema, scaling, and thickness; points NS)

  2. PASI

Notes

Incyte Corporation sponsored the trial.

Calzavara‐Pinton 2011

Methods

DESIGN
Within‐patient
Participant delivery
ALLOCATION
Random
Method of randomisation: not stated
Concealment: unclear
BLINDING
Single‐blind (investigator/outcome assessor)
WITHDRAWAL/DROPOUT
Described

Participants

N: 20

Treatment duration: 8 wks; FU: 16 wks

LF: 2 (10%)

BC: yes

Age: 40.2 (range = 19 to 68)

Gender (per cent men): 40%

Severity: PSI = median 8 (IQR = 7 to 9.25)

INCLUSION CRITERIA

  • Participants with mild plaque psoriasis

  • Symmetrical plaques

EXCLUSION CRITERIA

  • Not stated

Interventions

  • Budesonide 0.25 mg/g cream OM plus tacalcitol 4 mcg/g ointment ON

  • Calcipotriol 50 mcg/g and betamethasone dipropionate 0.5 mg/g once daily

Outcomes

  1. Psoriasis Severity Index (erythema + infiltration + scaling) (0 to 12)

  2. VAS (adverse events; itching): 0 to 10

  3. Patient preference and satisfaction (better/equal/worse)

Notes

The sponsor was not stated.

Henry 2011

Methods

DESIGN
Within‐patient
Participant delivery
ALLOCATION
Random
Method of randomisation: not stated
Concealment: unclear
BLINDING
Single‐blind (investigator)
WITHDRAWAL

Described

Participants

N: 13

Treatment duration: 4 wks; FU: 4 wks

LF: 3 (23.0%)

BC: NS

Age: NS

Gender (per cent men): NS

Severity: NS

INCLUSION CRITERIA

  • Participants with mild to moderate plaque psoriasis

EXCLUSION CRITERIA

  • NS

Interventions

  • Clobetasol propionate spray followed by calcitriol ointment twice daily

  • Calcitriol ointment followed by clobetasol propionate spray twice daily

Outcomes

  1. Signs: erythema, induration, scaling

Notes

Galderma sponsored the trial.

This was an abstract only.

Katoh 2003

Methods

DESIGN
Between‐patient
Participant delivery
ALLOCATION
Random
Method of randomisation: not stated
Concealment: unclear
BLINDING
Not stated
WITHDRAWAL/DROPOUT
Described

Participants

N: 61

Treatment duration: 12 wks; FU: 12 wks

LF: 2 (3%)

BC: yes

Age: 49.2 (14.3SD)

Gender (per cent men): 34%

Severity: PASI = 12.9 (5.3SD)

Ethnicity: Japanese

INCLUSION CRITERIA

  • Participants with stable plaque psoriasis

EXCLUSION CRITERIA

  • Participants requiring systemic therapy or use of any antipsoriatic treatment within previous 4 wks

Interventions

  • Calcipotriol 0.005% ointment once daily

  • Combination treatment with calcipotriol 0.004% and 0.01% clobetasol propionate ointment once daily

Treatments were applied after bathing.

Participants achieving 50% reduction in baseline PASI then used calcipotriol once daily for a further 12 weeks.

Outcomes

  1. Eruption score of trunk involvement: sum of erythema, scaling, and induration (0 to 12)

  2. PASI

Notes

The Japanese Ministry of Education, Science, Sports, and Culture sponsored the trial.

Matheson 2011

Methods

DESIGN
Between‐patient
Participant delivery
ALLOCATION
Random
Method of randomisation: not stated
Concealment: unclear
BLINDING
Open
WITHDRAWAL/DROPOUT
Not described

Participants

N: 32

Treatment duration: 2 wks; FU: 2 wks

LF: NS

BC: no

Age: NS

Gender (per cent men): NS

Severity: NS

INCLUSION CRITERIA

  • Participants aged ≥12 with mild to moderate plaque psoriasis

EXCLUSION CRITERIA

  • Not stated

Interventions

  • Calcipotriol ointment 0.005% twice daily

  • Calcipotriol foam 0.005% twice daily

Outcomes

  1. Safety: adverse events; serum calcium

Notes

Stiefel, a GSK company, sponsored the trial.

Paulsen 2005

Methods

DESIGN
Within‐patient
Participant delivery
ALLOCATION

Random
Method of randomisation: not stated
Concealment: unclear
BLINDING
Double‐blind (participant/investigator)
WITHDRAWAL/DROPOUT
Described

Participants

N: 41

Treatment duration: 4 wks; FU: 12 wks

LF: 1 (2%)

BC: yes

Age (median): 44 (23 to 77)

Gender (per cent men): 65%

Severity: duration (yrs; median) = 15 (range = 2 to 60)

INCLUSION CRITERIA

  • Participants aged ≥18 with stable mild to moderate plaque psoriasis

  • Test plaques similar within each participant (TSS ≤ 1), TSS ≤ 8

EXCLUSION CRITERIA

  • Concurrent use of topical steroids or vitamin D or emollients containing aloe vera

  • Pregnancy

  • Systemic or photo therapy within previous 2 mths

  • Topical antipsoriatic therapy within previous 2 wks

  • Known allergy to gel

  • Severe concomitant disease

  • Use of specific drugs

Interventions

  • Aloe vera gel twice daily

  • Placebo gel twice daily

Outcomes

  1. PASI

  2. Local PASI (TSS) (0 to 9)

  3. Patient preference

Notes

Psoriasisfonden sponsored the trial.

Sadeghian 2011

Methods

DESIGN
Between‐patient
Participant delivery
ALLOCATION
Random
Method of randomisation: not stated
Concealment: unclear
BLINDING
Double‐blind (participant/investigator)
WITHDRAWAL/DROPOUT
Described

Participants

N: 60

Treatment duration: 12 wks; FU: 12 wks

LF: 0 (0%)

BC: yes

Age: 32.5 (15.6SD)

Gender (per cent men): 51.7%

Severity: PASI = 3.9 (1.9SD)

INCLUSION CRITERIA

  • Participants aged ≥ 5 with plaque psoriasis

  • BSA ≤ 10%

EXCLUSION CRITERIA

  • Pregnancy

  • Non‐plaque types of psoriasis

  • Participants with scalp and facial lesions

Interventions

  • Zinc pyrithione 0.25% cream twice daily

  • Placebo cream twice daily

Outcomes

  1. PASI (0 to 72)

Notes

The sponsor was not stated.

Vahlquist 2004

Methods

DESIGN
Within‐patient
Participant delivery
ALLOCATION
Random
Method of randomisation: not stated
Concealment: unclear
BLINDING
Double‐blind (participant/investigator)
WITHDRAWAL/DROPOUT
Described

Participants

N: 12

Treatment duration: 8 wks; FU: x wks

LF: 0 (0%)

BC: no

Age: 43.8 (range = 21 to 58)

Gender (per cent men): 83.3%

Severity: NS

INCLUSION CRITERIA

  • Participants with mild to moderate plaque psoriasis

EXCLUSION CRITERIA

  • Systemic or topical therapy within previous 4 wks

Interventions

  • Thyroid hormone analogue (TriAc) 0.1% in hydrophilic ointment twice daily

  • Placebo ointment twice daily

Outcomes

  1. Psoriasis Severity Index

  2. VAS  to assess patient preference

Notes

Yang 1999

Methods

This will need to be translated; details to follow at next update.

Participants

N: 60

Treatment duration: 6 wks; FU: 6 wks

LF: unclear

BC: unclear

Age: range = 14 to 65

Gender (per cent men): unclear

Severity: unclear

INCLUSION CRITERIA

  • Unclear

EXCLUSION CRITERIA

  • Unclear

Interventions

  • Tacalcitol ointment

  • 17 alpha hydrocortisone cream

Outcomes

This will need to be translated; details to follow at next update.

Notes

This will need to be translated; details to follow at next update.

Characteristics of ongoing studies [ordered by study ID]

NCT00824980

Trial name or title

Combined Inhibition of Dipeptidyl Peptidase IV (DPIV/CD26) and Aminopeptidase N (APN/CD13) in the Treatment of Psoriasis ‐ Phase II Single Center Study

Methods

Allocation: randomised

End point classification: safety/efficacy study

Intervention model: parallel assignment

Masking: double‐blind (participant, caregiver, investigator, outcomes assessor)

Primary purpose: treatment

Participants

  • Age 18 years of age at pre‐study

  • Diagnosis of plaque type psoriasis at least 3 month prior to enrolment

  • Mild to moderate plaque type psoriasis with at least 2 plaques of approximately 15 cm² for which topical treatment is indicated

Interventions

  • Drug: IP10.C8 Gel

  • Placebo Gel

Outcomes

  1. Psoriasis Area and Severity Index at 4 weeks

Starting date

January 2009

Contact information

Alexander Narvarini, MD
Telephone: +41 44 255 1111
[email protected]

Notes

Immune Technologies & Medicine GmbH

http://clinicaltrials.gov/show/NCT00824980

NCT01018134

Trial name or title

A Double‐Blind, Vehicle‐Controlled, Randomized, Dose Ranging, Multiple‐Site Clinical Study to Evaluate the Efficacy and Safety of Desoximetasone Topical Sprays (0.05%, 0.25%) in Patients With Moderate to Severe Plaque Psoriasis

Methods

Allocation: randomised

End point classification: safety/efficacy study

Intervention model: parallel assignment

Masking: double‐blind (participant, caregiver, investigator, outcomes assessor)

Primary purpose: treatment

Participants

  • Have a definite clinical diagnosis of stable plaque psoriasis involving ≥ 10% of the body surface area (BSA)

  • Have a combined Total Lesion Severity Score (TLSS) of ≥ 7 for the target lesion

  • Have a plaque elevation score ≥ 3 of (moderate) for the target lesion

  • The target lesion must have an area of at least 5 cm²

  • Have a Physicians Global Assessment (PGA) score of 3 (moderate) or 4 (severe) at baseline for the overall disease severity

Interventions

  • Drug: desoximetasone 0.05% once daily

  • Drug: desoximetasone 0.05% twice daily

  • Drug: desoximetasone 0.25% once daily

  • Drug: desoximetasone 0.25% once daily

  • Drug: vehicle once daily

  • Drug: vehicle twice daily

Outcomes

  1. Clinical cure: Physician's Global Assessment (PGA) = 0 or 1 (time frame: 28 days)

  2. Lesion treatment success, score of 0 or 1, for each of the 3 signs of erythema, scaling, and plaque elevation (time frame: day 28)

Starting date

November 2009

Contact information

Darin B Brimhall, D.O., FACP

Study Director

Novum Pharmaceutical Research Services

Notes

Taro Pharmaceuticals USA

http://clinicaltrials.gov/show/NCT01018134

NCT01206387

Trial name or title

A Double‐Blind, Vehicle‐Controlled, Randomized, Parallel Design, Multiple‐Site Clinical Study to Evaluate the Efficacy and Safety of Desoximetasone 0.25% Topical Spray in Patients With Moderate to Severe Plaque Psoriasis

Methods

Allocation: randomised
End point classification: safety/efficacy study
Intervention model: parallel assignment
Masking: double‐blind (participant, investigator, outcomes assessor)
Primary purpose: treatment

Participants

Genders eligible for study: both

Accepts healthy volunteers: no

  • Men or non‐pregnant, non‐lactating women 18 years of age or older

  • Have a definite clinical diagnosis of stable plaque psoriasis involving ≥10% of the body surface area (BSA)

  • Have a combined Total Lesion Severity Score (TLSS) of ≥ 7 for the target lesion

  • Have a plaque elevation score ≥ 3 of (moderate) for the target lesion

  • The target lesion must have an area of at least 5 cm²

  • Have a Physicians Global Assessment (PGA) score of 3 (moderate) or 4 (severe) at baseline for the overall disease severity

Interventions

  • Drug: desoximetasone spray 0.25%

  • Drug: placebo comparator

Outcomes

  1. Clinical success (time frame: 28 days) ‐ a participant is considered a clinical success if the Physician's Global Assessment (PGA) is 0 (clear) or 1 (almost clear)

  2. Treatment success (time frame: 28 days) ‐ a participant is considered a treatment success for the target lesions if the target lesion has a score of 0 or 1 on the Target Lesion Severity Score (TLSS) for each of the 3 signs and symptoms (erythema, scaling, and plaque elevation)

SECONDARY OUTCOMES

  1. Change in PGA (time frame: 28 days) ‐ mean change from baseline to end of treatment in PGA

Starting date

August 2010

Contact information

Gail Gongas
Telephone: 412 363 3300 ext: 522
[email protected]

Notes

Taro Pharmaceuticals USA

Study ID number: DSXS‐0808

http://clinicaltrials.gov/show/NCT01206387

NCT01206660

Trial name or title

A Double‐Blind, Vehicle‐Controlled, Randomized, Parallel Design, Multiple‐Site Clinical Study to Evaluate the Efficacy and Safety of Desoximetasone 0.25% Topical Spray in Patients With Moderate to Severe Plaque Psoriasis

Methods

Study type: Interventional 

Study design: Allocation: randomised

End point classification: safety/efficacy study

Intervention model: parallel assignment

Masking: double‐blind (participant, investigator, outcomes assessor)

Primary purpose: treatment

Participants

Accepts healthy volunteers: no

  • Men or non‐pregnant, non‐lactating women 18 years of age or older

  • Have a definite clinical diagnosis of stable plaque psoriasis involving ≥ 10% of the body surface area (BSA)

  • Have a combined Total Lesion Severity Score (TLSS) of ≥ 7 for the target lesion

  • Have a plaque elevation score ≥ 3 of (moderate) for the target lesion

  • The target lesion must have an area of at least 5 cm²

  • Have a Physicians Global Assessment (PGA) score of 3 (moderate) or 4 (severe) at baseline for the overall disease severity

Interventions

  • Drug: desoximetasone spray 0.25%

  • Drug: placebo

Outcomes

PRIMARY OUTCOMES

  1. Clinical success (time frame: 28 days) ‐ a participant is considered a clinical success if the Physician's Global Assessment (PGA) is 0 (clear) or 1 (almost clear)

  2. Treatment success (time frame: 28 days) ‐ a participant is considered a treatment success for the target lesions if the target lesion has a score of 0 or 1 on the Target Lesion Severity Score (TLSS) for each of the 3 signs and symptoms (erythema, scaling, and plaque elevation)

SECONDARY OUTCOMES

  1. Change in PGA (time frame: 28 days)

  2. Mean change from baseline to end of treatment in PGA

Starting date

August 2010

Contact information

Gail Gongas

Telephone: 412 363 3300 ext: 522

[email protected]

Notes

Taro Pharmaceuticals USA

Study ID number: DSXS‐0914

http://clinicaltrials.gov/show/NCT01206660

NCT01246583

Trial name or title

A Phase 2a, Multi Site, Randomized, Double Blind, Placebo Controlled, Parallel Group Study Of The Pilot Efficacy, Safety, And Pharmacokinetics Of 2 Ointment Formulations Of CP‐690,550 In Subjects With Mild To Moderate Chronic Plaque Psoriasis

Methods

Study type: interventional 

Study design: allocation: randomised

End point classification: safety/efficacy study

Intervention model: parallel assignment

Masking: double‐blind (participant, investigator)

Primary purpose: treatment

Participants

Ages eligible for study: 18 years and older

Genders eligible for study: both

Accepts healthy volunteers: no

 

INCLUSION CRITERIA

  • Mild to moderate chronic plaque psoriasis (psoriasis vulgaris), with the duration of at least 6 months

  • A target plaque of at least 9 sq. cm

 

EXCLUSION CRITERIA

  • Demonstrates "rebound" or "flare" of chronic plaque psoriasis

  • Non‐plaque form of psoriasis

  • Currently have or history of psoriatic arthritis

  • Current drug‐induced psoriasis

  • Currently on systemic therapy or was on systemic therapy for psoriasis within the previous 6 months

  • Currently on phototherapy for psoriasis or was on phototherapy within the previous 3 months

Interventions

  • Drug: CP‐690,550 ointment 1

  • Drug: vehicle 1

  • Drug: CP‐690,550 ointment 2

  • Drug: vehicle 2

Outcomes

PRIMARY OUTCOMES

  • Per cent change from baseline at week 4 in Target Plaque Severity Score (TPSS)

SECONDARY OUTCOMES

  • Proportion of participants with Treatment Area Overall Severity of Psoriasis response of "clear" (0) or "almost clear"

  • Proportion of participants with a difference from baseline of > = 2 steps in Treatment Area Overall Severity of Psoriasis score

  • Per cent change from baseline at weeks 1, 2, 3, and 4 in target plaque area  

  • Change from baseline at weeks 1, 2, 3, and 4 in TPSS subscores for erythema, induration, and scaling

  • Per cent change from baseline in TPSS

  • Actual and change from baseline on the treatment area Itch Severity Item (ISI)

  • Proportion of participants in each Patient Satisfaction with Study Medication (PSSM) response category

  • Incidence, nature, and severity of observed and reported administration site adverse events over 4 weeks of treatment

  • Incidence and severity of burning/stinging of psoriatic or perilesional skin in the treatment area over 4 weeks of treatment

  • Incidence and severity of reactions of perilesional skin in the treatment area as measured by Draize scoring over 4 weeks of treatment

  • Incidence and severity of adverse events over 4 weeks of treatment

  • Incidence of clinical laboratory abnormalities and change from baseline in clinical laboratory values over 4 weeks of treatment

  • Incidence of clinically significant changes in physical examination from baseline over 4 weeks of treatment

  • Incidence of vital sign (blood pressure and heart rate) abnormalities and change from baseline in vital sign measures over 4 weeks of treatment

  • Incidence of electrocardiogram (ECG) abnormalities and change from baseline in ECG measures over 4 weeks of treatment

  • Plasma CP‐690,550 concentrations, from blood sampling

Starting date

November 22 2010

Contact information

Pfizer CT.gov Call Center

Notes

Pfizer

NCT01247818

Trial name or title

A Phase 2 Dose‐Randomized, Vehicle‐Controlled Study of PH‐10‐Aqueous Hydrogel for the Treatment of Plaque Psoriasis

Methods

Study type: interventional 

Study design: allocation: randomised

End point classification: safety/efficacy study

Intervention model: parallel assignment

Masking: single‐blind (outcomes assessor)

Primary purpose: treatment

Participants

Accepts healthy volunteers: no

  • Men or women, age 18 or older

  • Presence of mild to moderate plaque psoriasis on the trunk or extremities (excluding palms, soles, scalp, and facial or intertriginous areas)

  • Fitzpatrick skin type I to VI

  • Written informed consent by the participant or legal guardian

Interventions

  • Drug: PH‐10 (0.002% Rose Bengal)

  • Drug: PH‐10 (0.005% Rose Bengal)

  • Drug: PH‐10 (0.01% Rose Bengal)

  • Drug: vehicle

Outcomes

PRIMARY OUTCOMES

  • The primary efficacy end point is "Treatment Success," a static end point assessed at day 29 after initial PH‐10 treatment and defined as 0 or 1 on all Psoriasis Severity Index (PSI) components and 0 or 1 on the Plaque Response scale (time frame: 28 days)

  • The primary safety end point is incidence of adverse experiences, including pain and dermatologic/skin toxicity (incidence, severity, frequency, duration, and causality) (time frame: 8 weeks)

 

SECONDARY OUTCOMES

  • Psoriasis Severity Index (PSI) score changes at each visit from day 1 pre‐treatment (time frame: 8 weeks)

  • Plaque Response score changes at each visit from day 1 pre‐treatment (time frame: 8 weeks)

  • Pruritus Self‐Assessment score changes at each visit from day 1 pre‐treatment (time frame: 8 weeks)

Starting date

December 2010

Contact information

Eric Wachter, PhD

Provectus Pharmaceuticals

Notes

Provectus Pharmaceuticals

http://clinicaltrials.gov/show/NCT01247818

NCT01422434

Trial name or title

Efficacy and Safety of LEO 90105 Ointment (Calcipotriol Hydrate Plus Betamethasone Dipropionate) in Japanese Subjects With Psoriasis Vulgaris

Methods

Study type: interventional 

Study design: allocation: randomised

End point classification: efficacy study

Intervention model: parallel assignment

Masking: double‐blind (participant, caregiver, investigator, outcomes assessor)

Primary purpose: treatment

Participants

Accepts healthy volunteers: No

 

Participants having understood and signed a written informed consent form prior to any study related procedures being carried out.

  • Japanese participants

  • 20 years of age or above of either sex

  • Clinical diagnosis of psoriasis vulgaris amenable to topical treatment, involving arms, trunk, legs, or any of the aforementioned

  • A minimum mPASI score for extent of 2 in at least 1 body region (i.e. psoriasis affecting at least 10% of arms, 10% of trunk, 10% of legs, or any of the aforementioned)

  • Psoriasis vulgaris on the trunk/limbs (excluding psoriasis on the genitals/skin folds) of not more than 30% body surface area (BSA)

  • A target lesion of a minimum of 5 cm at its longest axis and preferably not located on an elbow or knee, scoring at least 3 for each of redness, thickness, and scaliness, and at least 10 in total by the physician's assessment of severity of the target lesion ‐ a physician's global assessment of disease severity of psoriasis on trunk/limbs of mild, moderate, severe, or very severe

  • Women of childbearing potential must have a negative result for a urine pregnancy test at day 0 (Visit 1) and must agree to use an adequate method of birth control, as judged by the (sub)investigator, during the study. The contraceptive method should have started an adequate amount of time before the pregnancy test, which is dependent on the particular method used and as judged by the (sub)investigator, and must continue for at least 1 week after the last application of study medication. A woman is defined as not of child‐bearing potential if she is postmenopausal (12 months with no menses without an alter‐native medical cause) or surgically sterile (tubal ligation/section, hysterectomy, or bilateral ovariectomy)

Interventions

  • Drug: LEO 90105 = calcipotriol + betamethasone dipropionate

  • Drug: Dovonex® = calcipotriol

  • Drug: Rinderon® ‐ DP = betamethasone dipropionate

Outcomes

PRIMARY OUTCOMES

  1. Change from baseline in Psoriasis Area and Severity Index (PASI) (time frame: week 0, week 4)

SECONDARY OUTCOMES

  1. Change from baseline in target lesion assessment (time frame: week 0, week 4

  2. Physician's global assessment of psoriasis (time frame: week 4)

  3. Adverse events (time frame: week 4)

Starting date

July 2011

Contact information

Akira Ozawa, MD, Professor, Principal Investigator

Tokai University School of Medicine

Notes

LEO 90105 ointment contains both calcipotriol and betamethasone dipropionate. It has been approved for the treatment of psoriasis in more than 60 centres, including most European countries, the US, China, Korea, and Taiwan. This trial will investigate its safety and efficacy in the treatment of Japanese participants with psoriasis.

LEO Pharma
http://clinicaltrials.gov/show/NCT01422434

NCT01465282

Trial name or title

A Randomized, Placebo‐controlled, Phase IIb Study to Evaluate the Efficacy, Safety and Tolerability of 0.05%, 0.1% and 0.5% w/w Topical CT327 When Applied Twice Daily in Subjects With Psoriasis Vulgaris

Methods

Study type: interventional 

Study design: allocation: randomised

End point classification: safety/efficacy study

Intervention model: single group assignment

Masking: double‐blind (participant, caregiver, investigator, outcomes assessor)

Primary purpose: treatment

Participants

Accepts healthy volunteers: no

INCLUSION CRITERIA

  • Men and women aged at least 18 years.

  • Stable psoriasis vulgaris

EXCLUSION CRITERIA

  • Participants with guttate, erythrodermic, exfoliative, or pustular psoriasis.

Interventions

  • Drug: CT327 0.05%

  • Drug: CT327 0.1%

  • Drug: CT327 0.5%

  • Drug: placebo

Outcomes

PRIMARY OUTCOMES

  1. Efficacy of CT327 ointment (0.05%, 0.1%, and 0.5% w/w) compared with placebo ointment

SECONDARY OUTCOMES

  1. Local and systemic toleration

Starting date

November 1, 2011

Contact information

No contacts or locations provided

Notes

Creabilis SA

NCT01536886

Trial name or title

LEO 90100 Compared With Calcipotriol Plus Betamethasone Dipropionate Ointment, LEO 90100 Vehicle and Ointment Vehicle in Subjects With Psoriasis Vulgaris

Methods

Allocation: randomised

End point classification: efficacy study

Intervention model: parallel assignment

Masking: double‐blind (caregiver, investigator, outcomes assessor)

Primary purpose: treatment

Participants

Accepts healthy volunteers: no

 

INCLUSION CRITERIA

  • Signed and dated informed consent obtained prior to any trial‐related activities (including wash‐out period)

  • Age 18 years or above

  • Either sex

  • Any race or ethnicity

  • All skin types

  • Women of childbearing potential must have a negative pregnancy test at day 0 (Visit 1)

  • Women of childbearing potential must agree to use a highly effective method of birth control during the study. A highly effective method of birth control is defined as 1 which results in a low failure rate (less than 1% per year)

  • Able to communicate with the investigator and understand and comply with the requirements of the study

EXCLUSION CRITERIA

  • Systemic treatment with biological therapies, whether marketed or not, with a possible effect on psoriasis vulgaris within the following time periods prior to randomisation:

    • etanercept ‐ within 4 weeks prior to randomisation

    • adalimumab, alefacept, infliximab ‐ within 8 weeks prior to randomisation

    • ustekinumab ‐ within 16 weeks prior to randomisation

    • other products ‐ 4 weeks/5 half‐lives (whichever is longer)

  • Systemic treatment with all other therapies with a possible effect on psoriasis vulgaris (e.g. corticosteroids, retinoids, methotrexate, ciclosporin, and other immunosuppressants) within 4 weeks prior to randomisation

  • Participants who have received treatment with any non‐marketed drug substance (i.e. a drug which has not yet been made available for clinical use following registration) within 4 weeks/5 half‐lives (whichever is longer) prior to randomisation

  • PUVA therapy within 4 weeks prior to randomisation

  • UVB therapy within 2 weeks prior to randomisation

  • Planned excessive exposure of area(s) to be treated with study medication to either natural or artificial sunlight (including tanning booths, sun lamps, etc) during the study

  • Planned initiation of, or changes to, concomitant medication that could affect psoriasis vulgaris (e.g. beta blockers, antimalarial drugs, lithium, ACE inhibitors) during the study

  • Current diagnosis of guttate, erythrodermic, exfoliative, or pustular psoriasis

  • Participants with any of the following conditions present on the treatment area: viral (e.g. herpes or varicella) lesions of the skin, fungal and bacterial skin infections, parasitic infections, skin manifestations in relation to syphilis or tuberculosis, acne vulgaris, atrophic skin, striae atrophicae, fragility of skin veins, icthyosis, ulcers, and wounds

  • Other inflammatory skin disorders (e.g. seborrhoeic dermatitis or contact dermatitis) on the treatment area that may confound the evaluation of psoriasis vulgaris

  • Known or suspected disorders of calcium metabolism associated with hypercalcaemia

  • Known or suspected severe renal insufficiency or severe hepatic disorders.

  • Known or suspected hypersensitivity to component(s) of the investigational products

  • Current participation in any other interventional clinical study

  • Previously randomised in this study

  • Women who are pregnant, wishing to become pregnant during the study, or are breast‐feeding

Interventions

  • Drug: LEO 90100

  • Drug: betamethasone plus calcipotriol

  • Drug: ointment vehicle

  • Drug: LEO 90100 vehicle

Outcomes

  1. Investigator's Global Assessment of Disease Severity (time frame: 4 weeks) Designated as safety issue: no

Starting date

May 2012

Contact information

Anders Ninn Hansen, MSc Pharm
Telephone: +45 72 26 28 18 ext: 2818
anders.n‐hansen@leo‐pharma.com

Notes

NCT01536938

Trial name or title

LEO 90100 in the Treatment of Psoriasis Vulgaris

Methods

Study type: interventional

Study design: allocation: randomised

End point classification: efficacy study

Intervention model: parallel assignment

Masking: double‐blind (participant, caregiver, investigator, outcomes assessor)

Primary purpose: treatment

Participants

Accepts healthy volunteers: no

INCLUSION CRITERIA

  • Signed and dated informed consent obtained prior to any trial related activities (including wash‐out period)

  • Age 18 years or above of either sex

  • Any race or ethnicity

  • All skin types

  • Women of childbearing potential must have a negative pregnancy test at day 0 (Visit 1)

  • Women of childbearing potential must agree to use a highly effective method of birth control during the study. A highly effective method of birth control is defined as one which results in a low failure rate (less than 1% per year)

  • Able to communicate with the investigator and understand and comply with the requirements of the study

 EXCLUSION CRITERIA

  • Systemic treatment with biological therapies, whether marketed or not, with a possible effect on psoriasis vulgaris within the following time periods prior to randomisation:

    • etanercept ‐ within 4 weeks prior to randomisation

    • adalimumab, alefacept, infliximab ‐ within 8 weeks prior to randomisation

    • ustekinumab ‐ within 16 weeks prior to randomisation

    • other products ‐ 4 weeks/5 half‐lives (whichever is longer)

  • Systemic treatment with all other therapies with a possible effect on psoriasis vulgaris (e.g. corticosteroids, retinoids, methotrexate, ciclosporin, and other immunosuppressants) within 4 weeks prior to randomisation

  • Participants who have received treatment with any non‐marketed drug substance (i.e. a drug which has not yet been made available for clinical use following registration) within 4 weeks/5 half‐lives (whichever is longer) prior to randomisation

  • PUVA therapy within 4 weeks prior to randomisation

  • UVB therapy within 2 weeks prior to randomisation

  • Planned excessive exposure of area(s) to be treated with study medication to either natural or artificial sunlight (including tanning booths, sun lamps, etc) during the study

  • Planned initiation of, or changes to, concomitant medication that could affect psoriasis vulgaris (e.g. beta blockers, antimalarial drugs, lithium, ACE inhibitors) during the study

  • Current diagnosis of guttate, erythrodermic, exfoliative, or pustular psoriasis

  • Participants with any of the following conditions present on the treatment area: viral (e.g. herpes or varicella) lesions of the skin, fungal and bacterial skin infections, parasitic infections, skin manifestations in relation to syphilis or tuberculosis, acne vulgaris, atrophic skin, striae atrophicae, fragility of skin veins, icthyosis, ulcers, and wounds

  • Other inflammatory skin disorders (e.g. seborrhoeic dermatitis or contact dermatitis) on the treatment area that may confound the evaluation of psoriasis vulgaris

  • Known or suspected disorders of calcium metabolism associated with hypercalcaemia

  • Known or suspected severe renal insufficiency or severe hepatic disorders

  • Known or suspected hypersensitivity to component(s) of the investigational products

  • Current participation in any other interventional clinical study

  • Previously randomised in this study

Interventions

  • Drug: LEO 90100

  • Drug: calcipotriol

  • Drug: betamethasone

Outcomes

  1. Investigator's Global Assessment of Disease Severity (time frame: 4 weeks)

(Designated as safety issue: no)

Starting date

May 2012

Contact information

Anders Ninn Hansen, MSc Pharm
Telephone: +45 72 26 28 18 ext: 2818
anders.n‐hansen@leo‐pharma.com

Notes

Data and analyses

Open in table viewer
Comparison 1. Vitamin D analogues versus placebo

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 IAGI Show forest plot

20

Std. Mean Difference (IV, Random, 95% CI)

Subtotals only

Analysis 1.1

Comparison 1 Vitamin D analogues versus placebo, Outcome 1 IAGI.

Comparison 1 Vitamin D analogues versus placebo, Outcome 1 IAGI.

1.1 Calcipotriol

10

2287

Std. Mean Difference (IV, Random, 95% CI)

‐0.93 [‐1.17, ‐0.68]

1.2 Calcipotriol plus occlusion

0

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

1.3 Calcitriol

6

1120

Std. Mean Difference (IV, Random, 95% CI)

‐1.03 [‐1.71, ‐0.36]

1.4 Tacalcitol

2

433

Std. Mean Difference (IV, Random, 95% CI)

‐0.84 [‐1.41, ‐0.26]

1.5 Maxacalcitol

1

103

Std. Mean Difference (IV, Random, 95% CI)

‐1.43 [‐1.91, ‐0.96]

1.6 Paricalcitol OD

1

22

Std. Mean Difference (IV, Random, 95% CI)

‐1.66 [‐2.66, ‐0.67]

1.7 Becocalcidiol OD

1

121

Std. Mean Difference (IV, Random, 95% CI)

‐0.22 [‐0.58, 0.14]

1.8 Becocalcidiol twice daily

1

119

Std. Mean Difference (IV, Random, 95% CI)

‐0.67 [‐1.04, ‐0.30]

2 TSS Show forest plot

19

Std. Mean Difference (IV, Random, 95% CI)

Subtotals only

Analysis 1.2

Comparison 1 Vitamin D analogues versus placebo, Outcome 2 TSS.

Comparison 1 Vitamin D analogues versus placebo, Outcome 2 TSS.

2.1 Calcipotriol

10

1208

Std. Mean Difference (IV, Random, 95% CI)

‐1.15 [‐1.41, ‐0.89]

2.2 Calcipotriol plus occlusion

1

187

Std. Mean Difference (IV, Random, 95% CI)

‐0.15 [‐0.44, 0.14]

2.3 Calcitriol

4

1027

Std. Mean Difference (IV, Random, 95% CI)

‐1.22 [‐2.38, ‐0.07]

2.4 Tacalcitol

3

496

Std. Mean Difference (IV, Random, 95% CI)

‐0.66 [‐0.95, ‐0.36]

2.5 Maxacalcitol

1

103

Std. Mean Difference (IV, Random, 95% CI)

‐1.61 [‐2.10, ‐1.12]

2.6 Paricalcitol OD

1

22

Std. Mean Difference (IV, Random, 95% CI)

‐2.15 [‐3.24, ‐1.06]

2.7 Becocalcidiol OD

1

121

Std. Mean Difference (IV, Random, 95% CI)

‐0.02 [‐0.37, 0.34]

2.8 Becocalcidiol twice daily

1

119

Std. Mean Difference (IV, Random, 95% CI)

‐0.46 [‐0.83, ‐0.10]

3 PASI Show forest plot

9

2422

Std. Mean Difference (IV, Random, 95% CI)

‐0.58 [‐0.71, ‐0.45]

Analysis 1.3

Comparison 1 Vitamin D analogues versus placebo, Outcome 3 PASI.

Comparison 1 Vitamin D analogues versus placebo, Outcome 3 PASI.

3.1 Calcipotriol

8

2195

Std. Mean Difference (IV, Random, 95% CI)

‐0.65 [‐0.75, ‐0.55]

3.2 Calcipotriol plus occlusion

0

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

3.3 Calcitriol

0

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

3.4 Tacalcitol

1

227

Std. Mean Difference (IV, Random, 95% CI)

‐0.27 [‐0.56, 0.03]

3.5 Maxacalcitol

0

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

3.6 Paricalcitol OD

0

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

3.7 Becocalcidiol OD

0

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

3.8 Becocalcidiol twice daily

0

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

4 PAGI Show forest plot

5

1467

Std. Mean Difference (IV, Random, 95% CI)

‐0.54 [‐0.72, ‐0.36]

Analysis 1.4

Comparison 1 Vitamin D analogues versus placebo, Outcome 4 PAGI.

Comparison 1 Vitamin D analogues versus placebo, Outcome 4 PAGI.

4.1 Calcipotriol

2

439

Std. Mean Difference (IV, Random, 95% CI)

‐0.64 [‐0.97, ‐0.30]

4.2 Calcipotriol plus occlusion

0

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

4.3 Calcitriol

2

801

Std. Mean Difference (IV, Random, 95% CI)

‐0.59 [‐0.76, ‐0.41]

4.4 Tacalcitol

1

227

Std. Mean Difference (IV, Random, 95% CI)

‐0.24 [‐0.53, 0.05]

4.5 Maxacalcitol

0

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

4.6 Paricalcitol OD

0

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

4.7 Becocalcidiol OD

0

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

4.8 Becocalcidiol twice daily

0

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

5 Combined end point (IAGI/TSS/PASI/PAGI) Show forest plot

30

Std. Mean Difference (IV, Random, 95% CI)

Subtotals only

Analysis 1.5

Comparison 1 Vitamin D analogues versus placebo, Outcome 5 Combined end point (IAGI/TSS/PASI/PAGI).

Comparison 1 Vitamin D analogues versus placebo, Outcome 5 Combined end point (IAGI/TSS/PASI/PAGI).

5.1 Calcipotriol

17

3269

Std. Mean Difference (IV, Random, 95% CI)

‐0.96 [‐1.15, ‐0.77]

5.2 Calcipotriol plus occlusion

1

187

Std. Mean Difference (IV, Random, 95% CI)

‐0.15 [‐0.44, 0.14]

5.3 Calcitriol

7

1140

Std. Mean Difference (IV, Random, 95% CI)

‐0.92 [‐1.54, ‐0.29]

5.4 Tacalcitol

4

723

Std. Mean Difference (IV, Random, 95% CI)

‐0.73 [‐1.09, ‐0.37]

5.5 Maxacalcitol

1

103

Std. Mean Difference (IV, Random, 95% CI)

‐1.43 [‐1.91, ‐0.96]

5.6 Paricalcitol OD

1

22

Std. Mean Difference (IV, Random, 95% CI)

‐1.66 [‐2.66, ‐0.67]

5.7 Becocalcidiol OD

1

121

Std. Mean Difference (IV, Random, 95% CI)

‐0.22 [‐0.58, 0.14]

5.8 Becocalcidiol twice daily

1

119

Std. Mean Difference (IV, Random, 95% CI)

‐0.67 [‐1.04, ‐0.30]

6 Total withdrawals Show forest plot

25

4715

Risk Difference (M‐H, Random, 95% CI)

‐0.02 [‐0.05, 0.00]

Analysis 1.6

Comparison 1 Vitamin D analogues versus placebo, Outcome 6 Total withdrawals.

Comparison 1 Vitamin D analogues versus placebo, Outcome 6 Total withdrawals.

6.1 Calcipotriol

14

3132

Risk Difference (M‐H, Random, 95% CI)

‐0.03 [‐0.06, 0.00]

6.2 Calcipotriol plus occlusion

0

0

Risk Difference (M‐H, Random, 95% CI)

0.0 [0.0, 0.0]

6.3 Calcitriol

5

339

Risk Difference (M‐H, Random, 95% CI)

‐0.00 [‐0.02, 0.02]

6.4 Tacalcitol

4

857

Risk Difference (M‐H, Random, 95% CI)

‐0.05 [‐0.14, 0.05]

6.5 Maxacalcitol

1

120

Risk Difference (M‐H, Random, 95% CI)

0.11 [‐0.01, 0.23]

6.6 Paricalcitol OD

1

22

Risk Difference (M‐H, Random, 95% CI)

0.0 [‐0.16, 0.16]

6.7 Becocalcidiol OD

1

124

Risk Difference (M‐H, Random, 95% CI)

‐0.01 [‐0.12, 0.11]

6.8 Becocalcidiol twice daily

1

121

Risk Difference (M‐H, Random, 95% CI)

‐0.01 [‐0.13, 0.10]

7 Withdrawals due to adverse events Show forest plot

23

4463

Risk Difference (M‐H, Random, 95% CI)

‐0.00 [‐0.02, 0.01]

Analysis 1.7

Comparison 1 Vitamin D analogues versus placebo, Outcome 7 Withdrawals due to adverse events.

Comparison 1 Vitamin D analogues versus placebo, Outcome 7 Withdrawals due to adverse events.

7.1 Calcipotriol

12

2880

Risk Difference (M‐H, Random, 95% CI)

‐0.02 [‐0.04, 0.00]

7.2 Calcipotriol plus occlusion

0

0

Risk Difference (M‐H, Random, 95% CI)

0.0 [0.0, 0.0]

7.3 Calcitriol

5

339

Risk Difference (M‐H, Random, 95% CI)

‐0.00 [‐0.02, 0.02]

7.4 Tacalcitol

4

857

Risk Difference (M‐H, Random, 95% CI)

0.00 [‐0.01, 0.02]

7.5 Maxacalcitol

1

120

Risk Difference (M‐H, Random, 95% CI)

‐0.01 [‐0.08, 0.06]

7.6 Paricalcitol OD

1

22

Risk Difference (M‐H, Random, 95% CI)

0.0 [‐0.16, 0.16]

7.7 Becocalcidiol OD

1

124

Risk Difference (M‐H, Random, 95% CI)

0.03 [‐0.02, 0.08]

7.8 Becocalcidiol twice daily

1

121

Risk Difference (M‐H, Random, 95% CI)

0.05 [‐0.01, 0.11]

8 Withdrawals due to treatment failure Show forest plot

14

2752

Risk Difference (M‐H, Random, 95% CI)

‐0.03 [‐0.05, 0.00]

Analysis 1.8

Comparison 1 Vitamin D analogues versus placebo, Outcome 8 Withdrawals due to treatment failure.

Comparison 1 Vitamin D analogues versus placebo, Outcome 8 Withdrawals due to treatment failure.

8.1 Calcipotriol

7

1770

Risk Difference (M‐H, Random, 95% CI)

‐0.03 [‐0.08, 0.01]

8.2 Calcipotriol plus occlusion

0

0

Risk Difference (M‐H, Random, 95% CI)

0.0 [0.0, 0.0]

8.3 Calcitriol

4

281

Risk Difference (M‐H, Random, 95% CI)

‐0.03 [‐0.12, 0.05]

8.4 Tacalcitol

1

314

Risk Difference (M‐H, Random, 95% CI)

0.0 [‐0.01, 0.01]

8.5 Maxacalcitol

1

120

Risk Difference (M‐H, Random, 95% CI)

‐0.03 [‐0.11, 0.04]

8.6 Paricalcitol OD

1

22

Risk Difference (M‐H, Random, 95% CI)

0.0 [‐0.16, 0.16]

8.7 Becocalcidiol OD

1

124

Risk Difference (M‐H, Random, 95% CI)

‐0.02 [‐0.07, 0.04]

8.8 Becocalcidiol twice daily

1

121

Risk Difference (M‐H, Random, 95% CI)

‐0.03 [‐0.09, 0.02]

9 Adverse events (local) Show forest plot

19

4402

Risk Difference (M‐H, Random, 95% CI)

0.00 [‐0.01, 0.02]

Analysis 1.9

Comparison 1 Vitamin D analogues versus placebo, Outcome 9 Adverse events (local).

Comparison 1 Vitamin D analogues versus placebo, Outcome 9 Adverse events (local).

9.1 Calcipotriol

11

2652

Risk Difference (M‐H, Random, 95% CI)

0.01 [‐0.03, 0.05]

9.2 Calcipotriol plus occlusion

0

0

Risk Difference (M‐H, Random, 95% CI)

0.0 [0.0, 0.0]

9.3 Calcitriol

4

917

Risk Difference (M‐H, Random, 95% CI)

‐0.01 [‐0.03, 0.02]

9.4 Tacalcitol

2

566

Risk Difference (M‐H, Random, 95% CI)

‐0.00 [‐0.03, 0.03]

9.5 Maxacalcitol

0

0

Risk Difference (M‐H, Random, 95% CI)

0.0 [0.0, 0.0]

9.6 Paricalcitol OD

1

22

Risk Difference (M‐H, Random, 95% CI)

0.0 [‐0.16, 0.16]

9.7 Becocalcidiol OD

1

124

Risk Difference (M‐H, Random, 95% CI)

0.01 [‐0.06, 0.08]

9.8 Becocalcidiol twice daily

1

121

Risk Difference (M‐H, Random, 95% CI)

0.10 [0.00, 0.19]

10 Adverse events (systemic) Show forest plot

14

2463

Risk Difference (M‐H, Random, 95% CI)

0.0 [‐0.01, 0.01]

Analysis 1.10

Comparison 1 Vitamin D analogues versus placebo, Outcome 10 Adverse events (systemic).

Comparison 1 Vitamin D analogues versus placebo, Outcome 10 Adverse events (systemic).

10.1 Calcipotriol

8

1182

Risk Difference (M‐H, Random, 95% CI)

0.0 [‐0.01, 0.01]

10.2 Calcipotriol plus occlusion

0

0

Risk Difference (M‐H, Random, 95% CI)

0.0 [0.0, 0.0]

10.3 Calcitriol

3

647

Risk Difference (M‐H, Random, 95% CI)

0.0 [‐0.01, 0.01]

10.4 Tacalcitol

1

244

Risk Difference (M‐H, Random, 95% CI)

0.0 [‐0.02, 0.02]

10.5 Maxacalcitol

1

120

Risk Difference (M‐H, Random, 95% CI)

0.0 [‐0.05, 0.05]

10.6 Paricalcitol OD

1

22

Risk Difference (M‐H, Random, 95% CI)

0.0 [‐0.16, 0.16]

10.7 Becocalcidiol OD

1

124

Risk Difference (M‐H, Random, 95% CI)

0.0 [‐0.03, 0.03]

10.8 Becocalcidiol twice daily

1

124

Risk Difference (M‐H, Random, 95% CI)

0.0 [‐0.03, 0.03]

Open in table viewer
Comparison 2. Corticosteroid (potent) versus placebo

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 IAGI Show forest plot

11

1904

Std. Mean Difference (IV, Random, 95% CI)

1.00 [‐1.18, ‐0.82]

Analysis 2.1

Comparison 2 Corticosteroid (potent) versus placebo, Outcome 1 IAGI.

Comparison 2 Corticosteroid (potent) versus placebo, Outcome 1 IAGI.

1.1 Betamethasone dipropionate OD

2

739

Std. Mean Difference (IV, Random, 95% CI)

‐0.81 [‐0.98, ‐0.64]

1.2 Betamethasone dipropionate twice daily

4

537

Std. Mean Difference (IV, Random, 95% CI)

‐1.35 [‐1.56, ‐1.15]

1.3 Betamethasone dipropionate, maintenance

0

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

1.4 Betamethasone valerate

1

74

Std. Mean Difference (IV, Random, 95% CI)

‐1.41 [‐1.92, ‐0.90]

1.5 Budesonide

0

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

1.6 Desonide

1

76

Std. Mean Difference (IV, Random, 95% CI)

‐0.81 [‐1.34, ‐0.28]

1.7 Diflorasone diacetate

0

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

1.8 Fluticasone propionate

2

383

Std. Mean Difference (IV, Random, 95% CI)

‐0.93 [‐1.14, ‐0.72]

1.9 Hydrocortisone buteprate

0

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

1.10 Mometasone furoate

1

95

Std. Mean Difference (IV, Random, 95% CI)

‐0.75 [‐1.17, ‐0.34]

2 TSS Show forest plot

7

611

Std. Mean Difference (IV, Random, 95% CI)

‐0.77 [‐1.01, ‐0.52]

Analysis 2.2

Comparison 2 Corticosteroid (potent) versus placebo, Outcome 2 TSS.

Comparison 2 Corticosteroid (potent) versus placebo, Outcome 2 TSS.

2.1 Betamethasone dipropionate OD

1

93

Std. Mean Difference (IV, Random, 95% CI)

‐0.74 [‐1.16, ‐0.32]

2.2 Betamethasone dipropionate twice daily

1

33

Std. Mean Difference (IV, Random, 95% CI)

‐0.77 [‐1.48, ‐0.06]

2.3 Betamethasone dipropionate, maintenance

1

38

Std. Mean Difference (IV, Random, 95% CI)

‐0.95 [‐1.62, ‐0.27]

2.4 Betamethasone valerate

1

22

Std. Mean Difference (IV, Random, 95% CI)

‐1.09 [‐2.00, ‐0.18]

2.5 Budesonide

0

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

2.6 Desonide

1

76

Std. Mean Difference (IV, Random, 95% CI)

‐1.16 [‐1.70, ‐0.61]

2.7 Diflorasone diacetate

1

93

Std. Mean Difference (IV, Random, 95% CI)

‐0.32 [‐0.73, 0.09]

2.8 Fluticasone propionate

0

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

2.9 Hydrocortisone buteprate

1

161

Std. Mean Difference (IV, Random, 95% CI)

‐0.46 [‐0.77, ‐0.15]

2.10 Mometasone furoate

1

95

Std. Mean Difference (IV, Random, 95% CI)

‐1.12 [‐1.55, ‐0.68]

3 PASI Show forest plot

3

1158

Std. Mean Difference (IV, Random, 95% CI)

‐0.97 [‐1.31, ‐0.62]

Analysis 2.3

Comparison 2 Corticosteroid (potent) versus placebo, Outcome 3 PASI.

Comparison 2 Corticosteroid (potent) versus placebo, Outcome 3 PASI.

3.1 Betamethasone dipropionate OD

2

739

Std. Mean Difference (IV, Random, 95% CI)

‐0.79 [‐1.44, ‐0.14]

3.2 Betamethasone dipropionate twice daily

1

419

Std. Mean Difference (IV, Random, 95% CI)

‐1.21 [‐1.44, ‐0.97]

3.3 Betamethasone dipropionate, maintenance

0

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

3.4 Betamethasone valerate

0

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

3.5 Budesonide

0

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

3.6 Desonide

0

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

3.7 Diflorasone diacetate

0

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

3.8 Fluticasone propionate

0

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

3.9 Hydrocortisone buteprate

0

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

3.10 Mometasone furoate

0

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

4 PAGI

0

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

4.1 Betamethasone dipropionate OD

0

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

4.2 Betamethasone dipropionate twice daily

0

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

4.3 Betamethasone dipropionate, maintenance

0

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

4.4 Betamethasone valerate

0

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

4.5 Budesonide

0

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

4.6 Desonide

0

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

4.7 Diflorasone diacetate

0

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

4.8 Fluticasone propionate

0

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

4.9 Hydrocortisone buteprate

0

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

4.10 Mometasone furoate

0

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

5 Combined end point (IAGI/TSS/PASI/PAGI) Show forest plot

15

2311

Std. Mean Difference (IV, Random, 95% CI)

‐0.89 [‐1.06, ‐0.72]

Analysis 2.5

Comparison 2 Corticosteroid (potent) versus placebo, Outcome 5 Combined end point (IAGI/TSS/PASI/PAGI).

Comparison 2 Corticosteroid (potent) versus placebo, Outcome 5 Combined end point (IAGI/TSS/PASI/PAGI).

5.1 Betamethasone dipropionate OD

3

832

Std. Mean Difference (IV, Random, 95% CI)

‐0.80 [‐0.96, ‐0.64]

5.2 Betamethasone dipropionate twice daily

4

537

Std. Mean Difference (IV, Random, 95% CI)

‐1.35 [‐1.56, ‐1.15]

5.3 Betamethasone dipropionate, maintenance

1

38

Std. Mean Difference (IV, Random, 95% CI)

‐0.95 [‐1.62, ‐0.27]

5.4 Betamethasone valerate

2

96

Std. Mean Difference (IV, Random, 95% CI)

‐1.33 [‐1.78, ‐0.89]

5.5 Budesonide

0

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

5.6 Desonide

1

76

Std. Mean Difference (IV, Random, 95% CI)

‐0.81 [‐1.34, ‐0.28]

5.7 Diflorasone diacetate

1

93

Std. Mean Difference (IV, Random, 95% CI)

‐0.32 [‐0.73, 0.09]

5.8 Fluticasone propionate

2

383

Std. Mean Difference (IV, Random, 95% CI)

‐0.93 [‐1.14, ‐0.72]

5.9 Hydrocortisone buteprate

1

161

Std. Mean Difference (IV, Random, 95% CI)

‐0.46 [‐0.77, ‐0.15]

5.10 Mometasone furoate

1

95

Std. Mean Difference (IV, Random, 95% CI)

‐0.75 [‐1.17, ‐0.34]

6 Total withdrawals Show forest plot

9

1673

Risk Difference (M‐H, Random, 95% CI)

‐0.14 [‐0.22, ‐0.05]

Analysis 2.6

Comparison 2 Corticosteroid (potent) versus placebo, Outcome 6 Total withdrawals.

Comparison 2 Corticosteroid (potent) versus placebo, Outcome 6 Total withdrawals.

6.1 Betamethasone dipropionate OD

2

756

Risk Difference (M‐H, Random, 95% CI)

‐0.16 [‐0.28, ‐0.04]

6.2 Betamethasone dipropionate twice daily

1

421

Risk Difference (M‐H, Random, 95% CI)

‐0.06 [‐0.12, 0.01]

6.3 Betamethasone dipropionate, maintenance

2

134

Risk Difference (M‐H, Random, 95% CI)

‐0.45 [‐0.60, ‐0.30]

6.4 Betamethasone valerate

1

80

Risk Difference (M‐H, Random, 95% CI)

0.0 [‐0.12, 0.12]

6.5 Budesonide

1

22

Risk Difference (M‐H, Random, 95% CI)

0.0 [‐0.16, 0.16]

6.6 Desonide

1

80

Risk Difference (M‐H, Random, 95% CI)

‐0.18 [‐0.38, 0.02]

6.7 Diflorasone diacetate

0

0

Risk Difference (M‐H, Random, 95% CI)

0.0 [0.0, 0.0]

6.8 Fluticasone propionate

0

0

Risk Difference (M‐H, Random, 95% CI)

0.0 [0.0, 0.0]

6.9 Hydrocortisone buteprate

1

180

Risk Difference (M‐H, Random, 95% CI)

0.00 [‐0.09, 0.10]

6.10 Mometasone furoate

0

0

Risk Difference (M‐H, Random, 95% CI)

0.0 [0.0, 0.0]

7 Withdrawals due to adverse events Show forest plot

9

1292

Risk Difference (M‐H, Random, 95% CI)

‐0.01 [‐0.05, 0.02]

Analysis 2.7

Comparison 2 Corticosteroid (potent) versus placebo, Outcome 7 Withdrawals due to adverse events.

Comparison 2 Corticosteroid (potent) versus placebo, Outcome 7 Withdrawals due to adverse events.

7.1 Betamethasone dipropionate OD

1

633

Risk Difference (M‐H, Random, 95% CI)

‐0.07 [‐0.11, ‐0.02]

7.2 Betamethasone dipropionate twice daily

1

33

Risk Difference (M‐H, Random, 95% CI)

0.0 [‐0.11, 0.11]

7.3 Betamethasone dipropionate, maintenance

2

134

Risk Difference (M‐H, Random, 95% CI)

0.0 [‐0.04, 0.04]

7.4 Betamethasone valerate

1

80

Risk Difference (M‐H, Random, 95% CI)

0.08 [‐0.02, 0.17]

7.5 Budesonide

1

22

Risk Difference (M‐H, Random, 95% CI)

0.0 [‐0.16, 0.16]

7.6 Desonide

1

80

Risk Difference (M‐H, Random, 95% CI)

‐0.1 [‐0.24, 0.04]

7.7 Diflorasone diacetate

0

0

Risk Difference (M‐H, Random, 95% CI)

0.0 [0.0, 0.0]

7.8 Fluticasone propionate

0

0

Risk Difference (M‐H, Random, 95% CI)

0.0 [0.0, 0.0]

7.9 Hydrocortisone buteprate

1

190

Risk Difference (M‐H, Random, 95% CI)

0.01 [‐0.02, 0.04]

7.10 Mometasone furoate

1

120

Risk Difference (M‐H, Random, 95% CI)

‐0.05 [‐0.11, 0.01]

8 Withdrawals due to treatment failure Show forest plot

6

Risk Difference (M‐H, Random, 95% CI)

Subtotals only

Analysis 2.8

Comparison 2 Corticosteroid (potent) versus placebo, Outcome 8 Withdrawals due to treatment failure.

Comparison 2 Corticosteroid (potent) versus placebo, Outcome 8 Withdrawals due to treatment failure.

8.1 Betamethasone dipropionate OD

0

0

Risk Difference (M‐H, Random, 95% CI)

0.0 [0.0, 0.0]

8.2 Betamethasone dipropionate twice daily

0

0

Risk Difference (M‐H, Random, 95% CI)

0.0 [0.0, 0.0]

8.3 Betamethasone dipropionate, maintenance

2

130

Risk Difference (M‐H, Random, 95% CI)

‐0.46 [‐0.61, ‐0.31]

8.4 Betamethasone valerate

1

80

Risk Difference (M‐H, Random, 95% CI)

0.0 [‐0.05, 0.05]

8.5 Budesonide

1

22

Risk Difference (M‐H, Random, 95% CI)

0.0 [‐0.16, 0.16]

8.6 Desonide

1

80

Risk Difference (M‐H, Random, 95% CI)

0.0 [‐0.07, 0.07]

8.7 Diflorasone diacetate

0

0

Risk Difference (M‐H, Random, 95% CI)

0.0 [0.0, 0.0]

8.8 Fluticasone propionate

0

0

Risk Difference (M‐H, Random, 95% CI)

0.0 [0.0, 0.0]

8.9 Hydrocortisone buteprate

1

190

Risk Difference (M‐H, Random, 95% CI)

0.0 [‐0.02, 0.02]

8.10 Mometasone furoate

0

0

Risk Difference (M‐H, Random, 95% CI)

0.0 [0.0, 0.0]

9 Adverse events (local) Show forest plot

10

2117

Risk Difference (M‐H, Random, 95% CI)

‐0.04 [‐0.08, ‐0.00]

Analysis 2.9

Comparison 2 Corticosteroid (potent) versus placebo, Outcome 9 Adverse events (local).

Comparison 2 Corticosteroid (potent) versus placebo, Outcome 9 Adverse events (local).

9.1 Betamethasone dipropionate OD

2

756

Risk Difference (M‐H, Random, 95% CI)

‐0.10 [‐0.15, ‐0.04]

9.2 Betamethasone dipropionate twice daily

2

454

Risk Difference (M‐H, Random, 95% CI)

‐0.05 [‐0.12, 0.03]

9.3 Betamethasone dipropionate, maintenance

2

134

Risk Difference (M‐H, Random, 95% CI)

0.0 [‐0.04, 0.04]

9.4 Betamethasone valerate

0

0

Risk Difference (M‐H, Random, 95% CI)

0.0 [0.0, 0.0]

9.5 Budesonide

0

0

Risk Difference (M‐H, Random, 95% CI)

0.0 [0.0, 0.0]

9.6 Desonide

1

80

Risk Difference (M‐H, Random, 95% CI)

0.0 [‐0.11, 0.11]

9.7 Diflorasone diacetate

0

0

Risk Difference (M‐H, Random, 95% CI)

0.0 [0.0, 0.0]

9.8 Fluticasone propionate

1

383

Risk Difference (M‐H, Random, 95% CI)

0.00 [‐0.05, 0.05]

9.9 Hydrocortisone buteprate

1

190

Risk Difference (M‐H, Random, 95% CI)

‐0.06 [‐0.18, 0.07]

9.10 Mometasone furoate

1

120

Risk Difference (M‐H, Random, 95% CI)

‐0.10 [‐0.23, 0.02]

10 Adverse events (systemic) Show forest plot

4

675

Risk Difference (M‐H, Random, 95% CI)

0.00 [‐0.01, 0.01]

Analysis 2.10

Comparison 2 Corticosteroid (potent) versus placebo, Outcome 10 Adverse events (systemic).

Comparison 2 Corticosteroid (potent) versus placebo, Outcome 10 Adverse events (systemic).

10.1 Betamethasone dipropionate OD

0

0

Risk Difference (M‐H, Random, 95% CI)

0.0 [0.0, 0.0]

10.2 Betamethasone dipropionate twice daily

1

421

Risk Difference (M‐H, Random, 95% CI)

0.0 [‐0.01, 0.01]

10.3 Betamethasone dipropionate, maintenance

2

134

Risk Difference (M‐H, Random, 95% CI)

0.01 [‐0.07, 0.10]

10.4 Budesonide

0

0

Risk Difference (M‐H, Random, 95% CI)

0.0 [0.0, 0.0]

10.5 Desonide

0

0

Risk Difference (M‐H, Random, 95% CI)

0.0 [0.0, 0.0]

10.6 Diflorasone diacetate

0

0

Risk Difference (M‐H, Random, 95% CI)

0.0 [0.0, 0.0]

10.7 Fluticasone propionate

0

0

Risk Difference (M‐H, Random, 95% CI)

0.0 [0.0, 0.0]

10.8 Hydrocortisone buteprate

0

0

Risk Difference (M‐H, Random, 95% CI)

0.0 [0.0, 0.0]

10.9 Betamethasone valerate

0

0

Risk Difference (M‐H, Random, 95% CI)

0.0 [0.0, 0.0]

10.10 Mometasone furoate

1

120

Risk Difference (M‐H, Random, 95% CI)

0.0 [‐0.03, 0.03]

Open in table viewer
Comparison 3. Corticosteroid (very potent) versus placebo

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 IAGI Show forest plot

5

540

Std. Mean Difference (IV, Random, 95% CI)

‐1.87 [‐2.38, ‐1.36]

Analysis 3.1

Comparison 3 Corticosteroid (very potent) versus placebo, Outcome 1 IAGI.

Comparison 3 Corticosteroid (very potent) versus placebo, Outcome 1 IAGI.

1.1 Clobetasol propionate

4

471

Std. Mean Difference (IV, Random, 95% CI)

‐1.89 [‐2.53, ‐1.24]

1.2 Halcinonide

0

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

1.3 Halobetasol

1

69

Std. Mean Difference (IV, Random, 95% CI)

‐1.81 [‐2.37, ‐1.24]

2 TSS Show forest plot

3

545

Std. Mean Difference (IV, Random, 95% CI)

‐1.35 [‐1.80, ‐0.89]

Analysis 3.2

Comparison 3 Corticosteroid (very potent) versus placebo, Outcome 2 TSS.

Comparison 3 Corticosteroid (very potent) versus placebo, Outcome 2 TSS.

2.1 Clobetasol propionate

3

545

Std. Mean Difference (IV, Random, 95% CI)

‐1.35 [‐1.80, ‐0.89]

2.2 Halcinonide

0

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

2.3 Halobetasol

0

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

3 PASI

0

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

3.1 Clobetasol propionate

0

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

3.2 Halcinonide

0

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

3.3 Halobetasol

0

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

4 PAGI Show forest plot

3

487

Std. Mean Difference (IV, Random, 95% CI)

‐1.22 [‐1.42, ‐1.02]

Analysis 3.4

Comparison 3 Corticosteroid (very potent) versus placebo, Outcome 4 PAGI.

Comparison 3 Corticosteroid (very potent) versus placebo, Outcome 4 PAGI.

4.1 Clobetasol propionate

1

79

Std. Mean Difference (IV, Random, 95% CI)

‐1.01 [‐1.55, ‐0.47]

4.2 Halcinonide

0

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

4.3 Halobetasol

2

408

Std. Mean Difference (IV, Random, 95% CI)

‐1.25 [‐1.46, ‐1.04]

5 Combined end point (IAGI/TSS/PASI/PAGI) Show forest plot

10

1493

Std. Mean Difference (IV, Random, 95% CI)

‐1.56 [‐1.87, ‐1.26]

Analysis 3.5

Comparison 3 Corticosteroid (very potent) versus placebo, Outcome 5 Combined end point (IAGI/TSS/PASI/PAGI).

Comparison 3 Corticosteroid (very potent) versus placebo, Outcome 5 Combined end point (IAGI/TSS/PASI/PAGI).

5.1 Clobetasol propionate

7

1016

Std. Mean Difference (IV, Random, 95% CI)

‐1.65 [‐2.10, ‐1.20]

5.2 Halcinonide

0

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

5.3 Halobetasol

3

477

Std. Mean Difference (IV, Random, 95% CI)

‐1.36 [‐1.65, ‐1.07]

6 Total withdrawals Show forest plot

8

1181

Risk Difference (M‐H, Random, 95% CI)

‐0.05 [‐0.10, 0.01]

Analysis 3.6

Comparison 3 Corticosteroid (very potent) versus placebo, Outcome 6 Total withdrawals.

Comparison 3 Corticosteroid (very potent) versus placebo, Outcome 6 Total withdrawals.

6.1 Clobetasol propionate

7

1037

Risk Difference (M‐H, Random, 95% CI)

‐0.06 [‐0.13, 0.01]

6.2 Halcinonide

0

0

Risk Difference (M‐H, Random, 95% CI)

0.0 [0.0, 0.0]

6.3 Halobetasol

1

144

Risk Difference (M‐H, Random, 95% CI)

0.0 [‐0.03, 0.03]

7 Withdrawals due to adverse events Show forest plot

10

1601

Risk Difference (M‐H, Random, 95% CI)

‐0.00 [‐0.01, 0.01]

Analysis 3.7

Comparison 3 Corticosteroid (very potent) versus placebo, Outcome 7 Withdrawals due to adverse events.

Comparison 3 Corticosteroid (very potent) versus placebo, Outcome 7 Withdrawals due to adverse events.

7.1 Clobetasol propionate

7

1037

Risk Difference (M‐H, Random, 95% CI)

‐0.00 [‐0.02, 0.01]

7.2 Halcinonide

0

0

Risk Difference (M‐H, Random, 95% CI)

0.0 [0.0, 0.0]

7.3 Halobetasol

3

564

Risk Difference (M‐H, Random, 95% CI)

0.0 [‐0.01, 0.01]

8 Withdrawals due to treatment failure Show forest plot

8

1189

Risk Difference (M‐H, Random, 95% CI)

‐0.00 [‐0.02, 0.01]

Analysis 3.8

Comparison 3 Corticosteroid (very potent) versus placebo, Outcome 8 Withdrawals due to treatment failure.

Comparison 3 Corticosteroid (very potent) versus placebo, Outcome 8 Withdrawals due to treatment failure.

8.1 Clobetasol propionate

6

845

Risk Difference (M‐H, Random, 95% CI)

‐0.01 [‐0.03, 0.01]

8.2 Halcinonide

0

0

Risk Difference (M‐H, Random, 95% CI)

0.0 [0.0, 0.0]

8.3 Halobetasol

2

344

Risk Difference (M‐H, Random, 95% CI)

0.0 [‐0.02, 0.02]

9 Adverse events (local) Show forest plot

8

1265

Risk Difference (M‐H, Random, 95% CI)

0.00 [‐0.02, 0.02]

Analysis 3.9

Comparison 3 Corticosteroid (very potent) versus placebo, Outcome 9 Adverse events (local).

Comparison 3 Corticosteroid (very potent) versus placebo, Outcome 9 Adverse events (local).

9.1 Clobetasol propionate

6

845

Risk Difference (M‐H, Random, 95% CI)

0.00 [‐0.03, 0.03]

9.2 Halcinonide

0

0

Risk Difference (M‐H, Random, 95% CI)

0.0 [0.0, 0.0]

9.3 Halobetasol

2

420

Risk Difference (M‐H, Random, 95% CI)

0.0 [‐0.02, 0.02]

10 Adverse events (systemic) Show forest plot

6

1056

Risk Difference (M‐H, Random, 95% CI)

‐0.00 [‐0.01, 0.01]

Analysis 3.10

Comparison 3 Corticosteroid (very potent) versus placebo, Outcome 10 Adverse events (systemic).

Comparison 3 Corticosteroid (very potent) versus placebo, Outcome 10 Adverse events (systemic).

10.1 Clobetasol propionate

3

480

Risk Difference (M‐H, Random, 95% CI)

‐0.01 [‐0.02, 0.01]

10.2 Halcinonide

1

156

Risk Difference (M‐H, Random, 95% CI)

0.0 [‐0.02, 0.02]

10.3 Halobetasol

2

420

Risk Difference (M‐H, Random, 95% CI)

0.0 [‐0.01, 0.01]

Open in table viewer
Comparison 4. Dithranol versus placebo

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 IAGI

0

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

2 TSS Show forest plot

3

94

Std. Mean Difference (IV, Random, 95% CI)

‐1.06 [‐1.66, ‐0.46]

Analysis 4.2

Comparison 4 Dithranol versus placebo, Outcome 2 TSS.

Comparison 4 Dithranol versus placebo, Outcome 2 TSS.

3 PASI

0

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

4 PAGI

0

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

5 Combined end point (IAGI/TSS/PASI/PAGI) Show forest plot

3

94

Std. Mean Difference (IV, Random, 95% CI)

‐1.06 [‐1.66, ‐0.46]

Analysis 4.5

Comparison 4 Dithranol versus placebo, Outcome 5 Combined end point (IAGI/TSS/PASI/PAGI).

Comparison 4 Dithranol versus placebo, Outcome 5 Combined end point (IAGI/TSS/PASI/PAGI).

6 Total withdrawals Show forest plot

4

124

Risk Difference (M‐H, Random, 95% CI)

0.0 [‐0.09, 0.09]

Analysis 4.6

Comparison 4 Dithranol versus placebo, Outcome 6 Total withdrawals.

Comparison 4 Dithranol versus placebo, Outcome 6 Total withdrawals.

7 Withdrawals due to adverse events Show forest plot

3

104

Risk Difference (M‐H, Random, 95% CI)

0.0 [‐0.05, 0.05]

Analysis 4.7

Comparison 4 Dithranol versus placebo, Outcome 7 Withdrawals due to adverse events.

Comparison 4 Dithranol versus placebo, Outcome 7 Withdrawals due to adverse events.

8 Withdrawals due to treatment failure Show forest plot

2

44

Risk Difference (M‐H, Random, 95% CI)

0.0 [‐0.11, 0.11]

Analysis 4.8

Comparison 4 Dithranol versus placebo, Outcome 8 Withdrawals due to treatment failure.

Comparison 4 Dithranol versus placebo, Outcome 8 Withdrawals due to treatment failure.

9 Adverse events (local) Show forest plot

3

94

Risk Difference (M‐H, Random, 95% CI)

0.26 [‐0.30, 0.82]

Analysis 4.9

Comparison 4 Dithranol versus placebo, Outcome 9 Adverse events (local).

Comparison 4 Dithranol versus placebo, Outcome 9 Adverse events (local).

10 Adverse events (systemic) Show forest plot

1

20

Risk Difference (M‐H, Random, 95% CI)

0.0 [‐0.35, 0.35]

Analysis 4.10

Comparison 4 Dithranol versus placebo, Outcome 10 Adverse events (systemic).

Comparison 4 Dithranol versus placebo, Outcome 10 Adverse events (systemic).

Open in table viewer
Comparison 5. Vitamin D combination products versus placebo

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 IAGI Show forest plot

5

2264

Std. Mean Difference (IV, Random, 95% CI)

‐1.44 [‐1.76, ‐1.12]

Analysis 5.1

Comparison 5 Vitamin D combination products versus placebo, Outcome 1 IAGI.

Comparison 5 Vitamin D combination products versus placebo, Outcome 1 IAGI.

1.1 Combination calcipotriol/betamethasone dipropionate, once daily

4

1416

Std. Mean Difference (IV, Random, 95% CI)

‐1.21 [‐1.50, ‐0.91]

1.2 Combination calcipotriol/betamethasone dipropionate, twice daily

2

848

Std. Mean Difference (IV, Random, 95% CI)

‐1.90 [‐2.09, ‐1.71]

2 TSS

0

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

2.1 Combination calcipotriol/betamethasone dipropionate, once daily

0

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

2.2 Combination calcipotriol/betamethasone dipropionate, twice daily

0

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

3 PASI Show forest plot

5

2263

Std. Mean Difference (IV, Random, 95% CI)

‐1.24 [‐1.53, ‐0.95]

Analysis 5.3

Comparison 5 Vitamin D combination products versus placebo, Outcome 3 PASI.

Comparison 5 Vitamin D combination products versus placebo, Outcome 3 PASI.

3.1 Combination calcipotriol/betamethasone dipropionate, once daily

4

1414

Std. Mean Difference (IV, Random, 95% CI)

‐1.14 [‐1.57, ‐0.70]

3.2 Combination calcipotriol/betamethasone dipropionate, twice daily

2

849

Std. Mean Difference (IV, Random, 95% CI)

‐1.41 [‐1.86, ‐0.97]

4 PAGI Show forest plot

1

Std. Mean Difference (IV, Random, 95% CI)

Totals not selected

Analysis 5.4

Comparison 5 Vitamin D combination products versus placebo, Outcome 4 PAGI.

Comparison 5 Vitamin D combination products versus placebo, Outcome 4 PAGI.

4.1 Combination calcipotriol/betamethasone dipropionate, once daily

1

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

4.2 Combination calcipotriol/betamethasone dipropionate, twice daily

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

5 Combined end point (IAGI/TSS/PASI/PAGI) Show forest plot

5

2264

Std. Mean Difference (IV, Random, 95% CI)

‐1.44 [‐1.76, ‐1.12]

Analysis 5.5

Comparison 5 Vitamin D combination products versus placebo, Outcome 5 Combined end point (IAGI/TSS/PASI/PAGI).

Comparison 5 Vitamin D combination products versus placebo, Outcome 5 Combined end point (IAGI/TSS/PASI/PAGI).

5.1 Combination calcipotriol/betamethasone dipropionate, once daily

4

1416

Std. Mean Difference (IV, Random, 95% CI)

‐1.21 [‐1.50, ‐0.91]

5.2 Combination calcipotriol/betamethasone dipropionate, twice daily

2

848

Std. Mean Difference (IV, Random, 95% CI)

‐1.90 [‐2.09, ‐1.71]

6 Total withdrawals Show forest plot

5

2340

Risk Difference (M‐H, Random, 95% CI)

‐0.12 [‐0.17, ‐0.07]

Analysis 5.6

Comparison 5 Vitamin D combination products versus placebo, Outcome 6 Total withdrawals.

Comparison 5 Vitamin D combination products versus placebo, Outcome 6 Total withdrawals.

6.1 Combination calcipotriol/betamethasone dipropionate, once daily

4

1483

Risk Difference (M‐H, Random, 95% CI)

‐0.15 [‐0.22, ‐0.09]

6.2 Combination calcipotriol/betamethasone dipropionate, twice daily

2

857

Risk Difference (M‐H, Random, 95% CI)

‐0.07 [‐0.12, ‐0.03]

7 Withdrawals due to adverse events Show forest plot

3

1723

Risk Difference (M‐H, Random, 95% CI)

‐0.07 [‐0.11, ‐0.04]

Analysis 5.7

Comparison 5 Vitamin D combination products versus placebo, Outcome 7 Withdrawals due to adverse events.

Comparison 5 Vitamin D combination products versus placebo, Outcome 7 Withdrawals due to adverse events.

7.1 Combination calcipotriol/betamethasone dipropionate, once daily

3

1280

Risk Difference (M‐H, Random, 95% CI)

‐0.07 [‐0.11, ‐0.03]

7.2 Combination calcipotriol/betamethasone dipropionate, twice daily

1

443

Risk Difference (M‐H, Random, 95% CI)

‐0.10 [‐0.14, ‐0.05]

8 Withdrawals due to treatment failure Show forest plot

1

802

Risk Difference (M‐H, Random, 95% CI)

‐0.09 [‐0.12, ‐0.06]

Analysis 5.8

Comparison 5 Vitamin D combination products versus placebo, Outcome 8 Withdrawals due to treatment failure.

Comparison 5 Vitamin D combination products versus placebo, Outcome 8 Withdrawals due to treatment failure.

8.1 Combination calcipotriol/betamethasone dipropionate, once daily

1

359

Risk Difference (M‐H, Random, 95% CI)

‐0.09 [‐0.13, ‐0.05]

8.2 Combination calcipotriol/betamethasone dipropionate, twice daily

1

443

Risk Difference (M‐H, Random, 95% CI)

‐0.09 [‐0.13, ‐0.05]

9 Adverse events (local) Show forest plot

5

2334

Risk Difference (M‐H, Random, 95% CI)

‐0.05 [‐0.08, ‐0.02]

Analysis 5.9

Comparison 5 Vitamin D combination products versus placebo, Outcome 9 Adverse events (local).

Comparison 5 Vitamin D combination products versus placebo, Outcome 9 Adverse events (local).

9.1 Combination calcipotriol/betamethasone dipropionate, once daily

4

1479

Risk Difference (M‐H, Random, 95% CI)

‐0.07 [‐0.11, ‐0.02]

9.2 Combination calcipotriol/betamethasone dipropionate, twice daily

2

855

Risk Difference (M‐H, Random, 95% CI)

‐0.03 [‐0.08, 0.01]

10 Adverse events (systemic) Show forest plot

1

412

Risk Difference (M‐H, Random, 95% CI)

0.0 [‐0.01, 0.01]

Analysis 5.10

Comparison 5 Vitamin D combination products versus placebo, Outcome 10 Adverse events (systemic).

Comparison 5 Vitamin D combination products versus placebo, Outcome 10 Adverse events (systemic).

10.1 Combination calcipotriol/betamethasone dipropionate, once daily

0

0

Risk Difference (M‐H, Random, 95% CI)

0.0 [0.0, 0.0]

10.2 Combination calcipotriol/betamethasone dipropionate, twice daily

1

412

Risk Difference (M‐H, Random, 95% CI)

0.0 [‐0.01, 0.01]

Open in table viewer
Comparison 6. Other treatment versus placebo

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 IAGI Show forest plot

8

Std. Mean Difference (IV, Random, 95% CI)

Totals not selected

Analysis 6.1

Comparison 6 Other treatment versus placebo, Outcome 1 IAGI.

Comparison 6 Other treatment versus placebo, Outcome 1 IAGI.

1.1 Aloe vera extract 0.5% hydrophilic cream, three times per day

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

1.2 Anti‐IL‐8 monoclonal antibody cream

1

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

1.3 Betamethasone 17‐valerate 21‐acetate plus tretinoin plus salicylic acid

1

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

1.4 Caffeine (topical) 10%, TD

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

1.5 Calcipotriene 0.005% ointment + nicotinamide 0.05% or 0.1% or 0.7% or 1.4%, twice daily

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

1.6 Dead Sea salts emollient lotion

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

1.7 Fish oil plus occlusion

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

1.8 Herbal skin care (Dr Michaels® cleansing gel, ointment and skin conditioner), twice daily

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

1.9 Hexafluoro‐1,25‐dihydroxyvitamin D3

1

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

1.10 Indigo naturalis 1.4% ointment

1

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

1.11 Kukui nut oil, TD

1

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

1.12 Mahonia aquifolium (Reliéva™), twice daily

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

1.13 Methotrexate gel

1

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

1.14 Mycophenolic acid ointment

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

1.15 NG‐monomethyl‐L‐arginine (L‐NMMA) cream

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

1.16 Nicotinamide 1.4%, twice daily

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

1.17 Oleum horwathiensis (Psoricur®)

1

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

1.18 Omega‐3‐polyunsaturated fatty acids ointment

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

1.19 Platelet aggregation activating factor (PAF)(Ro 24‐0238)

1

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

1.20 Polymyxin B cream 200,000 U/g

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

1.21 PTH (1‐34) in Novasome A® liposomal cream, twice daily

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

1.22 Sirolimus (topical), 2.2% for 6 wks, then 8% for a further 6 wks

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

1.23 Tacrolimus ointment

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

1.24 Tar

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

1.25 Tazarotene

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

1.26 Theophylline 1% ointment, twice daily

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

2 TSS Show forest plot

17

Std. Mean Difference (IV, Random, 95% CI)

Subtotals only

Analysis 6.2

Comparison 6 Other treatment versus placebo, Outcome 2 TSS.

Comparison 6 Other treatment versus placebo, Outcome 2 TSS.

2.1 Aloe vera extract 0.5% hydrophilic cream, three times per day

0

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

2.2 Anti‐IL‐8 monoclonal antibody cream

1

89

Std. Mean Difference (IV, Random, 95% CI)

‐0.70 [‐1.13, ‐0.27]

2.3 Betamethasone 17‐valerate 21‐acetate plus tretinoin plus salicylic acid

0

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

2.4 Caffeine (topical) 10%, TD

0

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

2.5 Calcipotriene 0.005% ointment + nicotinamide 0.05% or 0.1% or 0.7% or 1.4%, twice daily

1

192

Std. Mean Difference (IV, Random, 95% CI)

‐0.48 [‐0.81, ‐0.15]

2.6 Dead Sea salts emollient lotion

0

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

2.7 Fish oil plus occlusion

1

50

Std. Mean Difference (IV, Random, 95% CI)

‐1.05 [‐1.64, ‐0.46]

2.8 Herbal skin care (Dr Michaels® cleansing gel, ointment and skin conditioner), twice daily

0

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

2.9 Hexafluoro‐1,25‐dihydroxyvitamin D3, twice daily

1

30

Std. Mean Difference (IV, Random, 95% CI)

‐1.13 [‐1.91, ‐0.35]

2.10 Indigo naturalis 1.4% ointment

2

88

Std. Mean Difference (IV, Random, 95% CI)

‐1.64 [‐2.13, ‐1.15]

2.11 Kukui nut oil, TD

1

24

Std. Mean Difference (IV, Random, 95% CI)

0.33 [‐0.48, 1.14]

2.12 Mahonia aquifolium (Reliéva™), twice daily

0

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

2.13 Methotrexate gel

1

82

Std. Mean Difference (IV, Random, 95% CI)

‐0.48 [‐0.92, ‐0.04]

2.14 Mycophenolic acid ointment

1

14

Std. Mean Difference (IV, Random, 95% CI)

‐1.44 [‐2.67, ‐0.22]

2.15 NG‐monomethyl‐L‐arginine (L‐NMMA) cream

1

34

Std. Mean Difference (IV, Random, 95% CI)

0.08 [‐0.60, 0.75]

2.16 Nicotinamide 1.4%, twice daily

1

96

Std. Mean Difference (IV, Random, 95% CI)

‐0.20 [‐0.60, 0.20]

2.17 Oleum horwathiensis (Psoricur®)

1

42

Std. Mean Difference (IV, Random, 95% CI)

‐0.77 [‐1.40, ‐0.14]

2.18 Omega‐3‐polyunsaturated fatty acids ointment

0

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

2.19 Platelet aggregation activating factor (PAF)(Ro 24‐0238)

0

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

2.20 Polymyxin B cream 200,000 U/g

1

30

Std. Mean Difference (IV, Random, 95% CI)

0.13 [‐0.59, 0.85]

2.21 PTH (1‐34) in Novasome A® liposomal cream, twice daily

1

30

Std. Mean Difference (IV, Random, 95% CI)

‐2.31 [‐3.26, ‐1.36]

2.22 Sirolimus (topical), 2.2% for 6 wks, then 8% for a further 6 wks

1

44

Std. Mean Difference (IV, Random, 95% CI)

‐0.39 [‐0.98, 0.21]

2.23 Tacrolimus ointment

1

47

Std. Mean Difference (IV, Random, 95% CI)

0.06 [‐0.52, 0.63]

2.24 Tar

1

36

Std. Mean Difference (IV, Random, 95% CI)

‐0.45 [‐1.11, 0.22]

2.25 Tazarotene

1

318

Std. Mean Difference (IV, Random, 95% CI)

‐0.86 [‐1.11, ‐0.62]

2.26 Theophylline 1% ointment, twice daily

0

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

3 PASI Show forest plot

9

Std. Mean Difference (IV, Random, 95% CI)

Totals not selected

Analysis 6.3

Comparison 6 Other treatment versus placebo, Outcome 3 PASI.

Comparison 6 Other treatment versus placebo, Outcome 3 PASI.

3.1 Aloe vera extract 0.5% hydrophilic cream, three times per day

1

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

3.2 Anti‐IL‐8 monoclonal antibody cream

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

3.3 Betamethasone 17‐valerate 21‐acetate plus tretinoin plus salicylic acid

1

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

3.4 Caffeine (topical) 10%, TD

1

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

3.5 Calcipotriene 0.005% ointment + nicotinamide 0.05% or 0.1% or 0.7% or 1.4%, twice daily

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

3.6 Dead Sea salts emollient lotion, 30%

1

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

3.7 Fish oil plus occlusion

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

3.8 Herbal skin care (Dr Michaels® cleansing gel, ointment and skin conditioner), twice daily

1

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

3.9 Hexafluoro‐1,25‐dihydroxyvitamin D3, twice daily

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

3.10 Indigo naturalis 1.4% ointment

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

3.11 Kukui nut oil, twice daily

1

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

3.12 Mahonia aquifolium (Reliéva™), twice daily

1

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

3.13 Methotrexate gel

1

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

3.14 Mycophenolic acid ointment

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

3.15 NG‐monomethyl‐L‐arginine (L‐NMMA) cream

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

3.16 Nicotinamide 1.4%, twice daily

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

3.17 Oleum horwathiensis (Psoricur®)

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

3.18 Omega‐3‐polyunsaturated fatty acids ointment

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

3.19 Platelet aggregation activating factor (PAF)(Ro 24‐0238)

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

3.20 Polymyxin B cream 200,000 U/g

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

3.21 PTH (1‐34) in Novasome A® liposomal cream, twice daily

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

3.22 Sirolimus (topical), 2.2% for 6 wks, then 8% for a further 6 wks

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

3.23 Tacrolimus ointment

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

3.24 Tar

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

3.25 Tazarotene

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

3.26 Theophylline 1% ointment, twice daily

1

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

4 PAGI Show forest plot

2

Std. Mean Difference (IV, Random, 95% CI)

Totals not selected

Analysis 6.4

Comparison 6 Other treatment versus placebo, Outcome 4 PAGI.

Comparison 6 Other treatment versus placebo, Outcome 4 PAGI.

4.1 Aloe vera extract 0.5% hydrophilic cream, three times per day

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

4.2 Anti‐IL‐8 monoclonal antibody cream

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

4.3 Betamethasone 17‐valerate 21‐acetate plus tretinoin plus salicylic acid

1

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

4.4 Caffeine (topical) 10%, TD

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

4.5 Calcipotriene 0.005% ointment + nicotinamide 0.05% or 0.1% or 0.7% or 1.4%, twice daily

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

4.6 Dead Sea salts emollient lotion, 30%

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

4.7 Fish oil plus occlusion

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

4.8 Herbal skin care (Dr Michaels® cleansing gel, ointment and skin conditioner), twice daily

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

4.9 Hexafluoro‐1,25‐dihydroxyvitamin D3, twice daily

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

4.10 Indigo naturalis 1.4% ointment

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

4.11 Kukui nut oil, TD

1

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

4.12 Mahonia aquifolium (Reliéva™), twice daily

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

4.13 Methotrexate gel

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

4.14 Mycophenolic acid ointment

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

4.15 NG‐monomethyl‐L‐arginine (L‐NMMA) cream

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

4.16 Nicotinamide 1.4%, twice daily

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

4.17 Oleum horwathiensis (Psoricur®)

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

4.18 Omega‐3‐polyunsaturated fatty acids ointment

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

4.19 Platelet aggregation activating factor (PAF)(Ro 24‐0238)

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

4.20 Polymyxin B cream 200,000 U/g

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

4.21 PTH (1‐34) in Novasome A® liposomal cream, twice daily

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

4.22 Sirolimus (topical), 2.2% for 6 wks, then 8% for a further 6 wks

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

4.23 Tacrolimus ointment

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

4.24 Tar

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

4.25 Tazarotene

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

4.26 Theophylline 1% ointment, twice daily

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

5 Combined end point (IAGI/TSS/PASI/PAGI) Show forest plot

26

Std. Mean Difference (IV, Random, 95% CI)

Subtotals only

Analysis 6.5

Comparison 6 Other treatment versus placebo, Outcome 5 Combined end point (IAGI/TSS/PASI/PAGI).

Comparison 6 Other treatment versus placebo, Outcome 5 Combined end point (IAGI/TSS/PASI/PAGI).

5.1 Aloe vera extract 0.5% hydrophilic cream, three times per day

1

60

Std. Mean Difference (IV, Random, 95% CI)

‐1.58 [‐2.16, ‐0.99]

5.2 Anti‐IL‐8 monoclonal antibody cream

1

89

Std. Mean Difference (IV, Random, 95% CI)

‐0.59 [‐1.01, ‐0.16]

5.3 Betamethasone 17‐valerate 21‐acetate plus tretinoin plus salicylic acid

1

81

Std. Mean Difference (IV, Random, 95% CI)

‐0.76 [‐1.21, ‐0.31]

5.4 Caffeine (topical) 10%, TD

1

78

Std. Mean Difference (IV, Random, 95% CI)

‐0.39 [‐0.84, 0.06]

5.5 Calcipotriene 0.005% ointment + nicotinamide 0.05% or 0.1% or 0.7% or 1.4%, twice daily

1

192

Std. Mean Difference (IV, Random, 95% CI)

‐0.48 [‐0.81, ‐0.15]

5.6 Dead Sea salts emollient lotion, 30%

1

19

Std. Mean Difference (IV, Random, 95% CI)

0.57 [‐0.36, 1.51]

5.7 Fish oil plus occlusion

1

50

Std. Mean Difference (IV, Random, 95% CI)

‐1.05 [‐1.64, ‐0.46]

5.8 Herbal skin care (Dr Michaels® cleansing gel, ointment and skin conditioner), twice daily

1

24

Std. Mean Difference (IV, Random, 95% CI)

‐2.96 [‐4.19, ‐1.74]

5.9 Hexafluoro‐1,25‐dihydroxyvitamin D3

1

30

Std. Mean Difference (IV, Random, 95% CI)

‐0.62 [‐1.35, 0.12]

5.10 Indigo naturalis 1.4% ointment

2

88

Std. Mean Difference (IV, Random, 95% CI)

‐2.09 [‐2.62, ‐1.56]

5.11 Kukui nut oil, TD

1

24

Std. Mean Difference (IV, Random, 95% CI)

0.0 [‐0.80, 0.80]

5.12 Mahonia aquifolium (Reliéva™), twice daily

1

200

Std. Mean Difference (IV, Random, 95% CI)

‐0.77 [‐1.06, ‐0.48]

5.13 Methotrexate gel

2

142

Std. Mean Difference (IV, Random, 95% CI)

‐1.05 [‐2.04, ‐0.06]

5.14 Mycophenolic acid ointment

1

14

Std. Mean Difference (IV, Random, 95% CI)

‐1.44 [‐2.67, ‐0.22]

5.15 NG‐monomethyl‐L‐arginine (L‐NMMA) cream

1

34

Std. Mean Difference (IV, Random, 95% CI)

0.08 [‐0.60, 0.75]

5.16 Nicotinamide 1.4%, twice daily

1

96

Std. Mean Difference (IV, Random, 95% CI)

‐0.20 [‐0.60, 0.20]

5.17 Oleum horwathiensis (Psoricur®)

1

42

Std. Mean Difference (IV, Random, 95% CI)

‐0.02 [‐0.63, 0.58]

5.18 Omega‐3‐polyunsaturated fatty acids ointment

0

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

5.19 Platelet aggregation activating factor (PAF)(Ro 24‐0238)

1

80

Std. Mean Difference (IV, Random, 95% CI)

‐0.07 [‐0.50, 0.37]

5.20 Polymyxin B cream 200,000 U/g

1

30

Std. Mean Difference (IV, Random, 95% CI)

0.13 [‐0.59, 0.85]

5.21 PTH (1‐34) in Novasome A® liposomal cream, twice daily

1

30

Std. Mean Difference (IV, Random, 95% CI)

‐2.31 [‐3.26, ‐1.36]

5.22 Sirolimus (topical), 2.2% for 6 wks, then 8% for a further 6 wks

1

44

Std. Mean Difference (IV, Random, 95% CI)

‐0.39 [‐0.98, 0.21]

5.23 Tacrolimus ointment

1

47

Std. Mean Difference (IV, Random, 95% CI)

0.06 [‐0.52, 0.63]

5.24 Tar

1

36

Std. Mean Difference (IV, Random, 95% CI)

‐0.45 [‐1.11, 0.22]

5.25 Tazarotene

1

318

Std. Mean Difference (IV, Random, 95% CI)

‐0.86 [‐1.11, ‐0.62]

5.26 Theophylline 1% ointment, twice daily

1

22

Std. Mean Difference (IV, Random, 95% CI)

‐2.87 [‐4.13, ‐1.62]

6 Total withdrawals Show forest plot

23

Risk Difference (M‐H, Random, 95% CI)

Subtotals only

Analysis 6.6

Comparison 6 Other treatment versus placebo, Outcome 6 Total withdrawals.

Comparison 6 Other treatment versus placebo, Outcome 6 Total withdrawals.

6.1 Aloe vera extract 0.5% hydrophilic cream, three times per day

1

60

Risk Difference (M‐H, Random, 95% CI)

0.0 [‐0.06, 0.06]

6.2 Anti‐IL‐8 monoclonal antibody cream

1

96

Risk Difference (M‐H, Random, 95% CI)

‐0.02 [‐0.12, 0.08]

6.3 Betamethasone 17‐valerate 21‐acetate plus tretinoin plus salicylic acid

1

85

Risk Difference (M‐H, Random, 95% CI)

‐0.00 [‐0.09, 0.09]

6.4 Caffeine (topical) 10%, TD

1

78

Risk Difference (M‐H, Random, 95% CI)

0.0 [‐0.12, 0.12]

6.5 Calcipotriene 0.005% ointment + nicotinamide 0.05% or 0.1% or 0.7% or 1.4%, twice daily

1

192

Risk Difference (M‐H, Random, 95% CI)

0.03 [‐0.01, 0.08]

6.6 Dead Sea salts emollient lotion

1

24

Risk Difference (M‐H, Random, 95% CI)

0.25 [‐0.06, 0.56]

6.7 Fish oil plus occlusion

1

50

Risk Difference (M‐H, Random, 95% CI)

0.0 [‐0.07, 0.07]

6.8 Herbal skin care (Dr Michaels® cleansing gel, ointment and skin conditioner), twice daily

0

0

Risk Difference (M‐H, Random, 95% CI)

0.0 [0.0, 0.0]

6.9 Hexafluoro‐1,25‐dihydroxyvitamin D3

1

30

Risk Difference (M‐H, Random, 95% CI)

0.0 [‐0.12, 0.12]

6.10 Indigo naturalis 1.4% ointment

2

112

Risk Difference (M‐H, Random, 95% CI)

0.0 [‐0.15, 0.15]

6.11 Kukui nut oil, TD

1

30

Risk Difference (M‐H, Random, 95% CI)

‐0.13 [‐0.42, 0.15]

6.12 Mahonia aquifolium (Reliéva™), twice daily

1

200

Risk Difference (M‐H, Random, 95% CI)

‐0.23 [‐0.32, ‐0.14]

6.13 Methotrexate gel

1

60

Risk Difference (M‐H, Random, 95% CI)

0.0 [‐0.06, 0.06]

6.14 Mycophenolic acid ointment

1

14

Risk Difference (M‐H, Random, 95% CI)

0.0 [‐0.24, 0.24]

6.15 NG‐monomethyl‐L‐arginine (L‐NMMA) cream

1

34

Risk Difference (M‐H, Random, 95% CI)

0.0 [‐0.11, 0.11]

6.16 Nicotinamide 1.4%, twice daily

1

96

Risk Difference (M‐H, Random, 95% CI)

0.02 [‐0.04, 0.08]

6.17 Oleum horwathiensis

1

50

Risk Difference (M‐H, Random, 95% CI)

0.16 [‐0.04, 0.36]

6.18 Omega‐3‐polyunsaturated fatty acids ointment

1

146

Risk Difference (M‐H, Random, 95% CI)

0.0 [‐0.15, 0.15]

6.19 Platelet aggregation activating factor (PAF)(Ro 24‐0238)

1

104

Risk Difference (M‐H, Random, 95% CI)

0.0 [‐0.16, 0.16]

6.20 Polymyxin B cream 200,000 U/g

1

30

Risk Difference (M‐H, Random, 95% CI)

0.0 [‐0.24, 0.24]

6.21 PTH (1‐34) in Novasome A® liposomal cream, twice daily

1

30

Risk Difference (M‐H, Random, 95% CI)

0.0 [‐0.12, 0.12]

6.22 Sirolimus (topical)

0

0

Risk Difference (M‐H, Random, 95% CI)

0.0 [0.0, 0.0]

6.23 Tacrolimus ointment

0

0

Risk Difference (M‐H, Random, 95% CI)

0.0 [0.0, 0.0]

6.24 Tar

0

0

Risk Difference (M‐H, Random, 95% CI)

0.0 [0.0, 0.0]

6.25 Tazarotene

2

1627

Risk Difference (M‐H, Random, 95% CI)

0.04 [‐0.01, 0.09]

6.26 Theophylline 1% ointment, twice daily

1

22

Risk Difference (M‐H, Random, 95% CI)

0.0 [‐0.16, 0.16]

7 Withdrawals due to adverse events Show forest plot

19

Risk Difference (M‐H, Random, 95% CI)

Subtotals only

Analysis 6.7

Comparison 6 Other treatment versus placebo, Outcome 7 Withdrawals due to adverse events.

Comparison 6 Other treatment versus placebo, Outcome 7 Withdrawals due to adverse events.

7.1 Aloe vera extract 0.5% hydrophilic cream, three times per day

1

60

Risk Difference (M‐H, Random, 95% CI)

0.0 [‐0.06, 0.06]

7.2 Anti‐IL‐8 monoclonal antibody cream

0

0

Risk Difference (M‐H, Random, 95% CI)

0.0 [0.0, 0.0]

7.3 Betamethasone 17‐valerate 21‐acetate plus tretinoin plus salicylic acid

1

85

Risk Difference (M‐H, Random, 95% CI)

‐0.00 [‐0.07, 0.06]

7.4 Caffeine (topical) 10%, TD

1

78

Risk Difference (M‐H, Random, 95% CI)

0.0 [‐0.05, 0.05]

7.5 Calcipotriene 0.005% ointment + nicotinamide 0.05% or 0.1% or 0.7% or 1.4%, twice daily

1

192

Risk Difference (M‐H, Random, 95% CI)

0.0 [‐0.03, 0.03]

7.6 Dead Sea salts emollient lotion

1

24

Risk Difference (M‐H, Random, 95% CI)

0.08 [‐0.18, 0.35]

7.7 Fish oil plus occlusion

1

50

Risk Difference (M‐H, Random, 95% CI)

0.0 [‐0.07, 0.07]

7.8 Herbal skin care (Dr Michaels® cleansing gel, ointment and skin conditioner), twice daily

0

0

Risk Difference (M‐H, Random, 95% CI)

0.0 [0.0, 0.0]

7.9 Hexafluoro‐1,25‐dihydroxyvitamin D3

1

30

Risk Difference (M‐H, Random, 95% CI)

0.0 [‐0.12, 0.12]

7.10 Indigo naturalis 1.4% ointment

2

112

Risk Difference (M‐H, Random, 95% CI)

0.0 [‐0.04, 0.04]

7.11 Kukui nut oil, TD

1

30

Risk Difference (M‐H, Random, 95% CI)

0.0 [‐0.12, 0.12]

7.12 Mahonia aquifolium (Reliéva™), twice daily

0

0

Risk Difference (M‐H, Random, 95% CI)

0.0 [0.0, 0.0]

7.13 Methotrexate gel

1

60

Risk Difference (M‐H, Random, 95% CI)

0.0 [‐0.06, 0.06]

7.14 Mycophenolic acid ointment

1

14

Risk Difference (M‐H, Random, 95% CI)

0.0 [‐0.24, 0.24]

7.15 NG‐monomethyl‐L‐arginine (L‐NMMA) cream

1

34

Risk Difference (M‐H, Random, 95% CI)

0.0 [‐0.11, 0.11]

7.16 Nicotinamide 1.4%, twice daily

1

96

Risk Difference (M‐H, Random, 95% CI)

0.0 [‐0.04, 0.04]

7.17 Oleum horwathiensis

1

50

Risk Difference (M‐H, Random, 95% CI)

0.0 [‐0.07, 0.07]

7.18 Omega‐3‐polyunsaturated fatty acids ointment

1

146

Risk Difference (M‐H, Random, 95% CI)

0.0 [‐0.03, 0.03]

7.19 Platelet aggregation activating factor (PAF)(Ro 24‐0238)

0

0

Risk Difference (M‐H, Random, 95% CI)

0.0 [0.0, 0.0]

7.20 Polymyxin B cream 200,000 U/g

0

0

Risk Difference (M‐H, Random, 95% CI)

0.0 [0.0, 0.0]

7.21 PTH (1‐34) in Novasome A® liposomal cream, twice daily

1

30

Risk Difference (M‐H, Random, 95% CI)

0.0 [‐0.12, 0.12]

7.22 Sirolimus (topical)

0

0

Risk Difference (M‐H, Random, 95% CI)

0.0 [0.0, 0.0]

7.23 Tacrolimus ointment

0

0

Risk Difference (M‐H, Random, 95% CI)

0.0 [0.0, 0.0]

7.24 Tar

0

0

Risk Difference (M‐H, Random, 95% CI)

0.0 [0.0, 0.0]

7.25 Tazarotene

2

1627

Risk Difference (M‐H, Random, 95% CI)

0.07 [0.05, 0.10]

7.26 Theophylline 1% ointment, twice daily

1

22

Risk Difference (M‐H, Random, 95% CI)

0.0 [‐0.16, 0.16]

8 Withdrawals due to treatment failure Show forest plot

18

Risk Difference (M‐H, Random, 95% CI)

Subtotals only

Analysis 6.8

Comparison 6 Other treatment versus placebo, Outcome 8 Withdrawals due to treatment failure.

Comparison 6 Other treatment versus placebo, Outcome 8 Withdrawals due to treatment failure.

8.1 Aloe vera extract 0.5% hydrophilic cream, three times per day

1

60

Risk Difference (M‐H, Random, 95% CI)

0.0 [‐0.06, 0.06]

8.2 Anti‐IL‐8 monoclonal antibody cream

0

0

Risk Difference (M‐H, Random, 95% CI)

0.0 [0.0, 0.0]

8.3 Betamethasone 17‐valerate 21‐acetate plus tretinoin plus salicylic acid

1

85

Risk Difference (M‐H, Random, 95% CI)

0.02 [‐0.04, 0.08]

8.4 Caffeine (topical) 10%, TD

1

78

Risk Difference (M‐H, Random, 95% CI)

0.0 [‐0.05, 0.05]

8.5 Calcipotriene 0.005% ointment + nicotinamide 0.05% or 0.1% or 0.7% or 1.4%, twice daily

1

192

Risk Difference (M‐H, Random, 95% CI)

0.0 [‐0.03, 0.03]

8.6 Dead Sea salts emollient lotion

1

24

Risk Difference (M‐H, Random, 95% CI)

0.08 [‐0.12, 0.29]

8.7 Fish oil plus occlusion

1

50

Risk Difference (M‐H, Random, 95% CI)

0.0 [‐0.07, 0.07]

8.8 Herbal skin care (Dr Michaels® cleansing gel, ointment and skin conditioner), twice daily

0

0

Risk Difference (M‐H, Random, 95% CI)

0.0 [0.0, 0.0]

8.9 Hexafluoro‐1,25‐dihydroxyvitamin D3

1

30

Risk Difference (M‐H, Random, 95% CI)

0.0 [‐0.12, 0.12]

8.10 Indigo naturalis 1.4% ointment

1

28

Risk Difference (M‐H, Random, 95% CI)

0.0 [‐0.13, 0.13]

8.11 Kukui nut oil, TD

1

30

Risk Difference (M‐H, Random, 95% CI)

0.0 [‐0.12, 0.12]

8.12 Mahonia aquifolium (Reliéva™), twice daily

0

0

Risk Difference (M‐H, Random, 95% CI)

0.0 [0.0, 0.0]

8.13 Methotrexate gel

1

60

Risk Difference (M‐H, Random, 95% CI)

0.0 [‐0.06, 0.06]

8.14 Mycophenolic acid ointment

1

14

Risk Difference (M‐H, Random, 95% CI)

0.0 [‐0.24, 0.24]

8.15 NG‐monomethyl‐L‐arginine (L‐NMMA) cream

1

34

Risk Difference (M‐H, Random, 95% CI)

0.0 [‐0.11, 0.11]

8.16 Nicotinamide 1.4%, twice daily

1

96

Risk Difference (M‐H, Random, 95% CI)

0.0 [‐0.04, 0.04]

8.17 Oleum horwathiensis

1

50

Risk Difference (M‐H, Random, 95% CI)

0.0 [‐0.07, 0.07]

8.18 Omega‐3‐polyunsaturated fatty acids ointment

1

146

Risk Difference (M‐H, Random, 95% CI)

0.0 [‐0.03, 0.03]

8.19 Platelet aggregation activating factor (PAF)(Ro 24‐0238)

0

0

Risk Difference (M‐H, Random, 95% CI)

0.0 [0.0, 0.0]

8.20 Polymyxin B cream 200,000 U/g

0

0

Risk Difference (M‐H, Random, 95% CI)

0.0 [0.0, 0.0]

8.21 PTH (1‐34) in Novasome A® liposomal cream, twice daily

1

30

Risk Difference (M‐H, Random, 95% CI)

0.0 [‐0.12, 0.12]

8.22 Sirolimus (topical)

0

0

Risk Difference (M‐H, Random, 95% CI)

0.0 [0.0, 0.0]

8.23 Tacrolimus ointment

0

0

Risk Difference (M‐H, Random, 95% CI)

0.0 [0.0, 0.0]

8.24 Tar

0

0

Risk Difference (M‐H, Random, 95% CI)

0.0 [0.0, 0.0]

8.25 Tazarotene

2

1627

Risk Difference (M‐H, Random, 95% CI)

‐0.02 [‐0.04, 0.01]

8.26 Theophylline 1% ointment, twice daily

1

22

Risk Difference (M‐H, Random, 95% CI)

0.0 [‐0.16, 0.16]

9 Adverse events (local) Show forest plot

21

Risk Difference (M‐H, Random, 95% CI)

Subtotals only

Analysis 6.9

Comparison 6 Other treatment versus placebo, Outcome 9 Adverse events (local).

Comparison 6 Other treatment versus placebo, Outcome 9 Adverse events (local).

9.1 Aloe vera extract 0.5% hydrophilic cream, three times per day

1

60

Risk Difference (M‐H, Random, 95% CI)

0.0 [‐0.06, 0.06]

9.2 Anti‐IL‐8 monoclonal antibody cream

1

92

Risk Difference (M‐H, Random, 95% CI)

0.02 [‐0.10, 0.14]

9.3 Betamethasone 17‐valerate 21‐acetate plus tretinoin plus salicylic acid

1

85

Risk Difference (M‐H, Random, 95% CI)

‐0.00 [‐0.07, 0.06]

9.4 Caffeine (topical) 10%, TD

1

78

Risk Difference (M‐H, Random, 95% CI)

0.05 [‐0.03, 0.13]

9.5 Calcipotriene 0.005% ointment + nicotinamide 0.05% or 0.1% or 0.7% or 1.4%, twice daily

1

192

Risk Difference (M‐H, Random, 95% CI)

0.13 [‐0.02, 0.27]

9.6 Dead Sea salts emollient lotion

1

24

Risk Difference (M‐H, Random, 95% CI)

0.08 [‐0.18, 0.35]

9.7 Fish oil plus occlusion

1

50

Risk Difference (M‐H, Random, 95% CI)

0.04 [‐0.06, 0.14]

9.8 Herbal skin care (Dr Michaels® cleansing gel, ointment and skin conditioner), twice daily

1

24

Risk Difference (M‐H, Random, 95% CI)

‐0.09 [‐0.44, 0.27]

9.9 Hexafluoro‐1,25‐dihydroxyvitamin D3

1

30

Risk Difference (M‐H, Random, 95% CI)

0.13 [‐0.06, 0.33]

9.10 Indigo naturalis 1.4% ointment

2

88

Risk Difference (M‐H, Random, 95% CI)

0.0 [‐0.05, 0.05]

9.11 Kukui nut oil, TD

1

30

Risk Difference (M‐H, Random, 95% CI)

0.0 [‐0.12, 0.12]

9.12 Mahonia aquifolium (Reliéva™), twice daily

1

200

Risk Difference (M‐H, Random, 95% CI)

‐0.02 [‐0.06, 0.02]

9.13 Methotrexate gel

1

60

Risk Difference (M‐H, Random, 95% CI)

0.0 [‐0.06, 0.06]

9.14 Mycophenolic acid ointment

1

14

Risk Difference (M‐H, Random, 95% CI)

0.0 [‐0.24, 0.24]

9.15 NG‐monomethyl‐L‐arginine (L‐NMMA) cream

1

34

Risk Difference (M‐H, Random, 95% CI)

0.0 [‐0.11, 0.11]

9.16 Nicotinamide 1.4%, twice daily

1

96

Risk Difference (M‐H, Random, 95% CI)

0.10 [‐0.07, 0.28]

9.17 Oleum horwathiensis

1

50

Risk Difference (M‐H, Random, 95% CI)

0.04 [‐0.06, 0.14]

9.18 Omega‐3‐polyunsaturated fatty acids ointment

1

146

Risk Difference (M‐H, Random, 95% CI)

0.01 [‐0.02, 0.05]

9.19 Platelet aggregation activating factor (PAF)(Ro 24‐0238)

1

104

Risk Difference (M‐H, Random, 95% CI)

0.0 [‐0.19, 0.19]

9.20 Polymyxin B cream 200,000 U/g

0

0

Risk Difference (M‐H, Random, 95% CI)

0.0 [0.0, 0.0]

9.21 PTH (1‐34) in Novasome A® liposomal cream, twice daily

1

30

Risk Difference (M‐H, Random, 95% CI)

0.0 [‐0.12, 0.12]

9.22 Sirolimus (topical)

0

0

Risk Difference (M‐H, Random, 95% CI)

0.0 [0.0, 0.0]

9.23 Tacrolimus ointment

0

0

Risk Difference (M‐H, Random, 95% CI)

0.0 [0.0, 0.0]

9.24 Tar

0

0

Risk Difference (M‐H, Random, 95% CI)

0.0 [0.0, 0.0]

9.25 Tazarotene

0

0

Risk Difference (M‐H, Random, 95% CI)

0.0 [0.0, 0.0]

9.26 Theophylline 1% ointment, twice daily

1

22

Risk Difference (M‐H, Random, 95% CI)

0.0 [‐0.16, 0.16]

10 Adverse events (systemic) Show forest plot

12

Risk Difference (M‐H, Random, 95% CI)

Subtotals only

Analysis 6.10

Comparison 6 Other treatment versus placebo, Outcome 10 Adverse events (systemic).

Comparison 6 Other treatment versus placebo, Outcome 10 Adverse events (systemic).

10.1 Aloe vera extract 0.5% hydrophilic cream, three times per day

0

0

Risk Difference (M‐H, Random, 95% CI)

0.0 [0.0, 0.0]

10.2 Anti‐IL‐8 monoclonal antibody cream

0

0

Risk Difference (M‐H, Random, 95% CI)

0.0 [0.0, 0.0]

10.3 Betamethasone 17‐valerate 21‐acetate plus tretinoin plus salicylic acid

1

85

Risk Difference (M‐H, Random, 95% CI)

0.0 [‐0.04, 0.04]

10.4 Caffeine (topical) 10%, TD

0

0

Risk Difference (M‐H, Random, 95% CI)

0.0 [0.0, 0.0]

10.5 Calcipotriene 0.005% ointment + nicotinamide 0.05% or 0.1% or 0.7% or 1.4%, twice daily

0

0

Risk Difference (M‐H, Random, 95% CI)

0.0 [0.0, 0.0]

10.6 Dead Sea salts emollient lotion

0

0

Risk Difference (M‐H, Random, 95% CI)

0.0 [0.0, 0.0]

10.7 Fish oil plus occlusion

0

0

Risk Difference (M‐H, Random, 95% CI)

0.0 [0.0, 0.0]

10.8 Herbal skin care (Dr Michaels® cleansing gel, ointment and skin conditioner), twice daily

0

0

Risk Difference (M‐H, Random, 95% CI)

0.0 [0.0, 0.0]

10.9 Hexafluoro‐1,25‐dihydroxyvitamin D3

1

30

Risk Difference (M‐H, Random, 95% CI)

0.0 [‐0.12, 0.12]

10.10 Indigo naturalis 1.4% ointment

2

88

Risk Difference (M‐H, Random, 95% CI)

0.0 [‐0.05, 0.05]

10.11 Kukui nut oil, TD

0

0

Risk Difference (M‐H, Random, 95% CI)

0.0 [0.0, 0.0]

10.12 Mahonia aquifolium (Reliéva™), twice daily

0

0

Risk Difference (M‐H, Random, 95% CI)

0.0 [0.0, 0.0]

10.13 Methotrexate gel

2

166

Risk Difference (M‐H, Random, 95% CI)

0.0 [‐0.03, 0.03]

10.14 Mycophenolic acid ointment

0

0

Risk Difference (M‐H, Random, 95% CI)

0.0 [0.0, 0.0]

10.15 NG‐monomethyl‐L‐arginine (L‐NMMA) cream

1

34

Risk Difference (M‐H, Random, 95% CI)

0.0 [‐0.11, 0.11]

10.16 Nicotinamide 1.4%, twice daily

0

0

Risk Difference (M‐H, Random, 95% CI)

0.0 [0.0, 0.0]

10.17 Oleum horwathiensis

1

50

Risk Difference (M‐H, Random, 95% CI)

0.0 [‐0.07, 0.07]

10.18 Omega‐3‐polyunsaturated fatty acids ointment

0

0

Risk Difference (M‐H, Random, 95% CI)

0.0 [0.0, 0.0]

10.19 Platelet aggregation activating factor (PAF)(Ro 24‐0238)

1

104

Risk Difference (M‐H, Random, 95% CI)

0.0 [‐0.04, 0.04]

10.20 Polymyxin B cream 200,000 U/g

0

0

Risk Difference (M‐H, Random, 95% CI)

0.0 [0.0, 0.0]

10.21 PTH (1‐34) in Novasome A® liposomal cream, twice daily

1

30

Risk Difference (M‐H, Random, 95% CI)

0.0 [‐0.12, 0.12]

10.22 Sirolimus (topical)

0

0

Risk Difference (M‐H, Random, 95% CI)

0.0 [0.0, 0.0]

10.23 Tacrolimus ointment

0

0

Risk Difference (M‐H, Random, 95% CI)

0.0 [0.0, 0.0]

10.24 Tar

0

0

Risk Difference (M‐H, Random, 95% CI)

0.0 [0.0, 0.0]

10.25 Tazarotene

2

414

Risk Difference (M‐H, Random, 95% CI)

0.0 [‐0.01, 0.01]

10.26 Theophylline 1% ointment, twice daily

0

0

Risk Difference (M‐H, Random, 95% CI)

0.0 [0.0, 0.0]

Open in table viewer
Comparison 7. Vitamin D analogues versus corticosteroid (potent)

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 IAGI Show forest plot

8

Std. Mean Difference (IV, Random, 95% CI)

Subtotals only

Analysis 7.1

Comparison 7 Vitamin D analogues versus corticosteroid (potent), Outcome 1 IAGI.

Comparison 7 Vitamin D analogues versus corticosteroid (potent), Outcome 1 IAGI.

1.1 Calcipotriol vs. betamethasone dipropionate

3

1728

Std. Mean Difference (IV, Random, 95% CI)

0.43 [0.28, 0.58]

1.2 Calcipotriol vs. betamethasone valerate

1

412

Std. Mean Difference (IV, Random, 95% CI)

‐0.02 [‐0.21, 0.17]

1.3 Calcipotriol vs. desoxymetasone

0

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

1.4 Calcipotriol vs. diflorasone diacetate

1

256

Std. Mean Difference (IV, Random, 95% CI)

0.27 [0.02, 0.52]

1.5 Calcipotriol vs. fluocinonide

1

99

Std. Mean Difference (IV, Random, 95% CI)

‐0.58 [‐0.99, ‐0.18]

1.6 Calcitriol vs. betamethasone dipropionate

1

258

Std. Mean Difference (IV, Random, 95% CI)

0.21 [‐0.04, 0.45]

1.7 Calcitriol vs. betamethasone valerate

1

30

Std. Mean Difference (IV, Random, 95% CI)

‐0.19 [‐0.91, 0.53]

1.8 Tacalcitol vs. betamethasone valerate

0

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

2 TSS Show forest plot

6

Std. Mean Difference (IV, Random, 95% CI)

Subtotals only

Analysis 7.2

Comparison 7 Vitamin D analogues versus corticosteroid (potent), Outcome 2 TSS.

Comparison 7 Vitamin D analogues versus corticosteroid (potent), Outcome 2 TSS.

2.1 Calcipotriol vs. betamethasone dipropionate

0

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

2.2 Calcipotriol vs. betamethasone valerate

1

684

Std. Mean Difference (IV, Random, 95% CI)

‐0.26 [‐0.41, ‐0.11]

2.3 Calcipotriol vs. desoxymetasone

0

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

2.4 Calcipotriol vs. diflorasone diacetate

1

256

Std. Mean Difference (IV, Random, 95% CI)

0.40 [0.15, 0.65]

2.5 Calcipotriol vs. fluocinonide

1

89

Std. Mean Difference (IV, Random, 95% CI)

‐0.50 [‐0.92, ‐0.07]

2.6 Calcitriol vs. betamethasone dipropionate

1

258

Std. Mean Difference (IV, Random, 95% CI)

0.27 [0.02, 0.51]

2.7 Calcitriol vs. betamethasone valerate

0

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

2.8 Tacalcitol vs. betamethasone valerate

2

148

Std. Mean Difference (IV, Random, 95% CI)

0.41 [0.09, 0.74]

3 PASI Show forest plot

9

Std. Mean Difference (IV, Random, 95% CI)

Subtotals only

Analysis 7.3

Comparison 7 Vitamin D analogues versus corticosteroid (potent), Outcome 3 PASI.

Comparison 7 Vitamin D analogues versus corticosteroid (potent), Outcome 3 PASI.

3.1 Calcipotriol vs. betamethasone dipropionate

3

1728

Std. Mean Difference (IV, Random, 95% CI)

0.36 [0.22, 0.51]

3.2 Calcipotriol vs. betamethasone valerate

4

1505

Std. Mean Difference (IV, Random, 95% CI)

‐0.12 [‐0.22, ‐0.02]

3.3 Calcipotriol vs. desoxymetasone

1

20

Std. Mean Difference (IV, Random, 95% CI)

0.15 [‐0.73, 1.02]

3.4 Calcipotriol vs. diflorasone diacetate

0

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

3.5 Calcipotriol vs. fluocinonide

0

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

3.6 Calcitriol vs. betamethasone dipropionate

1

258

Std. Mean Difference (IV, Random, 95% CI)

0.39 [0.14, 0.63]

3.7 Calcitriol vs. betamethasone valerate

0

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

3.8 Tacalcitol vs. betamethasone valerate

0

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

4 PAGI Show forest plot

2

1080

Std. Mean Difference (IV, Random, 95% CI)

‐0.26 [‐0.38, ‐0.14]

Analysis 7.4

Comparison 7 Vitamin D analogues versus corticosteroid (potent), Outcome 4 PAGI.

Comparison 7 Vitamin D analogues versus corticosteroid (potent), Outcome 4 PAGI.

4.1 Calcipotriol vs. betamethasone dipropionate

0

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

4.2 Calcipotriol vs. betamethasone valerate

2

1080

Std. Mean Difference (IV, Random, 95% CI)

‐0.26 [‐0.38, ‐0.14]

4.3 Calcipotriol vs. desoxymetasone

0

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

4.4 Calcipotriol vs. diflorasone diacetate

0

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

4.5 Calcipotriol vs. fluocinonide

0

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

4.6 Calcitriol vs. betamethasone dipropionate

0

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

4.7 Calcitriol vs. betamethasone valerate

0

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

4.8 Tacalcitol vs. betamethasone valerate

0

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

5 Combined end point (IAGI/TSS/PASI/PAGI) Show forest plot

14

Std. Mean Difference (IV, Random, 95% CI)

Subtotals only

Analysis 7.5

Comparison 7 Vitamin D analogues versus corticosteroid (potent), Outcome 5 Combined end point (IAGI/TSS/PASI/PAGI).

Comparison 7 Vitamin D analogues versus corticosteroid (potent), Outcome 5 Combined end point (IAGI/TSS/PASI/PAGI).

5.1 Calcipotriol vs. betamethasone dipropionate

3

1728

Std. Mean Difference (IV, Random, 95% CI)

0.43 [0.28, 0.58]

5.2 Calcipotriol vs. betamethasone valerate

4

1557

Std. Mean Difference (IV, Random, 95% CI)

‐0.12 [‐0.26, 0.02]

5.3 Calcipotriol vs. desoxymetasone

1

20

Std. Mean Difference (IV, Random, 95% CI)

0.15 [‐0.73, 1.02]

5.4 Calcipotriol vs. diflorasone diacetate

1

256

Std. Mean Difference (IV, Random, 95% CI)

0.27 [0.02, 0.52]

5.5 Calcipotriol vs. fluocinonide

1

99

Std. Mean Difference (IV, Random, 95% CI)

‐0.58 [‐0.99, ‐0.18]

5.6 Calcitriol vs. betamethasone dipropionate

1

258

Std. Mean Difference (IV, Random, 95% CI)

0.21 [‐0.04, 0.45]

5.7 Calcitriol vs. betamethasone valerate

1

30

Std. Mean Difference (IV, Random, 95% CI)

‐0.19 [‐0.91, 0.53]

5.8 Tacalcitol vs. betamethasone valerate

2

148

Std. Mean Difference (IV, Random, 95% CI)

0.41 [0.09, 0.74]

6 Total withdrawals Show forest plot

11

3995

Risk Difference (M‐H, Random, 95% CI)

0.02 [0.00, 0.03]

Analysis 7.6

Comparison 7 Vitamin D analogues versus corticosteroid (potent), Outcome 6 Total withdrawals.

Comparison 7 Vitamin D analogues versus corticosteroid (potent), Outcome 6 Total withdrawals.

6.1 Calcipotriol vs. betamethasone dipropionate

3

1739

Risk Difference (M‐H, Random, 95% CI)

0.03 [0.01, 0.06]

6.2 Calcipotriol vs. betamethasone valerate

3

1520

Risk Difference (M‐H, Random, 95% CI)

0.01 [‐0.01, 0.04]

6.3 Calcipotriol vs. desoxymetasone

0

0

Risk Difference (M‐H, Random, 95% CI)

0.0 [0.0, 0.0]

6.4 Calcipotriol vs. diflorasone diacetate

1

268

Risk Difference (M‐H, Random, 95% CI)

0.0 [‐0.05, 0.05]

6.5 Calcipotriol vs. fluocinonide

0

0

Risk Difference (M‐H, Random, 95% CI)

0.0 [0.0, 0.0]

6.6 Calcitriol vs. betamethasone dipropionate

1

258

Risk Difference (M‐H, Random, 95% CI)

‐0.02 [‐0.08, 0.03]

6.7 Calcitriol vs. betamethasone valerate

1

30

Risk Difference (M‐H, Random, 95% CI)

0.07 [‐0.10, 0.23]

6.8 Tacalcitol vs. betamethasone valerate

2

180

Risk Difference (M‐H, Random, 95% CI)

0.0 [‐0.11, 0.11]

7 Withdrawals due to adverse events Show forest plot

9

3058

Risk Difference (M‐H, Random, 95% CI)

0.01 [‐0.00, 0.01]

Analysis 7.7

Comparison 7 Vitamin D analogues versus corticosteroid (potent), Outcome 7 Withdrawals due to adverse events.

Comparison 7 Vitamin D analogues versus corticosteroid (potent), Outcome 7 Withdrawals due to adverse events.

7.1 Calcipotriol vs. betamethasone dipropionate

1

956

Risk Difference (M‐H, Random, 95% CI)

0.02 [0.00, 0.04]

7.2 Calcipotriol vs. betamethasone valerate

3

1520

Risk Difference (M‐H, Random, 95% CI)

0.00 [‐0.00, 0.01]

7.3 Calcipotriol vs. desoxymetasone

0

0

Risk Difference (M‐H, Random, 95% CI)

0.0 [0.0, 0.0]

7.4 Calcipotriol vs. diflorasone diacetate

0

0

Risk Difference (M‐H, Random, 95% CI)

0.0 [0.0, 0.0]

7.5 Calcipotriol vs. fluocinonide

1

114

Risk Difference (M‐H, Random, 95% CI)

‐0.02 [‐0.06, 0.03]

7.6 Calcitriol vs. betamethasone dipropionate

1

258

Risk Difference (M‐H, Random, 95% CI)

0.01 [‐0.02, 0.03]

7.7 Calcitriol vs. betamethasone valerate

1

30

Risk Difference (M‐H, Random, 95% CI)

0.07 [‐0.10, 0.23]

7.8 Tacalcitol vs. betamethasone valerate

2

180

Risk Difference (M‐H, Random, 95% CI)

0.0 [‐0.02, 0.02]

8 Withdrawals due to treatment failure Show forest plot

5

1500

Risk Difference (M‐H, Random, 95% CI)

‐0.00 [‐0.01, 0.01]

Analysis 7.8

Comparison 7 Vitamin D analogues versus corticosteroid (potent), Outcome 8 Withdrawals due to treatment failure.

Comparison 7 Vitamin D analogues versus corticosteroid (potent), Outcome 8 Withdrawals due to treatment failure.

8.1 Calcipotriol vs. betamethasone dipropionate

0

0

Risk Difference (M‐H, Random, 95% CI)

0.0 [0.0, 0.0]

8.2 Calcipotriol vs. betamethasone valerate

2

1099

Risk Difference (M‐H, Random, 95% CI)

‐0.00 [‐0.01, 0.01]

8.3 Calcipotriol vs. desoxymetasone

0

0

Risk Difference (M‐H, Random, 95% CI)

0.0 [0.0, 0.0]

8.4 Calcipotriol vs. diflorasone diacetate

0

0

Risk Difference (M‐H, Random, 95% CI)

0.0 [0.0, 0.0]

8.5 Calcipotriol vs. fluocinonide

1

113

Risk Difference (M‐H, Random, 95% CI)

0.0 [‐0.03, 0.03]

8.6 Calcitriol vs. betamethasone dipropionate

1

258

Risk Difference (M‐H, Random, 95% CI)

0.01 [‐0.03, 0.05]

8.7 Calcitriol vs. betamethasone valerate

1

30

Risk Difference (M‐H, Random, 95% CI)

0.0 [‐0.12, 0.12]

8.8 Tacalcitol vs. betamethasone valerate

0

0

Risk Difference (M‐H, Random, 95% CI)

0.0 [0.0, 0.0]

9 Adverse events (local) Show forest plot

9

3778

Risk Difference (M‐H, Random, 95% CI)

0.07 [0.02, 0.11]

Analysis 7.9

Comparison 7 Vitamin D analogues versus corticosteroid (potent), Outcome 9 Adverse events (local).

Comparison 7 Vitamin D analogues versus corticosteroid (potent), Outcome 9 Adverse events (local).

9.1 Calcipotriol vs. betamethasone dipropionate

3

1739

Risk Difference (M‐H, Random, 95% CI)

0.07 [0.04, 0.09]

9.2 Calcipotriol vs. betamethasone valerate

3

1516

Risk Difference (M‐H, Random, 95% CI)

0.12 [‐0.02, 0.26]

9.3 Calcipotriol vs. desoxymetasone

0

0

Risk Difference (M‐H, Random, 95% CI)

0.0 [0.0, 0.0]

9.4 Calcipotriol vs. diflorasone diacetate

0

0

Risk Difference (M‐H, Random, 95% CI)

0.0 [0.0, 0.0]

9.5 Calcipotriol vs. fluocinonide

1

113

Risk Difference (M‐H, Random, 95% CI)

0.10 [‐0.02, 0.22]

9.6 Calcitriol vs. betamethasone dipropionate

1

258

Risk Difference (M‐H, Random, 95% CI)

0.00 [‐0.05, 0.06]

9.7 Calcitriol vs. betamethasone valerate

0

0

Risk Difference (M‐H, Random, 95% CI)

0.0 [0.0, 0.0]

9.8 Tacalcitol vs. betamethasone valerate

1

152

Risk Difference (M‐H, Random, 95% CI)

‐0.01 [‐0.07, 0.04]

10 Adverse events (systemic) Show forest plot

6

2547

Risk Difference (M‐H, Random, 95% CI)

‐0.00 [‐0.00, 0.00]

Analysis 7.10

Comparison 7 Vitamin D analogues versus corticosteroid (potent), Outcome 10 Adverse events (systemic).

Comparison 7 Vitamin D analogues versus corticosteroid (potent), Outcome 10 Adverse events (systemic).

10.1 Calcipotriol vs. betamethasone dipropionate

1

621

Risk Difference (M‐H, Random, 95% CI)

0.0 [‐0.01, 0.01]

10.2 Calcipotriol vs. betamethasone valerate

3

1516

Risk Difference (M‐H, Random, 95% CI)

‐0.00 [‐0.00, 0.00]

10.3 Calcipotriol vs. desoxymetasone

0

0

Risk Difference (M‐H, Random, 95% CI)

0.0 [0.0, 0.0]

10.4 Calcipotriol vs. diflorasone diacetate

0

0

Risk Difference (M‐H, Random, 95% CI)

0.0 [0.0, 0.0]

10.5 Calcipotriol vs. fluocinonide

0

0

Risk Difference (M‐H, Random, 95% CI)

0.0 [0.0, 0.0]

10.6 Calcitriol vs. betamethasone dipropionate

1

258

Risk Difference (M‐H, Random, 95% CI)

‐0.01 [‐0.04, 0.03]

10.7 Calcitriol vs. betamethasone valerate

0

0

Risk Difference (M‐H, Random, 95% CI)

0.0 [0.0, 0.0]

10.8 Tacalcitol vs. betamethasone valerate

1

152

Risk Difference (M‐H, Random, 95% CI)

0.0 [‐0.09, 0.09]

Open in table viewer
Comparison 8. Vitamin D analogues versus corticosteroid (very potent)

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 IAGI Show forest plot

1

Std. Mean Difference (IV, Random, 95% CI)

Totals not selected

Analysis 8.1

Comparison 8 Vitamin D analogues versus corticosteroid (very potent), Outcome 1 IAGI.

Comparison 8 Vitamin D analogues versus corticosteroid (very potent), Outcome 1 IAGI.

1.1 Calcipotriol vs. Clobetasol propionate

1

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

2 TSS

0

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

2.1 Calcipotriol vs. Clobetasol propionate

0

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

3 PASI Show forest plot

1

Std. Mean Difference (IV, Random, 95% CI)

Totals not selected

Analysis 8.3

Comparison 8 Vitamin D analogues versus corticosteroid (very potent), Outcome 3 PASI.

Comparison 8 Vitamin D analogues versus corticosteroid (very potent), Outcome 3 PASI.

3.1 Calcipotriol vs. Clobetasol propionate

1

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

4 PAGI Show forest plot

1

Std. Mean Difference (IV, Random, 95% CI)

Totals not selected

Analysis 8.4

Comparison 8 Vitamin D analogues versus corticosteroid (very potent), Outcome 4 PAGI.

Comparison 8 Vitamin D analogues versus corticosteroid (very potent), Outcome 4 PAGI.

4.1 Calcipotriol vs. Clobetasol propionate

1

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

5 Combined end point (IAGI/TSS/PASI/PAGI) Show forest plot

2

82

Std. Mean Difference (IV, Random, 95% CI)

‐0.06 [‐0.57, 0.44]

Analysis 8.5

Comparison 8 Vitamin D analogues versus corticosteroid (very potent), Outcome 5 Combined end point (IAGI/TSS/PASI/PAGI).

Comparison 8 Vitamin D analogues versus corticosteroid (very potent), Outcome 5 Combined end point (IAGI/TSS/PASI/PAGI).

5.1 Calcipotriol vs. Clobetasol propionate

2

82

Std. Mean Difference (IV, Random, 95% CI)

‐0.06 [‐0.57, 0.44]

6 Total withdrawals Show forest plot

1

Risk Difference (M‐H, Random, 95% CI)

Totals not selected

Analysis 8.6

Comparison 8 Vitamin D analogues versus corticosteroid (very potent), Outcome 6 Total withdrawals.

Comparison 8 Vitamin D analogues versus corticosteroid (very potent), Outcome 6 Total withdrawals.

6.1 Calcipotriol vs. Clobetasol propionate

1

Risk Difference (M‐H, Random, 95% CI)

0.0 [0.0, 0.0]

7 Withdrawals due to adverse events Show forest plot

1

Risk Difference (M‐H, Random, 95% CI)

Totals not selected

Analysis 8.7

Comparison 8 Vitamin D analogues versus corticosteroid (very potent), Outcome 7 Withdrawals due to adverse events.

Comparison 8 Vitamin D analogues versus corticosteroid (very potent), Outcome 7 Withdrawals due to adverse events.

7.1 Calcipotriol vs. Clobetasol propionate

1

Risk Difference (M‐H, Random, 95% CI)

0.0 [0.0, 0.0]

8 Withdrawals due to treatment failure Show forest plot

1

Risk Difference (M‐H, Random, 95% CI)

Totals not selected

Analysis 8.8

Comparison 8 Vitamin D analogues versus corticosteroid (very potent), Outcome 8 Withdrawals due to treatment failure.

Comparison 8 Vitamin D analogues versus corticosteroid (very potent), Outcome 8 Withdrawals due to treatment failure.

8.1 Calcipotriol vs. Clobetasol propionate

1

Risk Difference (M‐H, Random, 95% CI)

0.0 [0.0, 0.0]

9 Adverse events (local) Show forest plot

1

Risk Difference (M‐H, Random, 95% CI)

Totals not selected

Analysis 8.9

Comparison 8 Vitamin D analogues versus corticosteroid (very potent), Outcome 9 Adverse events (local).

Comparison 8 Vitamin D analogues versus corticosteroid (very potent), Outcome 9 Adverse events (local).

9.1 Calcipotriol vs. Clobetasol propionate

1

Risk Difference (M‐H, Random, 95% CI)

0.0 [0.0, 0.0]

10 Adverse events (systemic) Show forest plot

1

Risk Difference (M‐H, Random, 95% CI)

Totals not selected

Analysis 8.10

Comparison 8 Vitamin D analogues versus corticosteroid (very potent), Outcome 10 Adverse events (systemic).

Comparison 8 Vitamin D analogues versus corticosteroid (very potent), Outcome 10 Adverse events (systemic).

10.1 Calcipotriol vs. Clobetasol propionate

1

Risk Difference (M‐H, Random, 95% CI)

0.0 [0.0, 0.0]

Open in table viewer
Comparison 9. Vitamin D combined with corticosteroid versus corticosteroid

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 IAGI Show forest plot

4

Std. Mean Difference (IV, Random, 95% CI)

Subtotals only

Analysis 9.1

Comparison 9 Vitamin D combined with corticosteroid versus corticosteroid, Outcome 1 IAGI.

Comparison 9 Vitamin D combined with corticosteroid versus corticosteroid, Outcome 1 IAGI.

1.1 Calcipotriol + betamethasone dipropionate vs. betamethasone dipropionate

3

1926

Std. Mean Difference (IV, Random, 95% CI)

‐0.40 [‐0.52, ‐0.27]

1.2 Calcipotriol + betamethasone dipropionate vs. clobetasol propionate

0

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

1.3 Calcipotriol + clobetasol propionate vs. clobetasol propionate

1

65

Std. Mean Difference (IV, Random, 95% CI)

‐0.69 [‐1.22, ‐0.15]

2 TSS Show forest plot

1

Std. Mean Difference (IV, Random, 95% CI)

Totals not selected

Analysis 9.2

Comparison 9 Vitamin D combined with corticosteroid versus corticosteroid, Outcome 2 TSS.

Comparison 9 Vitamin D combined with corticosteroid versus corticosteroid, Outcome 2 TSS.

2.1 Calcipotriol + betamethasone dipropionate vs. betamethasone dipropionate

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

2.2 Calcipotriol + betamethasone dipropionate vs. clobetasol propionate

1

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

2.3 Calcipotriol + clobetasol propionate vs. clobetasol propionate

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

3 PASI Show forest plot

3

1876

Std. Mean Difference (IV, Random, 95% CI)

‐0.44 [‐0.55, ‐0.33]

Analysis 9.3

Comparison 9 Vitamin D combined with corticosteroid versus corticosteroid, Outcome 3 PASI.

Comparison 9 Vitamin D combined with corticosteroid versus corticosteroid, Outcome 3 PASI.

3.1 Calcipotriol + betamethasone dipropionate vs. betamethasone dipropionate

3

1876

Std. Mean Difference (IV, Random, 95% CI)

‐0.44 [‐0.55, ‐0.33]

3.2 Calcipotriol + betamethasone dipropionate vs. clobetasol propionate

0

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

3.3 Calcipotriol + clobetasol propionate vs. clobetasol propionate

0

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

4 PAGI Show forest plot

1

Std. Mean Difference (IV, Random, 95% CI)

Totals not selected

Analysis 9.4

Comparison 9 Vitamin D combined with corticosteroid versus corticosteroid, Outcome 4 PAGI.

Comparison 9 Vitamin D combined with corticosteroid versus corticosteroid, Outcome 4 PAGI.

4.1 Calcipotriol + betamethasone dipropionate vs. betamethasone dipropionate

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

4.2 Calcipotriol + betamethasone dipropionate vs. clobetasol propionate

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

4.3 Calcipotriol + clobetasol propionate vs. clobetasol propionate

1

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

5 Combined end point (IAGI/TSS/PASI/PAGI) Show forest plot

5

Std. Mean Difference (IV, Random, 95% CI)

Subtotals only

Analysis 9.5

Comparison 9 Vitamin D combined with corticosteroid versus corticosteroid, Outcome 5 Combined end point (IAGI/TSS/PASI/PAGI).

Comparison 9 Vitamin D combined with corticosteroid versus corticosteroid, Outcome 5 Combined end point (IAGI/TSS/PASI/PAGI).

5.1 Calcipotriol + betamethasone dipropionate vs. betamethasone dipropionate

3

1926

Std. Mean Difference (IV, Random, 95% CI)

‐0.40 [‐0.52, ‐0.27]

5.2 Calcipotriol + betamethasone dipropionate vs. clobetasol propionate

1

122

Std. Mean Difference (IV, Random, 95% CI)

0.45 [0.09, 0.81]

5.3 Calcipotriol + clobetasol propionate vs. clobetasol propionate

1

65

Std. Mean Difference (IV, Random, 95% CI)

‐0.69 [‐1.22, ‐0.15]

6 Total withdrawals Show forest plot

5

2135

Risk Difference (M‐H, Random, 95% CI)

‐0.00 [‐0.02, 0.01]

Analysis 9.6

Comparison 9 Vitamin D combined with corticosteroid versus corticosteroid, Outcome 6 Total withdrawals.

Comparison 9 Vitamin D combined with corticosteroid versus corticosteroid, Outcome 6 Total withdrawals.

6.1 Calcipotriol + betamethasone dipropionate vs. betamethasone dipropionate

3

1948

Risk Difference (M‐H, Random, 95% CI)

‐0.00 [‐0.03, 0.03]

6.2 Calcipotriol + betamethasone dipropionate vs. clobetasol propionate

1

122

Risk Difference (M‐H, Random, 95% CI)

0.0 [‐0.03, 0.03]

6.3 Calcipotriol + clobetasol propionate vs. clobetasol propionate

1

65

Risk Difference (M‐H, Random, 95% CI)

0.0 [‐0.07, 0.07]

7 Withdrawals due to adverse events Show forest plot

3

Risk Difference (M‐H, Random, 95% CI)

Totals not selected

Analysis 9.7

Comparison 9 Vitamin D combined with corticosteroid versus corticosteroid, Outcome 7 Withdrawals due to adverse events.

Comparison 9 Vitamin D combined with corticosteroid versus corticosteroid, Outcome 7 Withdrawals due to adverse events.

7.1 Calcipotriol + betamethasone dipropionate vs. betamethasone dipropionate

1

Risk Difference (M‐H, Random, 95% CI)

0.0 [0.0, 0.0]

7.2 Calcipotriol + betamethasone dipropionate vs. clobetasol propionate

1

Risk Difference (M‐H, Random, 95% CI)

0.0 [0.0, 0.0]

7.3 Calcipotriol + clobetasol propionate vs. clobetasol propionate

1

Risk Difference (M‐H, Random, 95% CI)

0.0 [0.0, 0.0]

8 Withdrawals due to treatment failure Show forest plot

2

Risk Difference (M‐H, Random, 95% CI)

Totals not selected

Analysis 9.8

Comparison 9 Vitamin D combined with corticosteroid versus corticosteroid, Outcome 8 Withdrawals due to treatment failure.

Comparison 9 Vitamin D combined with corticosteroid versus corticosteroid, Outcome 8 Withdrawals due to treatment failure.

8.1 Calcipotriol + betamethasone dipropionate vs. betamethasone dipropionate

0

Risk Difference (M‐H, Random, 95% CI)

0.0 [0.0, 0.0]

8.2 Calcipotriol + betamethasone dipropionate vs. clobetasol propionate

1

Risk Difference (M‐H, Random, 95% CI)

0.0 [0.0, 0.0]

8.3 Calcipotriol + clobetasol propionate vs. clobetasol propionate

1

Risk Difference (M‐H, Random, 95% CI)

0.0 [0.0, 0.0]

9 Adverse events (local) Show forest plot

4

Risk Difference (M‐H, Random, 95% CI)

Subtotals only

Analysis 9.9

Comparison 9 Vitamin D combined with corticosteroid versus corticosteroid, Outcome 9 Adverse events (local).

Comparison 9 Vitamin D combined with corticosteroid versus corticosteroid, Outcome 9 Adverse events (local).

9.1 Calcipotriol + betamethasone dipropionate vs. betamethasone dipropionate

3

1946

Risk Difference (M‐H, Random, 95% CI)

0.02 [‐0.00, 0.04]

9.2 Calcipotriol + betamethasone dipropionate vs. clobetasol propionate

1

122

Risk Difference (M‐H, Random, 95% CI)

‐0.04 [‐0.13, 0.06]

9.3 Calcipotriol + clobetasol propionate vs. clobetasol propionate

0

0

Risk Difference (M‐H, Random, 95% CI)

0.0 [0.0, 0.0]

10 Adverse events (systemic) Show forest plot

1

Risk Difference (M‐H, Random, 95% CI)

Totals not selected

Analysis 9.10

Comparison 9 Vitamin D combined with corticosteroid versus corticosteroid, Outcome 10 Adverse events (systemic).

Comparison 9 Vitamin D combined with corticosteroid versus corticosteroid, Outcome 10 Adverse events (systemic).

10.1 Calcipotriol + betamethasone dipropionate vs. betamethasone dipropionate

1

Risk Difference (M‐H, Random, 95% CI)

0.0 [0.0, 0.0]

10.2 Calcipotriol + betamethasone dipropionate vs. clobetasol propionate

0

Risk Difference (M‐H, Random, 95% CI)

0.0 [0.0, 0.0]

10.3 Calcipotriol + clobetasol propionate vs. clobetasol propionate

0

Risk Difference (M‐H, Random, 95% CI)

0.0 [0.0, 0.0]

Open in table viewer
Comparison 10. Vitamin D alone or in combination versus dithranol

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 IAGI Show forest plot

5

Std. Mean Difference (IV, Random, 95% CI)

Subtotals only

Analysis 10.1

Comparison 10 Vitamin D alone or in combination versus dithranol, Outcome 1 IAGI.

Comparison 10 Vitamin D alone or in combination versus dithranol, Outcome 1 IAGI.

1.1 Calcipotriol vs. dithranol

4

994

Std. Mean Difference (IV, Random, 95% CI)

‐0.43 [‐0.85, ‐0.01]

1.2 Calcitriol vs. dithranol

1

114

Std. Mean Difference (IV, Random, 95% CI)

0.51 [0.13, 0.88]

1.3 Tacalcitol vs. dithranol

0

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

2 TSS Show forest plot

4

Std. Mean Difference (IV, Random, 95% CI)

Subtotals only

Analysis 10.2

Comparison 10 Vitamin D alone or in combination versus dithranol, Outcome 2 TSS.

Comparison 10 Vitamin D alone or in combination versus dithranol, Outcome 2 TSS.

2.1 Calcipotriol vs. dithranol

2

210

Std. Mean Difference (IV, Random, 95% CI)

‐0.54 [‐1.16, 0.08]

2.2 Calcitriol vs. dithranol

1

114

Std. Mean Difference (IV, Random, 95% CI)

0.13 [‐0.24, 0.50]

2.3 Tacalcitol vs. dithranol

1

84

Std. Mean Difference (IV, Random, 95% CI)

‐0.18 [‐0.60, 0.25]

3 PASI Show forest plot

5

Std. Mean Difference (IV, Random, 95% CI)

Totals not selected

Analysis 10.3

Comparison 10 Vitamin D alone or in combination versus dithranol, Outcome 3 PASI.

Comparison 10 Vitamin D alone or in combination versus dithranol, Outcome 3 PASI.

3.1 Calcipotriol vs. dithranol

3

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

3.2 Calcitriol vs. dithranol

1

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

3.3 Tacalcitol vs. dithranol

1

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

4 PAGI Show forest plot

2

Std. Mean Difference (IV, Random, 95% CI)

Subtotals only

Analysis 10.4

Comparison 10 Vitamin D alone or in combination versus dithranol, Outcome 4 PAGI.

Comparison 10 Vitamin D alone or in combination versus dithranol, Outcome 4 PAGI.

4.1 Calcipotriol vs. dithranol

2

544

Std. Mean Difference (IV, Random, 95% CI)

‐0.05 [‐0.90, 0.80]

4.2 Calcitriol vs. dithranol

0

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

4.3 Tacalcitol vs. dithranol

0

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

5 Combined end point (IAGI/TSS/PASI/PAGI) Show forest plot

8

Std. Mean Difference (IV, Random, 95% CI)

Totals not selected

Analysis 10.5

Comparison 10 Vitamin D alone or in combination versus dithranol, Outcome 5 Combined end point (IAGI/TSS/PASI/PAGI).

Comparison 10 Vitamin D alone or in combination versus dithranol, Outcome 5 Combined end point (IAGI/TSS/PASI/PAGI).

5.1 Calcipotriol vs. dithranol

6

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

5.2 Calcitriol vs. dithranol

1

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

5.3 Tacalcitol vs. dithranol

1

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

6 Total withdrawals Show forest plot

7

615

Risk Difference (M‐H, Random, 95% CI)

‐0.02 [‐0.06, 0.01]

Analysis 10.6

Comparison 10 Vitamin D alone or in combination versus dithranol, Outcome 6 Total withdrawals.

Comparison 10 Vitamin D alone or in combination versus dithranol, Outcome 6 Total withdrawals.

6.1 Calcipotriol vs. dithranol

5

417

Risk Difference (M‐H, Random, 95% CI)

‐0.01 [‐0.07, 0.04]

6.2 Calcitriol vs. dithranol

1

114

Risk Difference (M‐H, Random, 95% CI)

‐0.10 [‐0.25, 0.06]

6.3 Tacalcitol vs. dithranol

1

84

Risk Difference (M‐H, Random, 95% CI)

‐0.02 [‐0.16, 0.11]

7 Withdrawals due to adverse events Show forest plot

7

1265

Risk Difference (M‐H, Random, 95% CI)

‐0.03 [‐0.06, ‐0.00]

Analysis 10.7

Comparison 10 Vitamin D alone or in combination versus dithranol, Outcome 7 Withdrawals due to adverse events.

Comparison 10 Vitamin D alone or in combination versus dithranol, Outcome 7 Withdrawals due to adverse events.

7.1 Calcipotriol vs. dithranol

6

1151

Risk Difference (M‐H, Random, 95% CI)

‐0.03 [‐0.06, 0.00]

7.2 Calcitriol vs. dithranol

1

114

Risk Difference (M‐H, Random, 95% CI)

‐0.06 [‐0.13, 0.02]

7.3 Tacalcitol vs. dithranol

0

0

Risk Difference (M‐H, Random, 95% CI)

0.0 [0.0, 0.0]

8 Withdrawals due to treatment failure Show forest plot

5

788

Risk Difference (M‐H, Random, 95% CI)

‐0.00 [‐0.02, 0.02]

Analysis 10.8

Comparison 10 Vitamin D alone or in combination versus dithranol, Outcome 8 Withdrawals due to treatment failure.

Comparison 10 Vitamin D alone or in combination versus dithranol, Outcome 8 Withdrawals due to treatment failure.

8.1 Calcipotriol vs. dithranol

4

674

Risk Difference (M‐H, Random, 95% CI)

0.00 [‐0.02, 0.02]

8.2 Calcitriol vs. dithranol

1

114

Risk Difference (M‐H, Random, 95% CI)

‐0.02 [‐0.08, 0.04]

8.3 Tacalcitol vs. dithranol

0

0

Risk Difference (M‐H, Random, 95% CI)

0.0 [0.0, 0.0]

9 Adverse events (local) Show forest plot

9

1543

Risk Difference (M‐H, Random, 95% CI)

‐0.32 [‐0.43, ‐0.20]

Analysis 10.9

Comparison 10 Vitamin D alone or in combination versus dithranol, Outcome 9 Adverse events (local).

Comparison 10 Vitamin D alone or in combination versus dithranol, Outcome 9 Adverse events (local).

9.1 Calcipotriol vs. dithranol

7

1345

Risk Difference (M‐H, Random, 95% CI)

‐0.25 [‐0.32, ‐0.17]

9.2 Calcitriol vs. dithranol

1

114

Risk Difference (M‐H, Random, 95% CI)

‐0.67 [‐0.80, ‐0.54]

9.3 Tacalcitol vs. dithranol

1

84

Risk Difference (M‐H, Random, 95% CI)

‐0.36 [‐0.52, ‐0.20]

10 Adverse events (systemic) Show forest plot

4

746

Risk Difference (M‐H, Random, 95% CI)

‐0.00 [‐0.01, 0.01]

Analysis 10.10

Comparison 10 Vitamin D alone or in combination versus dithranol, Outcome 10 Adverse events (systemic).

Comparison 10 Vitamin D alone or in combination versus dithranol, Outcome 10 Adverse events (systemic).

10.1 Calcipotriol vs. dithranol

2

548

Risk Difference (M‐H, Random, 95% CI)

‐0.00 [‐0.02, 0.01]

10.2 Calcitriol vs. dithranol

1

114

Risk Difference (M‐H, Random, 95% CI)

0.0 [‐0.03, 0.03]

10.3 Tacalcitol vs. dithranol

1

84

Risk Difference (M‐H, Random, 95% CI)

0.0 [‐0.05, 0.05]

Open in table viewer
Comparison 11. Vitamin D alone or in combination versus other vitamin D analogue

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 IAGI Show forest plot

3

Std. Mean Difference (IV, Random, 95% CI)

Subtotals only

Analysis 11.1

Comparison 11 Vitamin D alone or in combination versus other vitamin D analogue, Outcome 1 IAGI.

Comparison 11 Vitamin D alone or in combination versus other vitamin D analogue, Outcome 1 IAGI.

1.1 Calcipotriol vs. calcitriol

1

246

Std. Mean Difference (IV, Random, 95% CI)

0.0 [‐0.25, 0.25]

1.2 Calcipotriol vs. tacalcitol

1

226

Std. Mean Difference (IV, Random, 95% CI)

‐0.47 [‐0.73, ‐0.21]

1.3 Calcipotriol vs. maxacalcitol

1

52

Std. Mean Difference (IV, Random, 95% CI)

0.43 [‐0.12, 0.98]

2 TSS Show forest plot

3

589

Std. Mean Difference (IV, Random, 95% CI)

‐0.31 [‐0.55, ‐0.06]

Analysis 11.2

Comparison 11 Vitamin D alone or in combination versus other vitamin D analogue, Outcome 2 TSS.

Comparison 11 Vitamin D alone or in combination versus other vitamin D analogue, Outcome 2 TSS.

2.1 Calcipotriol vs. calcitriol

1

250

Std. Mean Difference (IV, Random, 95% CI)

‐0.32 [‐0.57, ‐0.07]

2.2 Calcipotriol vs. tacalcitol

1

287

Std. Mean Difference (IV, Random, 95% CI)

‐0.45 [‐0.68, ‐0.22]

2.3 Calcipotriol vs. maxacalcitol

1

52

Std. Mean Difference (IV, Random, 95% CI)

0.13 [‐0.41, 0.68]

3 PASI Show forest plot

1

Std. Mean Difference (IV, Random, 95% CI)

Totals not selected

Analysis 11.3

Comparison 11 Vitamin D alone or in combination versus other vitamin D analogue, Outcome 3 PASI.

Comparison 11 Vitamin D alone or in combination versus other vitamin D analogue, Outcome 3 PASI.

3.1 Calcipotriol vs. calcitriol

1

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

3.2 Calcipotriol vs. tacalcitol

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

3.3 Calcipotriol vs. maxacalcitol

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

4 PAGI Show forest plot

1

Std. Mean Difference (IV, Random, 95% CI)

Totals not selected

Analysis 11.4

Comparison 11 Vitamin D alone or in combination versus other vitamin D analogue, Outcome 4 PAGI.

Comparison 11 Vitamin D alone or in combination versus other vitamin D analogue, Outcome 4 PAGI.

4.1 Calcipotriol vs. calcitriol

1

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

4.2 Calcipotriol vs. tacalcitol

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

4.3 Calcipotriol vs. maxacalcitol

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

5 Combined end point (IAGI/TSS/PASI/PAGI) Show forest plot

4

539

Std. Mean Difference (IV, Random, 95% CI)

‐0.17 [‐0.62, 0.27]

Analysis 11.5

Comparison 11 Vitamin D alone or in combination versus other vitamin D analogue, Outcome 5 Combined end point (IAGI/TSS/PASI/PAGI).

Comparison 11 Vitamin D alone or in combination versus other vitamin D analogue, Outcome 5 Combined end point (IAGI/TSS/PASI/PAGI).

5.1 Calcipotriol vs. calcitriol

2

261

Std. Mean Difference (IV, Random, 95% CI)

‐0.41 [‐1.46, 0.64]

5.2 Calcipotriol vs. tacalcitol

1

226

Std. Mean Difference (IV, Random, 95% CI)

‐0.47 [‐0.73, ‐0.21]

5.3 Calcipotriol vs. maxacalcitol

1

52

Std. Mean Difference (IV, Random, 95% CI)

0.43 [‐0.12, 0.98]

6 Total withdrawals Show forest plot

3

334

Risk Difference (M‐H, Random, 95% CI)

0.02 [‐0.04, 0.08]

Analysis 11.6

Comparison 11 Vitamin D alone or in combination versus other vitamin D analogue, Outcome 6 Total withdrawals.

Comparison 11 Vitamin D alone or in combination versus other vitamin D analogue, Outcome 6 Total withdrawals.

6.1 Calcipotriol vs. calcitriol

2

274

Risk Difference (M‐H, Random, 95% CI)

0.02 [‐0.04, 0.09]

6.2 Calcipotriol vs. tacalcitol

0

0

Risk Difference (M‐H, Random, 95% CI)

0.0 [0.0, 0.0]

6.3 Calcipotriol vs. maxacalcitol

1

60

Risk Difference (M‐H, Random, 95% CI)

0.0 [‐0.17, 0.17]

7 Withdrawals due to adverse events Show forest plot

3

334

Risk Difference (M‐H, Random, 95% CI)

0.02 [‐0.01, 0.06]

Analysis 11.7

Comparison 11 Vitamin D alone or in combination versus other vitamin D analogue, Outcome 7 Withdrawals due to adverse events.

Comparison 11 Vitamin D alone or in combination versus other vitamin D analogue, Outcome 7 Withdrawals due to adverse events.

7.1 Calcipotriol vs. calcitriol

2

274

Risk Difference (M‐H, Random, 95% CI)

0.03 [‐0.01, 0.07]

7.2 Calcipotriol vs. tacalcitol

0

0

Risk Difference (M‐H, Random, 95% CI)

0.0 [0.0, 0.0]

7.3 Calcipotriol vs. maxacalcitol

1

60

Risk Difference (M‐H, Random, 95% CI)

0.0 [‐0.06, 0.06]

8 Withdrawals due to treatment failure Show forest plot

3

334

Risk Difference (M‐H, Random, 95% CI)

‐0.00 [‐0.02, 0.01]

Analysis 11.8

Comparison 11 Vitamin D alone or in combination versus other vitamin D analogue, Outcome 8 Withdrawals due to treatment failure.

Comparison 11 Vitamin D alone or in combination versus other vitamin D analogue, Outcome 8 Withdrawals due to treatment failure.

8.1 Calcipotriol vs. calcitriol

2

274

Risk Difference (M‐H, Random, 95% CI)

‐0.01 [‐0.08, 0.07]

8.2 Calcipotriol vs. tacalcitol

0

0

Risk Difference (M‐H, Random, 95% CI)

0.0 [0.0, 0.0]

8.3 Calcipotriol vs. maxacalcitol

1

60

Risk Difference (M‐H, Random, 95% CI)

0.0 [‐0.06, 0.06]

9 Adverse events (local) Show forest plot

2

537

Risk Difference (M‐H, Random, 95% CI)

0.03 [‐0.05, 0.12]

Analysis 11.9

Comparison 11 Vitamin D alone or in combination versus other vitamin D analogue, Outcome 9 Adverse events (local).

Comparison 11 Vitamin D alone or in combination versus other vitamin D analogue, Outcome 9 Adverse events (local).

9.1 Calcipotriol vs. calcitriol

1

250

Risk Difference (M‐H, Random, 95% CI)

0.07 [0.01, 0.14]

9.2 Calcipotriol vs. tacalcitol

1

287

Risk Difference (M‐H, Random, 95% CI)

‐0.01 [‐0.09, 0.07]

9.3 Calcipotriol vs. maxacalcitol

0

0

Risk Difference (M‐H, Random, 95% CI)

0.0 [0.0, 0.0]

10 Adverse events (systemic) Show forest plot

3

597

Risk Difference (M‐H, Random, 95% CI)

0.0 [‐0.01, 0.01]

Analysis 11.10

Comparison 11 Vitamin D alone or in combination versus other vitamin D analogue, Outcome 10 Adverse events (systemic).

Comparison 11 Vitamin D alone or in combination versus other vitamin D analogue, Outcome 10 Adverse events (systemic).

10.1 Calcipotriol vs. calcitriol

1

250

Risk Difference (M‐H, Random, 95% CI)

0.0 [‐0.02, 0.02]

10.2 Calcipotriol vs. tacalcitol

1

287

Risk Difference (M‐H, Random, 95% CI)

0.0 [‐0.01, 0.01]

10.3 Calcipotriol vs. maxacalcitol

1

60

Risk Difference (M‐H, Random, 95% CI)

0.0 [‐0.06, 0.06]

Open in table viewer
Comparison 12. Vitamin D alone or in combination versus vitamin D + corticosteroid

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 IAGI Show forest plot

11

Std. Mean Difference (IV, Random, 95% CI)

Subtotals only

Analysis 12.1

Comparison 12 Vitamin D alone or in combination versus vitamin D + corticosteroid, Outcome 1 IAGI.

Comparison 12 Vitamin D alone or in combination versus vitamin D + corticosteroid, Outcome 1 IAGI.

1.1 Calcipotriol twice daily vs. calcipotriol OM, BMD ON

1

154

Std. Mean Difference (IV, Random, 95% CI)

0.56 [0.23, 0.88]

1.2 Calcipotriol OD vs. combined calcipotriol + BMD OD

2

1194

Std. Mean Difference (IV, Random, 95% CI)

0.66 [0.31, 1.02]

1.3 Calcipotriol twice daily vs. combined calcipotriol + BMD OD

1

377

Std. Mean Difference (IV, Random, 95% CI)

0.27 [0.06, 0.48]

1.4 Calcipotriol twice daily vs. combined calcipotriol + BMD twice daily

3

1804

Std. Mean Difference (IV, Random, 95% CI)

0.66 [0.40, 0.93]

1.5 Calcipotriol twice daily vs. calcipotriol OM, BMV ON

2

510

Std. Mean Difference (IV, Random, 95% CI)

0.27 [‐0.19, 0.74]

1.6 Calcipotriol twice daily vs. calcipotriol OM, clobetasone butyrate ON

1

344

Std. Mean Difference (IV, Random, 95% CI)

0.27 [0.05, 0.48]

1.7 Calcipotriol twice daily vs. calcipotriol twice daily + clobetasol propionate twice daily

1

65

Std. Mean Difference (IV, Random, 95% CI)

0.88 [0.34, 1.42]

1.8 Calcipotriol twice daily vs. calcipotriol OM, diflucortolone valerate ON

0

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

1.9 Calcipotriol OD vs. calcipotriol OM, fluocinonide acetonide ON

0

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

1.10 Calcipotriol OD vs. combined calcipotriol + hydrocortisone OD

1

408

Std. Mean Difference (IV, Random, 95% CI)

0.14 [‐0.06, 0.33]

1.11 Calcitriol twice daily vs. diflucortolone valerate OM, calcitriol ON

0

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

1.12 Tacalcitol OD vs. combined calcipotriol + BMD OD

1

334

Std. Mean Difference (IV, Random, 95% CI)

0.48 [0.26, 0.70]

2 TSS Show forest plot

1

Std. Mean Difference (IV, Random, 95% CI)

Totals not selected

Analysis 12.2

Comparison 12 Vitamin D alone or in combination versus vitamin D + corticosteroid, Outcome 2 TSS.

Comparison 12 Vitamin D alone or in combination versus vitamin D + corticosteroid, Outcome 2 TSS.

2.1 Calcipotriol twice daily vs. calcipotriol OM, BMD ON

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

2.2 Calcipotriol OD vs. combined calcipotriol + BMD OD

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

2.3 Calcipotriol twice daily vs. combined calcipotriol + BMD OD

1

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

2.4 Calcipotriol twice daily vs. combined calcipotriol + BMD twice daily

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

2.5 Calcipotriol twice daily vs. calcipotriol OM, BMV ON

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

2.6 Calcipotriol twice daily vs. calcipotriol OM, clobetasone butyrate ON

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

2.7 Calcipotriol twice daily vs. calcipotriol twice daily + clobetasol propionate twice daily

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

2.8 Calcipotriol twice daily vs. calcipotriol OM, diflucortolone valerate ON

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

2.9 Calcipotriol OD vs. calcipotriol OM, fluocinonide acetonide ON

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

2.10 Calcipotriol OD vs. combined calcipotriol + hydrocortisone OD

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

2.11 Calcitriol twice daily vs. diflucortolone valerate OM, calcitriol ON

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

2.12 Tacalcitol OD vs. combined calcipotriol + BMD OD

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

3 PASI Show forest plot

16

Std. Mean Difference (IV, Random, 95% CI)

Subtotals only

Analysis 12.3

Comparison 12 Vitamin D alone or in combination versus vitamin D + corticosteroid, Outcome 3 PASI.

Comparison 12 Vitamin D alone or in combination versus vitamin D + corticosteroid, Outcome 3 PASI.

3.1 Calcipotriol twice daily vs. calcipotriol OM, BMD ON

1

124

Std. Mean Difference (IV, Random, 95% CI)

0.46 [0.10, 0.82]

3.2 Calcipotriol OD vs. combined calcipotriol + BMD OD

2

1191

Std. Mean Difference (IV, Random, 95% CI)

0.67 [0.23, 1.11]

3.3 Calcipotriol twice daily vs. combined calcipotriol + BMD OD

4

1204

Std. Mean Difference (IV, Random, 95% CI)

0.52 [0.38, 0.67]

3.4 Calcipotriol twice daily vs. combined calcipotriol + BMD twice daily

3

1744

Std. Mean Difference (IV, Random, 95% CI)

0.64 [0.46, 0.83]

3.5 Calcipotriol twice daily vs. calcipotriol OM, BMV ON

2

515

Std. Mean Difference (IV, Random, 95% CI)

0.43 [‐0.07, 0.93]

3.6 Calcipotriol twice daily vs. calcipotriol OM, clobetasone butyrate ON

1

344

Std. Mean Difference (IV, Random, 95% CI)

0.17 [‐0.04, 0.38]

3.7 Calcipotriol twice daily vs. calcipotriol twice daily + clobetasol propionate twice daily

0

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

3.8 Calcipotriol twice daily vs. calcipotriol OM, diflucortolone valerate ON

1

116

Std. Mean Difference (IV, Random, 95% CI)

0.08 [‐0.29, 0.44]

3.9 Calcipotriol OD vs. calcipotriol OM, fluocinonide acetonide ON

1

38

Std. Mean Difference (IV, Random, 95% CI)

0.53 [‐0.11, 1.18]

3.10 Calcipotriol OD vs. combined calcipotriol + hydrocortisone OD

1

408

Std. Mean Difference (IV, Random, 95% CI)

0.08 [‐0.11, 0.28]

3.11 Calcitriol twice daily vs. diflucortolone valerate OM, calcitriol ON

1

142

Std. Mean Difference (IV, Random, 95% CI)

0.24 [‐0.09, 0.57]

3.12 Tacalcitol OD vs. combined calcipotriol + BMD OD

1

334

Std. Mean Difference (IV, Random, 95% CI)

0.47 [0.25, 0.69]

4 PAGI Show forest plot

2

399

Std. Mean Difference (IV, Random, 95% CI)

0.49 [0.29, 0.69]

Analysis 12.4

Comparison 12 Vitamin D alone or in combination versus vitamin D + corticosteroid, Outcome 4 PAGI.

Comparison 12 Vitamin D alone or in combination versus vitamin D + corticosteroid, Outcome 4 PAGI.

4.1 Calcipotriol twice daily vs. calcipotriol OM, BMD ON

0

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

4.2 Calcipotriol OD vs. combined calcipotriol + BMD OD

0

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

4.3 Calcipotriol twice daily vs. combined calcipotriol + BMD OD

0

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

4.4 Calcipotriol twice daily vs. combined calcipotriol + BMD twice daily

0

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

4.5 Calcipotriol twice daily vs. calcipotriol OM, BMV ON

0

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

4.6 Calcipotriol twice daily vs. calcipotriol OM, clobetasone butyrate ON

0

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

4.7 Calcipotriol twice daily vs. calcipotriol twice daily + clobetasol propionate twice daily

1

65

Std. Mean Difference (IV, Random, 95% CI)

0.70 [0.16, 1.23]

4.8 Calcipotriol twice daily vs. calcipotriol OM, diflucortolone valerate ON

0

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

4.9 Calcipotriol OD vs. calcipotriol OM, fluocinonide acetonide ON

0

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

4.10 Calcipotriol OD vs. combined calcipotriol + hydrocortisone OD

0

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

4.11 Calcitriol twice daily vs. diflucortolone valerate OM, calcitriol ON

0

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

4.12 Tacalcitol OD vs. combined calcipotriol + BMD OD

1

334

Std. Mean Difference (IV, Random, 95% CI)

0.46 [0.24, 0.68]

5 Combined end point (IAGI/TSS/PASI/PAGI) Show forest plot

17

Std. Mean Difference (IV, Random, 95% CI)

Subtotals only

Analysis 12.5

Comparison 12 Vitamin D alone or in combination versus vitamin D + corticosteroid, Outcome 5 Combined end point (IAGI/TSS/PASI/PAGI).

Comparison 12 Vitamin D alone or in combination versus vitamin D + corticosteroid, Outcome 5 Combined end point (IAGI/TSS/PASI/PAGI).

5.1 Calcipotriol twice daily vs. calcipotriol OM, BMD ON

1

154

Std. Mean Difference (IV, Random, 95% CI)

0.56 [0.23, 0.88]

5.2 Calcipotriol OD vs. combined calcipotriol + BMD OD

2

1194

Std. Mean Difference (IV, Random, 95% CI)

0.66 [0.31, 1.02]

5.3 Calcipotriol twice daily vs. combined calcipotriol + BMD OD

4

1204

Std. Mean Difference (IV, Random, 95% CI)

0.43 [0.20, 0.66]

5.4 Calcipotriol twice daily vs. combined calcipotriol + BMD twice daily

3

1804

Std. Mean Difference (IV, Random, 95% CI)

0.66 [0.40, 0.93]

5.5 Calcipotriol twice daily vs. calcipotriol OM, BMV ON

2

510

Std. Mean Difference (IV, Random, 95% CI)

0.27 [‐0.19, 0.74]

5.6 Calcipotriol twice daily vs. calcipotriol OM, clobetasone butyrate ON

1

344

Std. Mean Difference (IV, Random, 95% CI)

0.27 [0.05, 0.48]

5.7 Calcipotriol twice daily vs. calcipotriol twice daily + clobetasol propionate twice daily

1

65

Std. Mean Difference (IV, Random, 95% CI)

0.88 [0.34, 1.42]

5.8 Calcipotriol twice daily vs. calcipotriol OM, diflucortolone valerate ON

1

116

Std. Mean Difference (IV, Random, 95% CI)

0.08 [‐0.29, 0.44]

5.9 Calcipotriol OD vs. calcipotriol OM, fluocinonide acetonide ON

1

38

Std. Mean Difference (IV, Random, 95% CI)

0.53 [‐0.11, 1.18]

5.10 Calcipotriol OD vs. combined calcipotriol + hydrocortisone OD

1

408

Std. Mean Difference (IV, Random, 95% CI)

0.14 [‐0.06, 0.33]

5.11 Calcitriol twice daily vs. diflucortolone valerate OM, calcitriol ON

1

142

Std. Mean Difference (IV, Random, 95% CI)

0.24 [‐0.09, 0.57]

5.12 Tacalcitol OD vs. combined calcipotriol + BMD OD

1

334

Std. Mean Difference (IV, Random, 95% CI)

0.48 [0.26, 0.70]

6 Total withdrawals Show forest plot

15

5494

Risk Difference (M‐H, Random, 95% CI)

0.03 [0.02, 0.05]

Analysis 12.6

Comparison 12 Vitamin D alone or in combination versus vitamin D + corticosteroid, Outcome 6 Total withdrawals.

Comparison 12 Vitamin D alone or in combination versus vitamin D + corticosteroid, Outcome 6 Total withdrawals.

6.1 Talcipotriol vs. calcipotriol and corticosteroid

13

4985

Risk Difference (M‐H, Random, 95% CI)

0.03 [0.01, 0.05]

6.2 Calcitriol vs. calcitriol and corticosteroid

1

142

Risk Difference (M‐H, Random, 95% CI)

0.01 [‐0.08, 0.10]

6.3 Tacalcitol vs. calcipotriol and corticosteroid

1

367

Risk Difference (M‐H, Random, 95% CI)

0.05 [‐0.01, 0.11]

7 Withdrawals due to adverse events Show forest plot

13

4081

Risk Difference (M‐H, Random, 95% CI)

0.02 [0.01, 0.03]

Analysis 12.7

Comparison 12 Vitamin D alone or in combination versus vitamin D + corticosteroid, Outcome 7 Withdrawals due to adverse events.

Comparison 12 Vitamin D alone or in combination versus vitamin D + corticosteroid, Outcome 7 Withdrawals due to adverse events.

7.1 Calcipotriol vs. calcipotriol and corticosteroid

11

3572

Risk Difference (M‐H, Random, 95% CI)

0.02 [0.01, 0.03]

7.2 Calcitriol vs. calcitriol and corticosteroid

1

142

Risk Difference (M‐H, Random, 95% CI)

0.03 [‐0.02, 0.07]

7.3 Tacalcitol vs. calcipotriol and corticosteroid

1

367

Risk Difference (M‐H, Random, 95% CI)

0.01 [‐0.02, 0.03]

8 Withdrawals due to treatment failure Show forest plot

7

1925

Risk Difference (M‐H, Random, 95% CI)

0.01 [‐0.00, 0.02]

Analysis 12.8

Comparison 12 Vitamin D alone or in combination versus vitamin D + corticosteroid, Outcome 8 Withdrawals due to treatment failure.

Comparison 12 Vitamin D alone or in combination versus vitamin D + corticosteroid, Outcome 8 Withdrawals due to treatment failure.

8.1 Calcipotriol vs. calcipotriol and corticosteroid

7

1925

Risk Difference (M‐H, Random, 95% CI)

0.01 [‐0.00, 0.02]

8.2 Calcitriol vs. calcitriol and corticosteroid

0

0

Risk Difference (M‐H, Random, 95% CI)

0.0 [0.0, 0.0]

8.3 Tacalcitol vs. calcipotriol and corticosteroid

0

0

Risk Difference (M‐H, Random, 95% CI)

0.0 [0.0, 0.0]

9 Adverse events (local) Show forest plot

15

5581

Risk Difference (M‐H, Random, 95% CI)

0.06 [0.05, 0.08]

Analysis 12.9

Comparison 12 Vitamin D alone or in combination versus vitamin D + corticosteroid, Outcome 9 Adverse events (local).

Comparison 12 Vitamin D alone or in combination versus vitamin D + corticosteroid, Outcome 9 Adverse events (local).

9.1 Calcipotriol vs. calcipotriol and corticosteroid

13

5084

Risk Difference (M‐H, Random, 95% CI)

0.06 [0.04, 0.08]

9.2 Calcitriol vs. calcitriol and corticosteroid

1

131

Risk Difference (M‐H, Random, 95% CI)

0.10 [0.02, 0.19]

9.3 Tacalcitol vs. calcipotriol and corticosteroid

1

366

Risk Difference (M‐H, Random, 95% CI)

0.09 [0.02, 0.15]

10 Adverse events (systemic) Show forest plot

6

2099

Risk Difference (M‐H, Random, 95% CI)

0.00 [‐0.00, 0.00]

Analysis 12.10

Comparison 12 Vitamin D alone or in combination versus vitamin D + corticosteroid, Outcome 10 Adverse events (systemic).

Comparison 12 Vitamin D alone or in combination versus vitamin D + corticosteroid, Outcome 10 Adverse events (systemic).

10.1 Calcipotriol vs. calcipotriol and corticosteroid

5

1968

Risk Difference (M‐H, Random, 95% CI)

0.00 [‐0.00, 0.00]

10.2 Calcitriol vs. calcitriol and corticosteroid

1

131

Risk Difference (M‐H, Random, 95% CI)

0.0 [‐0.03, 0.03]

10.3 Tacalcitol vs. calcipotriol and corticosteroid

0

0

Risk Difference (M‐H, Random, 95% CI)

0.0 [0.0, 0.0]

Open in table viewer
Comparison 13. Vitamin D alone or in combination versus other treatments: complex regimens

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 IAGI Show forest plot

7

Std. Mean Difference (IV, Random, 95% CI)

Subtotals only

Analysis 13.1

Comparison 13 Vitamin D alone or in combination versus other treatments: complex regimens, Outcome 1 IAGI.

Comparison 13 Vitamin D alone or in combination versus other treatments: complex regimens, Outcome 1 IAGI.

1.1 Calcipotriol (12 wks) vs. combined calcipotriol + BMD (8 wks); then calcipotriol (4 wks)

1

577

Std. Mean Difference (IV, Random, 95% CI)

‐0.12 [‐0.29, 0.04]

1.2 Calcipotriol (12 wks) vs. combined calcipotriol + BMD (4 wks); then calcipotriol (8 wks)

0

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

1.3 Calcipotriol (12 wks) vs. combined calcipotriol + BMD (4 wks); then calcipotriol (w/dy) & combined calcipotriol + BMD (w/e) (8 wks)

1

585

Std. Mean Difference (IV, Random, 95% CI)

0.13 [‐0.04, 0.29]

1.4 Calcipotriol (6 wks) vs. clobetasol propionate (2 wks); then calcipotriol (4 wks)

1

92

Std. Mean Difference (IV, Random, 95% CI)

0.60 [0.18, 1.02]

1.5 Calcipotriol (6 wks) vs. calcipotriol OM, fluocinonide acetonide ON (2 wks); then calcipotriol twice daily (4 wks)

0

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

1.6 Calcipotriol (6 wks) vs. halometasone OM, calcipotriol ON (2 wks); then calcipotriol twice daily (w/dy), halometasone (w/e) (2 wks); then calcipotriol twice daily (2wks)

1

76

Std. Mean Difference (IV, Random, 95% CI)

0.41 [‐0.05, 0.86]

1.7 Calcipotriol ON, clobetasol propionate OM (2 to 4 wks); then calcipotriol twice daily (to wk 12) vs. calcitriol ON, clobetasol propionate OM (2 to 4 wks); then calcitriol twice daily (to wk 12)

1

125

Std. Mean Difference (IV, Random, 95% CI)

‐0.19 [‐0.54, 0.16]

1.8 Combined calcipotriol + BMD (4 wks); then placebo ointment twice daily (8 wks) vs. combined calcipotriol + BMD (4 wks); then calcipotriol ointment twice daily (8 wks)

1

759

Std. Mean Difference (IV, Random, 95% CI)

0.27 [0.12, 0.41]

1.9 Combined calcipotriol + BMD (4 wks); then placebo ointment twice daily (8 wks) vs. combined calcipotriol + BMD (4 wks); then calcipotriol (w/dy)+ combined calcipotriol + BMD (w/e) (8 wks)

1

753

Std. Mean Difference (IV, Random, 95% CI)

0.51 [0.37, 0.66]

1.10 Combined calcipotriol + BMD (4 wks); then calcipotriol ointment twice daily (8 wks) vs. combined calcipotriol + BMD (4 wks); then calcipotriol (w/dy)+ combined calcipotriol + BMD (w/e) (8 wks)

1

760

Std. Mean Difference (IV, Random, 95% CI)

0.26 [0.11, 0.40]

1.11 Combined calcipotriol + BMD (8 wks); then calcipotriol (4 wks) vs. combined calcipotriol + BMD (4 wks); then calcipotriol (w/dy) & combined calcipotriol + BMD (w/e) (8 wks)

1

596

Std. Mean Difference (IV, Random, 95% CI)

0.24 [0.08, 0.40]

1.12 Tacalcitol (8 wks) vs. combined calcipotriol + BMD (4 wks); then calcipotriol (4 wks)

1

493

Std. Mean Difference (IV, Random, 95% CI)

0.54 [0.36, 0.72]

2 TSS Show forest plot

1

Std. Mean Difference (IV, Random, 95% CI)

Subtotals only

Analysis 13.2

Comparison 13 Vitamin D alone or in combination versus other treatments: complex regimens, Outcome 2 TSS.

Comparison 13 Vitamin D alone or in combination versus other treatments: complex regimens, Outcome 2 TSS.

2.1 Calcipotriol (12 wks) vs. combined calcipotriol + BMD (8 wks); then calcipotriol (4 wks)

0

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

2.2 Calcipotriol (12 wks) vs. combined calcipotriol + BMD (4 wks); then calcipotriol (8 wks)

0

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

2.3 Calcipotriol (12 wks) vs. combined calcipotriol + BMD (4 wks); then calcipotriol (w/dy) & combined calcipotriol + BMD (w/e) (8 wks)

0

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

2.4 Calcipotriol (6 wks) vs. clobetasol propionate (2wks); then calcipotriol (4 wks)

1

92

Std. Mean Difference (IV, Random, 95% CI)

0.63 [0.21, 1.05]

2.5 Calcipotriol (6 wks) vs. calcipotriol OM, fluocinonide acetonide ON (2 wks); then calcipotriol twice daily (4 wks)

0

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

2.6 Calcipotriol (6 wks) vs. halometasone OM, calcipotriol ON (2 wks); then calcipotriol twice daily (w/dy), halometasone (w/e) (2 wks); then calcipotriol twice daily (2 wks)

0

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

2.7 Calcipotriol ON, clobetasol propionate OM (2 to 4 wks); then calcipotriol twice daily (to wk 12) vs. calcitriol ON, clobetasol propionate OM (2 to 4 wks); then calcitriol twice daily (to wk 12)

0

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

2.8 Combined calcipotriol + BMD (4 wks); then placebo ointment twice daily (8 wks) vs. combined calcipotriol + BMD (4 wks); then calcipotriol ointment twice daily (8 wks)

0

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

2.9 Combined calcipotriol + BMD (4 wks); then placebo ointment twice daily (8 wks) vs. combined calcipotriol + BMD (4 wks); then calcipotriol (w/dy) + combined calcipotriol + BMD (w/e) (8 wks)

0

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

2.10 Combined calcipotriol + BMD (4 wks); then calcipotriol ointment twice daily (8 wks) vs. combined calcipotriol + BMD (4 wks); then calcipotriol (w/dy) + combined calcipotriol + BMD (w/e) (8 wks)

0

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

2.11 Combined calcipotriol + BMD (8 wks); then calcipotriol (4 wks) vs. combined calcipotriol + BMD (4 wks); then calcipotriol (w/dy) & combined calcipotriol + BMD (w/e) (8 wks)

0

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

2.12 Tacalcitol (8 wks) vs. combined calcipotriol + BMD (4 wks); then calcipotriol (4 wks)

0

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

3 PASI Show forest plot

8

Std. Mean Difference (IV, Random, 95% CI)

Subtotals only

Analysis 13.3

Comparison 13 Vitamin D alone or in combination versus other treatments: complex regimens, Outcome 3 PASI.

Comparison 13 Vitamin D alone or in combination versus other treatments: complex regimens, Outcome 3 PASI.

3.1 Calcipotriol (12 wks) vs. combined calcipotriol + BMD (8 wks); then calcipotriol (4 wks)

1

649

Std. Mean Difference (IV, Random, 95% CI)

‐0.04 [‐0.19, 0.11]

3.2 Calcipotriol (12 wks) vs. combined calcipotriol + BMD (4 wks); then calcipotriol (8 wks)

1

143

Std. Mean Difference (IV, Random, 95% CI)

0.29 [‐0.04, 0.62]

3.3 Calcipotriol (12 wks) vs. combined calcipotriol + BMD (4 wks); then calcipotriol (w/dy) & combined calcipotriol + BMD (w/e) (8 wks)

1

650

Std. Mean Difference (IV, Random, 95% CI)

0.10 [‐0.05, 0.25]

3.4 Calcipotriol (6 wks) vs. clobetasol propionate (2 wks); then calcipotriol (4 wks)

0

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

3.5 Calcipotriol (6 wks) vs. calcipotriol OM, fluocinonide acetonide ON (2 wks); then calcipotriol twice daily (4 wks)

1

38

Std. Mean Difference (IV, Random, 95% CI)

0.66 [0.01, 1.32]

3.6 Calcipotriol (6 wks) vs. halometasone OM, calcipotriol ON (2 wks); then calcipotriol twice daily (w/dy), halometasone (w/e) (2 wks); then calcipotriol twice daily (2 wks)

1

76

Std. Mean Difference (IV, Random, 95% CI)

1.13 [0.64, 1.62]

3.7 Calcipotriol ON, clobetasol propionate OM (2 to 4 wks); then calcipotriol twice daily (to wk 12) vs. calcitriol ON, clobetasol propionate OM (2 to 4 wks); then calcitriol twice daily (to wk 12)

1

125

Std. Mean Difference (IV, Random, 95% CI)

‐0.27 [‐0.62, 0.09]

3.8 Combined calcipotriol + BMD (4 wks); then placebo ointment twice daily (8 wks) vs. combined calcipotriol + BMD (4 wks); then calcipotriol ointment twice daily (8 wks)

1

759

Std. Mean Difference (IV, Random, 95% CI)

0.25 [0.10, 0.39]

3.9 Combined calcipotriol + BMD (4 wks); then placebo ointment twice daily (8 wks) vs. combined calcipotriol + BMD (4 wks); then calcipotriol (w/dy) + combined calcipotriol + BMD (w/e) (8 wks)

1

753

Std. Mean Difference (IV, Random, 95% CI)

0.59 [0.45, 0.74]

3.10 Combined calcipotriol + BMD (4 wks); then calcipotriol ointment twice daily (8 wks) vs. combined calcipotriol + BMD (4 wks); then calcipotriol (w/dy) + combined calcipotriol + BMD (w/e) (8 wks)

1

760

Std. Mean Difference (IV, Random, 95% CI)

0.30 [0.16, 0.45]

3.11 Combined calcipotriol + BMD (8 wks); then calcipotriol (4 wks) vs. combined calcipotriol + BMD (4 wks); then calcipotriol (w/dy) & combined calcipotriol + BMD (w/e) (8 wks)

1

645

Std. Mean Difference (IV, Random, 95% CI)

0.15 [‐0.01, 0.30]

3.12 Tacalcitol (8 wks) vs. combined calcipotriol + BMD (4 wks); then calcipotriol (4 wks)

1

501

Std. Mean Difference (IV, Random, 95% CI)

0.49 [0.31, 0.67]

4 PAGI Show forest plot

4

Std. Mean Difference (IV, Random, 95% CI)

Subtotals only

Analysis 13.4

Comparison 13 Vitamin D alone or in combination versus other treatments: complex regimens, Outcome 4 PAGI.

Comparison 13 Vitamin D alone or in combination versus other treatments: complex regimens, Outcome 4 PAGI.

4.1 Calcipotriol (12 wks) vs. combined calcipotriol + BMD (8 wks); then calcipotriol (4 wks)

1

577

Std. Mean Difference (IV, Random, 95% CI)

‐0.14 [‐0.30, 0.02]

4.2 Calcipotriol (12 wks) vs. combined calcipotriol + BMD (4 wks); then calcipotriol (8 wks)

0

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

4.3 Calcipotriol (12 wks) vs. combined calcipotriol + BMD (4 wks); then calcipotriol (w/dy) & combined calcipotriol + BMD (w/e) (8 wks)

1

585

Std. Mean Difference (IV, Random, 95% CI)

0.10 [‐0.06, 0.26]

4.4 Calcipotriol (6 wks) vs. clobetasol propionate (2 wks); then calcipotriol (4 wks)

0

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

4.5 Calcipotriol (6 wks) vs. calcipotriol OM, fluocinonide acetonide ON (2 wks); then calcipotriol twice daily (4 wks)

0

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

4.6 Calcipotriol (6 wks) vs. halometasone OM, calcipotriol ON (2 wks); then calcipotriol twice daily (w/dy), halometasone (w/e) (2 wks); then calcipotriol twice daily (2 wks)

0

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

4.7 Calcipotriol ON, clobetasol propionate OM (2 to 4 wks); then calcipotriol twice daily (to wk 12) vs. calcitriol ON, clobetasol propionate OM (2 to 4 wks); then calcitriol twice daily (to wk 12)

0

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

4.8 Combined calcipotriol + BMD (4 wks); then placebo ointment twice daily (8 wks) vs. combined calcipotriol + BMD (4 wks); then calcipotriol ointment twice daily (8 wks)

1

759

Std. Mean Difference (IV, Random, 95% CI)

0.28 [0.13, 0.42]

4.9 Combined calcipotriol + BMD (4 wks); then placebo ointment twice daily (8 wks) vs. combined calcipotriol + BMD (4 wks); then calcipotriol (w/dy) + combined calcipotriol + BMD (w/e) (8 wks)

1

753

Std. Mean Difference (IV, Random, 95% CI)

0.71 [0.56, 0.85]

4.10 Combined calcipotriol + BMD (4 wks); then calcipotriol ointment twice daily (8 wks) vs. combined calcipotriol + BMD (4 wks); then calcipotriol (w/dy) + combined calcipotriol + BMD (w/e) (8 wks)

1

760

Std. Mean Difference (IV, Random, 95% CI)

0.44 [0.29, 0.58]

4.11 Combined calcipotriol + BMD (8 wks); then calcipotriol (4 wks) vs. combined calcipotriol + BMD (4 wks); then calcipotriol (w/dy) & combined calcipotriol + BMD (w/e) (8 wks)

1

596

Std. Mean Difference (IV, Random, 95% CI)

0.23 [0.07, 0.39]

4.12 Tacalcitol (8 wks) vs. combined calcipotriol + BMD (4 wks); then calcipotriol (4 wks)

1

493

Std. Mean Difference (IV, Random, 95% CI)

0.54 [0.36, 0.72]

5 Combined end point (IAGI/TSS/PASI/PAGI) Show forest plot

9

Std. Mean Difference (IV, Random, 95% CI)

Subtotals only

Analysis 13.5

Comparison 13 Vitamin D alone or in combination versus other treatments: complex regimens, Outcome 5 Combined end point (IAGI/TSS/PASI/PAGI).

Comparison 13 Vitamin D alone or in combination versus other treatments: complex regimens, Outcome 5 Combined end point (IAGI/TSS/PASI/PAGI).

5.1 Calcipotriol (12 wks) vs. combined calcipotriol + BMD (8 wks); then calcipotriol (4 wks)

1

577

Std. Mean Difference (IV, Random, 95% CI)

‐0.12 [‐0.29, 0.04]

5.2 Calcipotriol (12 wks) vs. combined calcipotriol + BMD (4 wks); then calcipotriol (8 wks)

1

143

Std. Mean Difference (IV, Random, 95% CI)

0.29 [‐0.04, 0.62]

5.3 Calcipotriol (12 wks) vs. combined calcipotriol + BMD (4 wks); then calcipotriol (w/dy) & combined calcipotriol + BMD (w/e) (8 wks)

1

585

Std. Mean Difference (IV, Random, 95% CI)

0.13 [‐0.04, 0.29]

5.4 Calcipotriol (6 wks) vs. clobetasol propionate (2 wks); then calcipotriol (4 wks)

1

92

Std. Mean Difference (IV, Random, 95% CI)

0.60 [0.18, 1.02]

5.5 Calcipotriol (6 wks) vs. calcipotriol OM, fluocinonide acetonide ON (2 wks); then calcipotriol twice daily (4 wks)

1

38

Std. Mean Difference (IV, Random, 95% CI)

0.66 [0.01, 1.32]

5.6 Calcipotriol (6 wks) vs. halometasone OM, calcipotriol ON (2 wks); then calcipotriol twice daily (w/dy), halometasone (w/e) (2 wks); then calcipotriol twice daily (2 wks)

1

76

Std. Mean Difference (IV, Random, 95% CI)

0.41 [‐0.05, 0.86]

5.7 Calcipotriol ON, clobetasol propionate OM (2 to 4 wks); then calcipotriol twice daily (to wk 12) vs. calcitriol ON, clobetasol propionate OM (2 to 4 wks); then calcitriol twice daily (to wk 12)

1

125

Std. Mean Difference (IV, Random, 95% CI)

‐0.19 [‐0.54, 0.16]

5.8 Combined calcipotriol + BMD (4 wks); then placebo ointment twice daily (8 wks) vs. combined calcipotriol + BMD (4 wks); then calcipotriol ointment twice daily (8 wks)

1

759

Std. Mean Difference (IV, Random, 95% CI)

0.27 [0.12, 0.41]

5.9 Combined calcipotriol + BMD (4 wks); then placebo ointment twice daily (8 wks) vs. combined calcipotriol + BMD (4 wks); then calcipotriol (w/dy)+ combined calcipotriol + BMD (w/e) (8 wks)

1

753

Std. Mean Difference (IV, Random, 95% CI)

0.51 [0.37, 0.66]

5.10 Combined calcipotriol + BMD (4 wks); then calcipotriol ointment twice daily (8 wks) vs. combined calcipotriol + BMD (4 wks); then calcipotriol (w/dy) + combined calcipotriol + BMD (w/e) (8 wks)

1

760

Std. Mean Difference (IV, Random, 95% CI)

0.26 [0.11, 0.40]

5.11 Combined calcipotriol + BMD (8 wks); then calcipotriol (4 wks) vs. combined calcipotriol + BMD (4 wks); then calcipotriol (w/dy) & combined calcipotriol + BMD (w/e) (8 wks)

1

596

Std. Mean Difference (IV, Random, 95% CI)

0.24 [0.08, 0.40]

5.12 Tacalcitol (8 wks) vs. combined calcipotriol + BMD (4 wks); then calcipotriol (4 wks)

1

493

Std. Mean Difference (IV, Random, 95% CI)

0.54 [0.36, 0.72]

6 Total withdrawals Show forest plot

9

Risk Difference (M‐H, Random, 95% CI)

Subtotals only

Analysis 13.6

Comparison 13 Vitamin D alone or in combination versus other treatments: complex regimens, Outcome 6 Total withdrawals.

Comparison 13 Vitamin D alone or in combination versus other treatments: complex regimens, Outcome 6 Total withdrawals.

6.1 Calcipotriol (12 wks) vs. combined calcipotriol + BMD (8 wks); then calcipotriol (4 wks)

1

649

Risk Difference (M‐H, Random, 95% CI)

0.05 [0.00, 0.10]

6.2 Calcipotriol (12 wks) vs. combined calcipotriol + BMD (4 wks); then calcipotriol (8 wks)

1

150

Risk Difference (M‐H, Random, 95% CI)

0.04 [‐0.09, 0.17]

6.3 Calcipotriol (12 wks) vs. combined calcipotriol + BMD (4 wks); then calcipotriol (w/dy) & combined calcipotriol + BMD (w/e) (8 wks)

1

649

Risk Difference (M‐H, Random, 95% CI)

0.08 [0.03, 0.13]

6.4 Calcipotriol (6 wks) vs. clobetasol propionate (2 wks); then calcipotriol (4 wks)

1

98

Risk Difference (M‐H, Random, 95% CI)

0.0 [‐0.09, 0.09]

6.5 Calcipotriol (6 wks) vs. calcipotriol OM, fluocinonide acetonide ON (2 wks); then calcipotriol twice daily (4 wks)

1

38

Risk Difference (M‐H, Random, 95% CI)

0.0 [‐0.10, 0.10]

6.6 Calcipotriol (6 wks) vs. halometasone OM, calcipotriol ON (2 wks); then calcipotriol twice daily (w/dy), halometasone (w/e) (2 wks); then calcipotriol twice daily (2 wks)

1

76

Risk Difference (M‐H, Random, 95% CI)

0.0 [‐0.05, 0.05]

6.7 Calcipotriol ON, clobetasol propionate OM (2 to 4 wks); then calcipotriol twice daily (to wk 12) vs. calcitriol ON, clobetasol propionate OM (2 to 4 wks); then calcitriol twice daily (to wk 12)

1

125

Risk Difference (M‐H, Random, 95% CI)

‐0.01 [‐0.12, 0.11]

6.8 Combined calcipotriol + BMD (4 wks); then placebo ointment twice daily (8 wks) vs. combined calcipotriol + BMD (4 wks); then calcipotriol ointment twice daily (8 wks)

1

759

Risk Difference (M‐H, Random, 95% CI)

0.08 [0.03, 0.14]

6.9 Combined calcipotriol + BMD (4 wks); then placebo ointment twice daily (8 wks) vs. combined calcipotriol + BMD (4 wks); then calcipotriol (w/dy) + combined calcipotriol + BMD (w/e) (8 wks)

1

753

Risk Difference (M‐H, Random, 95% CI)

0.11 [0.06, 0.17]

6.10 Combined calcipotriol + BMD (4 wks); then calcipotriol ointment twice daily (8 wks) vs. combined calcipotriol + BMD (4 wks); then calcipotriol (w/dy) + combined calcipotriol + BMD (w/e) (8 wks)

1

760

Risk Difference (M‐H, Random, 95% CI)

0.03 [‐0.01, 0.07]

6.11 Combined calcipotriol + BMD (8 wks); then calcipotriol (4 wks) vs. combined calcipotriol + BMD (4 wks); then calcipotriol (w/dy) & combined calcipotriol + BMD (w/e) (8 wks)

1

644

Risk Difference (M‐H, Random, 95% CI)

0.03 [‐0.01, 0.07]

6.12 Tacalcitol (8 wks) vs. combined calcipotriol + BMD (4 wks); then calcipotriol (4 wks)

1

501

Risk Difference (M‐H, Random, 95% CI)

0.05 [‐0.01, 0.12]

7 Withdrawals due to adverse events Show forest plot

8

Risk Difference (M‐H, Random, 95% CI)

Subtotals only

Analysis 13.7

Comparison 13 Vitamin D alone or in combination versus other treatments: complex regimens, Outcome 7 Withdrawals due to adverse events.

Comparison 13 Vitamin D alone or in combination versus other treatments: complex regimens, Outcome 7 Withdrawals due to adverse events.

7.1 Calcipotriol (12 wks) vs. combined calcipotriol + BMD (8 wks); then calcipotriol (4 wks)

0

0

Risk Difference (M‐H, Random, 95% CI)

0.0 [0.0, 0.0]

7.2 Calcipotriol (12 wks) vs. combined calcipotriol + BMD (4 wks); then calcipotriol (8 wks)

1

150

Risk Difference (M‐H, Random, 95% CI)

‐0.04 [‐0.09, 0.01]

7.3 Calcipotriol (12 wks) vs. combined calcipotriol + BMD (4 wks); then calcipotriol (w/dy) & combined calcipotriol + BMD (w/e) (8 wks)

0

0

Risk Difference (M‐H, Random, 95% CI)

0.0 [0.0, 0.0]

7.4 Calcipotriol (6 wks) vs. clobetasol propionate (2 wks); then calcipotriol (4 wks)

1

98

Risk Difference (M‐H, Random, 95% CI)

0.0 [‐0.04, 0.04]

7.5 Calcipotriol (6 wks) vs. calcipotriol OM, fluocinonide acetonide ON (2 wks); then calcipotriol twice daily (4 wks)

1

38

Risk Difference (M‐H, Random, 95% CI)

0.0 [‐0.10, 0.10]

7.6 Calcipotriol (6 wks) vs. halometasone OM, calcipotriol ON (2 wks); then calcipotriol twice daily (w/dy), halometasone (w/e) (2 wks); then calcipotriol twice daily (2 wks)

1

76

Risk Difference (M‐H, Random, 95% CI)

0.0 [‐0.05, 0.05]

7.7 Calcipotriol ON, clobetasol propionate OM (2 to 4 wks); then calcipotriol twice daily (to wk 12) vs. calcitriol ON, clobetasol propionate OM (2 to 4 wks); then calcitriol twice daily (to wk 12)

1

125

Risk Difference (M‐H, Random, 95% CI)

‐0.02 [‐0.06, 0.03]

7.8 Combined calcipotriol + BMD (4 wks); then placebo ointment twice daily (8 wks) vs. combined calcipotriol + BMD (4 wks); then calcipotriol ointment twice daily (8 wks)

1

759

Risk Difference (M‐H, Random, 95% CI)

0.01 [‐0.01, 0.02]

7.9 Combined calcipotriol + BMD (4 wks); then placebo ointment twice daily (8 wks) vs. combined calcipotriol + BMD (4 wks); then calcipotriol (w/dy) + combined calcipotriol + BMD (w/e) (8 wks)

1

753

Risk Difference (M‐H, Random, 95% CI)

‐0.00 [‐0.02, 0.02]

7.10 Combined calcipotriol + BMD (4 wks); then calcipotriol ointment twice daily (8 wks) vs. combined calcipotriol + BMD (4 wks); then calcipotriol (w/dy) + combined calcipotriol + BMD (w/e) (8 wks)

1

760

Risk Difference (M‐H, Random, 95% CI)

‐0.01 [‐0.03, 0.01]

7.11 Combined calcipotriol + BMD (8 wks); then calcipotriol (4 wks) vs. combined calcipotriol + BMD (4 wks); then calcipotriol (w/dy) & combined calcipotriol + BMD (w/e) (8 wks)

0

0

Risk Difference (M‐H, Random, 95% CI)

0.0 [0.0, 0.0]

7.12 Tacalcitol (8 wks) vs. combined calcipotriol + BMD (4 wks); then calcipotriol (4 wks)

1

501

Risk Difference (M‐H, Random, 95% CI)

0.02 [‐0.01, 0.05]

8 Withdrawals due to treatment failure Show forest plot

6

Risk Difference (M‐H, Random, 95% CI)

Subtotals only

Analysis 13.8

Comparison 13 Vitamin D alone or in combination versus other treatments: complex regimens, Outcome 8 Withdrawals due to treatment failure.

Comparison 13 Vitamin D alone or in combination versus other treatments: complex regimens, Outcome 8 Withdrawals due to treatment failure.

8.1 Calcipotriol (12 wks) vs. combined calcipotriol + BMD (8 wks); then calcipotriol (4 wks)

0

0

Risk Difference (M‐H, Random, 95% CI)

0.0 [0.0, 0.0]

8.2 Calcipotriol (12 wks) vs. combined calcipotriol + BMD (4 wks); then calcipotriol (8 wks)

1

150

Risk Difference (M‐H, Random, 95% CI)

0.21 [0.10, 0.33]

8.3 Calcipotriol (12 wks) vs. combined calcipotriol + BMD (4 wks); then calcipotriol (w/dy) & combined calcipotriol + BMD (w/e) (8 wks)

0

0

Risk Difference (M‐H, Random, 95% CI)

0.0 [0.0, 0.0]

8.4 Calcipotriol (6 wks) vs. clobetasol propionate (2 wks); then calcipotriol (4 wks)

1

98

Risk Difference (M‐H, Random, 95% CI)

0.0 [‐0.04, 0.04]

8.5 Calcipotriol (6 wks) vs. calcipotriol OM, fluocinonide acetonide ON (2 wks); then calcipotriol twice daily (4 wks)

1

38

Risk Difference (M‐H, Random, 95% CI)

0.0 [‐0.10, 0.10]

8.6 Calcipotriol (6 wks) vs. halometasone OM, calcipotriol ON (2 wks); then calcipotriol twice daily (w/dy), halometasone (w/e) (2 wks); then calcipotriol twice daily (2 wks)

1

76

Risk Difference (M‐H, Random, 95% CI)

0.0 [‐0.05, 0.05]

8.7 Calcipotriol ON, clobetasol propionate OM (2 to 4 wks); then calcipotriol twice daily (to wk 12) vs. calcitriol ON, clobetasol propionate OM (2 to 4 wks); then calcitriol twice daily (to wk 12)

1

125

Risk Difference (M‐H, Random, 95% CI)

0.03 [‐0.04, 0.10]

8.8 Combined calcipotriol + BMD (4 wks); then placebo ointment twice daily (8 wks) vs. combined calcipotriol + BMD (4 wks); then calcipotriol ointment twice daily (8 wks)

0

0

Risk Difference (M‐H, Random, 95% CI)

0.0 [0.0, 0.0]

8.9 Combined calcipotriol + BMD (4 wks); then placebo ointment twice daily (8 wks) vs. combined calcipotriol + BMD (4 wks); then calcipotriol (w/dy) + combined calcipotriol + BMD (w/e) (8 wks)

0

0

Risk Difference (M‐H, Random, 95% CI)

0.0 [0.0, 0.0]

8.10 Combined calcipotriol + BMD (4 wks); then calcipotriol ointment twice daily (8 wks) vs. combined calcipotriol + BMD (4 wks); then calcipotriol (w/dy)+ combined calcipotriol + BMD (w/e) (8 wks)

0

0

Risk Difference (M‐H, Random, 95% CI)

0.0 [0.0, 0.0]

8.11 Combined calcipotriol + BMD (8 wks); then calcipotriol (4 wks) vs. combined calcipotriol + BMD (4 wks); then calcipotriol (w/dy) & combined calcipotriol + BMD (w/e) (8 wks)

0

0

Risk Difference (M‐H, Random, 95% CI)

0.0 [0.0, 0.0]

8.12 Tacalcitol (8 wks) vs. combined calcipotriol + BMD (4 wks); then calcipotriol (4 wks)

1

501

Risk Difference (M‐H, Random, 95% CI)

0.05 [0.02, 0.08]

9 Adverse events (local) Show forest plot

8

Risk Difference (M‐H, Random, 95% CI)

Subtotals only

Analysis 13.9

Comparison 13 Vitamin D alone or in combination versus other treatments: complex regimens, Outcome 9 Adverse events (local).

Comparison 13 Vitamin D alone or in combination versus other treatments: complex regimens, Outcome 9 Adverse events (local).

9.1 Calcipotriol (12 wks) vs. combined calcipotriol + BMD (8 wks); then calcipotriol (4 wks)

1

649

Risk Difference (M‐H, Random, 95% CI)

0.11 [0.06, 0.17]

9.2 Calcipotriol (12 wks) vs. combined calcipotriol + BMD (4 wks); then calcipotriol (8 wks)

0

0

Risk Difference (M‐H, Random, 95% CI)

0.0 [0.0, 0.0]

9.3 Calcipotriol (12 wks) vs. combined calcipotriol + BMD (4 wks); then calcipotriol (w/dy) & combined calcipotriol + BMD (w/e) (8 wks)

1

649

Risk Difference (M‐H, Random, 95% CI)

0.11 [0.05, 0.17]

9.4 Calcipotriol (6 wks) vs. clobetasol propionate (2 wks); then calcipotriol (4 wks)

1

98

Risk Difference (M‐H, Random, 95% CI)

0.02 [‐0.08, 0.12]

9.5 Calcipotriol (6 wks) vs. calcipotriol OM, fluocinonide acetonide ON (2 wks); then calcipotriol twice daily (4 wks)

1

38

Risk Difference (M‐H, Random, 95% CI)

0.0 [‐0.14, 0.14]

9.6 Calcipotriol (6 wks) vs. halometasone OM, calcipotriol ON (2 wks); then calcipotriol twice daily (w/dy), halometasone (w/e) (2 wks); then calcipotriol twice daily (2 wks)

1

76

Risk Difference (M‐H, Random, 95% CI)

0.26 [0.07, 0.45]

9.7 Calcipotriol ON, clobetasol propionate OM (2 to 4 wks); then calcipotriol twice daily (to wk 12) vs. calcitriol ON, clobetasol propionate OM (2 to 4 wks); then calcitriol twice daily (to wk 12)

1

125

Risk Difference (M‐H, Random, 95% CI)

‐0.02 [‐0.10, 0.06]

9.8 Combined calcipotriol + BMD (4 wks); then placebo ointment twice daily (8 wks) vs. combined calcipotriol + BMD (4 wks); then calcipotriol ointment twice daily (8 wks)

1

752

Risk Difference (M‐H, Random, 95% CI)

‐0.03 [‐0.07, 0.02]

9.9 Combined calcipotriol + BMD (4 wks); then placebo ointment twice daily (8 wks) vs. combined calcipotriol + BMD (4 wks); then calcipotriol (w/dy) + combined calcipotriol + BMD (w/e) (8 wks)

1

743

Risk Difference (M‐H, Random, 95% CI)

0.01 [‐0.03, 0.05]

9.10 Combined calcipotriol + BMD (4 wks); then calcipotriol ointment twice daily (8 wks) vs. combined calcipotriol + BMD (4 wks); then calcipotriol (w/dy) + combined calcipotriol + BMD (w/e) (8 wks)

1

749

Risk Difference (M‐H, Random, 95% CI)

0.04 [‐0.00, 0.08]

9.11 Combined calcipotriol + BMD (8 wks); then calcipotriol (4 wks) vs. combined calcipotriol + BMD (4 wks); then calcipotriol (w/dy) & combined calcipotriol + BMD (w/e) (8 wks)

1

644

Risk Difference (M‐H, Random, 95% CI)

‐0.01 [‐0.05, 0.04]

9.12 Tacalcitol (8 wks) vs. combined calcipotriol + BMD (4 wks); then calcipotriol (4 wks)

1

501

Risk Difference (M‐H, Random, 95% CI)

0.06 [0.01, 0.11]

10 Adverse events (systemic)

0

0

Risk Difference (M‐H, Random, 95% CI)

0.0 [0.0, 0.0]

10.1 Calcipotriol (12 wks) vs. combined calcipotriol + BMD (8 wks); then calcipotriol (4 wks)

0

0

Risk Difference (M‐H, Random, 95% CI)

0.0 [0.0, 0.0]

10.2 Calcipotriol (12 wks) vs. combined calcipotriol + BMD (4 wks); then calcipotriol (8 wks)

0

0

Risk Difference (M‐H, Random, 95% CI)

0.0 [0.0, 0.0]

10.3 Calcipotriol (12 wks) vs. combined calcipotriol + BMD (4 wks); then calcipotriol (w/dy) & combined calcipotriol + BMD (w/e) (8 wks)

0

0

Risk Difference (M‐H, Random, 95% CI)

0.0 [0.0, 0.0]

10.4 Calcipotriol (6 wks) vs. clobetasol propionate (2 wks); then calcipotriol (4 wks)

0

0

Risk Difference (M‐H, Random, 95% CI)

0.0 [0.0, 0.0]

10.5 Calcipotriol (6 wks) vs. calcipotriol OM, fluocinonide acetonide ON (2 wks); then calcipotriol twice daily (4 wks)

0

0

Risk Difference (M‐H, Random, 95% CI)

0.0 [0.0, 0.0]

10.6 Calcipotriol (6 wks) vs. halometasone OM, calcipotriol ON (2 wks); then calcipotriol twice daily (w/dy), halometasone (w/e) (2 wks); then calcipotriol twice daily (2 wks)

0

0

Risk Difference (M‐H, Random, 95% CI)

0.0 [0.0, 0.0]

10.7 Calcipotriol ON, clobetasol propionate OM (2 to 4 wks); then calcipotriol twice daily (to wk 12) vs. calcitriol ON, clobetasol propionate OM (2 to 4 wks); then calcitriol twice daily (to wk 12)

0

0

Risk Difference (M‐H, Random, 95% CI)

0.0 [0.0, 0.0]

10.8 Combined calcipotriol + BMD (4 wks); then placebo ointment twice daily (8 wks) vs. combined calcipotriol + BMD (4 wks); then calcipotriol ointment twice daily (8 wks)

0

0

Risk Difference (M‐H, Random, 95% CI)

0.0 [0.0, 0.0]

10.9 Combined calcipotriol + BMD (4 wks); then placebo ointment twice daily (8 wks) vs. combined calcipotriol + BMD (4 wks); then calcipotriol (w/dy) + combined calcipotriol + BMD (w/e) (8 wks)

0

0

Risk Difference (M‐H, Random, 95% CI)

0.0 [0.0, 0.0]

10.10 Combined calcipotriol + BMD (4 wks); then calcipotriol ointment twice daily (8 wks) vs. combined calcipotriol + BMD (4 wks); then calcipotriol (w/dy) + combined calcipotriol + BMD (w/e) (8 wks)

0

0

Risk Difference (M‐H, Random, 95% CI)

0.0 [0.0, 0.0]

10.11 Combined calcipotriol + BMD (8 wks); then calcipotriol (4 wks) vs. combined calcipotriol + BMD (4 wks); then calcipotriol (w/dy) & combined calcipotriol + BMD (w/e) (8 wks)

0

0

Risk Difference (M‐H, Random, 95% CI)

0.0 [0.0, 0.0]

10.12 Tacalcitol (8 wks) vs. combined calcipotriol + BMD (4 wks); then calcipotriol (4 wks)

0

0

Risk Difference (M‐H, Random, 95% CI)

0.0 [0.0, 0.0]

Open in table viewer
Comparison 14. Vitamin D alone or in combination versus other treatment: long‐term studies (> 24 wks)

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 IAGI Show forest plot

1

Std. Mean Difference (IV, Random, 95% CI)

Totals not selected

Analysis 14.1

Comparison 14 Vitamin D alone or in combination versus other treatment: long‐term studies (> 24 wks), Outcome 1 IAGI.

Comparison 14 Vitamin D alone or in combination versus other treatment: long‐term studies (> 24 wks), Outcome 1 IAGI.

1.1 Combined calcipotriol + BMD (52 wks) vs. alternating: combined calcipotriol + BMD (4 wks); then calcipotriol (4 wks)

1

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

1.2 Combined calcipotriol + BMD (52 wks) vs. combined calcipotriol + BMD (4 wks); then calcipotriol (48 wks)

1

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

1.3 Alternating: combined calcipotriol + BMD (4 wks); then calcipotriol (4 wks) vs. combined calcipotriol + BMD (4 wks); then calcipotriol (48 wks)

1

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

2 TSS

0

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

2.1 Combined calcipotriol + BMD (52 wks) vs. alternating: combined calcipotriol + BMD (4 wks); then calcipotriol (4 wks)

0

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

2.2 Combined calcipotriol + BMD (52 wks) vs. combined calcipotriol + BMD (4 wks); then calcipotriol (48 wks)

0

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

2.3 Alternating: combined calcipotriol + BMD (4 wks); then calcipotriol (4 wks) vs. combined calcipotriol + BMD (4 wks); then calcipotriol (48 wks)

0

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

3 PASI

0

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

3.1 Combined calcipotriol + BMD (52 wks) vs. alternating: combined calcipotriol + BMD (4 wks); then calcipotriol (4 wks)

0

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

3.2 Combined calcipotriol + BMD (52 wks) vs. combined calcipotriol + BMD (4 wks); then calcipotriol (48 wks)

0

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

3.3 Alternating: combined calcipotriol + BMD (4 wks); then calcipotriol (4 wks) vs. combined calcipotriol + BMD (4 wks); then calcipotriol (48 wks)

0

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

4 PAGI

0

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

4.1 Combined calcipotriol + BMD (52 wks) vs. alternating: combined calcipotriol + BMD (4 wks); then calcipotriol (4 wks)

0

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

4.2 Combined calcipotriol + BMD (52 wks) vs. combined calcipotriol + BMD (4 wks); then calcipotriol (48 wks)

0

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

4.3 Alternating: combined calcipotriol + BMD (4 wks); then calcipotriol (4 wks) vs. combined calcipotriol + BMD (4 wks); then calcipotriol (48 wks)

0

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

5 Combined end point (IAGI/TSS/PASI/PAGI) Show forest plot

1

Std. Mean Difference (IV, Random, 95% CI)

Totals not selected

Analysis 14.5

Comparison 14 Vitamin D alone or in combination versus other treatment: long‐term studies (> 24 wks), Outcome 5 Combined end point (IAGI/TSS/PASI/PAGI).

Comparison 14 Vitamin D alone or in combination versus other treatment: long‐term studies (> 24 wks), Outcome 5 Combined end point (IAGI/TSS/PASI/PAGI).

5.1 Combined calcipotriol + BMD (52 wks) vs. alternating: combined calcipotriol + BMD (4 wks); then calcipotriol (4 wks)

1

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

5.2 Combined calcipotriol + BMD (52 wks) vs. combined calcipotriol + BMD (4 wks); then calcipotriol (48 wks)

1

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

5.3 Alternating: combined calcipotriol + BMD (4 wks); then calcipotriol (4 wks) vs. combined calcipotriol + BMD (4 wks); then calcipotriol (48 wks)

1

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

6 Total withdrawals Show forest plot

1

Risk Difference (M‐H, Random, 95% CI)

Totals not selected

Analysis 14.6

Comparison 14 Vitamin D alone or in combination versus other treatment: long‐term studies (> 24 wks), Outcome 6 Total withdrawals.

Comparison 14 Vitamin D alone or in combination versus other treatment: long‐term studies (> 24 wks), Outcome 6 Total withdrawals.

6.1 Combined calcipotriol + BMD (52 wks) vs. alternating: combined calcipotriol + BMD (4 wks); then calcipotriol (4 wks)

1

Risk Difference (M‐H, Random, 95% CI)

0.0 [0.0, 0.0]

6.2 Combined calcipotriol + BMD (52 wks) vs. combined calcipotriol + BMD (4 wks); then calcipotriol (48 wks)

1

Risk Difference (M‐H, Random, 95% CI)

0.0 [0.0, 0.0]

6.3 Alternating: combined calcipotriol + BMD (4 wks); then calcipotriol (4 wks) vs. combined calcipotriol + BMD (4 wks); then calcipotriol (48 wks)

1

Risk Difference (M‐H, Random, 95% CI)

0.0 [0.0, 0.0]

7 Withdrawals due to adverse events Show forest plot

1

Risk Difference (M‐H, Random, 95% CI)

Totals not selected

Analysis 14.7

Comparison 14 Vitamin D alone or in combination versus other treatment: long‐term studies (> 24 wks), Outcome 7 Withdrawals due to adverse events.

Comparison 14 Vitamin D alone or in combination versus other treatment: long‐term studies (> 24 wks), Outcome 7 Withdrawals due to adverse events.

7.1 Combined calcipotriol + BMD (52 wks) vs. alternating: combined calcipotriol + BMD (4 wks); then calcipotriol (4 wks)

1

Risk Difference (M‐H, Random, 95% CI)

0.0 [0.0, 0.0]

7.2 Combined calcipotriol + BMD (52 wks) vs. combined calcipotriol + BMD (4 wks); then calcipotriol (48 wks)

1

Risk Difference (M‐H, Random, 95% CI)

0.0 [0.0, 0.0]

7.3 Alternating: combined calcipotriol + BMD (4 wks); then calcipotriol (4 wks) vs. combined calcipotriol + BMD (4 wks); then calcipotriol (48 wks)

1

Risk Difference (M‐H, Random, 95% CI)

0.0 [0.0, 0.0]

8 Withdrawals due to treatment failure Show forest plot

1

Risk Difference (M‐H, Random, 95% CI)

Totals not selected

Analysis 14.8

Comparison 14 Vitamin D alone or in combination versus other treatment: long‐term studies (> 24 wks), Outcome 8 Withdrawals due to treatment failure.

Comparison 14 Vitamin D alone or in combination versus other treatment: long‐term studies (> 24 wks), Outcome 8 Withdrawals due to treatment failure.

8.1 Combined calcipotriol + BMD (52 wks) vs. alternating: combined calcipotriol + BMD (4 wks); then calcipotriol (4 wks)

1

Risk Difference (M‐H, Random, 95% CI)

0.0 [0.0, 0.0]

8.2 Combined calcipotriol + BMD (52 wks) vs. combined calcipotriol + BMD (4 wks); then calcipotriol (48 wks)

1

Risk Difference (M‐H, Random, 95% CI)

0.0 [0.0, 0.0]

8.3 Alternating: combined calcipotriol + BMD (4 wks); then calcipotriol (4 wks) vs. combined calcipotriol + BMD (4 wks); then calcipotriol (48 wks)

1

Risk Difference (M‐H, Random, 95% CI)

0.0 [0.0, 0.0]

9 Adverse events (local) Show forest plot

1

Risk Difference (M‐H, Random, 95% CI)

Totals not selected

Analysis 14.9

Comparison 14 Vitamin D alone or in combination versus other treatment: long‐term studies (> 24 wks), Outcome 9 Adverse events (local).

Comparison 14 Vitamin D alone or in combination versus other treatment: long‐term studies (> 24 wks), Outcome 9 Adverse events (local).

9.1 Combined calcipotriol + BMD (52 wks) vs. alternating: combined calcipotriol + BMD (4 wks); then calcipotriol (4 wks)

1

Risk Difference (M‐H, Random, 95% CI)

0.0 [0.0, 0.0]

9.2 Combined calcipotriol + BMD (52 wks) vs. combined calcipotriol + BMD (4 wks); then calcipotriol (48 wks)

1

Risk Difference (M‐H, Random, 95% CI)

0.0 [0.0, 0.0]

9.3 Alternating: combined calcipotriol + BMD (4 wks); then calcipotriol (4 wks) vs. combined calcipotriol + BMD (4 wks); then calcipotriol (48 wks)

1

Risk Difference (M‐H, Random, 95% CI)

0.0 [0.0, 0.0]

10 Adverse events (systemic)

0

Risk Difference (M‐H, Random, 95% CI)

Subtotals only

10.1 Combined calcipotriol + BMD (52 wks) vs. alternating: combined calcipotriol + BMD (4 wks); then calcipotriol (4 wks)

0

0

Risk Difference (M‐H, Random, 95% CI)

0.0 [0.0, 0.0]

10.2 Combined calcipotriol + BMD (52 wks) vs. combined calcipotriol + BMD (4 wks); then calcipotriol (48 wks)

0

0

Risk Difference (M‐H, Random, 95% CI)

0.0 [0.0, 0.0]

10.3 Alternating: combined calcipotriol + BMD (4 wks); then calcipotriol (4 wks) vs. combined calcipotriol + BMD (4 wks); then calcipotriol (48 wks)

0

0

Risk Difference (M‐H, Random, 95% CI)

0.0 [0.0, 0.0]

Open in table viewer
Comparison 15. Vitamin D analogues versus other treatment

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 IAGI Show forest plot

10

Std. Mean Difference (IV, Random, 95% CI)

Subtotals only

Analysis 15.1

Comparison 15 Vitamin D analogues versus other treatment, Outcome 1 IAGI.

Comparison 15 Vitamin D analogues versus other treatment, Outcome 1 IAGI.

1.1 Calcipotriol vs. coal tar

3

139

Std. Mean Difference (IV, Random, 95% CI)

‐0.53 [‐1.74, 0.68]

1.2 Calcipotriol vs. coal tar polytherapy

2

209

Std. Mean Difference (IV, Random, 95% CI)

‐0.59 [‐0.87, ‐0.31]

1.3 Calcipotriol vs. nicotinamide 1.4%, twice daily

0

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

1.4 Calcipotriol vs. calcipotriol + nicotinamide 1.4%, twice daily

0

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

1.5 Calcipotriol vs. corticosteroid + salicylic acid

1

200

Std. Mean Difference (IV, Random, 95% CI)

‐0.06 [‐0.33, 0.22]

1.6 Calcipotriol vs. propylthiouracil cream

0

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

1.7 Calcipotriol vs. tazarotene

0

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

1.8 Calcipotriol vs. tacrolimus ointment

1

124

Std. Mean Difference (IV, Random, 95% CI)

‐0.22 [‐0.60, 0.16]

1.9 Calcipotriol vs. tazarotene gel plus mometasone furoate cream

0

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

1.10 Calcipotriol vs. vitamin B12 cream

1

26

Std. Mean Difference (IV, Random, 95% CI)

‐0.55 [‐1.33, 0.24]

1.11 Head‐to‐head vitamin D alone or in combination: twice daily vs OD

2

728

Std. Mean Difference (IV, Random, 95% CI)

‐0.24 [‐0.38, ‐0.09]

1.12 Head‐to‐head vitamin D alone or in combination: no occlusion vs. occlusion

0

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

2 TSS Show forest plot

7

Std. Mean Difference (IV, Random, 95% CI)

Subtotals only

Analysis 15.2

Comparison 15 Vitamin D analogues versus other treatment, Outcome 2 TSS.

Comparison 15 Vitamin D analogues versus other treatment, Outcome 2 TSS.

2.1 Calcipotriol vs. coal tar

0

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

2.2 Calcipotriol vs. coal tar polytherapy

1

132

Std. Mean Difference (IV, Random, 95% CI)

‐0.51 [‐0.86, ‐0.16]

2.3 Calcipotriol vs. nicotinamide 1.4%, twice daily

1

96

Std. Mean Difference (IV, Random, 95% CI)

‐0.09 [‐0.49, 0.31]

2.4 Calcipotriol vs. calcipotriol+nicotinamide (0.05%, 0.1%, 0.7%, or 1.4%), twice daily

1

192

Std. Mean Difference (IV, Random, 95% CI)

0.19 [‐0.14, 0.52]

2.5 Calcipotriol vs. corticosteroid + salicylic acid

0

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

2.6 Calcipotriol vs. propylthiouracil cream

0

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

2.7 Calcipotriol vs. tacrolimus ointment

2

171

Std. Mean Difference (IV, Random, 95% CI)

‐0.35 [‐1.51, 0.81]

2.8 Calcipotriol vs. tazarotene

1

199

Std. Mean Difference (IV, Random, 95% CI)

‐0.05 [‐0.33, 0.23]

2.9 Calcipotriol vs. tazarotene gel plus mometasone furoate cream

0

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

2.10 Calcipotriol vs. vitamin B12 cream

0

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

2.11 Head‐to‐head vitamin D alone or in combination: twice daily vs OD

0

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

2.12 Head‐to‐head vitamin D alone or in combination: no occlusion vs. occlusion

2

247

Std. Mean Difference (IV, Random, 95% CI)

‐0.18 [‐2.04, 1.68]

3 PASI Show forest plot

9

Std. Mean Difference (IV, Random, 95% CI)

Subtotals only

Analysis 15.3

Comparison 15 Vitamin D analogues versus other treatment, Outcome 3 PASI.

Comparison 15 Vitamin D analogues versus other treatment, Outcome 3 PASI.

3.1 Calcipotriol vs. coal tar

2

109

Std. Mean Difference (IV, Random, 95% CI)

‐0.10 [‐1.54, 1.35]

3.2 Calcipotriol vs. coal tar polytherapy

1

87

Std. Mean Difference (IV, Random, 95% CI)

‐0.63 [‐1.06, ‐0.20]

3.3 Calcipotriol vs. nicotinamide 1.4%, twice daily

0

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

3.4 Calcipotriol vs. calcipotriol + nicotinamide 1.4%, twice daily

0

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

3.5 Calcipotriol vs. corticosteroid + salicylic acid

1

160

Std. Mean Difference (IV, Random, 95% CI)

‐0.05 [‐0.36, 0.26]

3.6 Calcipotriol vs. propylthiouracil cream

1

27

Std. Mean Difference (IV, Random, 95% CI)

‐2.24 [‐3.23, ‐1.25]

3.7 Calcipotriol vs. tacrolimus ointment

0

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

3.8 Calcipotriol vs. tazarotene

0

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

3.9 Calcipotriol vs. tazarotene gel plus mometasone furoate cream

0

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

3.10 Calcipotriol vs. vitamin B12 cream

1

26

Std. Mean Difference (IV, Random, 95% CI)

‐0.01 [‐0.78, 0.75]

3.11 Head‐to‐head vitamin D alone or in combination: twice daily vs OD

3

989

Std. Mean Difference (IV, Random, 95% CI)

‐0.12 [‐0.25, 0.00]

3.12 Head‐to‐head vitamin D alone or in combination: no occlusion vs. occlusion

0

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

4 PAGI Show forest plot

6

Std. Mean Difference (IV, Random, 95% CI)

Subtotals only

Analysis 15.4

Comparison 15 Vitamin D analogues versus other treatment, Outcome 4 PAGI.

Comparison 15 Vitamin D analogues versus other treatment, Outcome 4 PAGI.

4.1 Calcipotriol vs. coal tar

1

54

Std. Mean Difference (IV, Random, 95% CI)

‐1.51 [‐2.12, ‐0.90]

4.2 Calcipotriol vs. coal tar polytherapy

1

87

Std. Mean Difference (IV, Random, 95% CI)

‐0.56 [‐0.99, ‐0.13]

4.3 Calcipotriol vs. nicotinamide 1.4%, twice daily

0

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

4.4 Calcipotriol vs. calcipotriol + nicotinamide 1.4%, twice daily

0

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

4.5 Calcipotriol vs. corticosteroid + salicylic acid

1

186

Std. Mean Difference (IV, Random, 95% CI)

‐0.49 [‐0.79, ‐0.20]

4.6 Calcipotriol vs. propylthiouracil cream

0

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

4.7 Calcipotriol vs. tacrolimus ointment

1

124

Std. Mean Difference (IV, Random, 95% CI)

‐0.13 [‐0.51, 0.24]

4.8 Calcipotriol vs. tazarotene

1

38

Std. Mean Difference (IV, Random, 95% CI)

‐0.35 [‐0.99, 0.29]

4.9 Calcipotriol vs. tazarotene gel plus mometasone furoate cream

0

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

4.10 Calcipotriol vs. vitamin B12 cream

1

26

Std. Mean Difference (IV, Random, 95% CI)

‐0.55 [‐1.33, 0.24]

4.11 Head‐to‐head vitamin D alone or in combination: twice daily vs OD

0

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

4.12 Head‐to‐head vitamin D alone or in combination: no occlusion vs. occlusion

0

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

5 Combined end point (IAGI/TSS/PASI/PAGI) Show forest plot

19

Std. Mean Difference (IV, Random, 95% CI)

Subtotals only

Analysis 15.5

Comparison 15 Vitamin D analogues versus other treatment, Outcome 5 Combined end point (IAGI/TSS/PASI/PAGI).

Comparison 15 Vitamin D analogues versus other treatment, Outcome 5 Combined end point (IAGI/TSS/PASI/PAGI).

5.1 Calcipotriol vs. coal tar

3

139

Std. Mean Difference (IV, Random, 95% CI)

‐0.53 [‐1.74, 0.68]

5.2 Calcipotriol vs. coal tar polytherapy

2

209

Std. Mean Difference (IV, Random, 95% CI)

‐0.59 [‐0.87, ‐0.31]

5.3 Calcipotriol vs. nicotinamide 1.4%, twice daily

1

96

Std. Mean Difference (IV, Random, 95% CI)

‐0.09 [‐0.49, 0.31]

5.4 Calcipotriol vs. calcipotriol + nicotinamide (0.05%, 0.1%, 0.7%, or 1.4%), twice daily

1

192

Std. Mean Difference (IV, Random, 95% CI)

0.19 [‐0.14, 0.52]

5.5 Calcipotriol vs. corticosteroid + salicylic acid

2

360

Std. Mean Difference (IV, Random, 95% CI)

‐0.05 [‐0.26, 0.15]

5.6 Calcipotriol vs. propylthiouracil cream

1

27

Std. Mean Difference (IV, Random, 95% CI)

‐2.24 [‐3.23, ‐1.25]

5.7 Calcipotriol vs. tacrolimus ointment

2

171

Std. Mean Difference (IV, Random, 95% CI)

‐0.55 [‐1.28, 0.17]

5.8 Calcipotriol vs. tazarotene

2

237

Std. Mean Difference (IV, Random, 95% CI)

‐0.10 [‐0.35, 0.16]

5.9 Calcipotriol vs. tazarotene gel plus mometasone furoate cream

0

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

5.10 Calcipotriol vs. vitamin B12 cream

1

26

Std. Mean Difference (IV, Random, 95% CI)

‐0.55 [‐1.33, 0.24]

5.11 Head‐to‐head vitamin D alone or in combination: twice daily vs OD

3

988

Std. Mean Difference (IV, Random, 95% CI)

‐0.20 [‐0.32, ‐0.07]

5.12 Head‐to‐head vitamin D alone or in combination: no occlusion vs. occlusion

2

247

Std. Mean Difference (IV, Random, 95% CI)

‐0.18 [‐2.04, 1.68]

6 Total withdrawals Show forest plot

15

Risk Difference (M‐H, Random, 95% CI)

Subtotals only

Analysis 15.6

Comparison 15 Vitamin D analogues versus other treatment, Outcome 6 Total withdrawals.

Comparison 15 Vitamin D analogues versus other treatment, Outcome 6 Total withdrawals.

6.1 Calcipotriol vs. coal tar

2

120

Risk Difference (M‐H, Random, 95% CI)

‐0.02 [‐0.12, 0.08]

6.2 Calcipotriol vs. coal tar polytherapy

2

220

Risk Difference (M‐H, Random, 95% CI)

‐0.03 [‐0.10, 0.04]

6.3 Calcipotriol vs. nicotinamide 1.4%, twice daily

1

96

Risk Difference (M‐H, Random, 95% CI)

0.02 [‐0.05, 0.09]

6.4 Calcipotriol vs. calcipotriol + nicotinamide (0.05%, 0.1%, 0.7%, or 1.4%), twice daily

1

192

Risk Difference (M‐H, Random, 95% CI)

0.01 [‐0.06, 0.07]

6.5 Calcipotriol vs. corticosteroid + salicylic acid

1

160

Risk Difference (M‐H, Random, 95% CI)

0.04 [‐0.09, 0.17]

6.6 Calcipotriol vs. propylthiouracil cream

1

28

Risk Difference (M‐H, Random, 95% CI)

0.07 [‐0.16, 0.30]

6.7 Calcipotriol vs. tacrolimus ointment

1

124

Risk Difference (M‐H, Random, 95% CI)

‐0.13 [‐0.25, ‐0.01]

6.8 Calcipotriol vs. tazarotene

2

254

Risk Difference (M‐H, Random, 95% CI)

‐0.04 [‐0.10, 0.01]

6.9 Calcipotriol vs. tazarotene gel plus mometasone furoate cream

1

120

Risk Difference (M‐H, Random, 95% CI)

‐0.03 [‐0.15, 0.08]

6.10 Calcipotriol vs. vitamin B12 cream

1

26

Risk Difference (M‐H, Random, 95% CI)

0.0 [‐0.14, 0.14]

6.11 Head‐to‐head vitamin D alone or in combination: twice daily vs OD

3

1001

Risk Difference (M‐H, Random, 95% CI)

0.01 [‐0.03, 0.05]

6.12 Head‐to‐head vitamin D alone or in combination: no occlusion vs. occlusion

0

0

Risk Difference (M‐H, Random, 95% CI)

0.0 [0.0, 0.0]

7 Withdrawals due to adverse events Show forest plot

15

Risk Difference (M‐H, Random, 95% CI)

Subtotals only

Analysis 15.7

Comparison 15 Vitamin D analogues versus other treatment, Outcome 7 Withdrawals due to adverse events.

Comparison 15 Vitamin D analogues versus other treatment, Outcome 7 Withdrawals due to adverse events.

7.1 Calcipotriol vs. coal tar

2

120

Risk Difference (M‐H, Random, 95% CI)

0.01 [‐0.04, 0.06]

7.2 Calcipotriol vs. coal tar polytherapy

2

210

Risk Difference (M‐H, Random, 95% CI)

‐0.02 [‐0.07, 0.03]

7.3 Calcipotriol vs. nicotinamide 1.4%, twice daily

1

96

Risk Difference (M‐H, Random, 95% CI)

0.0 [‐0.04, 0.04]

7.4 Calcipotriol vs. calcipotriol + nicotinamide (0.05%, 0.1%, 0.7%, or 1.4%), twice daily

1

192

Risk Difference (M‐H, Random, 95% CI)

0.0 [‐0.03, 0.03]

7.5 Calcipotriol vs. corticosteroid + salicylic acid

1

160

Risk Difference (M‐H, Random, 95% CI)

0.05 [‐0.00, 0.10]

7.6 Calcipotriol vs. propylthiouracil cream

1

28

Risk Difference (M‐H, Random, 95% CI)

0.07 [‐0.16, 0.30]

7.7 Calcipotriol vs. tacrolimus ointment

1

124

Risk Difference (M‐H, Random, 95% CI)

0.02 [‐0.08, 0.11]

7.8 Calcipotriol vs. tazarotene

2

254

Risk Difference (M‐H, Random, 95% CI)

‐0.05 [‐0.16, 0.05]

7.9 Calcipotriol vs. tazarotene gel plus mometasone furoate cream

1

120

Risk Difference (M‐H, Random, 95% CI)

‐0.02 [‐0.10, 0.07]

7.10 Calcipotriol vs. vitamin B12 cream

1

26

Risk Difference (M‐H, Random, 95% CI)

0.0 [‐0.14, 0.14]

7.11 Head‐to‐head vitamin D alone or in combination: twice daily vs OD

3

998

Risk Difference (M‐H, Random, 95% CI)

0.01 [‐0.01, 0.02]

7.12 Head‐to‐head vitamin D alone or in combination: no occlusion vs. occlusion

0

0

Risk Difference (M‐H, Random, 95% CI)

0.0 [0.0, 0.0]

8 Withdrawals due to treatment failure Show forest plot

12

Risk Difference (M‐H, Random, 95% CI)

Subtotals only

Analysis 15.8

Comparison 15 Vitamin D analogues versus other treatment, Outcome 8 Withdrawals due to treatment failure.

Comparison 15 Vitamin D analogues versus other treatment, Outcome 8 Withdrawals due to treatment failure.

8.1 Calcipotriol vs. coal tar

1

60

Risk Difference (M‐H, Random, 95% CI)

0.0 [‐0.06, 0.06]

8.2 Calcipotriol vs. coal tar polytherapy

1

88

Risk Difference (M‐H, Random, 95% CI)

0.00 [‐0.06, 0.07]

8.3 Calcipotriol vs. nicotinamide 1.4%, twice daily

1

96

Risk Difference (M‐H, Random, 95% CI)

0.0 [‐0.04, 0.04]

8.4 Calcipotriol vs. calcipotriol + nicotinamide (0.05%, 0.1%, 0.7%, or 1.4%), twice daily

1

192

Risk Difference (M‐H, Random, 95% CI)

0.0 [‐0.03, 0.03]

8.5 Calcipotriol vs. corticosteroid + salicylic acid

1

160

Risk Difference (M‐H, Random, 95% CI)

‐0.02 [‐0.07, 0.02]

8.6 Calcipotriol vs. propylthiouracil cream

1

28

Risk Difference (M‐H, Random, 95% CI)

‐0.07 [‐0.25, 0.11]

8.7 Calcipotriol vs. tacrolimus ointment

1

124

Risk Difference (M‐H, Random, 95% CI)

‐0.02 [‐0.07, 0.03]

8.8 Calcipotriol vs. tazarotene

1

208

Risk Difference (M‐H, Random, 95% CI)

0.0 [‐0.02, 0.02]

8.9 Calcipotriol vs. tazarotene gel plus mometasone furoate cream

1

120

Risk Difference (M‐H, Random, 95% CI)

0.0 [‐0.05, 0.05]

8.10 Calcipotriol vs. vitamin B12 cream

1

26

Risk Difference (M‐H, Random, 95% CI)

0.0 [‐0.14, 0.14]

8.11 Head‐to‐head vitamin D alone or in combination: twice daily vs OD

3

998

Risk Difference (M‐H, Random, 95% CI)

0.00 [‐0.01, 0.01]

8.12 Head‐to‐head vitamin D alone or in combination: no occlusion vs. occlusion

0

0

Risk Difference (M‐H, Random, 95% CI)

0.0 [0.0, 0.0]

9 Adverse events (local) Show forest plot

11

Risk Difference (M‐H, Random, 95% CI)

Subtotals only

Analysis 15.9

Comparison 15 Vitamin D analogues versus other treatment, Outcome 9 Adverse events (local).

Comparison 15 Vitamin D analogues versus other treatment, Outcome 9 Adverse events (local).

9.1 Calcipotriol vs. coal tar

2

120

Risk Difference (M‐H, Random, 95% CI)

0.02 [‐0.06, 0.10]

9.2 Calcipotriol vs. coal tar polytherapy

1

122

Risk Difference (M‐H, Random, 95% CI)

0.06 [‐0.09, 0.20]

9.3 Calcipotriol vs. nicotinamide 1.4%, twice daily

1

96

Risk Difference (M‐H, Random, 95% CI)

‐0.15 [‐0.32, 0.03]

9.4 Calcipotriol vs. calcipotriol + nicotinamide (0.05%, 0.1%, 0.7%, or 1.4%), twice daily

1

192

Risk Difference (M‐H, Random, 95% CI)

‐0.17 [‐0.30, ‐0.03]

9.5 Calcipotriol vs. corticosteroid + salicylic acid

1

160

Risk Difference (M‐H, Random, 95% CI)

0.09 [0.02, 0.15]

9.6 Calcipotriol vs. propylthiouracil cream

1

28

Risk Difference (M‐H, Random, 95% CI)

‐0.07 [‐0.25, 0.11]

9.7 Calcipotriol vs. tacrolimus ointment

1

124

Risk Difference (M‐H, Random, 95% CI)

‐0.19 [‐0.37, ‐0.01]

9.8 Calcipotriol vs. tazarotene

1

204

Risk Difference (M‐H, Random, 95% CI)

‐0.03 [‐0.11, 0.06]

9.9 Calcipotriol vs. tazarotene gel plus mometasone furoate cream

0

0

Risk Difference (M‐H, Random, 95% CI)

0.0 [0.0, 0.0]

9.10 Calcipotriol vs. vitamin B12 cream

1

26

Risk Difference (M‐H, Random, 95% CI)

0.23 [‐0.06, 0.52]

9.11 Head‐to‐head vitamin D alone or in combination: twice daily vs OD

2

731

Risk Difference (M‐H, Random, 95% CI)

‐0.00 [‐0.06, 0.05]

9.12 Head‐to‐head vitamin D alone or in combination: no occlusion vs. occlusion

0

0

Risk Difference (M‐H, Random, 95% CI)

0.0 [0.0, 0.0]

10 Adverse events (systemic) Show forest plot

8

Risk Difference (M‐H, Random, 95% CI)

Subtotals only

Analysis 15.10

Comparison 15 Vitamin D analogues versus other treatment, Outcome 10 Adverse events (systemic).

Comparison 15 Vitamin D analogues versus other treatment, Outcome 10 Adverse events (systemic).

10.1 Calcipotriol vs. coal tar

1

60

Risk Difference (M‐H, Random, 95% CI)

0.0 [‐0.09, 0.09]

10.2 Calcipotriol vs. coal tar polytherapy

1

88

Risk Difference (M‐H, Random, 95% CI)

0.0 [‐0.04, 0.04]

10.3 Calcipotriol vs. nicotinamide 1.4%, twice daily

0

0

Risk Difference (M‐H, Random, 95% CI)

0.0 [0.0, 0.0]

10.4 Calcipotriol vs. calcipotriol + nicotinamide 1.4%, twice daily

0

0

Risk Difference (M‐H, Random, 95% CI)

0.0 [0.0, 0.0]

10.5 Calcipotriol vs. corticosteroid + salicylic acid

1

160

Risk Difference (M‐H, Random, 95% CI)

0.0 [‐0.02, 0.02]

10.6 Calcipotriol vs. propylthiouracil cream

1

28

Risk Difference (M‐H, Random, 95% CI)

0.0 [‐0.13, 0.13]

10.7 Calcipotriol vs. tacrolimus ointment

1

124

Risk Difference (M‐H, Random, 95% CI)

0.0 [‐0.04, 0.04]

10.8 Calcipotriol vs. tazarotene

1

183

Risk Difference (M‐H, Random, 95% CI)

‐0.01 [‐0.05, 0.03]

10.9 Calcipotriol vs. tazarotene gel plus mometasone furoate cream

0

0

Risk Difference (M‐H, Random, 95% CI)

0.0 [0.0, 0.0]

10.10 Calcipotriol vs. vitamin B12 cream

0

0

Risk Difference (M‐H, Random, 95% CI)

0.0 [0.0, 0.0]

10.11 Head‐to‐head vitamin D alone or in combination: twice daily vs OD

1

264

Risk Difference (M‐H, Random, 95% CI)

0.0 [‐0.01, 0.01]

10.12 Head‐to‐head vitamin D alone or in combination: no occlusion vs. occlusion

1

38

Risk Difference (M‐H, Random, 95% CI)

0.0 [‐0.10, 0.10]

Open in table viewer
Comparison 16. Flexural/facial psoriasis: placebo‐controlled trials

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 IAGI Show forest plot

1

Std. Mean Difference (IV, Random, 95% CI)

Totals not selected

Analysis 16.1

Comparison 16 Flexural/facial psoriasis: placebo‐controlled trials, Outcome 1 IAGI.

Comparison 16 Flexural/facial psoriasis: placebo‐controlled trials, Outcome 1 IAGI.

1.1 Betamethasone valerate 0.1%, OD

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

1.2 Calcipotriol ointment, OD

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

1.3 Pimecrolimus cream, 1% OD/twice daily

1

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

1.4 Tacrolimus ointment 0.1%, twice daily

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

2 TSS Show forest plot

1

Std. Mean Difference (IV, Random, 95% CI)

Totals not selected

Analysis 16.2

Comparison 16 Flexural/facial psoriasis: placebo‐controlled trials, Outcome 2 TSS.

Comparison 16 Flexural/facial psoriasis: placebo‐controlled trials, Outcome 2 TSS.

2.1 Betamethasone valerate 0.1%, OD

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

2.2 Calcipotriol ointment, OD

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

2.3 Pimecrolimus cream, 1% OD/twice daily

1

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

2.4 Tacrolimus ointment 0.1%, twice daily

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

3 PASI Show forest plot

1

Std. Mean Difference (IV, Random, 95% CI)

Totals not selected

Analysis 16.3

Comparison 16 Flexural/facial psoriasis: placebo‐controlled trials, Outcome 3 PASI.

Comparison 16 Flexural/facial psoriasis: placebo‐controlled trials, Outcome 3 PASI.

3.1 Betamethasone valerate 0.1%, OD

1

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

3.2 Calcipotriol ointment, OD

1

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

3.3 Pimecrolimus cream, 1% OD/twice daily

1

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

3.4 Tacrolimus ointment 0.1%, twice daily

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

4 PAGI Show forest plot

1

Std. Mean Difference (IV, Random, 95% CI)

Subtotals only

Analysis 16.4

Comparison 16 Flexural/facial psoriasis: placebo‐controlled trials, Outcome 4 PAGI.

Comparison 16 Flexural/facial psoriasis: placebo‐controlled trials, Outcome 4 PAGI.

4.1 Betamethasone valerate 0.1%, OD

0

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

4.2 Calcipotriol ointment, OD

0

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

4.3 Pimecrolimus cream, 1% OD/twice daily

1

47

Std. Mean Difference (IV, Random, 95% CI)

‐0.65 [‐1.24, ‐0.06]

4.4 Tacrolimus ointment 0.1%, twice daily

0

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

5 Combined end point (IAGI/TSS/PASI/PAGI) Show forest plot

2

Std. Mean Difference (IV, Random, 95% CI)

Subtotals only

Analysis 16.5

Comparison 16 Flexural/facial psoriasis: placebo‐controlled trials, Outcome 5 Combined end point (IAGI/TSS/PASI/PAGI).

Comparison 16 Flexural/facial psoriasis: placebo‐controlled trials, Outcome 5 Combined end point (IAGI/TSS/PASI/PAGI).

5.1 Betamethasone valerate 0.1%, OD

1

36

Std. Mean Difference (IV, Random, 95% CI)

‐2.83 [‐3.79, ‐1.88]

5.2 Calcipotriol ointment, OD

1

38

Std. Mean Difference (IV, Random, 95% CI)

‐1.08 [‐1.77, ‐0.40]

5.3 Pimecrolimus cream, 1% OD/twice daily

2

86

Std. Mean Difference (IV, Random, 95% CI)

‐0.86 [‐1.30, ‐0.41]

5.4 Tacrolimus ointment 0.1%, twice daily

0

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

6 Total withdrawals Show forest plot

3

Risk Difference (M‐H, Random, 95% CI)

Subtotals only

Analysis 16.6

Comparison 16 Flexural/facial psoriasis: placebo‐controlled trials, Outcome 6 Total withdrawals.

Comparison 16 Flexural/facial psoriasis: placebo‐controlled trials, Outcome 6 Total withdrawals.

6.1 Betamethasone valerate 0.1%, OD

1

40

Risk Difference (M‐H, Random, 95% CI)

0.10 [‐0.08, 0.28]

6.2 Calcipotriol ointment, OD

1

40

Risk Difference (M‐H, Random, 95% CI)

0.0 [‐0.14, 0.14]

6.3 Pimecrolimus cream, 1% OD/twice daily

2

97

Risk Difference (M‐H, Random, 95% CI)

‐0.06 [‐0.16, 0.04]

6.4 Tacrolimus ointment 0.1%, twice daily

1

167

Risk Difference (M‐H, Random, 95% CI)

‐0.17 [‐0.30, ‐0.03]

7 Withdrawals due to adverse events Show forest plot

3

Risk Difference (M‐H, Random, 95% CI)

Subtotals only

Analysis 16.7

Comparison 16 Flexural/facial psoriasis: placebo‐controlled trials, Outcome 7 Withdrawals due to adverse events.

Comparison 16 Flexural/facial psoriasis: placebo‐controlled trials, Outcome 7 Withdrawals due to adverse events.

7.1 Betamethasone valerate 0.1%, OD

1

40

Risk Difference (M‐H, Random, 95% CI)

0.0 [‐0.09, 0.09]

7.2 Calcipotriol ointment, OD

1

40

Risk Difference (M‐H, Random, 95% CI)

0.0 [‐0.09, 0.09]

7.3 Pimecrolimus cream, 1% OD/twice daily

2

97

Risk Difference (M‐H, Random, 95% CI)

0.0 [‐0.05, 0.05]

7.4 Tacrolimus ointment 0.1%, twice daily

1

167

Risk Difference (M‐H, Random, 95% CI)

‐0.02 [‐0.06, 0.03]

8 Withdrawals due to treatment failure Show forest plot

3

Risk Difference (M‐H, Random, 95% CI)

Subtotals only

Analysis 16.8

Comparison 16 Flexural/facial psoriasis: placebo‐controlled trials, Outcome 8 Withdrawals due to treatment failure.

Comparison 16 Flexural/facial psoriasis: placebo‐controlled trials, Outcome 8 Withdrawals due to treatment failure.

8.1 Betamethasone valerate 0.1%, OD

1

40

Risk Difference (M‐H, Random, 95% CI)

‐0.05 [‐0.18, 0.08]

8.2 Calcipotriol ointment, OD

1

40

Risk Difference (M‐H, Random, 95% CI)

‐0.05 [‐0.18, 0.08]

8.3 Pimecrolimus cream, 1% OD/twice daily

2

97

Risk Difference (M‐H, Random, 95% CI)

‐0.04 [‐0.13, 0.04]

8.4 Tacrolimus ointment 0.1%, twice daily

1

167

Risk Difference (M‐H, Random, 95% CI)

‐0.11 [‐0.19, ‐0.02]

9 Adverse events (local) Show forest plot

3

Risk Difference (M‐H, Random, 95% CI)

Subtotals only

Analysis 16.9

Comparison 16 Flexural/facial psoriasis: placebo‐controlled trials, Outcome 9 Adverse events (local).

Comparison 16 Flexural/facial psoriasis: placebo‐controlled trials, Outcome 9 Adverse events (local).

9.1 Betamethasone valerate 0.1%, OD

1

40

Risk Difference (M‐H, Random, 95% CI)

‐0.05 [‐0.18, 0.08]

9.2 Calcipotriol ointment, OD

1

40

Risk Difference (M‐H, Random, 95% CI)

0.05 [‐0.11, 0.21]

9.3 Pimecrolimus cream 1%, OD/twice daily

2

97

Risk Difference (M‐H, Random, 95% CI)

0.08 [‐0.15, 0.31]

9.4 Tacrolimus ointment 0.1%, twice daily

1

167

Risk Difference (M‐H, Random, 95% CI)

‐0.17 [‐0.30, ‐0.03]

10 Adverse events (systemic) Show forest plot

1

Risk Difference (M‐H, Random, 95% CI)

Totals not selected

Analysis 16.10

Comparison 16 Flexural/facial psoriasis: placebo‐controlled trials, Outcome 10 Adverse events (systemic).

Comparison 16 Flexural/facial psoriasis: placebo‐controlled trials, Outcome 10 Adverse events (systemic).

10.1 Betamethasone valerate 0.1%, OD

0

Risk Difference (M‐H, Random, 95% CI)

0.0 [0.0, 0.0]

10.2 Calcipotriol ointment, OD

0

Risk Difference (M‐H, Random, 95% CI)

0.0 [0.0, 0.0]

10.3 Pimecrolimus cream 1%, OD/twice daily

0

Risk Difference (M‐H, Random, 95% CI)

0.0 [0.0, 0.0]

10.4 Tacrolimus ointment 0.1%, twice daily

1

Risk Difference (M‐H, Random, 95% CI)

0.0 [0.0, 0.0]

Open in table viewer
Comparison 17. Flexural/facial psoriasis: vitamin D alone or in combination versus other treatment

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 IAGI Show forest plot

2

Std. Mean Difference (IV, Random, 95% CI)

Subtotals only

Analysis 17.1

Comparison 17 Flexural/facial psoriasis: vitamin D alone or in combination versus other treatment, Outcome 1 IAGI.

Comparison 17 Flexural/facial psoriasis: vitamin D alone or in combination versus other treatment, Outcome 1 IAGI.

1.1 Calcipotriol vs. BMV

0

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

1.2 Calcipotriol vs. calcipotriol + hydrocortisone

1

408

Std. Mean Difference (IV, Random, 95% CI)

0.30 [0.11, 0.50]

1.3 Calcipotriol vs. calcitriol

0

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

1.4 Calcipotriol vs. pimecrolimus

0

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

1.5 Calcitriol vs. tacrolimus

1

49

Std. Mean Difference (IV, Random, 95% CI)

0.42 [‐0.15, 0.98]

2 TSS Show forest plot

2

Std. Mean Difference (IV, Random, 95% CI)

Subtotals only

Analysis 17.2

Comparison 17 Flexural/facial psoriasis: vitamin D alone or in combination versus other treatment, Outcome 2 TSS.

Comparison 17 Flexural/facial psoriasis: vitamin D alone or in combination versus other treatment, Outcome 2 TSS.

2.1 Calcipotriol vs. BMV

0

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

2.2 Calcipotriol vs. calcipotriol + hydrocortisone

0

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

2.3 Calcipotriol vs. calcitriol

1

150

Std. Mean Difference (IV, Random, 95% CI)

0.61 [0.28, 0.94]

2.4 Calcipotriol vs. pimecrolimus

0

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

2.5 Calcitriol vs. tacrolimus

1

49

Std. Mean Difference (IV, Random, 95% CI)

0.29 [‐0.27, 0.85]

3 PASI Show forest plot

2

Std. Mean Difference (IV, Random, 95% CI)

Subtotals only

Analysis 17.3

Comparison 17 Flexural/facial psoriasis: vitamin D alone or in combination versus other treatment, Outcome 3 PASI.

Comparison 17 Flexural/facial psoriasis: vitamin D alone or in combination versus other treatment, Outcome 3 PASI.

3.1 Calcipotriol vs. BMV

1

36

Std. Mean Difference (IV, Random, 95% CI)

2.02 [1.20, 2.84]

3.2 Calcipotriol vs. calcipotriol + hydrocortisone

1

408

Std. Mean Difference (IV, Random, 95% CI)

0.32 [0.12, 0.51]

3.3 Calcipotriol vs. calcitriol

0

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

3.4 Calcipotriol vs. pimecrolimus

1

39

Std. Mean Difference (IV, Random, 95% CI)

‐0.53 [‐1.17, 0.11]

3.5 Calcitriol vs. tacrolimus

0

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

4 PAGI

0

Std. Mean Difference (IV, Random, 95% CI)

Subtotals only

4.1 Calcipotriol vs. BMV

0

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

4.2 Calcipotriol vs. calcipotriol + hydrocortisone

0

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

4.3 Calcipotriol vs. calcitriol

0

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

4.4 Calcipotriol vs. pimecrolimus

0

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

4.5 Calcitriol vs. tacrolimus

0

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

5 Combined end point (IAGI/TSS/PASI/PAGI) Show forest plot

4

Std. Mean Difference (IV, Random, 95% CI)

Subtotals only

Analysis 17.5

Comparison 17 Flexural/facial psoriasis: vitamin D alone or in combination versus other treatment, Outcome 5 Combined end point (IAGI/TSS/PASI/PAGI).

Comparison 17 Flexural/facial psoriasis: vitamin D alone or in combination versus other treatment, Outcome 5 Combined end point (IAGI/TSS/PASI/PAGI).

5.1 Calcipotriol vs. BMV

1

36

Std. Mean Difference (IV, Random, 95% CI)

2.02 [1.20, 2.84]

5.2 Calcipotriol vs. calcipotriol + hydrocortisone

1

408

Std. Mean Difference (IV, Random, 95% CI)

0.30 [0.11, 0.50]

5.3 Calcipotriol vs. calcitriol

1

150

Std. Mean Difference (IV, Random, 95% CI)

0.61 [0.28, 0.94]

5.4 Calcipotriol vs. pimecrolimus

1

39

Std. Mean Difference (IV, Random, 95% CI)

‐0.53 [‐1.17, 0.11]

5.5 Calcitriol vs. tacrolimus

1

49

Std. Mean Difference (IV, Random, 95% CI)

0.42 [‐0.15, 0.98]

6 Total withdrawals Show forest plot

4

Risk Difference (M‐H, Random, 95% CI)

Subtotals only

Analysis 17.6

Comparison 17 Flexural/facial psoriasis: vitamin D alone or in combination versus other treatment, Outcome 6 Total withdrawals.

Comparison 17 Flexural/facial psoriasis: vitamin D alone or in combination versus other treatment, Outcome 6 Total withdrawals.

6.1 Calcipotriol vs. BMV

1

40

Risk Difference (M‐H, Random, 95% CI)

‐0.10 [‐0.28, 0.08]

6.2 Calcipotriol vs. calcipotriol + hydrocortisone

1

408

Risk Difference (M‐H, Random, 95% CI)

0.04 [‐0.03, 0.11]

6.3 Calcipotriol vs. calcitriol

1

150

Risk Difference (M‐H, Random, 95% CI)

0.0 [‐0.11, 0.11]

6.4 Calcipotriol vs. pimecrolimus

1

40

Risk Difference (M‐H, Random, 95% CI)

0.05 [‐0.08, 0.18]

6.5 Calcitriol vs. tacrolimus

1

50

Risk Difference (M‐H, Random, 95% CI)

0.12 [‐0.02, 0.26]

7 Withdrawals due to adverse events Show forest plot

4

Risk Difference (M‐H, Random, 95% CI)

Subtotals only

Analysis 17.7

Comparison 17 Flexural/facial psoriasis: vitamin D alone or in combination versus other treatment, Outcome 7 Withdrawals due to adverse events.

Comparison 17 Flexural/facial psoriasis: vitamin D alone or in combination versus other treatment, Outcome 7 Withdrawals due to adverse events.

7.1 Calcipotriol vs. BMV

1

40

Risk Difference (M‐H, Random, 95% CI)

0.0 [‐0.09, 0.09]

7.2 Calcipotriol vs. calcipotriol + hydrocortisone

1

408

Risk Difference (M‐H, Random, 95% CI)

0.06 [0.02, 0.11]

7.3 Calcipotriol vs. calcitriol

1

150

Risk Difference (M‐H, Random, 95% CI)

0.09 [0.01, 0.18]

7.4 Calcipotriol vs. pimecrolimus

1

40

Risk Difference (M‐H, Random, 95% CI)

0.0 [‐0.09, 0.09]

7.5 Calcitriol vs. tacrolimus

1

50

Risk Difference (M‐H, Random, 95% CI)

0.0 [‐0.07, 0.07]

8 Withdrawals due to treatment failure Show forest plot

4

Risk Difference (M‐H, Random, 95% CI)

Subtotals only

Analysis 17.8

Comparison 17 Flexural/facial psoriasis: vitamin D alone or in combination versus other treatment, Outcome 8 Withdrawals due to treatment failure.

Comparison 17 Flexural/facial psoriasis: vitamin D alone or in combination versus other treatment, Outcome 8 Withdrawals due to treatment failure.

8.1 Calcipotriol vs. BMV

1

40

Risk Difference (M‐H, Random, 95% CI)

0.0 [‐0.09, 0.09]

8.2 Calcipotriol vs. calcipotriol + hydrocortisone

1

408

Risk Difference (M‐H, Random, 95% CI)

0.02 [‐0.01, 0.05]

8.3 Calcipotriol vs. calcitriol

1

150

Risk Difference (M‐H, Random, 95% CI)

0.0 [‐0.03, 0.03]

8.4 Calcipotriol vs. pimecrolimus

1

40

Risk Difference (M‐H, Random, 95% CI)

0.0 [‐0.09, 0.09]

8.5 Calcitriol vs. tacrolimus

1

50

Risk Difference (M‐H, Random, 95% CI)

0.0 [‐0.07, 0.07]

9 Adverse events (local) Show forest plot

3

Risk Difference (M‐H, Random, 95% CI)

Subtotals only

Analysis 17.9

Comparison 17 Flexural/facial psoriasis: vitamin D alone or in combination versus other treatment, Outcome 9 Adverse events (local).

Comparison 17 Flexural/facial psoriasis: vitamin D alone or in combination versus other treatment, Outcome 9 Adverse events (local).

9.1 calcipotriol vs. BMV

1

40

Risk Difference (M‐H, Random, 95% CI)

0.10 [‐0.05, 0.25]

9.2 Calcipotriol vs. calcipotriol + hydrocortisone

1

404

Risk Difference (M‐H, Random, 95% CI)

0.15 [0.08, 0.23]

9.3 Calcipotriol vs. calcitriol

1

150

Risk Difference (M‐H, Random, 95% CI)

0.09 [0.02, 0.17]

9.4 Calcipotriol vs. pimecrolimus

1

40

Risk Difference (M‐H, Random, 95% CI)

‐0.15 [‐0.38, 0.08]

9.5 Calcitriol vs. tacrolimus

0

0

Risk Difference (M‐H, Random, 95% CI)

0.0 [0.0, 0.0]

10 Adverse events (systemic)

0

Risk Difference (M‐H, Random, 95% CI)

Subtotals only

10.1 Calcipotriol vs. BMV

0

0

Risk Difference (M‐H, Random, 95% CI)

0.0 [0.0, 0.0]

10.2 Calcipotriol vs. calcipotriol + hydrocortisone

0

0

Risk Difference (M‐H, Random, 95% CI)

0.0 [0.0, 0.0]

10.3 Calcipotriol vs. calcitriol

0

0

Risk Difference (M‐H, Random, 95% CI)

0.0 [0.0, 0.0]

10.4 Calcipotriol vs. pimecrolimus

0

0

Risk Difference (M‐H, Random, 95% CI)

0.0 [0.0, 0.0]

10.5 Calcitriol vs. tacrolimus

0

0

Risk Difference (M‐H, Random, 95% CI)

0.0 [0.0, 0.0]

Open in table viewer
Comparison 18. Scalp psoriasis: placebo‐controlled trials

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 IAGI Show forest plot

9

Std. Mean Difference (IV, Random, 95% CI)

Subtotals only

Analysis 18.1

Comparison 18 Scalp psoriasis: placebo‐controlled trials, Outcome 1 IAGI.

Comparison 18 Scalp psoriasis: placebo‐controlled trials, Outcome 1 IAGI.

1.1 Vitamin D: calcipotriol

2

457

Std. Mean Difference (IV, Random, 95% CI)

‐0.72 [‐1.28, ‐0.16]

1.2 Potent steroid: betamethasone dipropionate

2

712

Std. Mean Difference (IV, Random, 95% CI)

‐1.09 [‐1.29, ‐0.90]

1.3 Potent steroid: betamethasone valerate

0

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

1.4 Very potent steroid: amcinonide

1

132

Std. Mean Difference (IV, Random, 95% CI)

‐1.42 [‐1.80, ‐1.04]

1.5 Very potent steroid: clobetasol propionate

2

458

Std. Mean Difference (IV, Random, 95% CI)

‐1.73 [‐1.99, ‐1.48]

1.6 Very potent steroid: halcinonide

1

54

Std. Mean Difference (IV, Random, 95% CI)

‐1.11 [‐1.69, ‐0.53]

1.7 Vitamin D in combination: calcipotriol + BMD

2

854

Std. Mean Difference (IV, Random, 95% CI)

‐0.97 [‐1.61, ‐0.32]

1.8 Other treatment: betamethasone‐17,21‐dipropionate plus salicylic acid

1

20

Std. Mean Difference (IV, Random, 95% CI)

‐1.48 [‐2.50, ‐0.47]

1.9 Other treatment: ciclopirox olamine shampoo

0

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

1.10 Other treatment: fluocinolone acetonide, plus occlusion

1

84

Std. Mean Difference (IV, Random, 95% CI)

‐1.22 [‐1.69, ‐0.76]

1.11 Other treatment: salicylic acid

1

20

Std. Mean Difference (IV, Random, 95% CI)

‐0.86 [‐1.79, 0.06]

2 TSS Show forest plot

11

Std. Mean Difference (IV, Random, 95% CI)

Subtotals only

Analysis 18.2

Comparison 18 Scalp psoriasis: placebo‐controlled trials, Outcome 2 TSS.

Comparison 18 Scalp psoriasis: placebo‐controlled trials, Outcome 2 TSS.

2.1 Vitamin D: calcipotriol

2

457

Std. Mean Difference (IV, Random, 95% CI)

‐0.44 [‐0.64, ‐0.25]

2.2 Potent steroid: betamethasone dipropionate

2

712

Std. Mean Difference (IV, Random, 95% CI)

‐1.00 [‐1.19, ‐0.81]

2.3 Potent steroid: betamethasone valerate

1

172

Std. Mean Difference (IV, Random, 95% CI)

‐1.40 [‐1.75, ‐1.05]

2.4 Very potent steroid: amcinonide

1

126

Std. Mean Difference (IV, Random, 95% CI)

‐1.58 [‐1.98, ‐1.18]

2.5 Very potent steroid: clobetasol propionate

3

707

Std. Mean Difference (IV, Random, 95% CI)

‐1.53 [‐1.77, ‐1.28]

2.6 Very potent steroid: halcinonide

0

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

2.7 Vitamin D in combination: calcipotriol + BMD

2

854

Std. Mean Difference (IV, Random, 95% CI)

‐0.92 [‐1.42, ‐0.43]

2.8 Other treatment: betamethasone‐17,21‐dipropionate plus salicylic acid

1

20

Std. Mean Difference (IV, Random, 95% CI)

‐1.15 [‐2.11, ‐0.19]

2.9 Other treatment: ciclopirox olamine shampoo

1

37

Std. Mean Difference (IV, Random, 95% CI)

‐0.07 [‐0.82, 0.68]

2.10 Other treatment: fluocinolone acetonide, plus occlusion

1

84

Std. Mean Difference (IV, Random, 95% CI)

‐0.89 [‐1.34, ‐0.44]

2.11 Other treatment: salicylic acid

1

20

Std. Mean Difference (IV, Random, 95% CI)

‐0.57 [‐1.47, 0.32]

3 PASI

0

Std. Mean Difference (IV, Random, 95% CI)

Subtotals only

3.1 Vitamin D: calcipotriol

0

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

3.2 Potent steroid: betamethasone dipropionate

0

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

3.3 Potent steroid: betamethasone valerate

0

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

3.4 Very potent steroid: amcinonide

0

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

3.5 Very potent steroid: clobetasol propionate

0

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

3.6 Very potent steroid: halcinonide

0

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

3.7 Vitamin D in combination: calcipotriol + BMD

0

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

3.8 Other treatment: betamethasone‐17,21‐dipropionate plus salicylic acid

0

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

3.9 Other treatment: ciclopirox olamine shampoo

0

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

3.10 Other treatment: fluocinolone acetonide, plus occlusion

0

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

3.11 Other treatment: salicylic acid

0

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

4 PAGI Show forest plot

5

Std. Mean Difference (IV, Random, 95% CI)

Subtotals only

Analysis 18.4

Comparison 18 Scalp psoriasis: placebo‐controlled trials, Outcome 4 PAGI.

Comparison 18 Scalp psoriasis: placebo‐controlled trials, Outcome 4 PAGI.

4.1 Vitamin D: calcipotriol

2

450

Std. Mean Difference (IV, Random, 95% CI)

‐0.66 [‐1.28, ‐0.05]

4.2 Potent steroid: betamethasone dipropionate

1

685

Std. Mean Difference (IV, Random, 95% CI)

‐1.23 [‐1.43, ‐1.03]

4.3 Potent steroid: betamethasone valerate

0

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

4.4 Very potent steroid: amcinonide

1

132

Std. Mean Difference (IV, Random, 95% CI)

‐0.97 [‐1.33, ‐0.61]

4.5 Very potent steroid: clobetasol propionate

0

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

4.6 Very potent steroid: halcinonide

0

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

4.7 Vitamin D in combination: calcipotriol + BMD

2

841

Std. Mean Difference (IV, Random, 95% CI)

‐1.00 [‐1.79, ‐0.22]

4.8 Other treatment: betamethasone‐17,21‐dipropionate plus salicylic acid

0

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

4.9 Other treatment: ciclopirox olamine shampoo

1

37

Std. Mean Difference (IV, Random, 95% CI)

‐0.11 [‐0.86, 0.64]

4.10 Other treatment: fluocinolone acetonide, plus occlusion

0

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

4.11 Other treatment: salicylic acid

0

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

5 Combined end point (IAGI/TSS/PASI/PAGI) Show forest plot

13

Std. Mean Difference (IV, Random, 95% CI)

Subtotals only

Analysis 18.5

Comparison 18 Scalp psoriasis: placebo‐controlled trials, Outcome 5 Combined end point (IAGI/TSS/PASI/PAGI).

Comparison 18 Scalp psoriasis: placebo‐controlled trials, Outcome 5 Combined end point (IAGI/TSS/PASI/PAGI).

5.1 Vitamin D: calcipotriol

2

457

Std. Mean Difference (IV, Random, 95% CI)

‐0.72 [‐1.28, ‐0.16]

5.2 Potent steroid: betamethasone dipropionate

2

712

Std. Mean Difference (IV, Random, 95% CI)

‐1.09 [‐1.29, ‐0.90]

5.3 Potent steroid: betamethasone valerate

1

172

Std. Mean Difference (IV, Random, 95% CI)

‐1.40 [‐1.75, ‐1.05]

5.4 Very potent steroid: amcinonide

1

132

Std. Mean Difference (IV, Random, 95% CI)

‐1.42 [‐1.80, ‐1.04]

5.5 Very potent steroid: clobetasol propionate

4

788

Std. Mean Difference (IV, Random, 95% CI)

‐1.57 [‐1.81, ‐1.34]

5.6 Very potent steroid: halcinonide

1

54

Std. Mean Difference (IV, Random, 95% CI)

‐1.11 [‐1.69, ‐0.53]

5.7 Vitamin D in combination: calcipotriol + BMD

2

854

Std. Mean Difference (IV, Random, 95% CI)

‐0.97 [‐1.61, ‐0.32]

5.8 Other treatment: betamethasone‐17,21‐dipropionate plus salicylic acid

1

20

Std. Mean Difference (IV, Random, 95% CI)

‐1.48 [‐2.50, ‐0.47]

5.9 Other treatment: ciclopirox olamine shampoo

1

37

Std. Mean Difference (IV, Random, 95% CI)

‐0.07 [‐0.82, 0.68]

5.10 Other treatment: fluocinolone acetonide, plus occlusion

1

84

Std. Mean Difference (IV, Random, 95% CI)

‐1.22 [‐1.69, ‐0.76]

5.11 Other treatment: salicylic acid

1

20

Std. Mean Difference (IV, Random, 95% CI)

‐0.86 [‐1.79, 0.06]

6 Total withdrawals Show forest plot

13

Risk Difference (M‐H, Random, 95% CI)

Subtotals only

Analysis 18.6

Comparison 18 Scalp psoriasis: placebo‐controlled trials, Outcome 6 Total withdrawals.

Comparison 18 Scalp psoriasis: placebo‐controlled trials, Outcome 6 Total withdrawals.

6.1 Vitamin D: calcipotriol

3

517

Risk Difference (M‐H, Random, 95% CI)

‐0.02 [‐0.08, 0.05]

6.2 Potent steroid: betamethasone dipropionate

1

692

Risk Difference (M‐H, Random, 95% CI)

‐0.14 [‐0.21, ‐0.06]

6.3 Potent steroid: betamethasone valerate

0

0

Risk Difference (M‐H, Random, 95% CI)

0.0 [0.0, 0.0]

6.4 Very potent steroid: amcinonide

1

165

Risk Difference (M‐H, Random, 95% CI)

‐0.00 [‐0.11, 0.11]

6.5 Very potent steroid: clobetasol propionate

5

1006

Risk Difference (M‐H, Random, 95% CI)

‐0.03 [‐0.10, 0.04]

6.6 Very potent steroid: halcinonide

1

58

Risk Difference (M‐H, Random, 95% CI)

0.0 [‐0.13, 0.13]

6.7 Vitamin D in combination: calcipotriol + BMD

2

854

Risk Difference (M‐H, Random, 95% CI)

‐0.09 [‐0.16, ‐0.03]

6.8 Other treatment: betamethasone‐17,21‐dipropionate plus salicylic acid

0

0

Risk Difference (M‐H, Random, 95% CI)

0.0 [0.0, 0.0]

6.9 Other treatment: ciclopirox olamine shampoo

1

40

Risk Difference (M‐H, Random, 95% CI)

‐0.15 [‐0.38, 0.09]

6.10 Other treatment: fluocinolone acetonide, plus occlusion

1

89

Risk Difference (M‐H, Random, 95% CI)

‐0.04 [‐0.13, 0.04]

6.11 Other treatment: salicylic acid

0

0

Risk Difference (M‐H, Random, 95% CI)

0.0 [0.0, 0.0]

7 Withdrawals due to adverse events Show forest plot

13

Risk Difference (M‐H, Random, 95% CI)

Subtotals only

Analysis 18.7

Comparison 18 Scalp psoriasis: placebo‐controlled trials, Outcome 7 Withdrawals due to adverse events.

Comparison 18 Scalp psoriasis: placebo‐controlled trials, Outcome 7 Withdrawals due to adverse events.

7.1 Vitamin D: calcipotriol

3

517

Risk Difference (M‐H, Random, 95% CI)

0.02 [‐0.02, 0.05]

7.2 Potent steroid: betamethasone dipropionate

2

712

Risk Difference (M‐H, Random, 95% CI)

‐0.04 [‐0.08, ‐0.00]

7.3 Potent steroid: betamethasone valerate

1

172

Risk Difference (M‐H, Random, 95% CI)

0.0 [‐0.03, 0.03]

7.4 Very potent steroid: amcinonide

1

165

Risk Difference (M‐H, Random, 95% CI)

0.01 [‐0.02, 0.04]

7.5 Very potent steroid: clobetasol propionate

5

1006

Risk Difference (M‐H, Random, 95% CI)

‐0.00 [‐0.02, 0.01]

7.6 Very potent steroid: halcinonide

1

58

Risk Difference (M‐H, Random, 95% CI)

0.0 [‐0.06, 0.06]

7.7 Vitamin D in combination: calcipotriol + BMD

1

677

Risk Difference (M‐H, Random, 95% CI)

‐0.04 [‐0.08, 0.00]

7.8 Other treatment: betamethasone‐17,21‐dipropionate plus salicylic acid

1

20

Risk Difference (M‐H, Random, 95% CI)

0.0 [‐0.17, 0.17]

7.9 Other treatment: ciclopirox olamine shampoo

1

40

Risk Difference (M‐H, Random, 95% CI)

‐0.18 [‐0.42, 0.05]

7.10 Other treatment: fluocinolone acetonide, plus occlusion

0

0

Risk Difference (M‐H, Random, 95% CI)

0.0 [0.0, 0.0]

7.11 Other treatment: salicylic acid

1

20

Risk Difference (M‐H, Random, 95% CI)

0.0 [‐0.17, 0.17]

8 Withdrawals due to treatment failure Show forest plot

9

Risk Difference (M‐H, Random, 95% CI)

Subtotals only

Analysis 18.8

Comparison 18 Scalp psoriasis: placebo‐controlled trials, Outcome 8 Withdrawals due to treatment failure.

Comparison 18 Scalp psoriasis: placebo‐controlled trials, Outcome 8 Withdrawals due to treatment failure.

8.1 Vitamin D: calcipotriol

2

457

Risk Difference (M‐H, Random, 95% CI)

‐0.05 [‐0.11, 0.00]

8.2 Potent steroid: betamethasone dipropionate

1

692

Risk Difference (M‐H, Random, 95% CI)

‐0.10 [‐0.16, ‐0.05]

8.3 Potent steroid: betamethasone valerate

0

0

Risk Difference (M‐H, Random, 95% CI)

0.0 [0.0, 0.0]

8.4 Very potent steroid: amcinonide

1

165

Risk Difference (M‐H, Random, 95% CI)

‐0.01 [‐0.05, 0.02]

8.5 Very potent steroid: clobetasol propionate

5

1006

Risk Difference (M‐H, Random, 95% CI)

‐0.01 [‐0.05, 0.02]

8.6 Very potent steroid: halcinonide

0

0

Risk Difference (M‐H, Random, 95% CI)

0.0 [0.0, 0.0]

8.7 Vitamin D in combination: calcipotriol + BMD

1

677

Risk Difference (M‐H, Random, 95% CI)

‐0.11 [‐0.17, ‐0.06]

8.8 Other treatment: betamethasone‐17,21‐dipropionate plus salicylic acid

0

0

Risk Difference (M‐H, Random, 95% CI)

0.0 [0.0, 0.0]

8.9 Other treatment: ciclopirox olamine shampoo

1

40

Risk Difference (M‐H, Random, 95% CI)

‐0.09 [‐0.28, 0.10]

8.10 Other treatment: fluocinolone acetonide, plus occlusion

0

0

Risk Difference (M‐H, Random, 95% CI)

0.0 [0.0, 0.0]

8.11 Other treatment: salicylic acid

0

0

Risk Difference (M‐H, Random, 95% CI)

0.0 [0.0, 0.0]

9 Adverse events (local) Show forest plot

12

Risk Difference (M‐H, Random, 95% CI)

Subtotals only

Analysis 18.9

Comparison 18 Scalp psoriasis: placebo‐controlled trials, Outcome 9 Adverse events (local).

Comparison 18 Scalp psoriasis: placebo‐controlled trials, Outcome 9 Adverse events (local).

9.1 Vitamin D: calcipotriol

3

510

Risk Difference (M‐H, Random, 95% CI)

‐0.00 [‐0.05, 0.04]

9.2 Potent steroid: betamethasone dipropionate

2

703

Risk Difference (M‐H, Random, 95% CI)

‐0.07 [‐0.13, ‐0.01]

9.3 Potent steroid: betamethasone valerate

0

0

Risk Difference (M‐H, Random, 95% CI)

0.0 [0.0, 0.0]

9.4 Very potent steroid: amcinonide

0

0

Risk Difference (M‐H, Random, 95% CI)

0.0 [0.0, 0.0]

9.5 Very potent steroid: clobetasol propionate

4

817

Risk Difference (M‐H, Random, 95% CI)

0.00 [‐0.03, 0.04]

9.6 Very potent steroid: halcinonide

1

58

Risk Difference (M‐H, Random, 95% CI)

‐0.03 [‐0.12, 0.06]

9.7 Vitamin D in combination: calcipotriol + BMD

2

831

Risk Difference (M‐H, Random, 95% CI)

‐0.06 [‐0.13, 0.02]

9.8 Other treatment: betamethasone‐17,21‐dipropionate plus salicylic acid

1

20

Risk Difference (M‐H, Random, 95% CI)

0.0 [‐0.17, 0.17]

9.9 Other treatment: ciclopirox olamine shampoo

1

40

Risk Difference (M‐H, Random, 95% CI)

‐0.06 [‐0.24, 0.13]

9.10 Other treatment: fluocinolone acetonide, plus occlusion

1

89

Risk Difference (M‐H, Random, 95% CI)

0.02 [‐0.04, 0.08]

9.11 Other treatment: salicylic acid

1

20

Risk Difference (M‐H, Random, 95% CI)

0.0 [‐0.17, 0.17]

10 Adverse events (systemic) Show forest plot

4

Risk Difference (M‐H, Random, 95% CI)

Subtotals only

Analysis 18.10

Comparison 18 Scalp psoriasis: placebo‐controlled trials, Outcome 10 Adverse events (systemic).

Comparison 18 Scalp psoriasis: placebo‐controlled trials, Outcome 10 Adverse events (systemic).

10.1 Vitamin D: calcipotriol

1

408

Risk Difference (M‐H, Random, 95% CI)

0.0 [‐0.01, 0.01]

10.2 Potent steroid: betamethasone dipropionate

1

692

Risk Difference (M‐H, Random, 95% CI)

0.0 [‐0.01, 0.01]

10.3 Potent steroid: betamethasone valerate

0

0

Risk Difference (M‐H, Random, 95% CI)

0.0 [0.0, 0.0]

10.4 Very potent steroid: amcinonide

0

0

Risk Difference (M‐H, Random, 95% CI)

0.0 [0.0, 0.0]

10.5 Very potent steroid: clobetasol propionate

2

385

Risk Difference (M‐H, Random, 95% CI)

‐0.01 [‐0.03, 0.02]

10.6 Very potent steroid: halcinonide

0

0

Risk Difference (M‐H, Random, 95% CI)

0.0 [0.0, 0.0]

10.7 Vitamin D in combination: calcipotriol + BMD

2

843

Risk Difference (M‐H, Random, 95% CI)

0.0 [‐0.01, 0.01]

10.8 Other treatment: betamethasone‐17,21‐dipropionate plus salicylic acid

0

0

Risk Difference (M‐H, Random, 95% CI)

0.0 [0.0, 0.0]

10.9 Other treatment: ciclopirox olamine shampoo

0

0

Risk Difference (M‐H, Random, 95% CI)

0.0 [0.0, 0.0]

10.10 Other treatment: fluocinolone acetonide, plus occlusion

0

0

Risk Difference (M‐H, Random, 95% CI)

0.0 [0.0, 0.0]

10.11 Other treatment: salicylic acid

0

0

Risk Difference (M‐H, Random, 95% CI)

0.0 [0.0, 0.0]

Open in table viewer
Comparison 19. Scalp psoriasis: vitamin D alone or in combination versus other treatments

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 IAGI Show forest plot

9

Std. Mean Difference (IV, Random, 95% CI)

Subtotals only

Analysis 19.1

Comparison 19 Scalp psoriasis: vitamin D alone or in combination versus other treatments, Outcome 1 IAGI.

Comparison 19 Scalp psoriasis: vitamin D alone or in combination versus other treatments, Outcome 1 IAGI.

1.1 Vitamin D vs. corticosteroid (potent): calcipotriol vs. BMD

2

1676

Std. Mean Difference (IV, Random, 95% CI)

0.48 [0.32, 0.64]

1.2 Vitamin D vs. corticosteroid (potent): calcipotriol vs. BMV

2

510

Std. Mean Difference (IV, Random, 95% CI)

0.37 [0.20, 0.55]

1.3 Vitamin D vs. corticosteroid (very potent): calcipotriol vs. clobetasol propionate

0

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

1.4 Vitamin D + corticosteroid vs. corticosteroid: calcipotriol + BMD vs. BMD

3

2444

Std. Mean Difference (IV, Random, 95% CI)

‐0.18 [‐0.26, ‐0.10]

1.5 Vitamin D vs. vitamin D + corticosteroid: calcipotriol vs. calcipotriol + BMD

4

2581

Std. Mean Difference (IV, Random, 95% CI)

0.64 [0.44, 0.84]

1.6 Vitamin D vs. other treatments: calcipotriol vs. coal tar polytherapy

2

748

Std. Mean Difference (IV, Random, 95% CI)

‐0.24 [‐0.73, 0.25]

2 TSS Show forest plot

10

Std. Mean Difference (IV, Random, 95% CI)

Subtotals only

Analysis 19.2

Comparison 19 Scalp psoriasis: vitamin D alone or in combination versus other treatments, Outcome 2 TSS.

Comparison 19 Scalp psoriasis: vitamin D alone or in combination versus other treatments, Outcome 2 TSS.

2.1 Vitamin D vs. corticosteroid (potent): calcipotriol vs. BMD

2

1676

Std. Mean Difference (IV, Random, 95% CI)

0.45 [0.28, 0.63]

2.2 Vitamin D vs. corticosteroid (potent): calcipotriol vs. BMV

2

487

Std. Mean Difference (IV, Random, 95% CI)

0.09 [‐0.09, 0.27]

2.3 Vitamin D vs. corticosteroid (very potent): calcipotriol vs. clobetasol propionate

1

151

Std. Mean Difference (IV, Random, 95% CI)

0.37 [0.05, 0.69]

2.4 Vitamin D + corticosteroid vs. corticosteroid: calcipotriol + BMD vs. BMD

3

2444

Std. Mean Difference (IV, Random, 95% CI)

‐0.19 [‐0.27, ‐0.11]

2.5 Vitamin D vs. vitamin D + corticosteroid: calcipotriol vs. calcipotriol + BMD

3

1978

Std. Mean Difference (IV, Random, 95% CI)

0.70 [0.56, 0.84]

2.6 Vitamin D vs. other treatments: calcipotriol vs. coal tar polytherapy

3

925

Std. Mean Difference (IV, Random, 95% CI)

‐0.30 [‐0.84, 0.24]

3 PASI

0

Std. Mean Difference (IV, Random, 95% CI)

Subtotals only

3.1 Vitamin D vs. corticosteroid (potent): calcipotriol vs. BMD

0

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

3.2 Vitamin D vs. corticosteroid (potent): calcipotriol vs. BMV

0

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

3.3 Vitamin D vs. corticosteroid (very potent): calcipotriol vs. clobetasol propionate

0

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

3.4 Vitamin D + corticosteroid vs. corticosteroid: calcipotriol + BMD vs. BMD

0

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

3.5 Vitamin D vs. vitamin D + corticosteroid: calcipotriol vs. calcipotriol + BMD

0

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

3.6 Vitamin D vs. other treatments: calcipotriol vs. coal tar polytherapy

0

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

4 PAGI Show forest plot

5

Std. Mean Difference (IV, Random, 95% CI)

Subtotals only

Analysis 19.4

Comparison 19 Scalp psoriasis: vitamin D alone or in combination versus other treatments, Outcome 4 PAGI.

Comparison 19 Scalp psoriasis: vitamin D alone or in combination versus other treatments, Outcome 4 PAGI.

4.1 Vitamin D vs. corticosteroid (potent): calcipotriol vs. BMD

2

1654

Std. Mean Difference (IV, Random, 95% CI)

0.56 [0.31, 0.81]

4.2 Vitamin D vs. corticosteroid (potent): calcipotriol vs. BMV

1

468

Std. Mean Difference (IV, Random, 95% CI)

0.41 [0.22, 0.59]

4.3 Vitamin D vs. corticosteroid (very potent): calcipotriol vs. clobetasol propionate

0

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

4.4 Vitamin D + corticosteroid vs. corticosteroid: calcipotriol + BMD vs. BMD

3

2414

Std. Mean Difference (IV, Random, 95% CI)

‐0.17 [‐0.25, ‐0.09]

4.5 Vitamin D vs. vitamin D + corticosteroid: calcipotriol vs. calcipotriol + BMD

3

1952

Std. Mean Difference (IV, Random, 95% CI)

0.84 [0.61, 1.08]

4.6 Vitamin D vs. other treatments: calcipotriol vs. coal tar polytherapy

0

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

5 Combined end point (IAGI/TSS/PASI/PAGI) Show forest plot

11

Std. Mean Difference (IV, Random, 95% CI)

Subtotals only

Analysis 19.5

Comparison 19 Scalp psoriasis: vitamin D alone or in combination versus other treatments, Outcome 5 Combined end point (IAGI/TSS/PASI/PAGI).

Comparison 19 Scalp psoriasis: vitamin D alone or in combination versus other treatments, Outcome 5 Combined end point (IAGI/TSS/PASI/PAGI).

5.1 Vitamin D vs. corticosteroid (potent): calcipotriol vs. BMD

2

1676

Std. Mean Difference (IV, Random, 95% CI)

0.48 [0.32, 0.64]

5.2 Vitamin D vs. corticosteroid (potent): calcipotriol vs. BMV

2

510

Std. Mean Difference (IV, Random, 95% CI)

0.37 [0.20, 0.55]

5.3 Vitamin D vs. corticosteroid (very potent): calcipotriol vs. clobetasol propionate

1

151

Std. Mean Difference (IV, Random, 95% CI)

0.37 [0.05, 0.69]

5.4 Vitamin D + corticosteroid vs. corticosteroid: calcipotriol + BMD vs. BMD

3

2444

Std. Mean Difference (IV, Random, 95% CI)

‐0.18 [‐0.26, ‐0.10]

5.5 Vitamin D vs. vitamin D + corticosteroid: calcipotriol vs. calcipotriol + BMD

4

2581

Std. Mean Difference (IV, Random, 95% CI)

0.64 [0.44, 0.84]

5.6 Vitamin D vs. other treatments: calcipotriol vs. coal tar polytherapy

3

835

Std. Mean Difference (IV, Random, 95% CI)

‐0.45 [‐0.92, 0.02]

6 Total withdrawals Show forest plot

10

Risk Difference (M‐H, Random, 95% CI)

Subtotals only

Analysis 19.6

Comparison 19 Scalp psoriasis: vitamin D alone or in combination versus other treatments, Outcome 6 Total withdrawals.

Comparison 19 Scalp psoriasis: vitamin D alone or in combination versus other treatments, Outcome 6 Total withdrawals.

6.1 Vitamin D vs. corticosteroid (potent): calcipotriol vs. BMD

2

1676

Risk Difference (M‐H, Random, 95% CI)

0.07 [‐0.04, 0.18]

6.2 Vitamin D vs. corticosteroid (potent): calcipotriol vs. BMV

2

516

Risk Difference (M‐H, Random, 95% CI)

0.04 [‐0.00, 0.08]

6.3 Vitamin D vs. corticosteroid (very potent): calcipotriol vs. clobetasol propionate

2

194

Risk Difference (M‐H, Random, 95% CI)

0.05 [‐0.07, 0.18]

6.4 Vitamin D + corticosteroid vs. corticosteroid: calcipotriol + BMD vs. BMD

3

2444

Risk Difference (M‐H, Random, 95% CI)

0.01 [‐0.04, 0.06]

6.5 Vitamin D vs. vitamin D + corticosteroid: calcipotriol vs. calcipotriol + BMD

4

2847

Risk Difference (M‐H, Random, 95% CI)

0.11 [0.05, 0.18]

6.6 Vitamin D vs. other treatments: calcipotriol vs. coal tar polytherapy

1

475

Risk Difference (M‐H, Random, 95% CI)

0.01 [‐0.07, 0.09]

7 Withdrawals due to adverse events Show forest plot

10

Risk Difference (M‐H, Random, 95% CI)

Subtotals only

Analysis 19.7

Comparison 19 Scalp psoriasis: vitamin D alone or in combination versus other treatments, Outcome 7 Withdrawals due to adverse events.

Comparison 19 Scalp psoriasis: vitamin D alone or in combination versus other treatments, Outcome 7 Withdrawals due to adverse events.

7.1 Vitamin D vs. corticosteroid (potent): calcipotriol vs. BMD

2

1676

Risk Difference (M‐H, Random, 95% CI)

0.04 [‐0.01, 0.09]

7.2 Vitamin D vs. corticosteroid (potent): calcipotriol vs. BMV

2

516

Risk Difference (M‐H, Random, 95% CI)

0.03 [0.01, 0.06]

7.3 Vitamin D vs. corticosteroid (very potent): calcipotriol vs. clobetasol propionate

2

194

Risk Difference (M‐H, Random, 95% CI)

0.05 [‐0.05, 0.15]

7.4 Vitamin D + corticosteroid vs. corticosteroid: calcipotriol + BMD vs. BMD

3

2444

Risk Difference (M‐H, Random, 95% CI)

‐0.00 [‐0.01, 0.01]

7.5 Vitamin D vs. vitamin D + corticosteroid: calcipotriol vs. calcipotriol + BMD

4

2847

Risk Difference (M‐H, Random, 95% CI)

0.06 [0.02, 0.09]

7.6 Vitamin D vs. other treatments: calcipotriol vs. coal tar polytherapy

1

445

Risk Difference (M‐H, Random, 95% CI)

0.08 [0.02, 0.14]

8 Withdrawals due to treatment failure Show forest plot

8

Risk Difference (M‐H, Random, 95% CI)

Subtotals only

Analysis 19.8

Comparison 19 Scalp psoriasis: vitamin D alone or in combination versus other treatments, Outcome 8 Withdrawals due to treatment failure.

Comparison 19 Scalp psoriasis: vitamin D alone or in combination versus other treatments, Outcome 8 Withdrawals due to treatment failure.

8.1 Vitamin D vs. corticosteroid (potent): calcipotriol vs. BMD

2

1676

Risk Difference (M‐H, Random, 95% CI)

0.03 [‐0.01, 0.07]

8.2 Vitamin D vs. corticosteroid (potent): calcipotriol vs. BMV

2

516

Risk Difference (M‐H, Random, 95% CI)

0.01 [‐0.01, 0.03]

8.3 Vitamin D vs. corticosteroid (very potent): calcipotriol vs. clobetasol propionate

2

194

Risk Difference (M‐H, Random, 95% CI)

0.01 [‐0.02, 0.04]

8.4 Vitamin D + corticosteroid vs. corticosteroid: calcipotriol + BMD vs. BMD

3

2444

Risk Difference (M‐H, Random, 95% CI)

‐0.01 [‐0.02, ‐0.00]

8.5 Vitamin D vs. vitamin D + corticosteroid: calcipotriol vs. calcipotriol + BMD

3

2535

Risk Difference (M‐H, Random, 95% CI)

0.05 [0.01, 0.10]

8.6 Vitamin D vs. other treatments: calcipotriol vs. coal tar polytherapy

0

0

Risk Difference (M‐H, Random, 95% CI)

0.0 [0.0, 0.0]

9 Adverse events (local) Show forest plot

10

Risk Difference (M‐H, Random, 95% CI)

Subtotals only

Analysis 19.9

Comparison 19 Scalp psoriasis: vitamin D alone or in combination versus other treatments, Outcome 9 Adverse events (local).

Comparison 19 Scalp psoriasis: vitamin D alone or in combination versus other treatments, Outcome 9 Adverse events (local).

9.1 Vitamin D vs. corticosteroid (potent): calcipotriol vs. BMD

2

1652

Risk Difference (M‐H, Random, 95% CI)

0.07 [0.04, 0.11]

9.2 Vitamin D vs. corticosteroid (potent): calcipotriol vs. BMV

2

516

Risk Difference (M‐H, Random, 95% CI)

0.17 [0.01, 0.33]

9.3 Vitamin D vs. corticosteroid (very potent): calcipotriol vs. clobetasol propionate

2

194

Risk Difference (M‐H, Random, 95% CI)

0.19 [0.10, 0.28]

9.4 Vitamin D + corticosteroid vs. corticosteroid: calcipotriol + BMD vs. BMD

3

2415

Risk Difference (M‐H, Random, 95% CI)

‐0.00 [‐0.02, 0.01]

9.5 Vitamin D vs. vitamin D + corticosteroid: calcipotriol vs. calcipotriol + BMD

4

2801

Risk Difference (M‐H, Random, 95% CI)

0.09 [0.06, 0.12]

9.6 Vitamin D vs. other treatments: calcipotriol vs. coal tar polytherapy

1

445

Risk Difference (M‐H, Random, 95% CI)

0.24 [0.15, 0.33]

10 Adverse events (systemic) Show forest plot

6

Risk Difference (M‐H, Random, 95% CI)

Subtotals only

Analysis 19.10

Comparison 19 Scalp psoriasis: vitamin D alone or in combination versus other treatments, Outcome 10 Adverse events (systemic).

Comparison 19 Scalp psoriasis: vitamin D alone or in combination versus other treatments, Outcome 10 Adverse events (systemic).

10.1 Vitamin D vs. corticosteroid (potent): calcipotriol vs. BMD

2

1666

Risk Difference (M‐H, Random, 95% CI)

0.0 [‐0.00, 0.00]

10.2 Vitamin D vs. corticosteroid (potent): calcipotriol vs. BMV

1

474

Risk Difference (M‐H, Random, 95% CI)

0.0 [‐0.01, 0.01]

10.3 Vitamin D vs. corticosteroid (very potent): calcipotriol vs. clobetasol propionate

1

151

Risk Difference (M‐H, Random, 95% CI)

0.0 [‐0.03, 0.03]

10.4 Vitamin D + corticosteroid vs. corticosteroid: calcipotriol + BMD vs. BMD

2

2216

Risk Difference (M‐H, Random, 95% CI)

0.0 [‐0.00, 0.00]

10.5 Vitamin D vs. vitamin D + corticosteroid: calcipotriol vs. calcipotriol + BMD

3

1970

Risk Difference (M‐H, Random, 95% CI)

0.0 [‐0.00, 0.00]

10.6 Vitamin D vs. other treatments: calcipotriol vs. coal tar polytherapy

1

445

Risk Difference (M‐H, Random, 95% CI)

0.0 [‐0.01, 0.01]

Chronic plaque psoriasis
 Source: Dermis Dermatology Atlas Online (used with permission)
Figuras y tablas -
Figure 1

Chronic plaque psoriasis
Source: Dermis Dermatology Atlas Online (used with permission)

The epidermis in the skin of people with and without psoriasis
Figuras y tablas -
Figure 2

The epidermis in the skin of people with and without psoriasis

Risk of bias graph: review authors' judgements about each risk of bias item presented as percentages across all included studies.
Figuras y tablas -
Figure 3

Risk of bias graph: review authors' judgements about each risk of bias item presented as percentages across all included studies.

Forest plot of comparison: 13 Vitamin D alone or in combination vs. other treatments: complex regimens, outcome: 13.5 Combined end point (IAGI/TSS/PASI/PAGI).
Figuras y tablas -
Figure 4

Forest plot of comparison: 13 Vitamin D alone or in combination vs. other treatments: complex regimens, outcome: 13.5 Combined end point (IAGI/TSS/PASI/PAGI).

Forest plot of comparison: 14 Vitamin D alone or in combination vs. other treatment: long term studies (>24wks), outcome: 14.5 Combined end point (IAGI/TSS/PASI/PAGI).
Figuras y tablas -
Figure 5

Forest plot of comparison: 14 Vitamin D alone or in combination vs. other treatment: long term studies (>24wks), outcome: 14.5 Combined end point (IAGI/TSS/PASI/PAGI).

Forest plot of comparison: 18 Scalp psoriasis: placebo‐controlled trials, outcome: 18.5 Combined end point (IAGI/TSS/PASI/PAGI).
Figuras y tablas -
Figure 6

Forest plot of comparison: 18 Scalp psoriasis: placebo‐controlled trials, outcome: 18.5 Combined end point (IAGI/TSS/PASI/PAGI).

Comparison 1 Vitamin D analogues versus placebo, Outcome 1 IAGI.
Figuras y tablas -
Analysis 1.1

Comparison 1 Vitamin D analogues versus placebo, Outcome 1 IAGI.

Comparison 1 Vitamin D analogues versus placebo, Outcome 2 TSS.
Figuras y tablas -
Analysis 1.2

Comparison 1 Vitamin D analogues versus placebo, Outcome 2 TSS.

Comparison 1 Vitamin D analogues versus placebo, Outcome 3 PASI.
Figuras y tablas -
Analysis 1.3

Comparison 1 Vitamin D analogues versus placebo, Outcome 3 PASI.

Comparison 1 Vitamin D analogues versus placebo, Outcome 4 PAGI.
Figuras y tablas -
Analysis 1.4

Comparison 1 Vitamin D analogues versus placebo, Outcome 4 PAGI.

Comparison 1 Vitamin D analogues versus placebo, Outcome 5 Combined end point (IAGI/TSS/PASI/PAGI).
Figuras y tablas -
Analysis 1.5

Comparison 1 Vitamin D analogues versus placebo, Outcome 5 Combined end point (IAGI/TSS/PASI/PAGI).

Comparison 1 Vitamin D analogues versus placebo, Outcome 6 Total withdrawals.
Figuras y tablas -
Analysis 1.6

Comparison 1 Vitamin D analogues versus placebo, Outcome 6 Total withdrawals.

Comparison 1 Vitamin D analogues versus placebo, Outcome 7 Withdrawals due to adverse events.
Figuras y tablas -
Analysis 1.7

Comparison 1 Vitamin D analogues versus placebo, Outcome 7 Withdrawals due to adverse events.

Comparison 1 Vitamin D analogues versus placebo, Outcome 8 Withdrawals due to treatment failure.
Figuras y tablas -
Analysis 1.8

Comparison 1 Vitamin D analogues versus placebo, Outcome 8 Withdrawals due to treatment failure.

Comparison 1 Vitamin D analogues versus placebo, Outcome 9 Adverse events (local).
Figuras y tablas -
Analysis 1.9

Comparison 1 Vitamin D analogues versus placebo, Outcome 9 Adverse events (local).

Comparison 1 Vitamin D analogues versus placebo, Outcome 10 Adverse events (systemic).
Figuras y tablas -
Analysis 1.10

Comparison 1 Vitamin D analogues versus placebo, Outcome 10 Adverse events (systemic).

Comparison 2 Corticosteroid (potent) versus placebo, Outcome 1 IAGI.
Figuras y tablas -
Analysis 2.1

Comparison 2 Corticosteroid (potent) versus placebo, Outcome 1 IAGI.

Comparison 2 Corticosteroid (potent) versus placebo, Outcome 2 TSS.
Figuras y tablas -
Analysis 2.2

Comparison 2 Corticosteroid (potent) versus placebo, Outcome 2 TSS.

Comparison 2 Corticosteroid (potent) versus placebo, Outcome 3 PASI.
Figuras y tablas -
Analysis 2.3

Comparison 2 Corticosteroid (potent) versus placebo, Outcome 3 PASI.

Comparison 2 Corticosteroid (potent) versus placebo, Outcome 5 Combined end point (IAGI/TSS/PASI/PAGI).
Figuras y tablas -
Analysis 2.5

Comparison 2 Corticosteroid (potent) versus placebo, Outcome 5 Combined end point (IAGI/TSS/PASI/PAGI).

Comparison 2 Corticosteroid (potent) versus placebo, Outcome 6 Total withdrawals.
Figuras y tablas -
Analysis 2.6

Comparison 2 Corticosteroid (potent) versus placebo, Outcome 6 Total withdrawals.

Comparison 2 Corticosteroid (potent) versus placebo, Outcome 7 Withdrawals due to adverse events.
Figuras y tablas -
Analysis 2.7

Comparison 2 Corticosteroid (potent) versus placebo, Outcome 7 Withdrawals due to adverse events.

Comparison 2 Corticosteroid (potent) versus placebo, Outcome 8 Withdrawals due to treatment failure.
Figuras y tablas -
Analysis 2.8

Comparison 2 Corticosteroid (potent) versus placebo, Outcome 8 Withdrawals due to treatment failure.

Comparison 2 Corticosteroid (potent) versus placebo, Outcome 9 Adverse events (local).
Figuras y tablas -
Analysis 2.9

Comparison 2 Corticosteroid (potent) versus placebo, Outcome 9 Adverse events (local).

Comparison 2 Corticosteroid (potent) versus placebo, Outcome 10 Adverse events (systemic).
Figuras y tablas -
Analysis 2.10

Comparison 2 Corticosteroid (potent) versus placebo, Outcome 10 Adverse events (systemic).

Comparison 3 Corticosteroid (very potent) versus placebo, Outcome 1 IAGI.
Figuras y tablas -
Analysis 3.1

Comparison 3 Corticosteroid (very potent) versus placebo, Outcome 1 IAGI.

Comparison 3 Corticosteroid (very potent) versus placebo, Outcome 2 TSS.
Figuras y tablas -
Analysis 3.2

Comparison 3 Corticosteroid (very potent) versus placebo, Outcome 2 TSS.

Comparison 3 Corticosteroid (very potent) versus placebo, Outcome 4 PAGI.
Figuras y tablas -
Analysis 3.4

Comparison 3 Corticosteroid (very potent) versus placebo, Outcome 4 PAGI.

Comparison 3 Corticosteroid (very potent) versus placebo, Outcome 5 Combined end point (IAGI/TSS/PASI/PAGI).
Figuras y tablas -
Analysis 3.5

Comparison 3 Corticosteroid (very potent) versus placebo, Outcome 5 Combined end point (IAGI/TSS/PASI/PAGI).

Comparison 3 Corticosteroid (very potent) versus placebo, Outcome 6 Total withdrawals.
Figuras y tablas -
Analysis 3.6

Comparison 3 Corticosteroid (very potent) versus placebo, Outcome 6 Total withdrawals.

Comparison 3 Corticosteroid (very potent) versus placebo, Outcome 7 Withdrawals due to adverse events.
Figuras y tablas -
Analysis 3.7

Comparison 3 Corticosteroid (very potent) versus placebo, Outcome 7 Withdrawals due to adverse events.

Comparison 3 Corticosteroid (very potent) versus placebo, Outcome 8 Withdrawals due to treatment failure.
Figuras y tablas -
Analysis 3.8

Comparison 3 Corticosteroid (very potent) versus placebo, Outcome 8 Withdrawals due to treatment failure.

Comparison 3 Corticosteroid (very potent) versus placebo, Outcome 9 Adverse events (local).
Figuras y tablas -
Analysis 3.9

Comparison 3 Corticosteroid (very potent) versus placebo, Outcome 9 Adverse events (local).

Comparison 3 Corticosteroid (very potent) versus placebo, Outcome 10 Adverse events (systemic).
Figuras y tablas -
Analysis 3.10

Comparison 3 Corticosteroid (very potent) versus placebo, Outcome 10 Adverse events (systemic).

Comparison 4 Dithranol versus placebo, Outcome 2 TSS.
Figuras y tablas -
Analysis 4.2

Comparison 4 Dithranol versus placebo, Outcome 2 TSS.

Comparison 4 Dithranol versus placebo, Outcome 5 Combined end point (IAGI/TSS/PASI/PAGI).
Figuras y tablas -
Analysis 4.5

Comparison 4 Dithranol versus placebo, Outcome 5 Combined end point (IAGI/TSS/PASI/PAGI).

Comparison 4 Dithranol versus placebo, Outcome 6 Total withdrawals.
Figuras y tablas -
Analysis 4.6

Comparison 4 Dithranol versus placebo, Outcome 6 Total withdrawals.

Comparison 4 Dithranol versus placebo, Outcome 7 Withdrawals due to adverse events.
Figuras y tablas -
Analysis 4.7

Comparison 4 Dithranol versus placebo, Outcome 7 Withdrawals due to adverse events.

Comparison 4 Dithranol versus placebo, Outcome 8 Withdrawals due to treatment failure.
Figuras y tablas -
Analysis 4.8

Comparison 4 Dithranol versus placebo, Outcome 8 Withdrawals due to treatment failure.

Comparison 4 Dithranol versus placebo, Outcome 9 Adverse events (local).
Figuras y tablas -
Analysis 4.9

Comparison 4 Dithranol versus placebo, Outcome 9 Adverse events (local).

Comparison 4 Dithranol versus placebo, Outcome 10 Adverse events (systemic).
Figuras y tablas -
Analysis 4.10

Comparison 4 Dithranol versus placebo, Outcome 10 Adverse events (systemic).

Comparison 5 Vitamin D combination products versus placebo, Outcome 1 IAGI.
Figuras y tablas -
Analysis 5.1

Comparison 5 Vitamin D combination products versus placebo, Outcome 1 IAGI.

Comparison 5 Vitamin D combination products versus placebo, Outcome 3 PASI.
Figuras y tablas -
Analysis 5.3

Comparison 5 Vitamin D combination products versus placebo, Outcome 3 PASI.

Comparison 5 Vitamin D combination products versus placebo, Outcome 4 PAGI.
Figuras y tablas -
Analysis 5.4

Comparison 5 Vitamin D combination products versus placebo, Outcome 4 PAGI.

Comparison 5 Vitamin D combination products versus placebo, Outcome 5 Combined end point (IAGI/TSS/PASI/PAGI).
Figuras y tablas -
Analysis 5.5

Comparison 5 Vitamin D combination products versus placebo, Outcome 5 Combined end point (IAGI/TSS/PASI/PAGI).

Comparison 5 Vitamin D combination products versus placebo, Outcome 6 Total withdrawals.
Figuras y tablas -
Analysis 5.6

Comparison 5 Vitamin D combination products versus placebo, Outcome 6 Total withdrawals.

Comparison 5 Vitamin D combination products versus placebo, Outcome 7 Withdrawals due to adverse events.
Figuras y tablas -
Analysis 5.7

Comparison 5 Vitamin D combination products versus placebo, Outcome 7 Withdrawals due to adverse events.

Comparison 5 Vitamin D combination products versus placebo, Outcome 8 Withdrawals due to treatment failure.
Figuras y tablas -
Analysis 5.8

Comparison 5 Vitamin D combination products versus placebo, Outcome 8 Withdrawals due to treatment failure.

Comparison 5 Vitamin D combination products versus placebo, Outcome 9 Adverse events (local).
Figuras y tablas -
Analysis 5.9

Comparison 5 Vitamin D combination products versus placebo, Outcome 9 Adverse events (local).

Comparison 5 Vitamin D combination products versus placebo, Outcome 10 Adverse events (systemic).
Figuras y tablas -
Analysis 5.10

Comparison 5 Vitamin D combination products versus placebo, Outcome 10 Adverse events (systemic).

Comparison 6 Other treatment versus placebo, Outcome 1 IAGI.
Figuras y tablas -
Analysis 6.1

Comparison 6 Other treatment versus placebo, Outcome 1 IAGI.

Comparison 6 Other treatment versus placebo, Outcome 2 TSS.
Figuras y tablas -
Analysis 6.2

Comparison 6 Other treatment versus placebo, Outcome 2 TSS.

Comparison 6 Other treatment versus placebo, Outcome 3 PASI.
Figuras y tablas -
Analysis 6.3

Comparison 6 Other treatment versus placebo, Outcome 3 PASI.

Comparison 6 Other treatment versus placebo, Outcome 4 PAGI.
Figuras y tablas -
Analysis 6.4

Comparison 6 Other treatment versus placebo, Outcome 4 PAGI.

Comparison 6 Other treatment versus placebo, Outcome 5 Combined end point (IAGI/TSS/PASI/PAGI).
Figuras y tablas -
Analysis 6.5

Comparison 6 Other treatment versus placebo, Outcome 5 Combined end point (IAGI/TSS/PASI/PAGI).

Comparison 6 Other treatment versus placebo, Outcome 6 Total withdrawals.
Figuras y tablas -
Analysis 6.6

Comparison 6 Other treatment versus placebo, Outcome 6 Total withdrawals.

Comparison 6 Other treatment versus placebo, Outcome 7 Withdrawals due to adverse events.
Figuras y tablas -
Analysis 6.7

Comparison 6 Other treatment versus placebo, Outcome 7 Withdrawals due to adverse events.

Comparison 6 Other treatment versus placebo, Outcome 8 Withdrawals due to treatment failure.
Figuras y tablas -
Analysis 6.8

Comparison 6 Other treatment versus placebo, Outcome 8 Withdrawals due to treatment failure.

Comparison 6 Other treatment versus placebo, Outcome 9 Adverse events (local).
Figuras y tablas -
Analysis 6.9

Comparison 6 Other treatment versus placebo, Outcome 9 Adverse events (local).

Comparison 6 Other treatment versus placebo, Outcome 10 Adverse events (systemic).
Figuras y tablas -
Analysis 6.10

Comparison 6 Other treatment versus placebo, Outcome 10 Adverse events (systemic).

Comparison 7 Vitamin D analogues versus corticosteroid (potent), Outcome 1 IAGI.
Figuras y tablas -
Analysis 7.1

Comparison 7 Vitamin D analogues versus corticosteroid (potent), Outcome 1 IAGI.

Comparison 7 Vitamin D analogues versus corticosteroid (potent), Outcome 2 TSS.
Figuras y tablas -
Analysis 7.2

Comparison 7 Vitamin D analogues versus corticosteroid (potent), Outcome 2 TSS.

Comparison 7 Vitamin D analogues versus corticosteroid (potent), Outcome 3 PASI.
Figuras y tablas -
Analysis 7.3

Comparison 7 Vitamin D analogues versus corticosteroid (potent), Outcome 3 PASI.

Comparison 7 Vitamin D analogues versus corticosteroid (potent), Outcome 4 PAGI.
Figuras y tablas -
Analysis 7.4

Comparison 7 Vitamin D analogues versus corticosteroid (potent), Outcome 4 PAGI.

Comparison 7 Vitamin D analogues versus corticosteroid (potent), Outcome 5 Combined end point (IAGI/TSS/PASI/PAGI).
Figuras y tablas -
Analysis 7.5

Comparison 7 Vitamin D analogues versus corticosteroid (potent), Outcome 5 Combined end point (IAGI/TSS/PASI/PAGI).

Comparison 7 Vitamin D analogues versus corticosteroid (potent), Outcome 6 Total withdrawals.
Figuras y tablas -
Analysis 7.6

Comparison 7 Vitamin D analogues versus corticosteroid (potent), Outcome 6 Total withdrawals.

Comparison 7 Vitamin D analogues versus corticosteroid (potent), Outcome 7 Withdrawals due to adverse events.
Figuras y tablas -
Analysis 7.7

Comparison 7 Vitamin D analogues versus corticosteroid (potent), Outcome 7 Withdrawals due to adverse events.

Comparison 7 Vitamin D analogues versus corticosteroid (potent), Outcome 8 Withdrawals due to treatment failure.
Figuras y tablas -
Analysis 7.8

Comparison 7 Vitamin D analogues versus corticosteroid (potent), Outcome 8 Withdrawals due to treatment failure.

Comparison 7 Vitamin D analogues versus corticosteroid (potent), Outcome 9 Adverse events (local).
Figuras y tablas -
Analysis 7.9

Comparison 7 Vitamin D analogues versus corticosteroid (potent), Outcome 9 Adverse events (local).

Comparison 7 Vitamin D analogues versus corticosteroid (potent), Outcome 10 Adverse events (systemic).
Figuras y tablas -
Analysis 7.10

Comparison 7 Vitamin D analogues versus corticosteroid (potent), Outcome 10 Adverse events (systemic).

Comparison 8 Vitamin D analogues versus corticosteroid (very potent), Outcome 1 IAGI.
Figuras y tablas -
Analysis 8.1

Comparison 8 Vitamin D analogues versus corticosteroid (very potent), Outcome 1 IAGI.

Comparison 8 Vitamin D analogues versus corticosteroid (very potent), Outcome 3 PASI.
Figuras y tablas -
Analysis 8.3

Comparison 8 Vitamin D analogues versus corticosteroid (very potent), Outcome 3 PASI.

Comparison 8 Vitamin D analogues versus corticosteroid (very potent), Outcome 4 PAGI.
Figuras y tablas -
Analysis 8.4

Comparison 8 Vitamin D analogues versus corticosteroid (very potent), Outcome 4 PAGI.

Comparison 8 Vitamin D analogues versus corticosteroid (very potent), Outcome 5 Combined end point (IAGI/TSS/PASI/PAGI).
Figuras y tablas -
Analysis 8.5

Comparison 8 Vitamin D analogues versus corticosteroid (very potent), Outcome 5 Combined end point (IAGI/TSS/PASI/PAGI).

Comparison 8 Vitamin D analogues versus corticosteroid (very potent), Outcome 6 Total withdrawals.
Figuras y tablas -
Analysis 8.6

Comparison 8 Vitamin D analogues versus corticosteroid (very potent), Outcome 6 Total withdrawals.

Comparison 8 Vitamin D analogues versus corticosteroid (very potent), Outcome 7 Withdrawals due to adverse events.
Figuras y tablas -
Analysis 8.7

Comparison 8 Vitamin D analogues versus corticosteroid (very potent), Outcome 7 Withdrawals due to adverse events.

Comparison 8 Vitamin D analogues versus corticosteroid (very potent), Outcome 8 Withdrawals due to treatment failure.
Figuras y tablas -
Analysis 8.8

Comparison 8 Vitamin D analogues versus corticosteroid (very potent), Outcome 8 Withdrawals due to treatment failure.

Comparison 8 Vitamin D analogues versus corticosteroid (very potent), Outcome 9 Adverse events (local).
Figuras y tablas -
Analysis 8.9

Comparison 8 Vitamin D analogues versus corticosteroid (very potent), Outcome 9 Adverse events (local).

Comparison 8 Vitamin D analogues versus corticosteroid (very potent), Outcome 10 Adverse events (systemic).
Figuras y tablas -
Analysis 8.10

Comparison 8 Vitamin D analogues versus corticosteroid (very potent), Outcome 10 Adverse events (systemic).

Comparison 9 Vitamin D combined with corticosteroid versus corticosteroid, Outcome 1 IAGI.
Figuras y tablas -
Analysis 9.1

Comparison 9 Vitamin D combined with corticosteroid versus corticosteroid, Outcome 1 IAGI.

Comparison 9 Vitamin D combined with corticosteroid versus corticosteroid, Outcome 2 TSS.
Figuras y tablas -
Analysis 9.2

Comparison 9 Vitamin D combined with corticosteroid versus corticosteroid, Outcome 2 TSS.

Comparison 9 Vitamin D combined with corticosteroid versus corticosteroid, Outcome 3 PASI.
Figuras y tablas -
Analysis 9.3

Comparison 9 Vitamin D combined with corticosteroid versus corticosteroid, Outcome 3 PASI.

Comparison 9 Vitamin D combined with corticosteroid versus corticosteroid, Outcome 4 PAGI.
Figuras y tablas -
Analysis 9.4

Comparison 9 Vitamin D combined with corticosteroid versus corticosteroid, Outcome 4 PAGI.

Comparison 9 Vitamin D combined with corticosteroid versus corticosteroid, Outcome 5 Combined end point (IAGI/TSS/PASI/PAGI).
Figuras y tablas -
Analysis 9.5

Comparison 9 Vitamin D combined with corticosteroid versus corticosteroid, Outcome 5 Combined end point (IAGI/TSS/PASI/PAGI).

Comparison 9 Vitamin D combined with corticosteroid versus corticosteroid, Outcome 6 Total withdrawals.
Figuras y tablas -
Analysis 9.6

Comparison 9 Vitamin D combined with corticosteroid versus corticosteroid, Outcome 6 Total withdrawals.

Comparison 9 Vitamin D combined with corticosteroid versus corticosteroid, Outcome 7 Withdrawals due to adverse events.
Figuras y tablas -
Analysis 9.7

Comparison 9 Vitamin D combined with corticosteroid versus corticosteroid, Outcome 7 Withdrawals due to adverse events.

Comparison 9 Vitamin D combined with corticosteroid versus corticosteroid, Outcome 8 Withdrawals due to treatment failure.
Figuras y tablas -
Analysis 9.8

Comparison 9 Vitamin D combined with corticosteroid versus corticosteroid, Outcome 8 Withdrawals due to treatment failure.

Comparison 9 Vitamin D combined with corticosteroid versus corticosteroid, Outcome 9 Adverse events (local).
Figuras y tablas -
Analysis 9.9

Comparison 9 Vitamin D combined with corticosteroid versus corticosteroid, Outcome 9 Adverse events (local).

Comparison 9 Vitamin D combined with corticosteroid versus corticosteroid, Outcome 10 Adverse events (systemic).
Figuras y tablas -
Analysis 9.10

Comparison 9 Vitamin D combined with corticosteroid versus corticosteroid, Outcome 10 Adverse events (systemic).

Comparison 10 Vitamin D alone or in combination versus dithranol, Outcome 1 IAGI.
Figuras y tablas -
Analysis 10.1

Comparison 10 Vitamin D alone or in combination versus dithranol, Outcome 1 IAGI.

Comparison 10 Vitamin D alone or in combination versus dithranol, Outcome 2 TSS.
Figuras y tablas -
Analysis 10.2

Comparison 10 Vitamin D alone or in combination versus dithranol, Outcome 2 TSS.

Comparison 10 Vitamin D alone or in combination versus dithranol, Outcome 3 PASI.
Figuras y tablas -
Analysis 10.3

Comparison 10 Vitamin D alone or in combination versus dithranol, Outcome 3 PASI.

Comparison 10 Vitamin D alone or in combination versus dithranol, Outcome 4 PAGI.
Figuras y tablas -
Analysis 10.4

Comparison 10 Vitamin D alone or in combination versus dithranol, Outcome 4 PAGI.

Comparison 10 Vitamin D alone or in combination versus dithranol, Outcome 5 Combined end point (IAGI/TSS/PASI/PAGI).
Figuras y tablas -
Analysis 10.5

Comparison 10 Vitamin D alone or in combination versus dithranol, Outcome 5 Combined end point (IAGI/TSS/PASI/PAGI).

Comparison 10 Vitamin D alone or in combination versus dithranol, Outcome 6 Total withdrawals.
Figuras y tablas -
Analysis 10.6

Comparison 10 Vitamin D alone or in combination versus dithranol, Outcome 6 Total withdrawals.

Comparison 10 Vitamin D alone or in combination versus dithranol, Outcome 7 Withdrawals due to adverse events.
Figuras y tablas -
Analysis 10.7

Comparison 10 Vitamin D alone or in combination versus dithranol, Outcome 7 Withdrawals due to adverse events.

Comparison 10 Vitamin D alone or in combination versus dithranol, Outcome 8 Withdrawals due to treatment failure.
Figuras y tablas -
Analysis 10.8

Comparison 10 Vitamin D alone or in combination versus dithranol, Outcome 8 Withdrawals due to treatment failure.

Comparison 10 Vitamin D alone or in combination versus dithranol, Outcome 9 Adverse events (local).
Figuras y tablas -
Analysis 10.9

Comparison 10 Vitamin D alone or in combination versus dithranol, Outcome 9 Adverse events (local).

Comparison 10 Vitamin D alone or in combination versus dithranol, Outcome 10 Adverse events (systemic).
Figuras y tablas -
Analysis 10.10

Comparison 10 Vitamin D alone or in combination versus dithranol, Outcome 10 Adverse events (systemic).

Comparison 11 Vitamin D alone or in combination versus other vitamin D analogue, Outcome 1 IAGI.
Figuras y tablas -
Analysis 11.1

Comparison 11 Vitamin D alone or in combination versus other vitamin D analogue, Outcome 1 IAGI.

Comparison 11 Vitamin D alone or in combination versus other vitamin D analogue, Outcome 2 TSS.
Figuras y tablas -
Analysis 11.2

Comparison 11 Vitamin D alone or in combination versus other vitamin D analogue, Outcome 2 TSS.

Comparison 11 Vitamin D alone or in combination versus other vitamin D analogue, Outcome 3 PASI.
Figuras y tablas -
Analysis 11.3

Comparison 11 Vitamin D alone or in combination versus other vitamin D analogue, Outcome 3 PASI.

Comparison 11 Vitamin D alone or in combination versus other vitamin D analogue, Outcome 4 PAGI.
Figuras y tablas -
Analysis 11.4

Comparison 11 Vitamin D alone or in combination versus other vitamin D analogue, Outcome 4 PAGI.

Comparison 11 Vitamin D alone or in combination versus other vitamin D analogue, Outcome 5 Combined end point (IAGI/TSS/PASI/PAGI).
Figuras y tablas -
Analysis 11.5

Comparison 11 Vitamin D alone or in combination versus other vitamin D analogue, Outcome 5 Combined end point (IAGI/TSS/PASI/PAGI).

Comparison 11 Vitamin D alone or in combination versus other vitamin D analogue, Outcome 6 Total withdrawals.
Figuras y tablas -
Analysis 11.6

Comparison 11 Vitamin D alone or in combination versus other vitamin D analogue, Outcome 6 Total withdrawals.

Comparison 11 Vitamin D alone or in combination versus other vitamin D analogue, Outcome 7 Withdrawals due to adverse events.
Figuras y tablas -
Analysis 11.7

Comparison 11 Vitamin D alone or in combination versus other vitamin D analogue, Outcome 7 Withdrawals due to adverse events.

Comparison 11 Vitamin D alone or in combination versus other vitamin D analogue, Outcome 8 Withdrawals due to treatment failure.
Figuras y tablas -
Analysis 11.8

Comparison 11 Vitamin D alone or in combination versus other vitamin D analogue, Outcome 8 Withdrawals due to treatment failure.

Comparison 11 Vitamin D alone or in combination versus other vitamin D analogue, Outcome 9 Adverse events (local).
Figuras y tablas -
Analysis 11.9

Comparison 11 Vitamin D alone or in combination versus other vitamin D analogue, Outcome 9 Adverse events (local).

Comparison 11 Vitamin D alone or in combination versus other vitamin D analogue, Outcome 10 Adverse events (systemic).
Figuras y tablas -
Analysis 11.10

Comparison 11 Vitamin D alone or in combination versus other vitamin D analogue, Outcome 10 Adverse events (systemic).

Comparison 12 Vitamin D alone or in combination versus vitamin D + corticosteroid, Outcome 1 IAGI.
Figuras y tablas -
Analysis 12.1

Comparison 12 Vitamin D alone or in combination versus vitamin D + corticosteroid, Outcome 1 IAGI.

Comparison 12 Vitamin D alone or in combination versus vitamin D + corticosteroid, Outcome 2 TSS.
Figuras y tablas -
Analysis 12.2

Comparison 12 Vitamin D alone or in combination versus vitamin D + corticosteroid, Outcome 2 TSS.

Comparison 12 Vitamin D alone or in combination versus vitamin D + corticosteroid, Outcome 3 PASI.
Figuras y tablas -
Analysis 12.3

Comparison 12 Vitamin D alone or in combination versus vitamin D + corticosteroid, Outcome 3 PASI.

Comparison 12 Vitamin D alone or in combination versus vitamin D + corticosteroid, Outcome 4 PAGI.
Figuras y tablas -
Analysis 12.4

Comparison 12 Vitamin D alone or in combination versus vitamin D + corticosteroid, Outcome 4 PAGI.

Comparison 12 Vitamin D alone or in combination versus vitamin D + corticosteroid, Outcome 5 Combined end point (IAGI/TSS/PASI/PAGI).
Figuras y tablas -
Analysis 12.5

Comparison 12 Vitamin D alone or in combination versus vitamin D + corticosteroid, Outcome 5 Combined end point (IAGI/TSS/PASI/PAGI).

Comparison 12 Vitamin D alone or in combination versus vitamin D + corticosteroid, Outcome 6 Total withdrawals.
Figuras y tablas -
Analysis 12.6

Comparison 12 Vitamin D alone or in combination versus vitamin D + corticosteroid, Outcome 6 Total withdrawals.

Comparison 12 Vitamin D alone or in combination versus vitamin D + corticosteroid, Outcome 7 Withdrawals due to adverse events.
Figuras y tablas -
Analysis 12.7

Comparison 12 Vitamin D alone or in combination versus vitamin D + corticosteroid, Outcome 7 Withdrawals due to adverse events.

Comparison 12 Vitamin D alone or in combination versus vitamin D + corticosteroid, Outcome 8 Withdrawals due to treatment failure.
Figuras y tablas -
Analysis 12.8

Comparison 12 Vitamin D alone or in combination versus vitamin D + corticosteroid, Outcome 8 Withdrawals due to treatment failure.

Comparison 12 Vitamin D alone or in combination versus vitamin D + corticosteroid, Outcome 9 Adverse events (local).
Figuras y tablas -
Analysis 12.9

Comparison 12 Vitamin D alone or in combination versus vitamin D + corticosteroid, Outcome 9 Adverse events (local).

Comparison 12 Vitamin D alone or in combination versus vitamin D + corticosteroid, Outcome 10 Adverse events (systemic).
Figuras y tablas -
Analysis 12.10

Comparison 12 Vitamin D alone or in combination versus vitamin D + corticosteroid, Outcome 10 Adverse events (systemic).

Comparison 13 Vitamin D alone or in combination versus other treatments: complex regimens, Outcome 1 IAGI.
Figuras y tablas -
Analysis 13.1

Comparison 13 Vitamin D alone or in combination versus other treatments: complex regimens, Outcome 1 IAGI.

Comparison 13 Vitamin D alone or in combination versus other treatments: complex regimens, Outcome 2 TSS.
Figuras y tablas -
Analysis 13.2

Comparison 13 Vitamin D alone or in combination versus other treatments: complex regimens, Outcome 2 TSS.

Comparison 13 Vitamin D alone or in combination versus other treatments: complex regimens, Outcome 3 PASI.
Figuras y tablas -
Analysis 13.3

Comparison 13 Vitamin D alone or in combination versus other treatments: complex regimens, Outcome 3 PASI.

Comparison 13 Vitamin D alone or in combination versus other treatments: complex regimens, Outcome 4 PAGI.
Figuras y tablas -
Analysis 13.4

Comparison 13 Vitamin D alone or in combination versus other treatments: complex regimens, Outcome 4 PAGI.

Comparison 13 Vitamin D alone or in combination versus other treatments: complex regimens, Outcome 5 Combined end point (IAGI/TSS/PASI/PAGI).
Figuras y tablas -
Analysis 13.5

Comparison 13 Vitamin D alone or in combination versus other treatments: complex regimens, Outcome 5 Combined end point (IAGI/TSS/PASI/PAGI).

Comparison 13 Vitamin D alone or in combination versus other treatments: complex regimens, Outcome 6 Total withdrawals.
Figuras y tablas -
Analysis 13.6

Comparison 13 Vitamin D alone or in combination versus other treatments: complex regimens, Outcome 6 Total withdrawals.

Comparison 13 Vitamin D alone or in combination versus other treatments: complex regimens, Outcome 7 Withdrawals due to adverse events.
Figuras y tablas -
Analysis 13.7

Comparison 13 Vitamin D alone or in combination versus other treatments: complex regimens, Outcome 7 Withdrawals due to adverse events.

Comparison 13 Vitamin D alone or in combination versus other treatments: complex regimens, Outcome 8 Withdrawals due to treatment failure.
Figuras y tablas -
Analysis 13.8

Comparison 13 Vitamin D alone or in combination versus other treatments: complex regimens, Outcome 8 Withdrawals due to treatment failure.

Comparison 13 Vitamin D alone or in combination versus other treatments: complex regimens, Outcome 9 Adverse events (local).
Figuras y tablas -
Analysis 13.9

Comparison 13 Vitamin D alone or in combination versus other treatments: complex regimens, Outcome 9 Adverse events (local).

Comparison 14 Vitamin D alone or in combination versus other treatment: long‐term studies (> 24 wks), Outcome 1 IAGI.
Figuras y tablas -
Analysis 14.1

Comparison 14 Vitamin D alone or in combination versus other treatment: long‐term studies (> 24 wks), Outcome 1 IAGI.

Comparison 14 Vitamin D alone or in combination versus other treatment: long‐term studies (> 24 wks), Outcome 5 Combined end point (IAGI/TSS/PASI/PAGI).
Figuras y tablas -
Analysis 14.5

Comparison 14 Vitamin D alone or in combination versus other treatment: long‐term studies (> 24 wks), Outcome 5 Combined end point (IAGI/TSS/PASI/PAGI).

Comparison 14 Vitamin D alone or in combination versus other treatment: long‐term studies (> 24 wks), Outcome 6 Total withdrawals.
Figuras y tablas -
Analysis 14.6

Comparison 14 Vitamin D alone or in combination versus other treatment: long‐term studies (> 24 wks), Outcome 6 Total withdrawals.

Comparison 14 Vitamin D alone or in combination versus other treatment: long‐term studies (> 24 wks), Outcome 7 Withdrawals due to adverse events.
Figuras y tablas -
Analysis 14.7

Comparison 14 Vitamin D alone or in combination versus other treatment: long‐term studies (> 24 wks), Outcome 7 Withdrawals due to adverse events.

Comparison 14 Vitamin D alone or in combination versus other treatment: long‐term studies (> 24 wks), Outcome 8 Withdrawals due to treatment failure.
Figuras y tablas -
Analysis 14.8

Comparison 14 Vitamin D alone or in combination versus other treatment: long‐term studies (> 24 wks), Outcome 8 Withdrawals due to treatment failure.

Comparison 14 Vitamin D alone or in combination versus other treatment: long‐term studies (> 24 wks), Outcome 9 Adverse events (local).
Figuras y tablas -
Analysis 14.9

Comparison 14 Vitamin D alone or in combination versus other treatment: long‐term studies (> 24 wks), Outcome 9 Adverse events (local).

Comparison 15 Vitamin D analogues versus other treatment, Outcome 1 IAGI.
Figuras y tablas -
Analysis 15.1

Comparison 15 Vitamin D analogues versus other treatment, Outcome 1 IAGI.

Comparison 15 Vitamin D analogues versus other treatment, Outcome 2 TSS.
Figuras y tablas -
Analysis 15.2

Comparison 15 Vitamin D analogues versus other treatment, Outcome 2 TSS.

Comparison 15 Vitamin D analogues versus other treatment, Outcome 3 PASI.
Figuras y tablas -
Analysis 15.3

Comparison 15 Vitamin D analogues versus other treatment, Outcome 3 PASI.

Comparison 15 Vitamin D analogues versus other treatment, Outcome 4 PAGI.
Figuras y tablas -
Analysis 15.4

Comparison 15 Vitamin D analogues versus other treatment, Outcome 4 PAGI.

Comparison 15 Vitamin D analogues versus other treatment, Outcome 5 Combined end point (IAGI/TSS/PASI/PAGI).
Figuras y tablas -
Analysis 15.5

Comparison 15 Vitamin D analogues versus other treatment, Outcome 5 Combined end point (IAGI/TSS/PASI/PAGI).

Comparison 15 Vitamin D analogues versus other treatment, Outcome 6 Total withdrawals.
Figuras y tablas -
Analysis 15.6

Comparison 15 Vitamin D analogues versus other treatment, Outcome 6 Total withdrawals.

Comparison 15 Vitamin D analogues versus other treatment, Outcome 7 Withdrawals due to adverse events.
Figuras y tablas -
Analysis 15.7

Comparison 15 Vitamin D analogues versus other treatment, Outcome 7 Withdrawals due to adverse events.

Comparison 15 Vitamin D analogues versus other treatment, Outcome 8 Withdrawals due to treatment failure.
Figuras y tablas -
Analysis 15.8

Comparison 15 Vitamin D analogues versus other treatment, Outcome 8 Withdrawals due to treatment failure.

Comparison 15 Vitamin D analogues versus other treatment, Outcome 9 Adverse events (local).
Figuras y tablas -
Analysis 15.9

Comparison 15 Vitamin D analogues versus other treatment, Outcome 9 Adverse events (local).

Comparison 15 Vitamin D analogues versus other treatment, Outcome 10 Adverse events (systemic).
Figuras y tablas -
Analysis 15.10

Comparison 15 Vitamin D analogues versus other treatment, Outcome 10 Adverse events (systemic).

Comparison 16 Flexural/facial psoriasis: placebo‐controlled trials, Outcome 1 IAGI.
Figuras y tablas -
Analysis 16.1

Comparison 16 Flexural/facial psoriasis: placebo‐controlled trials, Outcome 1 IAGI.

Comparison 16 Flexural/facial psoriasis: placebo‐controlled trials, Outcome 2 TSS.
Figuras y tablas -
Analysis 16.2

Comparison 16 Flexural/facial psoriasis: placebo‐controlled trials, Outcome 2 TSS.

Comparison 16 Flexural/facial psoriasis: placebo‐controlled trials, Outcome 3 PASI.
Figuras y tablas -
Analysis 16.3

Comparison 16 Flexural/facial psoriasis: placebo‐controlled trials, Outcome 3 PASI.

Comparison 16 Flexural/facial psoriasis: placebo‐controlled trials, Outcome 4 PAGI.
Figuras y tablas -
Analysis 16.4

Comparison 16 Flexural/facial psoriasis: placebo‐controlled trials, Outcome 4 PAGI.

Comparison 16 Flexural/facial psoriasis: placebo‐controlled trials, Outcome 5 Combined end point (IAGI/TSS/PASI/PAGI).
Figuras y tablas -
Analysis 16.5

Comparison 16 Flexural/facial psoriasis: placebo‐controlled trials, Outcome 5 Combined end point (IAGI/TSS/PASI/PAGI).

Comparison 16 Flexural/facial psoriasis: placebo‐controlled trials, Outcome 6 Total withdrawals.
Figuras y tablas -
Analysis 16.6

Comparison 16 Flexural/facial psoriasis: placebo‐controlled trials, Outcome 6 Total withdrawals.

Comparison 16 Flexural/facial psoriasis: placebo‐controlled trials, Outcome 7 Withdrawals due to adverse events.
Figuras y tablas -
Analysis 16.7

Comparison 16 Flexural/facial psoriasis: placebo‐controlled trials, Outcome 7 Withdrawals due to adverse events.

Comparison 16 Flexural/facial psoriasis: placebo‐controlled trials, Outcome 8 Withdrawals due to treatment failure.
Figuras y tablas -
Analysis 16.8

Comparison 16 Flexural/facial psoriasis: placebo‐controlled trials, Outcome 8 Withdrawals due to treatment failure.

Comparison 16 Flexural/facial psoriasis: placebo‐controlled trials, Outcome 9 Adverse events (local).
Figuras y tablas -
Analysis 16.9

Comparison 16 Flexural/facial psoriasis: placebo‐controlled trials, Outcome 9 Adverse events (local).

Comparison 16 Flexural/facial psoriasis: placebo‐controlled trials, Outcome 10 Adverse events (systemic).
Figuras y tablas -
Analysis 16.10

Comparison 16 Flexural/facial psoriasis: placebo‐controlled trials, Outcome 10 Adverse events (systemic).

Comparison 17 Flexural/facial psoriasis: vitamin D alone or in combination versus other treatment, Outcome 1 IAGI.
Figuras y tablas -
Analysis 17.1

Comparison 17 Flexural/facial psoriasis: vitamin D alone or in combination versus other treatment, Outcome 1 IAGI.

Comparison 17 Flexural/facial psoriasis: vitamin D alone or in combination versus other treatment, Outcome 2 TSS.
Figuras y tablas -
Analysis 17.2

Comparison 17 Flexural/facial psoriasis: vitamin D alone or in combination versus other treatment, Outcome 2 TSS.

Comparison 17 Flexural/facial psoriasis: vitamin D alone or in combination versus other treatment, Outcome 3 PASI.
Figuras y tablas -
Analysis 17.3

Comparison 17 Flexural/facial psoriasis: vitamin D alone or in combination versus other treatment, Outcome 3 PASI.

Comparison 17 Flexural/facial psoriasis: vitamin D alone or in combination versus other treatment, Outcome 5 Combined end point (IAGI/TSS/PASI/PAGI).
Figuras y tablas -
Analysis 17.5

Comparison 17 Flexural/facial psoriasis: vitamin D alone or in combination versus other treatment, Outcome 5 Combined end point (IAGI/TSS/PASI/PAGI).

Comparison 17 Flexural/facial psoriasis: vitamin D alone or in combination versus other treatment, Outcome 6 Total withdrawals.
Figuras y tablas -
Analysis 17.6

Comparison 17 Flexural/facial psoriasis: vitamin D alone or in combination versus other treatment, Outcome 6 Total withdrawals.

Comparison 17 Flexural/facial psoriasis: vitamin D alone or in combination versus other treatment, Outcome 7 Withdrawals due to adverse events.
Figuras y tablas -
Analysis 17.7

Comparison 17 Flexural/facial psoriasis: vitamin D alone or in combination versus other treatment, Outcome 7 Withdrawals due to adverse events.

Comparison 17 Flexural/facial psoriasis: vitamin D alone or in combination versus other treatment, Outcome 8 Withdrawals due to treatment failure.
Figuras y tablas -
Analysis 17.8

Comparison 17 Flexural/facial psoriasis: vitamin D alone or in combination versus other treatment, Outcome 8 Withdrawals due to treatment failure.

Comparison 17 Flexural/facial psoriasis: vitamin D alone or in combination versus other treatment, Outcome 9 Adverse events (local).
Figuras y tablas -
Analysis 17.9

Comparison 17 Flexural/facial psoriasis: vitamin D alone or in combination versus other treatment, Outcome 9 Adverse events (local).

Comparison 18 Scalp psoriasis: placebo‐controlled trials, Outcome 1 IAGI.
Figuras y tablas -
Analysis 18.1

Comparison 18 Scalp psoriasis: placebo‐controlled trials, Outcome 1 IAGI.

Comparison 18 Scalp psoriasis: placebo‐controlled trials, Outcome 2 TSS.
Figuras y tablas -
Analysis 18.2

Comparison 18 Scalp psoriasis: placebo‐controlled trials, Outcome 2 TSS.

Comparison 18 Scalp psoriasis: placebo‐controlled trials, Outcome 4 PAGI.
Figuras y tablas -
Analysis 18.4

Comparison 18 Scalp psoriasis: placebo‐controlled trials, Outcome 4 PAGI.

Comparison 18 Scalp psoriasis: placebo‐controlled trials, Outcome 5 Combined end point (IAGI/TSS/PASI/PAGI).
Figuras y tablas -
Analysis 18.5

Comparison 18 Scalp psoriasis: placebo‐controlled trials, Outcome 5 Combined end point (IAGI/TSS/PASI/PAGI).

Comparison 18 Scalp psoriasis: placebo‐controlled trials, Outcome 6 Total withdrawals.
Figuras y tablas -
Analysis 18.6

Comparison 18 Scalp psoriasis: placebo‐controlled trials, Outcome 6 Total withdrawals.

Comparison 18 Scalp psoriasis: placebo‐controlled trials, Outcome 7 Withdrawals due to adverse events.
Figuras y tablas -
Analysis 18.7

Comparison 18 Scalp psoriasis: placebo‐controlled trials, Outcome 7 Withdrawals due to adverse events.

Comparison 18 Scalp psoriasis: placebo‐controlled trials, Outcome 8 Withdrawals due to treatment failure.
Figuras y tablas -
Analysis 18.8

Comparison 18 Scalp psoriasis: placebo‐controlled trials, Outcome 8 Withdrawals due to treatment failure.

Comparison 18 Scalp psoriasis: placebo‐controlled trials, Outcome 9 Adverse events (local).
Figuras y tablas -
Analysis 18.9

Comparison 18 Scalp psoriasis: placebo‐controlled trials, Outcome 9 Adverse events (local).

Comparison 18 Scalp psoriasis: placebo‐controlled trials, Outcome 10 Adverse events (systemic).
Figuras y tablas -
Analysis 18.10

Comparison 18 Scalp psoriasis: placebo‐controlled trials, Outcome 10 Adverse events (systemic).

Comparison 19 Scalp psoriasis: vitamin D alone or in combination versus other treatments, Outcome 1 IAGI.
Figuras y tablas -
Analysis 19.1

Comparison 19 Scalp psoriasis: vitamin D alone or in combination versus other treatments, Outcome 1 IAGI.

Comparison 19 Scalp psoriasis: vitamin D alone or in combination versus other treatments, Outcome 2 TSS.
Figuras y tablas -
Analysis 19.2

Comparison 19 Scalp psoriasis: vitamin D alone or in combination versus other treatments, Outcome 2 TSS.

Comparison 19 Scalp psoriasis: vitamin D alone or in combination versus other treatments, Outcome 4 PAGI.
Figuras y tablas -
Analysis 19.4

Comparison 19 Scalp psoriasis: vitamin D alone or in combination versus other treatments, Outcome 4 PAGI.

Comparison 19 Scalp psoriasis: vitamin D alone or in combination versus other treatments, Outcome 5 Combined end point (IAGI/TSS/PASI/PAGI).
Figuras y tablas -
Analysis 19.5

Comparison 19 Scalp psoriasis: vitamin D alone or in combination versus other treatments, Outcome 5 Combined end point (IAGI/TSS/PASI/PAGI).

Comparison 19 Scalp psoriasis: vitamin D alone or in combination versus other treatments, Outcome 6 Total withdrawals.
Figuras y tablas -
Analysis 19.6

Comparison 19 Scalp psoriasis: vitamin D alone or in combination versus other treatments, Outcome 6 Total withdrawals.

Comparison 19 Scalp psoriasis: vitamin D alone or in combination versus other treatments, Outcome 7 Withdrawals due to adverse events.
Figuras y tablas -
Analysis 19.7

Comparison 19 Scalp psoriasis: vitamin D alone or in combination versus other treatments, Outcome 7 Withdrawals due to adverse events.

Comparison 19 Scalp psoriasis: vitamin D alone or in combination versus other treatments, Outcome 8 Withdrawals due to treatment failure.
Figuras y tablas -
Analysis 19.8

Comparison 19 Scalp psoriasis: vitamin D alone or in combination versus other treatments, Outcome 8 Withdrawals due to treatment failure.

Comparison 19 Scalp psoriasis: vitamin D alone or in combination versus other treatments, Outcome 9 Adverse events (local).
Figuras y tablas -
Analysis 19.9

Comparison 19 Scalp psoriasis: vitamin D alone or in combination versus other treatments, Outcome 9 Adverse events (local).

Comparison 19 Scalp psoriasis: vitamin D alone or in combination versus other treatments, Outcome 10 Adverse events (systemic).
Figuras y tablas -
Analysis 19.10

Comparison 19 Scalp psoriasis: vitamin D alone or in combination versus other treatments, Outcome 10 Adverse events (systemic).

Table 1. List of acronyms

Acronym

Full name

BC

baseline comparability demonstrated (clinical/demographic)

BD

twice daily

BMD

betamethasone dipropionate

BMV

betamethasone valerate

BSA

Body Surface Area

Btw‐patient

Between‐patient

CI

confidence interval

dys

days

EQ‐5D

EuroQOL

FU

follow up (includes treatment period)

heterogeneity statistic

IAGI

Investigator Assessment of Global Improvement (change score)

IGA

Investigator Global Assessment (static score)

IQR

interquartile range

ISGA

Investigator's Static Global Assessment Score

LAE

local adverse effects

LCD

liquor carbonis distillate

LF

loss to follow up (per cent of participants randomised, not contributing to primary outcome measure)

MEMS

Medication Event Monitoring System

mPASI

modified Psoriasis Area Severity Index

NA

not available/not applicable

NR

not reported

OD

once daily

OM

once in the morning

ON

once at night

ODS

overall disease severity

PAGI

Patient Assessment of Global Improvement (change score)

PASI

Psoriasis Area Severity Index

PDI

Psoriasis Disability Index

PGA

Patient Global Assessment (static score)

PMAQ‐3w

Medication Adherence Questionnaire, version 3W

pt

point

QOL

quality of life

RD

risk difference

SD

standard deviation

SMD

standardised mean difference

TCP

two‐compound product

TD

three times daily

TLPSS

Total Local Psoriasis Severity Score

TSS

Total Severity Score/total sum score

UV

ultra violet

VDRE

Vitamin D‐Responsive Element

wks

weeks

yrs

years

Figuras y tablas -
Table 1. List of acronyms
Table 2. Overview of outcome measures on effectiveness

Outcome

Acronym

Construct

Scale, minimum

Scale, maximum

Notes

* Investigator's Assessment of Overall Global Improvement

IAGI

Improvement from baseline variably defined. Common taxonomy ranges from worse to cleared

4‐pt

7‐pt

Calculated means and standard deviations by assigning zero to 'worse' (or equivalent). Higher scores indicate greater improvement

Investigator's Global Assessment of Disease Severity

IGA

Static equivalent of the IAGI

4‐pt

7‐pt

Calculated means and standard deviations by assigning zero to 'clear' (or equivalent). Higher scores indicate more severe disease

Total Severity Score

TSS

Redness (erythema), thickness (infiltration) and scaling (sometimes also itching (pruritis)) of target plaque(s). Scored separately then summed

0 to 3

0 to 24

Also known as the Local Psoriasis Severity Index or the Total Sum Score. Higher scores indicate more severe disease

Psoriasis Area and Severity Index

PASI

Redness, thickness, and scaliness of the lesions (each graded on a 0 to 4 scale), weighted by the area of involvement (0 to 6) and summed

0 to 68 (without head)

0 to 72 (including head)

Higher scores indicate more severe disease

* Patient's Assessment of Overall Global Improvement

PAGI

Assessed as IAGI

4‐pt

7‐pt

Less often reported than IAGI. Majority of included trials use 5‐pt scale

Patient's Global Assessment of Disease Severity

PGA

Assessed as IGA

4‐pt

5‐pt

Rarely reported (5/177 studies)

* IAGI/PAGI data are entered as a negative values; thus, a reduction denotes a positive improvement for the active treatment consistent with TSS and PASI measures.

Figuras y tablas -
Table 2. Overview of outcome measures on effectiveness
Table 3. Summary of imputed standard deviation values

Type of study/score

Placebo

IAGI (change)/IGA (end point)

Placebo

TSS

Placebo

PASI

Placebo

PAGI (change)/PGA (end point)

H2H

IAGI (change)/IGA (end point)

H2H

TSS

H2H

PASI

H2H

PAGI (change)/PGA (end point)

Between‐patient (end point)

0.93

1.33

3.76

1.13

1.01

1.65

3.61

1.12

Within‐patient (end point)

1.08

1.49

7.17

NA

NA

1.50

2.58

NA

Between‐patient (change)

1.17

1.52

5.75

1.31

1.10

1.73

7.85

1.20

Within‐patient (change)

1.02

1.58

NA

1.53

0.96

1.94

NA

0.83

Within‐patient (% change)

NA

0.18

NA

NA

NA

NA

NA

NA

Between‐patient (% change)

NA

NA

0.37

NA

NA

0.13

0.33

NA

Scalp between‐patient (end point)

1.08

1.74

NA

1.06

1.06

1.94

NA

1.18

Scalp within‐patient (end point)

1.33

NA

NA

NA

NA

NA

NA

NA

Scalp between‐patient (change)

1.20

NA

NA

1.28

1.30

1.75

NA

1.20

Scalp between‐patient (% change)

NA

NA

NA

NA

NA

0.25

NA

NA

NA: not available; H2H: head‐to‐head; IGA [PGA]: Investigator [Patient] Global Assessment of Disease Severity;

IAGI [PAGI]: Investigator (patient) Assessment of Global Improvement; TSS: Total Severity Score; PASI: Psoriasis Area and Severity Index

Figuras y tablas -
Table 3. Summary of imputed standard deviation values
Table 4. Overview of analyses: evidence of effectiveness outcomes

Comparison No.

Comparison Label

No. studies
(NB: a study may contribute to
more than one comparison)

Per cent studies with
between‐patient design

No.
participants

01

Vitamin D analogues vs. placebo

30

60%

4986

02

Corticosteroid (potent) vs. placebo

13

85%

2216

03

Corticosteroid (very potent) vs. placebo

10

70%

1264

04

Dithranol vs. placebo

3

0%

47

05

Vitamin D combination products vs. placebo

5

100%

2058

06

Other treatment vs. placebo

26

46%

1450

07

Vitamin D analogues vs. corticosteroid (potent)

14

64%

3542

08

Vitamin D analogues vs. corticosteroid (very potent)

2

100%

82

09

Vitamin D combined with corticosteroid vs. corticosteroid

5

100%

2113

10

Vitamin D alone or in combination vs. dithranol

8

88%

1284

11

Vitamin D alone or in combination vs. other vitamin D analogue

4

75%

513

12

Vitamin D alone or in combination vs. vitamin D + corticosteroid

17

94%

5856

13

Vitamin D alone or in combination vs. other treatments: complex regimens

9

89%

2936

14

Vitamin D alone or in combination vs. other treatment: long‐term studies (> 24 wks)

1

100%

297

15

Vitamin D analogues vs. other treatment

19

68%

2364

16

Flexural/facial psoriasis: placebo‐controlled trials

2

100%

122

17

Flexural/facial psoriasis: vitamin D alone or in combination vs. other treatment

4

75%

588

18

Scalp psoriasis: placebo‐controlled trials

14

93%

3011

19

Scalp psoriasis: vitamin D alone or in combination vs. other treatments

12

100%

5413

Figuras y tablas -
Table 4. Overview of analyses: evidence of effectiveness outcomes
Table 5. Analysis 01: Trial characteristics and outcomes: vitamin D vs. placebo

Subcategory

Measure

01 IAGI/IGA

02 TSS

03 PASI

04 PAGI/PGA

05 Combined end point

01 Calcipotriol OD/BD

Effect size [CI]

(SMD ‐0.93; 95% CI ‐1.17 to ‐0.68)

(SMD ‐1.15; 95% CI ‐1.41 to ‐0.89)

(SMD ‐0.65; 95% CI ‐0.75 to ‐0.55)

(SMD ‐0.64; 95% CI ‐0.97 to ‐0.30)

(SMD ‐0.96; 95% CI ‐1.15 to ‐0.77)

02 Calcipotriol plus occlusion

Effect size [CI]

NA

(SMD ‐0.15; 95% CI ‐0.44 to 0.14)

(SMD ‐0.15; 95% CI ‐0.44 to 0.14)

03 Calcitriol OD/BD

Effect size [CI]

(SMD ‐1.03; 95% CI ‐1.71 to ‐0.36)

(SMD ‐1.22; 95% CI ‐2.38 to ‐0.07)

(SMD ‐0.59; 95% CI ‐0.76 to ‐0.41)

(SMD ‐0.92; 95% CI ‐1.54 to ‐0.29)

04 Tacalcitol OD

Effect size [CI]

(SMD ‐0.84; 95% CI ‐1.41 to ‐0.26)

(SMD ‐0.66; 95% CI ‐0.95 to ‐0.36)

(SMD ‐0.27; 95% CI ‐0.56 to 0.03)

(SMD ‐0.24; 95% CI ‐0.53 to 0.05)

(SMD ‐0.73; 95% CI ‐1.09 to ‐0.37)

05 Maxacalcitol OD

Effect size [CI]

(SMD ‐1.43; 95% CI ‐1.91 to ‐0.96)

(SMD ‐1.61; 95% CI ‐2.10 to ‐1.12)

(SMD ‐1.43; 95% CI ‐1.91 to ‐0.96)

06 Paricalcitol OD

Effect size [CI]

(SMD ‐1.66; 95% CI ‐2.66 to ‐0.67)

(SMD ‐2.15; 95% CI ‐3.24 to ‐1.06)

(SMD ‐1.66; 95% CI ‐2.66 to ‐0.67)

07 Becocalcidiol OD

Effect size [CI]

(SMD ‐0.22; 95% CI ‐0.58 to 0.14)

(SMD ‐0.02; 95% CI ‐0.37 to 0.34)

(SMD ‐0.22; 95% CI ‐0.58 to 0.14)

08 Becocalcidiol BD

Effect size [CI]

(SMD ‐0.67; 95% CI ‐1.04 to ‐0.30)

(SMD ‐0.46; 95% CI ‐0.83 to ‐0.10)

(SMD ‐0.67; 95% CI ‐1.04 to ‐0.30)

All treatments

Effect size [CI]; I² statistic

(SMD ‐0.95; 95% CI ‐1.17 to ‐0.74):

I² statistic: 89.0%

(SMD ‐1.04; 95% CI ‐1.33 to ‐0.74) I² statistic: 93.0%

(SMD ‐0.58; 95% CI ‐0.71 to ‐0.45):

I² statistic: 42.3%

(SMD ‐0.54; 95% CI ‐0.72 to ‐0.36):

I² statistic: 55.5%

(SMD ‐0.90; 95% CI ‐1.07 to ‐0.72);

I² statistic: 87.5%

No. participants

3771

2647

2357

1467

4986

Between‐patient design

13

9

8

5

18

Within‐patient design

7

10

1

0

12

Treatment duration

4 wks to 12 wks

4 wks to 12 wks

3 wks to 8 wks

8 wks to 8 wks

3 wks to 12 wks

Sensitivity analyses

Within‐patient trials

(SMD ‐1.11; 95% CI ‐1.58 to ‐0.64)

Between‐patient trials

(SMD ‐0.80; 95% CI ‐0.96 to ‐0.63)

Calcitriol, Perez 1996 removed

(SMD ‐0.60; 95% CI ‐0.78 to ‐0.41)

Calcipotriol BD

(SMD ‐1.02; 95% CI ‐1.23 to ‐0.82)

Calcipotriol OD

(SMD ‐0.76; 95% CI ‐1.13 to ‐0.40)

correlation coefficient (rho) = 0

All trials

(SMD ‐0.85; 95% CI ‐1.00 to ‐0.71);
I² statistic: 87.8%

rho = 0

Btw‐patient trials

rho = 0.25

Within‐patient trials

(SMD ‐0.87; 95% CI ‐1.01 to ‐0.72);
I² statistic: 88.8%

rho = 0

Btw‐patient trials

rho = 0.50

Within‐patient trials

(SMD ‐0.88; 95% CI ‐1.03 to ‐0.73);
I² statistic = 90.3%

rho = 0

Btw‐patient trials

rho = 0.75

Within‐patient trials

(SMD ‐0.91; 95% CI ‐1.07 to ‐0.75);
I² statistic: 93.2%

For acronyms, see Table 1.

Figuras y tablas -
Table 5. Analysis 01: Trial characteristics and outcomes: vitamin D vs. placebo
Table 6. Analysis 02: Trial characteristics and outcomes: potent steroids vs. placebo

Subcategory

Measure

01 IAGI/IGA

02 TSS

03 PASI

04 PAGI/PGA

05 Combined end point

01 Betamethasone dipropionate OD

Effect size [CI]

(SMD ‐0.81; 95% CI ‐0.98 to ‐0.64)

(SMD ‐0.74; 95% CI ‐1.16 to ‐0.32)

(SMD ‐0.79; 95% CI ‐1.44 to ‐0.14)

(SMD ‐0.80; 95% CI ‐0.96 to ‐0.64)

02 Betamethasone dipropionate BD

Effect size [CI]

(SMD ‐1.35; 95% CI ‐1.56 to ‐1.15)

(SMD ‐0.77; 95% CI ‐1.48 to ‐0.06)

(SMD ‐1.21; 95% CI ‐1.44 to ‐0.97)

(SMD ‐1.35; 95% CI ‐1.56 to ‐1.15)

03 Betamethasone dipropionate, maintenance

Effect size [CI]

(SMD ‐0.95; 95% CI ‐1.62 to ‐0.27)

(SMD ‐0.95; 95% CI ‐1.62 to ‐0.27)

04 Betamethasone valerate

Effect size [CI]

(SMD ‐1.41; 95% CI ‐1.92 to ‐0.90)

(SMD ‐1.09; 95% CI ‐2.00 to ‐0.18)

(SMD ‐1.33; 95% CI ‐1.78 to ‐0.89)

05 Budesonide

Effect size [CI]

06 Desonide

Effect size [CI]

(SMD ‐0.81; 95% CI ‐1.34 to ‐0.28)

(SMD ‐1.16; 95% CI ‐1.70 to ‐0.61)

(SMD ‐0.81; 95% CI ‐1.34 to ‐0.28)

07 Diflorasone diacetate

Effect size [CI]

(SMD ‐0.32; 95% CI ‐0.73 to 0.09)

(SMD ‐0.32; 95% CI ‐0.73 to 0.09)

08 Fluticasone propionate

Effect size [CI]

(SMD ‐0.93; 95% CI ‐1.14 to ‐0.72)

(SMD ‐0.93; 95% CI ‐1.14 to ‐0.72)

09 Hydrocortisone buteprate

Effect size [CI]

(SMD ‐0.46; 95% CI ‐0.77 to ‐0.15)

(SMD ‐0.46; 95% CI ‐0.77 to ‐0.15)

10 Mometasone furoate

Effect size [CI]

(SMD ‐0.75; 95% CI ‐1.17 to ‐0.34)

(SMD ‐1.12; 95% CI ‐1.55 to ‐0.68)

(SMD ‐0.75; 95% CI ‐1.17 to ‐0.34)

All treatments

Effect size [CI]; I² statistic

(SMD ‐1.00; 95% CI ‐1.18 to ‐0.82); I² statistic: 57.6%

(SMD ‐0.77; 95% CI ‐1.01 to ‐0.52); I² statistic: 46.7%

(SMD ‐0.97; 95% CI ‐1.31 to ‐0.62); I² statistic: 79.6%

(SMD ‐0.89; 95% CI ‐1.06 to ‐0.72); I² statistic: 65.1%

No. participants

1867

553

1158

0

2216

Between‐patient design

8

6

3

0

11

Within‐patient design

1

1

0

0

2

Treatment duration

3 wks to 12 wks

2 wks to 12 wks

4 wks to 8 wks

2 wks to 12 wks

Sensitivity analyses

Within‐patient trials

(SMD ‐1.33; 95% CI ‐1.78 to ‐0.89)

Between‐patient trials

(SMD ‐0.85; 95% CI ‐1.03 to ‐0.67)

correlation coefficient (rho) = 0

All trials

(SMD ‐0.89; 95% CI ‐1.06 to ‐0.72) I² statistic: 77.7%

rho = 0

Btw‐patient trials

rho = 0.25

Within‐patient trials

(SMD ‐0.89; 95% CI ‐1.06 to ‐0.72) I² statistic: 78.0%

rho = 0

Btw‐patient trials

rho = 0.50

Within‐patient trials

(SMD ‐0.90; 95% CI ‐1.07 to ‐0.73) I² statistic: 78.6%

rho = 0

Btw‐patient trials

rho = 0.75

Within‐patient trials

(SMD ‐0.91; 95% CI ‐1.08 to ‐0.74) I² statistic: 80.2%

For acronyms, see Table 1. Both within‐patient trials compared betamethasone valerate with placebo.

Figuras y tablas -
Table 6. Analysis 02: Trial characteristics and outcomes: potent steroids vs. placebo
Table 7. Analysis 03: Trial characteristics and outcomes: v. potent steroids vs. placebo

Subcategory

Measure

01 IAGI/IGA

02 TSS

03 PASI

04 PAGI/PGA

05 Combined end point

01 Clobetasol propionate

Effect size [CI]

(SMD ‐1.89; 95% CI ‐2.53 to ‐1.24)

(SMD ‐1.35; 95% CI ‐1.80 to ‐0.89)

(SMD ‐1.01; 95% CI ‐1.55 to ‐0.47)

(SMD ‐1.65; 95% CI ‐2.10 to ‐1.20)

02 Halcinonide

Effect size [CI]

03 Halobetasol

Effect size [CI]

(SMD ‐1.81; 95% CI ‐2.37 to ‐1.24)

(SMD ‐1.25; 95% CI ‐1.46 to ‐1.04)

(SMD ‐1.36; 95% CI ‐1.65 to ‐1.07)

All treatments

Effect size [CI], N, I²

(SMD ‐1.87; 95% CI ‐2.38 to ‐1.36); I² statistic: 78.7%

(SMD ‐1.35; 95% CI ‐1.80 to ‐0.89); I² statistic: 75.3%

(SMD ‐1.22; 95% CI ‐1.42 to ‐1.02); I² statistic: 0%

(SMD ‐1.56; 95% CI ‐1.87 to ‐1.26); I² statistic: 81.7%

No. participants

515

545

0

283

1264

Between‐patient design

4

3

0

1

7

Within‐patient design

1

0

0

2

3

Treatment duration

2 wks to 4 wks

2 wks to 4 wks

2 wks to 2 wks

2 wks to 4 wks

Sensitivity analyses

Within‐patient trials

(SMD ‐1.52; 95% CI ‐2.02 to ‐1.02)

Between‐patient trials

(SMD ‐1.58; 95% CI ‐1.99 to ‐1.17)

correlation coefficient (rho) = 0

All trials

(SMD ‐1.52; 95% CI ‐1.80 to ‐1.24) I² statistic: 81.6%

rho = 0

Btw‐patient trials

rho = 0.25

Within‐patient trials

(SMD ‐1.52; 95% CI ‐1.80 to ‐1.25) I² statistic: 82.2%

rho = 0

Btw‐patient trials

rho = 0.50

Within‐patient trials

(SMD ‐1.53; 95% CI ‐1.80 to ‐1.26) I² statistic: 83.3%

rho = 0

Btw‐patient trials

rho = 0.75

Within‐patient trials

(SMD ‐1.55; 95% CI ‐1.80 to ‐1.29) I² statistic: 85.9%

For acronyms, see Table 1.

Figuras y tablas -
Table 7. Analysis 03: Trial characteristics and outcomes: v. potent steroids vs. placebo
Table 8. Analysis 05: Trial characteristics and outcomes: vitamin D combination vs. placebo

Subcategory

Measure

01 IAGI/IGA

02 TSS

03 PASI

04 PAGI/PGA

05 Combined end point

01 Combination calcipotriol/betamethasone dipropionate, OD

Effect size [CI]

(SMD ‐1.21; 95% CI ‐1.50 to ‐0.91)

(SMD ‐1.14; 95% CI ‐1.57 to ‐0.70)

(SMD ‐0.69; 95% CI ‐0.98 to ‐0.40)

(SMD ‐1.21; 95% CI ‐1.50 to ‐0.91)

02 Combination calcipotriol/betamethasone dipropionate, BD

Effect size [CI]

(SMD ‐1.90; 95% CI ‐2.09 to ‐1.71)

(SMD ‐1.41; 95% CI ‐1.86 to ‐0.97)

(SMD ‐1.90; 95% CI ‐2.09 to ‐1.71)

All treatments

Effect size [CI], N, I² statistic

(SMD ‐1.44; 95% CI ‐1.76 to ‐1.12); I² statistic: 89.4%

(SMD ‐1.24; 95% CI ‐1.53 to ‐0.95); I² statistic: 87.6%

(SMD ‐0.69; 95% CI ‐0.98 to ‐0.40); I² statistic: NA

(SMD ‐1.44; 95% CI ‐1.76 to ‐1.12); I² statistic: 89.4%

No. participants

2058

0

2056

235

2058

Between‐patient design

5

0

5

1

5

Within‐patient design

0

0

0

0

0

Treatment duration

4 wks to 8 wks

4 wks to 8 wks

8 wks

4 wks to 8 wks

For acronyms, see Table 1.

Figuras y tablas -
Table 8. Analysis 05: Trial characteristics and outcomes: vitamin D combination vs. placebo
Table 9. Analysis 06: Trial characteristics and outcomes: other treatments vs. placebo

Subcategory

Measure

01 IAGI/IGA

02 TSS

03 PASI

04 PAGI/PGA

05 Combined end point

01 Aloe vera extract

Effect size [CI]

(SMD ‐1.58; 95% CI ‐2.16 to ‐0.99)

(SMD ‐1.58; 95% CI ‐2.16 to ‐0.99)

02 Anti‐IL‐8 monoclonal antibody cream

Effect size [CI]

(SMD ‐0.59; 95% CI ‐1.01 to ‐0.16)

(SMD ‐0.70; 95% CI ‐1.13 to ‐0.27)

(SMD ‐0.59; 95% CI ‐1.01 to ‐0.16)

03 Betamethasone 17‐valerate 21‐acetate plus tretinoine plus salicylic acid

Effect size [CI]

(SMD ‐0.76; 95% CI ‐1.21 to ‐0.31)

(SMD ‐0.54; 95% CI ‐0.99 to ‐0.10)

(SMD ‐0.80; 95% CI ‐1.26 to ‐0.35)

(SMD ‐0.76; 95% CI ‐1.21 to ‐0.31)

04 Caffeine (topical) 10%, TD

Effect size [CI]

(SMD ‐0.39; 95% CI ‐0.84 to 0.06)

(SMD ‐0.39; 95% CI ‐0.84 to 0.06)

05 Calcipotriene 0.005% ointment + nicotinamide 0.05% or 0.1% or 0.7% or 1.4%, BD

Effect size [CI]

(SMD ‐0.48; 95% CI ‐0.81 to ‐0.15)

(SMD ‐0.48; 95% CI ‐0.81 to ‐0.15)

06 Dead sea salts emollient lotion

Effect size [CI]

(SMD 0.57; 95% CI ‐0.36 to 1.51)

(SMD 0.57; 95% CI ‐0.36 to 1.51)

07 Fish oil plus occlusion

Effect size [CI]

(SMD ‐1.05; 95% CI ‐1.64 to ‐0.46)

(SMD ‐1.05; 95% CI ‐1.64 to ‐0.46)

08 Herbal skin care (Dr Michaels® cleansing gel, ointment and skin conditioner), BD

Effect size [CI]

(SMD ‐2.96; 95% CI ‐4.19 to ‐1.74)

(SMD ‐2.96; 95% CI ‐4.19 to ‐1.74)

09 Hexafluoro‐1,25‐dihydroxyvitamin D3

Effect size [CI]

(SMD ‐0.62; 95% CI ‐1.35 to 0.12)

(SMD ‐1.13; 95% CI ‐1.91 to ‐0.35)

(SMD ‐0.62; 95% CI ‐1.35 to 0.12)

10 Indigo naturalis 1.4% ointment

Effect size [CI]

(SMD ‐2.14; 95% CI ‐2.74 to ‐1.53)

(SMD ‐1.64; 95% CI ‐2.13 to ‐1.15)

(SMD ‐2.09; 95% CI ‐2.62 to ‐1.56)

11 Kukui nut oil, TD

Effect size [CI]

(SMD 0.00; 95% CI ‐0.80 to 0.80)

(SMD 0.33; 95% CI ‐0.48 to 1.14)

(SMD ‐0.03; 95% CI ‐0.84 to 0.77)

(SMD 0.00; 95% CI ‐0.80 to 0.80)

(SMD 0.00; 95% CI ‐0.80 to 0.80)

12 Mahonia aquifolium (Reliéva™), BD

Effect size [CI]

(SMD ‐0.77; 95% CI ‐1.06 to ‐0.48)

13 Methotrexate gel

Effect size [CI]

(SMD ‐0.56; 95% CI ‐1.01 to ‐0.12)

(SMD ‐0.48; 95% CI ‐0.92 to ‐0.04)

(SMD ‐1.58; 95% CI ‐2.16 to ‐0.99)

(SMD ‐1.05; 95% CI ‐2.04 to ‐0.06)

14 Mycophenolic acid ointment

Effect size [CI]

(SMD ‐1.44; 95% CI ‐2.67 to ‐0.22)

(SMD ‐1.44; 95% CI ‐2.67 to ‐0.22)

15 NG‐monomethyl‐L‐arginine (L‐NMMA) cream

Effect size [CI]

(SMD 0.08; 95% CI ‐0.60 to 0.75)

(SMD 0.08; 95% CI ‐0.60 to 0.75)

16 Nicotinamide 1.4%, BD

Effect size [CI]

(SMD ‐0.20; 95% CI ‐0.60 to 0.20)

(SMD ‐0.20; 95% CI ‐0.60 to 0.20)

17 Oleum horwathiensis

Effect size [CI]

(SMD ‐0.02; 95% CI ‐0.63 to 0.58)

(SMD ‐0.77; 95% CI ‐1.40 to ‐0.14)

(SMD ‐0.02; 95% CI ‐0.63 to 0.58)

18 Omega‐3‐polyunsaturated fatty acids ointment

Effect size [CI]

19 Platelet aggregation activating factor (PAF) (Ro 24‐0238)

Effect size [CI]

(SMD ‐0.07; 95% CI ‐0.50 to 0.37)

(SMD ‐0.07; 95% CI ‐0.50 to 0.37)

20 Polymyxin B cream, 200,000 U/g

Effect size [CI]

(SMD 0.13; 95% CI ‐0.59 to 0.85)

(SMD 0.13; 95% CI ‐0.59 to 0.85)

21 PTH (1‐34) in Novasome A® liposomal cream, BD

Effect size [CI]

(SMD ‐2.31; 95% CI ‐3.26 to ‐1.36)

(SMD ‐2.31; 95% CI ‐3.26 to ‐1.36)

22 Sirolimus (topical), 2.2% for 6 wks, then 8% for a further 6 wks

Effect size [CI]

(SMD ‐0.39; 95% CI ‐0.98 to 0.21)

(SMD ‐0.39; 95% CI ‐0.98 to 0.21)

23 Tacrolimus ointment

Effect size [CI]

(SMD 0.06; 95% CI ‐0.52 to 0.63)

(SMD 0.06; 95% CI ‐0.52 to 0.63)

24 Tar

Effect size [CI]

(SMD ‐0.45; 95% CI ‐1.11 to 0.22)

(SMD ‐0.45; 95% CI ‐1.11 to 0.22)

25 Tazarotene

Effect size [CI]

(SMD ‐0.86; 95% CI ‐1.11 to ‐0.62)

(SMD ‐0.86; 95% CI ‐1.11 to ‐0.62)

26 Theophylline 1% ointment, BD

Effect size [CI]

(SMD ‐2.87; 95% CI ‐4.13 to ‐1.62)

(SMD ‐2.87; 95% CI ‐4.13 to ‐1.62)

All treatments

(not pooled)

No. participants

364

907

529

105

1450

Between‐patient design

4

5

8

2

12

Within‐patient design

4

12

1

0

14

Treatment duration

3 wks to 12 wks

3 wks to 12 wks

2 wks to 12 wks

3 wks to 12 wks

2 wks to 12 wks

For acronyms, see Table 1.

Figuras y tablas -
Table 9. Analysis 06: Trial characteristics and outcomes: other treatments vs. placebo
Table 10. Analysis 07: Trial characteristics and outcomes: vitamin D vs. potent steroids

Subcategory

Measure

01 IAGI/IGA

02 TSS

03 PASI

04 PAGI/PGA

05 Combined end point

01 Calcipotriol vs. betamethasone dipropionate

Effect size [CI]

(SMD 0.43; 95% CI 0.28 to 0.58)

(SMD 0.36; 95% CI 0.22 to 0.51)

(SMD 0.43; 95% CI 0.28 to 0.58)

02 Calcipotriol vs. betamethasone valerate

Effect size [CI]

(SMD ‐0.02; 95% CI ‐0.21 to 0.17)

(SMD ‐0.26; 95% CI ‐0.41 to ‐0.11)

(SMD ‐0.12; 95% CI ‐0.22 to ‐0.02)

(SMD ‐0.26; 95% CI ‐0.38 to ‐0.14)

(SMD ‐0.12; 95% CI ‐0.26 to 0.02)

03 Calcipotriol vs. desoxymetasone

Effect size [CI]

(SMD 0.15; 95% CI ‐0.73 to 1.02)

(SMD 0.15; 95% CI ‐0.73 to 1.02)

04 Calcipotriol vs. diflorasone diacetate

Effect size [CI]

(SMD 0.27; 95% CI 0.02 to 0.52)

(SMD 0.40; 95% CI 0.15 to 0.65)

(SMD 0.27; 95% CI 0.02 to 0.52)

05 Calcipotriol vs. fluocinonide

Effect size [CI]

(SMD ‐0.58; 95% CI ‐0.99 to ‐0.18)

(SMD ‐0.50; 95% CI ‐0.92 to ‐0.07)

(SMD ‐0.58; 95% CI ‐0.99 to ‐0.18)

06 Calcitriol vs. betamethasone dipropionate

Effect size [CI]

(SMD 0.21; 95% CI ‐0.04 to 0.45)

(SMD 0.27; 95% CI 0.02 to 0.51)

(SMD 0.39; 95% CI 0.14 to 0.63)

(SMD 0.21; 95% CI ‐0.04 to 0.45)

07 Calcitriol vs. betamethasone valerate

Effect size [CI]

(SMD ‐0.19; 95% CI ‐0.91 to 0.53)

(SMD ‐0.19; 95% CI ‐0.91 to 0.53)

08 Tacalcitol vs. betamethasone valerate

Effect size [CI]

(SMD 0.41; 95% CI 0.09 to 0.74)

(SMD 0.41; 95% CI 0.09 to 0.74)

All treatments

Effect size [CI]; I² statistic

(SMD 0.17; 95% CI ‐0.04 to 0.37); I² statistic: 83.4%

(SMD 0.11; 95% CI ‐0.22 to 0.44); I² statistic: 86.7%

(SMD 0.12; 95% CI ‐0.07 to 0.32); I² statistic: 86.2%

(SMD ‐0.26; 95% CI ‐0.38 to ‐0.14); I² statistic: 0%

(SMD 0.11; 95% CI ‐0.07 to 0.30); I² statistic: 85.6%

No. participants

2655

891

3185

738

3542

Between‐patient design

7

2

7

1

9

Within‐patient design

1

4

2

1

5

Treatment duration

3 wks to 8 wks

3 wks to 6 wks

4 wks to 8 wks

6 wks

3 wks to 8 wks

Sensitivity analyses

Within‐patient trials

(SMD 0.17; 95% CI ‐0.20 to 0.54)

Between‐patient trials

(SMD 0.10; 95% CI ‐0.11 to 0.31)

correlation coefficient (rho) = 0

All trials

(SMD 0.10; 95% CI ‐0.08 to 0.28);
I² statistic: 90.5%

rho = 0

Btw‐patient trials

rho = 0.25

Within‐patient trials

(SMD 0.10; 95% CI ‐0.07 to 0.28)
I² statistic: 91.3%

rho = 0

Btw‐patient trials

rho = 0.50

Within‐patient trials

(SMD 0.11; 95% CI ‐0.07 to 0.29)
I² statistic: 92.4%

rho = 0

Btw‐patient trials

rho = 0.75

Within‐patient trials

(SMD 0.12; 95% CI ‐0.06 to 0.30)
I² statistic: 94.3%

For acronyms, see Table 1.

Figuras y tablas -
Table 10. Analysis 07: Trial characteristics and outcomes: vitamin D vs. potent steroids
Table 11. Analysis 08: Trial characteristics and outcomes: vitamin D vs. v. potent steroids

Subcategory

Measure

01 IAGI/IGA

02 TSS

03 PASI

04 PAGI/PGA

05 Combined end point

01 Calcipotriol vs. clobetasol propionate

Effect size [CI]

(SMD 0.19; 95% CI ‐0.42 to 0.80)

(SMD ‐0.32; 95% CI ‐0.95 to 0.30)

(SMD 0.42; 95% CI ‐0.20 to 1.03)

(SMD ‐0.06; 95% CI ‐0.57 to 0.44); I² statistic: 25.7%

All treatments

No. participants

42

0

40

42

82

Between‐patient design

1

0

1

1

2

Within‐patient design

0

0

0

0

0

Treatment duration

2 wks

6 wks

2 wks

2 wks to 6 wks

Figuras y tablas -
Table 11. Analysis 08: Trial characteristics and outcomes: vitamin D vs. v. potent steroids
Table 12. Analysis 09: Trial characteristics and outcomes: vitamin D + steroid vs. steroid

Subcategory

Measure

01 IAGI/IGA

02 TSS

03 PASI

04 PAGI/PGA

05 Combined end point

01 Calcipotriol + betamethasone dipropionate vs. betamethasone dipropionate

Effect size [CI]

(SMD ‐0.40; 95% CI ‐0.52 to ‐0.27)

(SMD ‐0.44; 95% CI ‐0.55 to ‐0.33)

(SMD ‐0.40; 95% CI ‐0.52 to ‐0.27)

02 Calcipotriol + betamethasone dipropionate vs. clobetasol propionate

Effect size [CI]

(SMD 0.45; 95% CI 0.09 to 0.81)

(SMD 0.45; 95% CI 0.09 to 0.81)

03 Calcipotriol + clobetasol propionate vs. clobetasol propionate

Effect size [CI]

(SMD ‐0.69; 95% CI ‐1.22 to ‐0.15)

(SMD ‐0.28; 95% CI ‐0.80 to 0.24)

(SMD ‐0.69; 95% CI ‐1.22 to ‐0.15)

Effect size [CI], I²

(SMD ‐0.41; 95% CI ‐0.53 to ‐0.29); I² statistic: 32.0%

(SMD 0.45; 95% CI 0.09 to 0.81): I² statistic: NA

(SMD ‐0.44; 95% CI ‐0.55 to ‐0.33) I² statistic: 22.4%

(SMD ‐0.28; 95% CI ‐0.80 to 0.24) I² statistic: NA

(SMD ‐0.26; 95% CI ‐0.52 to ‐0.00); I² statistic: 84.4%

No. participants

1991

122

1876

65

2113

Between‐patient design

4

1

3

1

5

Within‐patient design

0

0

0

0

0

Treatment duration

2 wks to 8 wks

4 wks

4 wks to 8 wks

2 wks

2 wks to 8 wks

Figuras y tablas -
Table 12. Analysis 09: Trial characteristics and outcomes: vitamin D + steroid vs. steroid
Table 13. Analysis 10: Trial characteristics and outcomes: vitamin D vs. dithranol

Subcategory

Measure

01 IAGI/IGA

02 TSS

03 PASI

04 PAGI/PGA

05 Combined end point

01 Calcipotriol vs. dithranol

Effect size [CI]

(SMD ‐0.43; 95% CI ‐0.85 to ‐0.01)

(SMD ‐0.54; 95% CI ‐1.16 to 0.08)

(SMD 0.73; 95% CI ‐0.55 to 2.00)

(SMD ‐0.05; 95% CI ‐0.90 to 0.80)

(SMD 0.07; 95% CI ‐0.57 to 0.71)

02 Calcitriol vs. dithranol

Effect size [CI]

(SMD 0.51; 95% CI 0.13 to 0.88)

(SMD 0.13; 95% CI ‐0.24 to 0.50)

(SMD ‐0.21; 95% CI ‐0.58 to 0.16)

(SMD 0.51; 95% CI 0.13 to 0.88)

03 Tacalcitol vs. dithranol

Effect size [CI]

(SMD ‐0.18; 95% CI ‐0.60 to 0.25)

(SMD ‐0.07; 95% CI ‐0.50 to 0.36)

(SMD ‐0.18; 95% CI ‐0.60 to 0.25)

All treatments

Effect size [CI], I² statistic

(SMD ‐0.24; 95% CI ‐0.72 to 0.25); I² statistic:93.0%

(SMD ‐0.27; 95% CI ‐0.73 to 0.20); I² statistic: 80.6%

(SMD 0.36; 95% CI ‐0.33 to 1.04); I² statistic: 94.5%

(SMD ‐0.05; 95% CI ‐0.90 to 0.80); I² statistic: 92.5%

(SMD 0.09; 95% CI ‐0.44 to 0.63); I² statistic: 94.9%

No. participants

1108

386

796

544

1284

Between‐patient design

5

3

5

2

7

Within‐patient design

0

1

0

0

1

Treatment duration

8 wks to 12 wks

4 wks to 8 wks

8 wks to 12 wks

8 wks to 12 wks

4 wks to 12 wks

Figuras y tablas -
Table 13. Analysis 10: Trial characteristics and outcomes: vitamin D vs. dithranol
Table 14. Analysis 11: Trial characteristics and outcomes: vitamin D vs. vitamin D

Subcategory

Measure

01 IAGI/IGA

02 TSS

03 PASI

04 PAGI/PGA

05 Combined end point

01 Calcipotriol vs. calcitriol

Effect size [CI]

(SMD 0.00; 95% CI ‐0.25 to 0.25)

(SMD ‐0.32; 95% CI ‐0.57 to ‐0.07)

(SMD ‐1.11; 95% CI ‐2.22 to 0.01)

(SMD 0.04; 95% CI ‐0.21 to 0.29)

(SMD ‐0.41; 95% CI ‐1.46 to 0.64)

02 Calcipotriol vs. tacalcitol

Effect size [CI]

(SMD ‐0.47; 95% CI ‐0.73 to ‐0.21)

(SMD ‐0.45; 95% CI ‐0.68 to ‐0.22)

(SMD ‐0.47; 95% CI ‐0.73 to ‐0.21)

03 Calcipotriol vs. maxacalcitol

Effect size [CI]

(SMD 0.43; 95% CI ‐0.12 to 0.98)

(SMD 0.13; 95% CI ‐0.41 to 0.68)

(SMD 0.43; 95% CI ‐0.12 to 0.98)

All treatments

Effect size [CI], I²

(SMD ‐0.06; 95% CI ‐0.51 to 0.38); I² statistic: 82.2%

(SMD ‐0.31; 95% CI ‐0.55 to ‐0.06); I² statistic: 46.9%

(SMD ‐1.11; 95% CI ‐2.22 to 0.01); I² statistic: NA

(SMD 0.04; 95% CI ‐0.21 to 0.29); I² statistic: NA

(SMD ‐0.17; 95% CI ‐0.62 to 0.27); I² statistic: 78.5%

No. participants

498

563

15

250

513

Between‐patient design

2

2

1

1

3

Within‐patient design

1

1

0

0

1

Treatment duration

8 wks to 12 wks

8 wks to 12 wks

8 wks

12 wks

8 wks to 12 wks

Sensitivity analyses

TSS data from Ji 2008 used in combined end point:

01 Calcipotriol vs. calcitriol

(SMD ‐0.52; 95% CI ‐1.19 to 0.15; I² statistic: 44.9%)

TSS data from Ji 2008 used in combined end point:

all treatments

(SMD ‐0.28; 95% CI ‐0.66 to 0.10; I² statistic: 70.6%)

Figuras y tablas -
Table 14. Analysis 11: Trial characteristics and outcomes: vitamin D vs. vitamin D
Table 15. Analysis 12: Trial characteristics and outcomes: vitamin D vs. vitamin D + steroid

Subcategory

Measure

01 IAGI/IGA

02 TSS

03 PASI

04 PAGI/PGA

05 Combined end point

01 Calcipotriol BD vs. calcipotriol OM, BMD ON

Effect size [CI]

(SMD 0.56; 95% CI 0.23 to 0.88)

(SMD 0.46; 95% CI 0.10 to 0.82)

(SMD 0.56; 95% CI 0.23 to 0.88)

02 Calcipotriol OD vs. combined calcipotriol + BMD OD

Effect size [CI]

(SMD 0.66; 95% CI 0.31 to 1.02)

(SMD 0.67; 95% CI 0.23 to 1.11)

(SMD 0.66; 95% CI 0.31 to 1.02)

03 Calcipotriol BD vs. combined calcipotriol + BMD OD

Effect size [CI]

(SMD 0.27; 95% CI 0.06 to 0.48)

(SMD 0.25; 95% CI 0.03 to 0.48)

(SMD 0.52; 95% CI 0.38 to 0.67)

(SMD 0.43; 95% CI 0.20 to 0.66)

04 Calcipotriol BD vs. combined calcipotriol + BMD BD

Effect size [CI]

(SMD 0.66; 95% CI 0.40 to 0.93)

(SMD 0.64; 95% CI 0.46 to 0.83)

(SMD 0.66; 95% CI 0.40 to 0.93)

05 Calcipotriol BD vs. calcipotriol OM, BMV ON

Effect size [CI]

(SMD 0.27; 95% CI ‐0.19 to 0.74)

(SMD 0.43; 95% CI ‐0.07 to 0.93)

(SMD 0.27; 95% CI ‐0.19 to 0.74)

06 Calcipotriol BD vs. calcipotriol OM, clobetasone butyrate ON

Effect size [CI]

(SMD 0.27; 95% CI 0.05 to 0.48)

(SMD 0.17; 95% CI ‐0.04 to 0.38)

(SMD 0.27; 95% CI 0.05 to 0.48)

07 Calcipotriol BD vs. calcipotriol BD + clobetasol propionate BD

Effect size [CI]

(SMD 0.88; 95% CI 0.34 to 1.42)

(SMD 0.70; 95% CI 0.16 to 1.23)

(SMD 0.88; 95% CI 0.34 to 1.42)

08 Calcipotriol BD vs. calcipotriol OM, diflucortolone valerate ON

Effect size [CI]

(SMD 0.08; 95% CI ‐0.29 to 0.44)

(SMD 0.08; 95% CI ‐0.29 to 0.44)

09 Calcipotriol OD vs. calcipotriol OM, fluocinonide acetonide ON

Effect size [CI]

(SMD 0.53; 95% CI ‐0.11 to 1.18)

(SMD 0.53; 95% CI ‐0.11 to 1.18)

10 Calcipotriol OD vs. combined calcipotriol + hydrocortisone OD

Effect size [CI]

(SMD 0.14; 95% CI ‐0.06 to 0.33)

(SMD 0.08; 95% CI ‐0.11 to 0.28)

(SMD 0.14; 95% CI ‐0.06 to 0.33)

11 calcitriol BD vs. diflucortolone valerate OM, calcitriol ON

Effect size [CI]

(SMD 0.24; 95% CI ‐0.09 to 0.57)

(SMD 0.24; 95% CI ‐0.09 to 0.57)

12 Tacalcitol OD vs. combined calcipotriol + BMD OD

Effect size [CI]

(SMD 0.48; 95% CI 0.26 to 0.70)

(SMD 0.47; 95% CI 0.25 to 0.69)

(SMD 0.46; 95% CI 0.24 to 0.68)

(SMD 0.48; 95% CI 0.26 to 0.70)

All treatments

Effect size [CI], I² statistic

(SMD 0.48; 95% CI 0.32 to 0.65), I² statistic: 86.9%

(SMD 0.25; 95% CI 0.03 to 0.48)

(SMD 0.47; 95% CI 0.34 to 0.59), I² statistic: 82.3%

(SMD 0.49; 95% CI 0.29 to 0.69), I² statistic: 0%

(SMD 0.46; 95% CI 0.33 to 0.59), I² statistic: 83.3%

No. participants

4791

301

5703

399

5856

Between‐patient design

11

1

15

2

16

Within‐patient design

0

0

1

0

1

Treatment duration

2 wks to 8 wks

4 wks

2 wks to 12 wks

2 wks to 8 wks

2 wks to 12 wks

For acronyms, see Table 1.

Figuras y tablas -
Table 15. Analysis 12: Trial characteristics and outcomes: vitamin D vs. vitamin D + steroid
Table 16. Analysis 13: Trial characteristics and outcomes: vitamin D vs. other treatments: complex regimens

Subcategory

Measure

01 IAGI/IGA

02 TSS

03 PASI

04 PAGI/PGA

05 Combined end point

01 Calcipotriol (12 wks) vs. combined calcipotriol + BMD (8 wks); then calcipotriol (4 wks)

Effect size [CI]

(SMD ‐0.12; 95% CI ‐0.29 to 0.04)

(SMD ‐0.04; 95% CI ‐0.19 to 0.11)

(SMD ‐0.14; 95% CI ‐0.30 to 0.02)

(SMD ‐0.12; 95% CI ‐0.29 to 0.04)

02 Calcipotriol (12 wks) vs. combined calcipotriol + BMD (4 wks); then calcipotriol (8 wks)

Effect size [CI]

(SMD 0.29; 95% CI ‐0.04 to 0.62)

(SMD 0.29; 95% CI ‐0.04 to 0.62)

03 Calcipotriol (12 wks) vs. combined calcipotriol + BMD (4 wks); then calcipotriol (w/dy) & combined calcipotriol + BMD (w/e) (8 wks)

Effect size [CI]

(SMD 0.13; 95% CI ‐0.04 to 0.29)

(SMD 0.10; 95% CI ‐0.05 to 0.25)

(SMD 0.10; 95% CI ‐0.06 to 0.26)

(SMD 0.13; 95% CI ‐0.04 to 0.29)

04 Calcipotriol (6 wks) vs. clobetasol propionate (2 wks); then calcipotriol (4 wks)

Effect size [CI]

(SMD 0.60; 95% CI 0.18 to 1.02)

(SMD 0.63; 95% CI 0.21 to 1.05)

(SMD 0.60; 95% CI 0.18 to 1.02)

05 Calcipotriol (6 wks) vs. calcipotriol OM, fluocinonide acetonide ON (2 wks); then calcipotriol BD (4 wks)

Effect size [CI]

(SMD 0.66; 95% CI 0.01 to 1.32)

(SMD 0.66; 95% CI 0.01 to 1.32)

06 Calcipotriol (6 wks) vs. halometasone OM, calcipotriol ON (2 wks); then calcipotriol BD (w/dy), halometasone (w/e) (2 wks); then calcipotriol BD (2wks)

Effect size [CI]

(SMD 0.41; 95% CI ‐0.05 to 0.86)

(SMD 1.13; 95% CI 0.64 to 1.62)

(SMD 0.41; 95% CI ‐0.05 to 0.86)

07 Calcipotriol ON, clobetasol propionate OM (2 to 4 wks); then calcipotriol BD (to wk12) vs. calcitriol ON, clobetasol propionate OM (2 to 4 wks); then calcitriol BD (to wk12)

Effect size [CI]

(SMD ‐0.19; 95% CI ‐0.54 to 0.16)

(SMD ‐0.27; 95% CI ‐0.62 to 0.09)

(SMD ‐0.19; 95% CI ‐0.54 to 0.16)

08 Combined calcipotriol + BMD (4 wks); then placebo ointment BD (8 wks) vs. combined calcipotriol + BMD (4 wks); then calcipotriol ointment BD (8 wks)

Effect size [CI]

(SMD 0.27; 95% CI 0.12 to 0.41)

(SMD 0.25; 95% CI 0.10 to 0.39)

(SMD 0.28; 95% CI 0.13 to 0.42)

(SMD 0.27; 95% CI 0.12 to 0.41)

09 Combined calcipotriol + BMD (4 wks); then placebo ointment BD (8 wks) vs. combined calcipotriol + BMD (4 wks); then calcipotriol (w/dy)+ combined calcipotriol + BMD (w/e) (8 wks)

Effect size [CI]

(SMD 0.51; 95% CI 0.37 to 0.66)

(SMD 0.59; 95% CI 0.45 to 0.74)

(SMD 0.71; 95% CI 0.56 to 0.85)

(SMD 0.51; 95% CI 0.37 to 0.66)

10 combined calcipotriol + BMD (4 wks); then calcipotriol ointment BD (8 wks) vs. combined calcipotriol + BMD (4 wks); then calcipotriol (w/dy) + combined calcipotriol + BMD (w/e) (8 wks)

Effect size [CI]

(SMD 0.26; 95% CI 0.11 to 0.40)

(SMD 0.30; 95% CI 0.16 to 0.45)

(SMD 0.44; 95% CI 0.29 to 0.58)

(SMD 0.26; 95% CI 0.11 to 0.40)

11 Combined calcipotriol + BMD (8 wks); then calcipotriol (4 wks) vs. combined calcipotriol + BMD (4 wks); then calcipotriol (w/dy) & combined calcipotriol + BMD (w/e) (8 wks)

Effect size [CI]

(SMD 0.24; 95% CI 0.08 to 0.40)

(SMD 0.15; 95% CI ‐0.01 to 0.30)

(SMD 0.23; 95% CI 0.07 to 0.39)

(SMD 0.24; 95% CI 0.08 to 0.40)

12 Tacalcitol (8 wks) vs. combined calcipotriol + BMD (4 wks); then calcipotriol (4 wks)

Effect size [CI]

(SMD 0.54; 95% CI 0.36 to 0.72)

(SMD 0.49; 95% CI 0.31 to 0.67)

(SMD 0.54; 95% CI 0.36 to 0.72)

(SMD 0.54; 95% CI 0.36 to 0.72)

All treatments

(not pooled)

No. participants

2755

46

2991

2508

2936

Between‐patient design

6

0

8

4

8

Within‐patient design

1

1

0

0

1

Treatment duration

6 wks to 12 wks

6 wks

2 wks to 12 wks

8 wks to 12 wks

2 wks to 12 wks

For acronyms, see Table 1.

Figuras y tablas -
Table 16. Analysis 13: Trial characteristics and outcomes: vitamin D vs. other treatments: complex regimens
Table 17. Analysis 14: Trial characteristics and outcomes: vitamin D vs. other treatment: long‐term studies (> 24 wks)

Subcategory

Measure

01 IAGI/IGA

02 TSS

03 PASI

04 PAGI/PGA

05 Combined end point

01 Combined calcipotriol + BMD (52 wks) vs. alternating: combined calcipotriol + BMD (4 wks); then calcipotriol (4 wks)

Effect size [CI]

(SMD ‐0.09; 95% CI ‐0.36 to 0.18)

(SMD ‐0.09; 95% CI ‐0.36 to 0.18)

02 Combined calcipotriol+BMD (52 wks) vs. combined calcipotriol+ BMD (4 wks); then calcipotriol (48 wks)

Effect size [CI]

(SMD ‐0.18; 95% CI ‐0.47 to 0.10)

(SMD ‐0.18; 95% CI ‐0.47 to 0.10)

03 Alternating: combined calcipotriol + BMD (4 wks); then calcipotriol (4 wks) vs. combined calcipotriol + BMD (4 wks); then calcipotriol (48 wks)

Effect size [CI]

(SMD ‐0.09; 95% CI ‐0.37 to 0.19)

(SMD ‐0.09; 95% CI ‐0.37 to 0.19)

All treatments

(no pooling)

No. participants

297

0

0

0

297

Between‐patient design

1

0

0

0

1

Within‐patient design

0

0

0

0

0

Treatment duration

52 wks

52 wks

For acronyms, see Table 1.

Figuras y tablas -
Table 17. Analysis 14: Trial characteristics and outcomes: vitamin D vs. other treatment: long‐term studies (> 24 wks)
Table 18. Analysis 15: Trial characteristics and outcomes: vitamin D/other treatment

Subcategory

Measure

01 IAGI/IGA

02 TSS

03 PASI

04 PAGI/PGA

05 Combined end point

01 Calcipotriol vs. coal tar

Effect size [CI]

(SMD ‐0.53; 95% CI ‐1.74 to 0.68)

(SMD ‐0.10; 95% CI ‐1.54 to 1.35)

(SMD ‐0.10; 95% CI ‐1.54 to 1.35)

(SMD ‐0.53; 95% CI ‐1.74 to 0.68)

02 Calcipotriol vs. coal tar polytherapy

Effect size [CI]

(SMD ‐0.59; 95% CI ‐0.87 to ‐0.31)

(SMD ‐0.51; 95% CI ‐0.86 to ‐0.16)

(SMD ‐0.63; 95% CI ‐1.06 to ‐0.20)

(SMD ‐0.63; 95% CI ‐1.06 to ‐0.20)

(SMD ‐0.59; 95% CI ‐0.87 to ‐0.31)

03 Calcipotriol vs. nicotinamide 1.4%, BD

Effect size [CI]

(SMD ‐0.09; 95% CI ‐0.49 to 0.31)

(SMD ‐0.09; 95% CI ‐0.49 to 0.31)

04 Calcipotriol vs. calcipotriol + nicotinamide 1.4%, BD

Effect size [CI]

(SMD 0.19; 95% CI ‐0.14 to 0.52)

(SMD 0.19; 95% CI ‐0.14 to 0.52)

05 Calcipotriol vs. corticosteroid + salicylic acid

Effect size [CI]

(SMD ‐0.06; 95% CI ‐0.33 to 0.22)

(SMD ‐0.05; 95% CI ‐0.36 to 0.26)

(SMD ‐0.49; 95% CI ‐0.79 to ‐0.20)

(SMD ‐0.05; 95% CI ‐0.26 to 0.15)

06 Calcipotriol vs. propylthiouracil cream

Effect size [CI]

(SMD ‐2.24; 95% CI ‐3.23 to ‐1.25)

(SMD ‐2.24; 95% CI ‐3.23 to ‐1.25)

07 Calcipotriol vs. tacrolimus ointment

Effect size [CI]

(SMD ‐0.35; 95% CI ‐1.51 to 0.81)

(SMD ‐0.13; 95% CI ‐0.51 to 0.24)

(SMD ‐0.55; 95% CI ‐1.28 to 0.17)

08 Calcipotriol vs. tazarotene

Effect size [CI]

(SMD ‐0.22; 95% CI ‐0.60 to 0.16)

(SMD ‐0.05; 95% CI ‐0.33 to 0.23)

(SMD ‐0.35; 95% CI ‐0.99 to 0.29)

(SMD ‐0.10; 95% CI ‐0.35 to 0.16)

09 Calcipotriol vs. tazarotene gel plus mometasone furoate cream

Effect size [CI]

10 Calcipotriol vs. vitamin B12 cream

Effect size [CI]

(SMD ‐0.55; 95% CI ‐1.33 to 0.24)

(SMD ‐0.01; 95% CI ‐0.78 to 0.75)

(SMD ‐0.55; 95% CI ‐1.33 to 0.24)

(SMD ‐0.55; 95% CI ‐1.33 to 0.24)

11 Head‐to‐head vitamin D alone or in combination: dosing

Effect size [CI]

(SMD ‐0.24; 95% CI ‐0.38 to ‐0.09)

(SMD ‐0.12; 95% CI ‐0.25 to 0.00)

(SMD ‐0.20; 95% CI ‐0.32 to ‐0.07)

12 Head‐to‐head vitamin D alone or in combination: occlusion

Effect size [CI]

(SMD ‐0.18; 95% CI ‐2.04 to 1.68)

(SMD ‐0.18; 95% CI ‐2.04 to 1.68)

All treatments

(not pooled)

No. participants

1386

898

1228

456

2364

Between‐patient design

8

5

6

3

13

Within‐patient design

2

2

3

3

6

Treatment duration

4 wks to 12 wks

6 wks to 12 wks

4 wks to 12 wks

4 wks to 12 wks

4 wks to 12 wks

For acronyms, see Table 1.

Figuras y tablas -
Table 18. Analysis 15: Trial characteristics and outcomes: vitamin D/other treatment
Table 19. Analysis 16: Trial characteristics and outcomes: flexural/facial psoriasis: placebo trials

Subcategory

Measure

01 IAGI/IGA

02 TSS

03 PASI

04 PAGI/PGA

05 Combined end point

01 Betamethasone valerate 0.1%, OD

Effect size [CI]

(SMD ‐2.83; 95% CI ‐3.79 to ‐1.88)

(SMD ‐2.83; 95% CI ‐3.79 to ‐1.88)

02 Calcipotriol ointment, OD

Effect size [CI]

(SMD ‐1.08; 95% CI ‐1.77 to ‐0.40)

(SMD ‐1.08; 95% CI ‐1.77 to ‐0.40)

03 Pimecrolimus cream, 1% OD/BD

Effect size [CI]

(SMD ‐1.07; 95% CI ‐1.69 to ‐0.45)

(SMD ‐1.37; 95% CI ‐1.95 to ‐0.79)

(SMD ‐0.62; 95% CI ‐1.27 to 0.02)

(SMD ‐0.65; 95% CI ‐1.24 to ‐0.06)

(SMD ‐0.86; 95% CI ‐1.30 to ‐0.41)

04 Tacrolimus ointment 0.1%, BD

Effect size [CI]

All treatments

(no pooling)

No. participants

47

57

75

47

122

Between‐patient design

1

1

1

1

2

Within‐patient design

0

0

0

0

0

Treatment duration

8 wks

8 wks

4 wks

8 wks

4 wks to 8 wks

For acronyms, see Table 1.

Figuras y tablas -
Table 19. Analysis 16: Trial characteristics and outcomes: flexural/facial psoriasis: placebo trials
Table 20. Analysis 17: Trial characteristics and outcomes: flexural/facial psoriasis: vitamin D vs. other treatment

Subcategory

Measure

01 IAGI/IGA

02 TSS

03 PASI

04 PAGI/PGA

05 Combined end point

01 Calcipotriol vs. BMV

Effect size [CI]

(SMD 2.02; 95% CI 1.20 to 2.84)

(SMD 2.02; 95% CI 1.20 to 2.84)

02 Calcipotriol vs. calcipotriol + hydrocortisone

Effect size [CI]

(SMD 0.30; 95% CI 0.11 to 0.50)

(SMD 0.32; 95% CI 0.12 to 0.51)

(SMD 0.30; 95% CI 0.11 to 0.50)

03 Calcipotriol vs. calcitriol

Effect size [CI]

(SMD 0.61; 95% CI 0.28 to 0.94)

(SMD 0.61; 95% CI 0.28 to 0.94)

04 Calcipotriol vs. pimecrolimus

Effect size [CI]

(SMD ‐0.53; 95% CI ‐1.17 to 0.11)

(SMD ‐0.53; 95% CI ‐1.17 to 0.11)

05 Calcitriol vs. tacrolimus

Effect size [CI]

(SMD 0.42; 95% CI ‐0.15 to 0.98)

(SMD 0.29; 95% CI ‐0.27 to 0.85)

(SMD 0.42; 95% CI ‐0.15 to 0.98)

All treatments

(no pooling)

No. participants

457

124

464

0

588

Between‐patient design

2

1

2

0

3

Within‐patient design

0

1

0

0

1

Treatment duration

6 wks to 8 wks

6 wks

4 wks to 8 wks

0

4 wks to 8 wks

For acronyms, see Table 1.

Figuras y tablas -
Table 20. Analysis 17: Trial characteristics and outcomes: flexural/facial psoriasis: vitamin D vs. other treatment
Table 21. Analysis 18: Trial characteristics and outcomes: scalp psoriasis: placebo‐controlled trials

Subcategory

Measure

01 IAGI/IGA

02 TSS

03 PASI

04 PAGI/PGA

05 Combined end point

01 Vitamin D: calcipotriol

Effect size [CI]

(SMD ‐0.72; 95% CI ‐1.28 to ‐0.16)

(SMD ‐0.44; 95% CI ‐0.64 to ‐0.25)

(SMD ‐0.66; 95% CI ‐1.28 to ‐0.05)

(SMD ‐0.72; 95% CI ‐1.28 to ‐0.16)

02 Potent steroid: betamethasone dipropionate

Effect size [CI]

(SMD ‐1.09; 95% CI ‐1.29 to ‐0.90)

(SMD ‐1.00; 95% CI ‐1.19 to ‐0.81)

(SMD ‐1.23; 95% CI ‐1.43 to ‐1.03)

(SMD ‐1.09; 95% CI ‐1.29 to ‐0.90)

03 Potent steroid: betamethasone valerate

Effect size [CI]

(SMD ‐1.40; 95% CI ‐1.75 to ‐1.05)

(SMD ‐1.40; 95% CI ‐1.75 to ‐1.05)

04 Very potent steroid: amcinonide

Effect size [CI]

(SMD ‐1.42; 95% CI ‐1.80 to ‐1.04)

(SMD ‐1.58; 95% CI ‐1.98 to ‐1.18)

(SMD ‐0.97; 95% CI ‐1.33 to ‐0.61)

(SMD ‐1.42; 95% CI ‐1.80 to ‐1.04)

05 Very potent steroid: clobetasol propionate

Effect size [CI]

(SMD ‐1.73; 95% CI ‐1.99 to ‐1.48)

(SMD ‐1.53; 95% CI ‐1.77 to ‐1.28)

(SMD ‐1.57; 95% CI ‐1.81 to ‐1.34)

06 Very potent steroid: halcinonide

Effect size [CI]

(SMD ‐1.11; 95% CI ‐1.69 to ‐0.53)

(SMD ‐1.11; 95% CI ‐1.69 to ‐0.53)

07 Vitamin D in combination: calcipotriol + BMD

Effect size [CI]

(SMD ‐0.97; 95% CI ‐1.61 to ‐0.32)

(SMD ‐0.92; 95% CI ‐1.42 to ‐0.43)

(SMD ‐1.00; 95% CI ‐1.79 to ‐0.22)

(SMD ‐0.97; 95% CI ‐1.61 to ‐0.32)

08 Other treatment: betamethasone‐17,21‐dipropionate plus salicylic acid

Effect size [CI]

(SMD ‐1.48; 95% CI ‐2.50 to ‐0.47)

(SMD ‐1.15; 95% CI ‐2.11 to ‐0.19)

(SMD ‐1.48; 95% CI ‐2.50 to ‐0.47)

09 Other treatment: ciclopirox olamine shampoo

Effect size [CI]

(SMD ‐0.07; 95% CI ‐0.82 to 0.68)

(SMD ‐0.11; 95% CI ‐0.86 to 0.64)

(SMD ‐0.07; 95% CI ‐0.82 to 0.68)

10 Other treatment: fluocinolone acetonide, plus occlusion

Effect size [CI]

(SMD ‐1.22; 95% CI ‐1.69 to ‐0.76)

(SMD ‐0.89; 95% CI ‐1.34 to ‐0.44)

(SMD ‐1.22; 95% CI ‐1.69 to ‐0.76)

11 Other treatment: salicylic acid

Effect size [CI]

(SMD ‐0.86; 95% CI ‐1.79 to 0.06)

(SMD ‐0.57; 95% CI ‐1.47 to 0.32)

(SMD ‐0.86; 95% CI ‐1.79 to 0.06)

All treatments

No. participants

2472

2897

0

1875

3011

Between‐patient design

9

12

0

5

13

Within‐patient design

1

0

0

0

1

Treatment duration

2 wks to 8 wks

2 wks to 8 wks

3 wks to 8 wks

2 wks to 8 wks

Sensitivity analysis: potent corticosteroids

Effect size [CI]; I² statistic

(SMD ‐1.18; 95% CI ‐1.40 to ‐0.96); I² statistic: 19.9%

Sensitivity analysis: very potent corticosteroids

Effect size [CI]; I² statistic

(SMD ‐1.51; 95% CI ‐1.70 to ‐1.31); I² statistic: 37.5%

For acronyms, see Table 1.

Figuras y tablas -
Table 21. Analysis 18: Trial characteristics and outcomes: scalp psoriasis: placebo‐controlled trials
Table 22. Analysis 19: Trial characteristics and outcomes: scalp psoriasis: vitamin D vs. other treatment

Subcategory

Measure

01 IAGI/IGA

02 TSS

03 PASI

04 PAGI/PGA

05 Combined end point

01 Vitamin D vs. corticosteroid (potent): calcipotriol vs. BMD

Effect size [CI]

(SMD 0.48; 95% CI 0.32 to 0.64)

(SMD 0.45; 95% CI 0.28 to 0.63)

(SMD 0.56; 95% CI 0.31 to 0.81)

(SMD 0.48; 95% CI 0.32 to 0.64)

02 Vitamin D vs. corticosteroid (potent): calcipotriol vs. BMV

Effect size [CI]

(SMD 0.37; 95% CI 0.20 to 0.55)

(SMD 0.09; 95% CI ‐0.09 to 0.27)

(SMD 0.41; 95% CI 0.22 to 0.59)

(SMD 0.37; 95% CI 0.20 to 0.55)

03 Vitamin D vs. corticosteroid (very potent): calcipotriol vs. clobetasol propionate

Effect size [CI]

(SMD 0.37; 95% CI 0.05 to 0.69)

(SMD 0.37; 95% CI 0.05 to 0.69)

04 Vitamin D + corticosteroid vs. corticosteroid: calcipotriol + BMD vs. BMD

Effect size [CI]

(SMD ‐0.18; 95% CI ‐0.26 to ‐0.10)

(SMD ‐0.19; 95% CI ‐0.27 to ‐0.11)

(SMD ‐0.17; 95% CI ‐0.25 to ‐0.09)

(SMD ‐0.18; 95% CI ‐0.26 to ‐0.10)

05 Vitamin D vs. vitamin D + corticosteroid: calcipotriol vs. calcipotriol + BMD

Effect size [CI]

(SMD 0.64; 95% CI 0.44 to 0.84)

(SMD 0.70; 95% CI 0.56 to 0.84)

(SMD 0.84; 95% CI 0.61 to 1.08)

(SMD 0.64; 95% CI 0.44 to 0.84)

06 Vitamin D vs. other treatments: calcipotriol vs. coal tar polytherapy

Effect size [CI]

(SMD ‐0.24; 95% CI ‐0.73 to 0.25)

(SMD ‐0.30; 95% CI ‐0.84 to 0.24)

(SMD ‐0.45; 95% CI ‐0.92 to 0.02)

All treatments

No. participants

5175

4877

0

3742

5413

Between‐patient design

10

11

0

6

12

Within‐patient design

0

0

0

0

0

Treatment duration

4 wks to 52 wks

4 wks to 8 wks

0

4 wks to 8 wks

4 wks to 52 wks

For acronyms, see Table 1.

Figuras y tablas -
Table 22. Analysis 19: Trial characteristics and outcomes: scalp psoriasis: vitamin D vs. other treatment
Table 23. Analysis 04: Trial characteristics and outcomes: dithranol vs. placebo

Subcategory

Measure

01 IAGI/IGA

02 TSS

03 PASI

04 PAGI/PGA

05 Combined end point

01 Dithranol

Effect size [CI], N, I² statistic

(SMD ‐1.06; 95% CI ‐1.66 to ‐0.46); I² statistic: 37.4%

(SMD ‐1.06; 95% CI ‐1.66 to ‐0.46); I² statistic: 37.4%

No. participants

0

47

0

0

47

Between‐patient design

0

0

0

0

0

Within‐patient design

0

3

0

0

3

Treatment duration

3 wks to 8 wks

3 wks to 8 wks

correlation coefficient (rho) = 0

All trials

(SMD ‐0.98; 95% CI ‐1.56 to ‐0.41)

I² statistic: 13.9%

rho = 0

Btw‐patient trials

rho = 0.25

Within‐patient trials

(SMD ‐1.05; 95% CI ‐1.67 to ‐0.44)

I² statistic: 35.4%

rho = 0

Btw‐patient trials

rho = 0.50

Within‐patient trials

(SMD ‐1.12; 95% CI ‐1.75 to ‐0.48)

I² statistic: 56.9%

rho = 0

Btw‐patient trials

rho = 0.75

Within‐patient trials

(SMD ‐1.17; 95% CI ‐1.81 to ‐0.52)

I² statistic: 78.5%

For acronyms, see Table 1.

Figuras y tablas -
Table 23. Analysis 04: Trial characteristics and outcomes: dithranol vs. placebo
Table 24. Included studies of adverse events

Study

Methods

Participants

Intervention(s)

Outcomes (AEs)

Summary findings

Notes

Allocation concealment

Andres 2006

DESIGN: between‐patient

patient delivery
ALLOCATION: random
Method of randomisation: computer‐generated list

Concealment: unclear
BLINDING: single‐blind (investigator)
WITHDRAWAL/DROPOUT:
described

N: 26
TD: 4 wks; FU: 4 wks
LF: 0 (0%)
BC: characteristics reported, but not demonstrated to be comparable (shampoo group had more severe disease and higher proportion of males)
Age: 34.3 (9.5SD)
Gender (per cent men): 58%
Severity:
DSS: 5.3 (1.3SD)
% scalp affected: 63.8%
INCLUSION CRITERIA: people with scalp psoriasis affecting > = 25% scalp; DSS > = 3
EXCLUSION CRITERIA: pregnancy or risk thereof; lactation; ophthalmological disorder; contact lens wearer

Clobetasol propionate 0.05% shampoo, OD. Applied to dry scalp, rinsed off after 15 minutes

Clobetasol propionate 0.05% gel, OD. Applied to dry scalp and left in. 

Serum cortisol

atrophogenicity (ultrasound measurement of skin thickness (epidermis + dermis) (mm), averaged over 3 sites of the scalp)

ocular safety (intraocular pressure)

DSS (10‐pt; sum of erythema, adherent desquamation, and plaque thickening; 0 (none) to 3 (severe) with half‐point ratings permitted)

Patient‐reported ocular stinging (0 to 3)

Compliance

Neither formulation had an impact on ocular safety, no report of ocular stinging.

LAE:
CS: 1/14; CG: 2/14

HPA suppression:
CS: 0/14; CG: 2/14

Atrophy:
CS: 0/14; CG: 0/14

Decrease in skin thickness from baseline: mean difference:
CS: 0.04 mm
CG: ‐0.24 mm
(difference: P < = 0.025)

Efficacy results of the 2 formulations were similar. Compliance with protocol was good in both groups.

Exploratory safety study

Sponsored by Galderma Laboratories

Unclear

Barnes 2000

DESIGN: within‐patient
patient delivery

ALLOCATION: non‐random
Method of randomisation: NA
Concealment: NA
BLINDING: open
WITHDRAWAL/DROPOUT: described

N: 202
TD: 52 wks; FU: 52 wks
LF: 64 (32%)
BC: NA
Age: 46 (14.5SD)
Gender (per cent men): 60%
Severity:
Scalp: TSS (0 to 12): 5.9; Overall assessment (investigator): mild (31%); moderate (58%); severe (11%)
Body: PASI (modified): 6.8 Overall assessment (investigator): mild (41.5%); moderate (55%); severe (3.5%)
INCLUSION CRITERIA: chronic plaque psoriasis on scalp and body; adult (≥18); outpatient
EXCLUSION CRITERIA: pregnancy or risk thereof; severe (i.e. requiring additional therapy) or unstable psoriasis; hypercalcaemia; history of hypo‐ or hyperparathyroidism, renal/hepatic disease; systemic or phototherapies within previous 6 wks; other medication that could affect course of disease

Calcipotriol scalp solution 50 mcg/ml BD
plus calcipotriol cream 50 mcg/g BD (up to 70 g/wk)

No control

Local AEs:
number of AEs/participant
% severe AEs
withdrawals due to adverse events (WA)

Systemic AEs:

serum calcium
serum PTH
urinary calcium/creatinine ratio

Local AEs:
the most common local AE was facial irritation (60/202 participants at wk 2), though the incidence declined rapidly over time (1/141 at wk 46).
20% of local AEs considered by investigator to be 'severe'. 14% of participants withdrew because of adverse events

Systemic AEs:
no significant changes observed

Sponsored by Leo Pharmaceuticals

Not applicable

Berth‐Jones 1993; Berth‐Jones 1992c

DESIGN: uncontrolled study
patient delivery
ALLOCATION: non‐random
Method of randomisation: NA

Concealment: NA
BLINDING: open
WITHDRAWAL/DROPOUT: NA

STUDY A:
N: 20
TD: 52 wks; FU: 52 wks
LF: 0 (0%)
BC: NA
Age: 43
Gender (per cent men): 65%
Severity: mean PASI: 7.6 (3.5SD)

STUDY B:
N: intervention: 10 {32 controls}
TD: 4 wks; FU: 4 wks
LF: 0 (0%)
BC: not demonstrated
Age: 48 {42}
Gender (per cent men): 50% {44%}
Severity: mean PASI: 18.0 (13.9SD) {NR}

INCLUSION CRITERIA: people with chronic plaque psoriasis; aged ≥18; under long‐term care of investigators. Study A: compliant patients, responsive to calcipotriol.
Study B: more extensive disease, failing to respond to low doses of topical agents. Controls received no calcipotriol.
EXCLUSION CRITERIA: pregnancy

Study A: calcipotriol ointment 50 mcg/g BD up to 100 g/wk
No control

Study B: calcipotriol ointment 50 mcg/g BD, using 100 g/wk for 4 wks
Control: people using alternative therapies

Local AEs:
not assessed

Systemic AEs: urine calcium and phosphate excretion; serum total calcium, phosphate and alkaline phosphatase

Study A: no significant trend in urine calcium excretion

Study B: significant increase in urine calcium excretion (relative to controls and to baseline)

Sponsorship not reported

For study B, baseline comparability of intervention and control groups not demonstrated.

Berth Jones 1992 reports findings for study A at 10 mths

Not applicable

Bleiker 1998

DESIGN: uncontrolled study
Delivery: unclear

ALLOCATION: non‐random
Method of randomisation: NA

Concealment: NA

BLINDING: open WITHDRAWAL/DROPOUT:

not described

N: 28
TD: 2 wks; FU: 26 wks
LF: unclear
BC: NA
Age: 47 (range: 18 to 83)
Gender (per cent men): 50%
Severity: PASI: 21.4 (range: 8.2 to 53.7)
INCLUSION CRITERIA: inpatients with severe chronic plaque psoriasis (> 15% BSA)
EXCLUSION CRITERIA: renal impairment, pregnancy, lactation, systemic treatment, diuretics

STUDY A: 200 g calcipotriol ointment 50 mcg/g (wk 1) plus 300 g 50 mcg/g calcipotriol (wk 2)

STUDY B: Calcipotriol 50 mcg/g PRN < = 360 g/wk

Local AEs:
not assessed

Systemic AEs:
serum total adjusted calcium
urinary calcium

5 participants developed hypercalcaemia during treatment, all had received a dose > 5 g/kg
9 participants became hypercalciuric during treatment; this was uncorrelated with dose

Sponsorship not reported

Not applicable

Brodell 2011b

DESIGN: uncontrolled study
patient delivery
ALLOCATION: non‐randomised
BLINDING: open
WITHDRAWAL/DROPOUT: not described

N: 305
TD: 12 wks; FU: 12
LF: unclear
BC: NA
Age: 50.3 (13.7SD); range: 22 to 84
Gender (per cent men): 61.8%
Severity:
ODS: all patients scored as moderate/severe/very severe
% BSA: 7.1%

% white: 91.8%
INCLUSION CRITERIA: people with moderate to severe plaque psoriasis; affected; aged 18 to 80
EXCLUSION CRITERIA: not stated

Clobetasol propionate 0.05% spray BD (2 to 4 wks); treatment responders (ODS < = 3) then treated with calcitriol 3 mg/g ointment (8 wks)

Pruritis, telangiectasias, burning/stinging (0 to 3), skin atrophy, folliculitis

Overall disease severity (ODS) (5‐pt: 0 = clear to 4 = severe/very severe) based on erythema, scaling, and plaque elevation.

Treatment success (change from baseline ODS > = 1 at wk 12)

 

 

At 4 wks:

skin atrophy 7/285

telangiectasias 2/285

stinging/Burning 39/285

folliculitis 11/285

 

At 12 wks:

skin atrophy 2/235

telangiectasias 5/235

stinging/Burning 35/235

folliculitis 3/235

 

Any adverse event: 100/305

 

Sponsored by Galderma laboratories

Not applicable

Corbett 1976

DESIGN: within‐patient
patient delivery
ALLOCATION: random
Method of randomisation: NR
Concealment: unclear
BLINDING: double‐blind (participant/investigator)
WITHDRAWAL/DROPOUT: not described

N: 14
TD: 26 wks; FU: 26 wks
LF: 2 (14.3%)
BC (clinical): NR Age: 44 (18.4SD) Gender (per cent men): 64%
Severity: NR INCLUSION CRITERIA: bilateral psoriasis involving < = 15% BSA; willing to participate for 6 months

EXCLUSION CRITERIA: NR

Clobetasol propionate 0.05% ointment, BD Betamethasone valerate 0.1% ointment, BD

Local AEs: NR

Systemic AEs:
synacthen test for function of pituitary‐adrenal axis at 0, 3, and 6 months

Quantities used by study participants were small (mean: 7 g/wk)

No pituitary‐adrenal suppression observed

Sponsorship not reported

Unclear

Gerritsen 2001; Langner 1996; van de Kerkhof 1996c

DESIGN: uncontrolled study

patient delivery

ALLOCATION: NA

Method of randomisation: NA

Concealment: NA

BLINDING: open WITHDRAWAL/DROPOUT: described

N: 257
TD: < = 78 wks; FU: <= 78 wks
LF: 4 (1.6%)
BC: NA
Age: 42 (13SD)
Gender (per cent men): 61.3%
Severity: BSA: 14.0% (14.2%SD); PASI: 9.7; 47% had severe disease
INCLUSION CRITERIA: chronic plaque psoriasis; aged ≥18
EXCLUSION CRITERIA: non‐compliant; pregnancy; use of systemic/phototherapy within previous 2 mths; use of topical therapy within previous 1 wk; concomitant disease; clinically relevant abnormality in laboratory assessments; known hypersensitivity to vitamin D/vehicle

Calcitriol 3 mcg/g BD

No control

Local AEs:
serious AEs reported; withdrawals due to adverse events (WA)

Systemic AEs:
laboratory levels for: protein albumin; calcium, phosphorus, sodium, potassium, plasma calcitriol
Urinary calcium, creatinine, phosphorus; creatinine clearance; urinary calcium/creatinine ratio

Local AEs:
WA: 7/253;
AEs: 37/353;
no serious local adverse events

Systemic AEs: WA: 1/253. 4 additional participants experienced hypercalcaemia. All mean values for all parameters remained within normal levels. Mean use: 6 g/day (range: 1 to 24 g/day)

Sponsored by Solvay‐Duphar BV

Excludes scalp

Not applicable

Guzzo 1996

DESIGN: between‐patient
patient delivery

ALLOCATION: random
Method of randomisation: NR
Concealment: unclear
BLINDING: double‐blind (participant/investigator)
WITHDRAWAL/DROPOUT: described

N: 78
TD: 8 wks; FU: 8 wks
LF: 2 (2.6%)
BC: no (1 statistically significant difference (% BSA higher in intervention group)
Age: 48
Gender (per cent men): 67%
Severity: mean BSA: 9%
INCLUSION CRITERIA: aged ≥18; stable plaque psoriasis; BSA: 5% to 20%

EXCLUSION CRITERIA: hypercalcaemia, bone, thyroid or parathyroid disease; topical therapy within previous 2 wks; systemic/phototherapy within previous 8 wks

Calcipotriol 50 mcg/g ointment BD, up to 120 g/wk

Placebo

Local AEs: not assessed

Systemic AEs: blood and urine chemistry analysis: parathyroid hormone, serum calcium, bone‐specific alkaline phosphatase, urinary hyroxyproline, 24‐hr urinary calcium excretion. Bone densitometry

No adverse effects on bone metabolism or calcium

Sponsored by Bristol‐Myers Squibb

Unclear

Heng 1990

DESIGN: between‐patient (retrospective study)
patient delivery

ALLOCATION: non‐random
Method of randomisation: NA
Concealment: NA
BLINDING: NA
WITHDRAWAL/DROPOUT: NA

N: 28
TD: 6 mths to 12 ys; FU: 6 mths to 12 years
LF: NA
BC: demographic: yes; clinical: not demonstrated
Age: 49 (13SD)
Gender (per cent men): 82%
Severity: NR INCLUSION CRITERIA: psoriasis (any severity; types include plaque (16), generalised, seborrhoeic, guttate, erythrodermic); previous prolonged treatment with topical fluorinated steroids (range: 6 mths to 12 years). Control group matched for age and gender

EXCLUSION CRITERIA: NR

Previous prolonged treatment with topical fluorinated steroids

Control: 'steroid‐negative' group ‐ previous tar/UVB/sunlight or no treatment

Local AEs: light/electron microscopy for examination of basal keratinocyte herniation (BKH); layers of basement membrane

Systemic AEs: NR

Local AEs: light microscopy revealed no between‐group differences. Electron microscopy revealed multi‐layered, fragmented and disorganised basal laminae in the steroid group, which appeared to be correlated with duration of treatment. Fragmentation was not observed in the control group

Sponsorship not reported

Non‐psoriatic control group also considered

16/28 participants had plaque psoriasis

Not applicable

Katz 1987b

DESIGN: between‐patient
patient delivery

ALLOCATION: random

Method of randomisation: NS
Concealment: unclear
BLINDING: double‐blind (participant/investigator)
WITHDRAWAL/DROPOUT: described

N: 40
TD: 3 wks; FU: 3 wks
LF: NA
BC: demographic: yes; clinical: yes (gender imbalance)
Age: 44 (range: 18 to 66)
Gender (per cent men): 53%
Severity: 55% moderate disease; 45% severe disease
INCLUSION CRITERIA:
aged ≥ 18; stable or worsening, moderate or severe chronic plaque psoriasis; baseline laboratory values within normal range (5 to 25 mcg%)
EXCLUSION CRITERIA: pregnancy or risk thereof; lactation; hypersensitivity to study medications; concurrent medication that could affect study outcomes; use of systemic therapies within previous 4 wks; use of topical therapies within previous 2 wks

Betamethasone dipropionate (0.05%) in optimised vehicle BD; Clobetasol 17 propionate (0.05%) ointment BD

Local AEs: not assessed

Systemic AEs: morning plasma cortisol levels; 24‐hr urine steroid levels; FBC, blood chemistry, urinalysis

Temporary reversible suppression of the hypothalamic‐pituitary‐adrenal axis in 8/40 participants

Sponsorship not reported; 1 author from Schering Corporation

Unclear

Katz 1989

DESIGN: within‐patient
patient delivery

ALLOCATION: random
Method of randomisation: unclear
Concealment: unclear

BLINDING: double‐blind (participant/investigator)
WITHDRAWAL/DROPOUT: described

N: 30
TD: 2 wks; FU: 4 wks
LF: 0 (0%)
BC: yes
Age: 55 (range: 36 to 69)
Gender (per cent men): 53%
Severity: NR INCLUSION CRITERIA: bilateral symmetric chronic plaque psoriasis EXCLUSION CRITERIA: pregnancy or risk thereof; people with overt signs of atrophy

Betamethasone dipropionate (0.05%) in optimised vehicle BD (BMD)

Clobetasol propionate (0.05%) ointment BD (CP)

Uninvolved (non‐psoriatic) area used as test area for each participant

Local AEs: skin surface microscopic examination with photographic documentation; oil and magnifying (8 x) lens to detect 'preatrophy' (visibility of subpapillary vascular plexus caused by thinning of epidermis and papillary dermis)

Systemic AEs: NR

Local AEs: no serious adverse events observed with either treatment. Preatrophy identified in 20% of involved plaques (BMD: 11/59; CP: 12/59) and was more likely in females. In the test area (non‐psoriatic skin), 5% of plaques showed preatrophy (BMD: 2/30; CP: 1/30). Preatrophy appeared to be usually reversible following treatment cessation.

Sponsored by Schering Corporation

Unclear

Kimball 2008

Phase II

DESIGN: uncontrolled
patient delivery
ALLOCATION: unclear

BLINDING: open WITHDRAWAL/DROPOUT:
described

N: 32
TD: 2 wks; FU: NS
LF: 1 (3.1%)
BC: NA
Age: 24 to 72
Gender (per cent men): NS
Severity: NS
% white: 94%
INCLUSION CRITERIA
people with mild to moderate plaque psoriasis; aged > = 12
EXCLUSION CRITERIA: NS

Clobetasol 0.05% foam BD

Clobetasol 0.05% ointment BD (= 7 g/day, up to 50 g/wk)

 

 

Maximal plasma concentration of clobetasol propionate

 

Higher but non‐significant levels of clobetasol in ointment group

Supported by Stiefel Laboratories, Inc.

Review of phase II studies on AD and psoriasis (clobetasol foam)

Not applicable

Kimball 2008

Phase III

DESIGN: between‐patient
patient delivery
ALLOCATION: random
Method of randomisation: not stated
Concealment: unclear
BLINDING: double‐blind (participant/investigator)
WITHDRAWAL/DROPOUT: described

N: 497
TD: 2 wks; FU: NS
LF: 16 (3%)
BC: NS
Age: NS
Gender (per cent men): NS
Severity: most had baseline ISGA of 3
INCLUSION CRITERIA: people with mild to moderate plaque psoriasis; aged > = 12
EXCLUSION CRITERIA: NS

Clobetasol 0.05% foam BD

Clobetasol 0.05% ointment BD

Placebo foam BD

Face, scalp, and intertriginous areas excluded from treatment

 

Treatment‐related adverse events:

  • all

  • atrophy

  • burning

  • pruritis

  • folliculitis

ISGA (investigator's static global assessment score)(scale NR)

Atrophy:

C foam: 2% (N = 253)
C ointment: NS (N = 121)
Placebo foam: 1% (N = 123)

Burning:

C foam: 2% (N = 253)
C ointment: NS (N = 121)
Placebo foam: 2% (N = 123)

All treatment‐related adverse events:

C foam: 8% (N = 253)
C ointment: 2% (N = 121)
Placebo foam: 7% (N = 123)

 

Supported by Stiefel Laboratories Inc.

Review of phase III studies on AD and psoriasis (clobetasol foam).

Unclear

Kragballe 1991b

DESIGN: uncontrolled study

patient delivery

ALLOCATION: non‐random
Method of randomisation: NA Concealment: NA

BLINDING: open WITHDRAWAL/DROPOUT: described

N: 15
TD: 26 wks; FU: 26 wks
LF: 1(6.7%)
BC: NA
Age: 42 (range: 21 to 71)
Gender (per cent men): 53%
Severity: % BSA: 14% (range: 5% to 30%)
Most 'moderate' severity
INCLUSION CRITERIA: participants previously responding to calcipotriol during 8‐wk clinical trial, but who had since relapsed

EXCLUSION CRITERIA: hypercalcaemia, impaired renal/hepatic function, daily receiving > 400 i.u. vitamin D

Calcipotriol ointment 50 mcg/g BD (max: 100 g/wk)

No control

Local AEs: patient report of adverse events
Investigator report of adverse events (skin examination). Skin biopsies to determine histologic signs of epidermal and dermal atrophy.

Systemic AEs: laboratory tests: FBC, serum alkaline phosphatase, aspartate aminotransferase, bilirubin, creatinine, total calcium, total phosphate

Local AEs:
AE(L): 3/15 (reported to be transient & mild).
Cases of mild to moderate atrophy found in 4/8 participants

Systemic AEs: no consistent changes in laboratory analyses, with no clinically important changes in serum calcium

Sponsorship not reported. Leo Pharmaceuticals supplied study medication

Face and scalp treated with emollient or hydrocortisone cream 1% (not calcipotriol)

Not applicable

Lambert 2002

DESIGN: uncontrolled study

patient delivery

ALLOCATION: non‐random
Method of randomisation: NA
Concealment: NA
BLINDING: open
WITHDRAWAL/DROPOUT: described

N: 157
TD: 26 wks; FU: 26 wks
LF: 8 (5.1%)
BC: NA
Age: 44.4 (14.0SD)
Gender (per cent men): 57%
Severity: mean BSA: 13%; mean PASI: 9.4 (5.4SD)

INCLUSION CRITERIA: chronic plaque psoriasis; aged 18 to 70; BSA 7% to 20%; laboratory parameters normal at baseline

EXCLUSION CRITERIA: pregnancy or risk thereof; topical antipsoriatic therapy within previous 2 wks; systemic antipsoriatic therapy within previous 6 wks; retinoids within previous 52 wks.; history of hyperparathyroidism; concomitant use of drugs affecting calcium metabolism

Tacalcitol ointment, 4 mcg/g OD. No control

Local AEs: participants asked about adverse events. Tolerability assessed by investigator (4‐pt: 1 = excellent to 4 = poor).

Systemic AEs:
Routine haematology and biochemistry: FBC, haemoglobin, bilirubin, creatinine, alkaline phosphatase, aspartate aminotransferase, alanine aminotransferase, gamma glutamyltranspeptidase, calcium, phosphate, sodium, potassium, glucose, urea, albumin. Urinalysis: calcium, creatinine, phosphate.

Local AEs:
WA: 5/157 (3.4%) (treatment‐related).
AE(L): 26/157 (transient skin irritation)
Tolerability at least moderate in 95% of participants

Systemic AEs: no serious adverse events and no hypercalcaemia

Sponsored by Hermal/BHI, Germany

Scalp excluded

Similar study to van de Kerkhof 2002, but unclear whether Lambert 2002 is a report of a subgroup or a distinct study

Not applicable

Lebwohl 1998b

DESIGN: between‐patient
patient delivery

ALLOCATION: random.
Method of randomisation: unclear
Concealment: unclear
BLINDING: double‐blind (participant/investigator)
WITHDRAWAL/DROPOUT: described

N: 40
TD: 26 wks; FU: 26 wks
LF: 4 (10%)
BC: no (Group A had less severe disease at baseline)
Age: NR
Gender (per cent men): NR
Severity: mild to moderate psoriasis
INCLUSION CRITERIA: people with at least moderate improvement in response to initial 2‐wk therapy regimen; aged ≥18; stable disease; BSA < = 20% (excluding face/scalp); plaque elevation at least moderate; willing to comply with study protocol

EXCLUSION CRITERIA: history of sensitivity to study ingredients; topical antipsoriatics within previous 2 wks; UVB/PUVA within previous 8 wks; history of hypercalcaemia, recurrent illness

Initial regimen: all participants received 2 wks of calcipotriol (OM), halobetasol ointment (ON)

Group A: Calcipotriol ointment 50 mcg/g (weekdays) plus halobetasol 0.05% ointment BD (weekends)

Group B: Placebo ointment (weekdays) plus halobetasol 0.05% ointment BD (weekends)

Local AEs: treatment‐related adverse events

Systemic AEs: not assessed

Local AEs:
AE(L) (treatment‐related; all irritant contact dermatitis): Group A: 4/17 Group B: 1/20 No cutaneous atrophy observed

Sponsored by Westwood Squibb Pharmaceuticals

Unclear

Lebwohl 2001

DESIGN: between‐patient

patient delivery

ALLOCATION: random
Method of randomisation: NR
Concealment: unclear
BLINDING: double‐blind (participant/investigator)
WITHDRAWAL/DROPOUT: not described

N: 50
TD: 26 wks; FU: 26 wks
LF: NR
BC: NR
Age: 55
Gender (per cent men): NR
Severity: NR INCLUSION CRITERIA: moderate to severe plaque psoriasis; BSA < = 15%. All participants participated in an open‐label treatment phase for 6 wks (tazarotene gel 0.1% OM, clobetasol propionate ointment 0.05% ON) EXCLUSION CRITERIA: topical antipsoriatic treatment within previous 2 wks; UV treatment within previous 4 wks; systemic antipsoriatic treatment within previous 8 wks

Open‐label phase: tazarotene 0.1% gel plus clobetasol propionate 0.05% ointment for 6 wks. Once daily initially, then 'tapered'.

Maintenance phase (20 wks): tazarotene gel, 0.1%, OM (3/7 days), plus clobetasol propionate 0.05% ointment ON (2/7days) (TC)

Tazarotene gel, 0.1%, OM (3/7 days), placebo ointment OM (2/7 days), placebo ointment ON (2/7 days) (TP)

Placebo gel OM (3/7 days), placebo ointment ON (2/7 days) (P)

Local AEs: no. steroid‐specific side‐effects
Withdrawals due to adverse events (WA) Drug‐related adverse events
Systemic AEs: not assessed

Local AEs: no steroid‐specific side‐effects
WA: 0/50
AE(L) (treatment‐related): TC: 24% TP: 29% P: 0%

Sponsorship: not reported

No adequate effectiveness data reported. Numbers of participants in each group NR

Unclear

Menter 2007; Feldman 2007a

DESIGN: uncontrolled
patient delivery
ALLOCATION: NA

BLINDING: open
WITHDRAWAL/DROPOUT: described

N: 1423
TD: 4 wks; FU: 4 wks
LF: 2 (0.1%)
BC: NA
Age: 49.7 (14.7SD)
Gender (per cent men): NS
Severity:
Duration (yrs): 12.5 (13SD)
BSA: 10.6% (5.75% SD)
INCLUSION CRITERIA:
people with moderate to severe plaque psoriasis; 3% to 20% BSA involvement
EXCLUSION CRITERIA: current systemic therapy, phototherapy or topical therapy

Clobetasol 0.05% foam BD, up to 50 g/wk either as monotherapy or adjunctive to existing therapy

 

Erythema, peeling/scaling, dryness, stinging/burning (0 none to 3 severe).

Telangiectasia, skin atrophy, pruritus, folliculitis (absent/present)

 

Also assessed efficacy and QoL

Erythema: 23.7%
peeling/scaling: 21.0%
dryness: 28.3%
stinging/burning: 15.1%

Telangiectasia, skin atrophy, folliculitis: present in less than 1% of participants (findings not reported separately)

Pruritus: 5.7%

Clobex Spray Community‐Based Research Assessment (COBRA)

Sponsorship not reported

Not applicable

Miyachi 2002

DESIGN: uncontrolled study

patient delivery

ALLOCATION: non‐random
Method of randomisation: NA
Concealment: NA
BLINDING: open
WITHDRAWAL/DROPOUT: described

N: 160
TD: 54 wks; FU: 54 wks
LF: 6 (3.8%)
BC: NA
Age: 48.2 (16.1SD)
Gender (per cent men): 82%
Severity: mean PASI: 22.49 (10.2SD) INCLUSION CRITERIA: inpatients and outpatients with BSA ≥10% EXCLUSION CRITERIA: pregnancy; lactation; severe liver disease, heart disease, impaired renal function, hypercalcaemia; treatment with topical, UV or systemic antipsoriatics within previous 2 wks

Tacalcitol ointment 20 mcg/g OD (max: 10 g/day)

No control

Local AEs: treatment‐related adverse events

Systemic events: haematological tests (FBC), blood biochemical tests (calcium, inorganic phosphorus, albumin, protein, bilirubin, urea nitrogen, creatinine, GP/AST, GPT/ALT, alkaline phosphatase, LDH, intact PTH), urinalysis (glucose, protein); serum tacalcitol and vitamin D₃ levels.

Local AEs:
AE(L): 16/154 (29 events, all mild to moderate)

Systemic AEs:
AE(S): 85/154 (155 events, of which 6 were considered treatment‐related). Serum levels of intact PTH and tacalcitol decreased, suggesting percutaneous absorption of tacalcitol. However, mean levels of serum calcium remained within the standard level. Data on individual responses not reported.
High‐dose tacalcitol affected serum calcium in participants with reduced renal function

Sponsorship: not reported

Scalp treated in 74/154 participants

Usual dosing regimen for tacalcitol is 4 mcg/g OD

Not applicable

Poyner 1993

DESIGN: uncontrolled study

patient delivery

ALLOCATION: non‐random
Method of randomisation: NA
Concealment: NA

BLINDING: open
WITHDRAWAL/DROPOUT: described

N: 203
TD: 48 wks; FU: 48 wks
LF: 59 (29.1%)
BC: NA
Age: 43.8 (range: 17 to 80)
Gender (per cent men): 52.7%
Severity (assessment methods NR): mild (8%); moderate (63%); severe (30%) INCLUSION CRITERIA: aged ≥18; chronic plaque psoriasis ≥ 100 cm². EXCLUSION CRITERIA: PUVA within previous 8 wks; elevated serum calcium, unstable disease, impaired hepatic/renal function' pregnancy; concomitant oral calcium/vitamin D. topical antipsoriatics, lithium, systemic steroids

Calcipotriol 50 mcg/g ointment

No control

Loca AEs: self report of adverse events.
Withdrawals due to adverse events (WA)

Systemic AEs: biochemical and haematological tests

Compliance: self‐reported usage at each visit; weighing of ointment tubes

Local AEs:
WA: 8/203
AE(L): 83/203
142 events reported by 83 (41%) participants with 20.2% being lesional/perilesional irritation

Systemic AEs: no significant changes in haematological values. Mean serum calcium did not change significantly over study period. Significant fall in serum urate in those treated ≥ 36 wks

Compliance: median weekly use (wks 0 to 5): 16.5g; (wks 43 to 48): 11.6g

Sponsored by Leo Pharmaceuticals

Face/scalp excluded

Not applicable

Ramsay 1994

DESIGN: uncontrolled open study
patient delivery

ALLOCATION: non‐random
Method of randomisation: NA
Concealment: NA
BLINDING: open
WITHDRAWAL/DROPOUT: described

N: 167 TD: 52 wks; FU: 52 wks LF: 39 (23.4%)

BC: NA

Age: 49 (range: 20 to 85)

Gender (per cent men): 60%

Severity: PASI (modified): 8.1 (6.7SD)

INCLUSION CRITERIA: chronic plaque psoriasis; previous response to calcipotriol; managed by specialists EXCLUSION CRITERIA: pregnancy or risk thereof; abnormal serum calcium or phosphate; impaired hepatic/renal function; concomitant oral calcium/vitamin D; systemic therapy within previous 8 wks; topical therapy within previous 4 wks

Calcipotriol 50 mcg/g ointment. Max dose: 100 g/wk; 2500 g/pa Face/scalp/neck excluded

No control

Local AEs: self report of adverse events: mild, moderate, severe; unlikely, possibly, or probably treatment‐related

Systemic AEs: haematology (erythrocyte, haemoglobin, leukocyte, platelet counts) and biochemistry (bilirubin, AST/ALT, alkaline phosphatase, albumin, urate, creatinine, phosphate, total calcium) tests Compliance: self report of number tubes used and number daily doses

AE(L): 52/161 60 (46 considered to be treatment‐related) events reported by 52 of 161 participants. 1 participant developed a significant rise in serum calcium. No other abnormalities in haematology or biochemistry tests. 118/161 participants reported continuous medication use and 80% to 90% used it twice daily. Mean use: 35.1 g/wk ('initially') to 23.4 g/wk during last 6 mths

Sponsored by Leo Pharmaceuticals

Not applicable

Roelofzen 2010

DESIGN: observational study using retrospective data (medical records, cancer registry) and prospective (survey) data (treatments/lifestyle). Multivariate proportional hazards regression.
ALLOCATION: NA
BLINDING: NA
WITHDRAWAL/DROPOUT: described

N: 4315
TD: pix lithantracis (med): 4 mths (1 to 300 mths) liquor carbonis detergens (med): 6 mths (1 to 500 mths)
FU: (med) 21 yrs
LF: 329 (7.6%)
BC: NA
Age (at diagnosis): 31 (0 to 95.7)
Gender (per cent men): 52%
Severity: % BSA < 1%: 9%
% BSA 2% to 9%: 30%
% BSA 10% to 30%: 39%
% BSA > 30%: 22%
INCLUSION CRITERIA: people with psoriasis or eczema, diagnosed 1960 to 1990 and treated in 1 of 3 Dutch hospitals;
EXCLUSION CRITERIA: people who could not be traced

All topical, phototherapy, and systemic therapies. Focus of study is on coal tar:

  • Liquor carbonis only (LCD)

  • Pix lithantiacis (PL)

Any cancer

Skin cancer

Internal malignancies

Specific tumour groups:

  • haematological

  • breast

  • lung

  • gastrointestinal

  • bladder/urinary tract

  • prostate

  • female reproductive organs

No statistically significant increased risk of any cancer.

Hazard ratios:

Any cancer:

LCD: 0.85 (95% CI 0.60 to 1.19)
PL: 0.64 (95% CI 0.40 to 1.03)

Skin cancer:

LCD: 1.35 (95% CI 0.53 to 3.44)
PL: 0.33 (95% CI 0.07 to 1.69)

Analysis adjusted for smoking status, other treatments, skin type, alcohol consumption.  However, data on duration of tar therapy, smoking status and alcohol consumption were missing for most participants

Not applicable‐

van de Kerkhof 1997b

DESIGN: uncontrolled study

patient delivery

ALLOCATION: non‐random
Method of randomisation: NA Concealment: NA

BLINDING: open
WITHDRAWAL/DROPOUT: described

N: 58
TD: < = 60 wks; FU: < = 60 wks
LF: 16 (27.6%)
BC: NA
Age: 45 (range: 19 to 78)
Gender (per cent men): 69.0%
Severity: BSA: 8.6% (3.9SD); TSS (0 to 12):7.9 (2.1SD) INCLUSION CRITERIA: people with chronic plaque psoriasis participating in previous double‐blind study (Van de Kerkhof 1996b); aged 25 to 80; normal serum calcium/phosphate. EXCLUSION CRITERIA: pregnancy or risk thereof; topical therapy within previous 4 wks; systemic therapy within previous 8 wks; serious disease; known allergy to study medication; concomitant medication that could interfere with study drug or systemic calcium metabolism

Part 1: double‐blind study (8 wks): tacalcitol 4 mcg/g ointment OD Placebo

Part 2: open follow‐up study (4 wk wash‐out period): tacalcitol 4 mcg/g ointment OD, < = 20 mg/day and < 2000 g per participant over study period. Participants could discontinue treatment after 12 wks

No control

Local AEs: occurrence of adverse events (duration, severity, and whether treatment‐related)
Participant and investigator assessments of tolerability (4‐pt: v. good (3) to insufficient (0))

Systemic AEs: haematology (erythrocytes, platelets, haemoglobin, haematocrit); blood chemistry (serum calcium, inorganic phosphate, creatinine, ASAT, alkaline phosphatase, LDH)

Local AEs:
WA: 0/58
AE(L): 10/58 (19 events) AE(L)(treatment‐related): 8/58
Tolerability: investigator assessment: 2.60 (0.53SD, N = 58); participant assessment: 2.53 (0.63SD, N = 58)

Systemic AEs:
AE(S): 0/58

No case of hypercalcaemia

Sponsorship not reported

Follow‐up study to Van de Kerkhof 1996b ‐ 3 of 15 centres participated

Scalp excluded

Not applicable

van de Kerkhof 2002c (see also Lambert 2002)

DESIGN: uncontrolled study

patient delivery

ALLOCATION: non‐random

Method of randomisation: NA

Concealment: NA

BLINDING: open WITHDRAWAL/DROPOUT: described

Part 1:
N: 304
TD: 13 wks; FU: 13 wks
LF: 47 (15.5%)
BC: NA
Age: 44 (range: 15 to 76)
Gender (per cent men): 57%
Severity: median PASI (modified to exclude head): 9.5 (range: 2.2 to 24.4); TSS (0 to 12): 6.0

Part 2: n: 197
TD: 65 wks; FU: 65 wks
LF: 83 (42.1%)
BC: NA
Age: NR
Gender (per cent men): NR
Severity: NR
INCLUSION CRITERIA: chronic plaque psoriasis; BSA 7% to 20% (excluding scalp); aged 18 to 70; normal baseline laboratory values

Part 2 of study: responders to part 1 (≥ 30% reduction in sum score (TSS) from baseline)

EXCLUSION CRITERIA: topical steroids in previous 2 wks; systemic antipsoriatics within previous 6 wks; retinoids within previous 52 wks; known hypersensitivity to vitamin D₃ analogues; serious concomitant disease; disease that might interfere with study assessments; concomitant use of oral calcium/vitamin D; pregnancy or risk thereof

Tacalcitol 4 mcg/g OD. Treatment discontinued during remission and restarted if relapse

No control

Local AEs: number treatment‐related adverse events; withdrawals due to adverse events (WA); investigator assessment of tolerability; participant assessment of tolerability

Systemic AEs: Haematology: serum calcium, parathyroid hormone (PTH), calcitonin, calcitriol Urine: calcium, creatinine, calcium/creatinine ratio. Compliance with medication

Local AEs:
WA: 18/304
AE(L): 65/304
Tolerability excellent/good in 76% (patient assessment) to 92% (investigator assessment) of participants at final assessment.

Systemic AEs:
No clinically significant changes in routine haematology, urinalysis or serum chemistry. Compliance with treatment regimen varied between 82% and 92%. However, 54% of those with BSA 10% to 20% exceeded recommended daily dose of 5 g (up to 13 g daily), but there was no effect on calcium homeostasis. Duration of excess dosing not reported

Sponsored by Hermal/BHI, Germany

Scalp excluded

Not applicable

Vazquez‐Lopez 2004

DESIGN: uncontrolled study

patient delivery

ALLOCATION: non‐random
Method of randomisation: NA
Concealment: NA

BLINDING: open WITHDRAWAL/DROPOUT: described

N: 20
TD: 26 wks; FU: 34 wks
LF: 0 (0%)
BC: NA
Age: 28.2 (range: 20 to 55)
Gender (per cent men): 40%
Severity: NR

INCLUSION CRITERIA:
absence of visible or dermascopic red lines (linear telangiectasias)

EXCLUSION CRITERIA: use of topical steroids in previous 2 mths

Clobetasol propionate 0.05% cream, OD (weekends) plus calcipotriol 50 mcg/g ointment BD (weekdays)

No control

Local AEs: clinical (naked eye) examination of psoriatic plaque and surrounding area
Dermoscopic examination of psoriatic plaque and surrounding area

Systemic AEs: NR

Compliance: quantity and frequency of study drug use (tubes weighed)

Overuse of topical steroids resulted in appearance of clinically unapparent but dermoscopically apparent linear telangiectasias. 7/20 participants failed to adhere to recommended steroid dosing schedules. Dermoscopic red lines not apparent in 15/20 participants. Dermoscopic red lines apparent in 5/20 participants, of whom 4 had overused topical steroid cream. Steroid discontinued in participants with red lines and there was complete resolution within 2 mths

Links compliance with adverse events

Study received no funding

Not applicable

Veraldi 2006

DESIGN: uncontrolled study
patient delivery
ALLOCATION: sequential recruitment
BLINDING: open
WITHDRAWAL/DROPOUT: described

N: 48
TD: 45 dys; FU: 45 dys
LF: 5 (10.4%)
BC: NA
Age: 48.9 (range: 21 to 71)
Gender (per cent men): 62.5%
Severity: NR
INCLUSION CRITERIA: people with chronic stable plaque psoriasis; % BSA < = 20%
EXCLUSION CRITERIA: use of antipsoriatic therapy within previous 2 wks; concurrent use of other topical, photo or systemic therapies

0.1% tazarotene gel, short contact therapy (applied OD for 20 minutes then rinsed off with water)

Pruritis (4‐pt: 0 = absent to 3 = severe)

Burning (4‐pt: 0 = absent to 3 = severe)

At day 45: pruritis (0 to 3): 0.17 (0.38SD)

14/43 had mild pruritis

 

Burning (0 to 3) 0.17 (0.38SD)

14/43

14/43 had mild burning

No participant withdrew because of irritation on treated lesion

Sponsorship not reported

Not applicable

Wishart 1994

DESIGN: uncontrolled study

patient delivery
ALLOCATION: groups determined according to BSA affected.
BLINDING: open
WITHDRAWAL/DROPOUT: described

N: 30
TD: 6 wks; FU: 6 wks
LF: 1 (3%)
BC: NA
Age: 42.5 (13.2SD)
Gender (per cent men): 47%
Severity:
Duration (mths): 202 (176SD)
INCLUSION CRITERIA: people aged >18 with severe chronic plaque psoriasis; lesion severity > = 3 (GSS 0 to 4)
EXCLUSION CRITERIA: pregnancy, other type of psoriasis, concurrent use of medicines containing calcium or vitamin D, antacids or digitalis

Calcitriol 15 mcg/g ointment OD

Quantity of study drug varied by group:

Group 1 (N =12): 4% to 8% BSA treated (300 to 600 cm^2)

Group 2 (N = 10): 8% to 15% BSA treated (600 to 1200 cm^2)

Group 3 (N = 8): 15% to 30% BSA treated (1200 to 2400 cm^2)

IAGI (6‐pt)

ECG

Haematology, biochemistry, urine protein and glucose.

Serum calcium, phosphorus, plasma PTH, serum 25‐hydroxyvitaim D, 1‐alpha,25dihydroxy‐vitaim D, 24 hr urine tests for calcium, creatinine and phosphorus.

Compliance also assessed (medication weight)

Mean daily usage: 74.0 to 306.1 mcg.

No systemic adverse events, no skin irritation.

No clinically relevant changes in vital signs, haematology, biochemistry, urine or ECGs.

IAGI (0 to 5): ‐3.57 (1.01SD, N = 30)

Usual dose is 3 mcg/g BD, max. 30 g daily

Sponsored by Solvay Duphar

Not applicable

per cent men: per cent male; AE(L): number local adverse events/number participants; AE(S): number systemic adverse events/number participants; AE: adverse events; BC: baseline comparability; BD: twice daily; BSA: body surface area; FU: follow up (includes TD); N: number enrolled; NA: not applicable; NR: not reported; OD: once daily; PASI: Psoriasis Area and Severity Index; PRN: as required; TD: treatment duration; TSS: Total Severity Score; WA: withdrawal due to adverse events

Figuras y tablas -
Table 24. Included studies of adverse events
Table 25. Excluded studies of adverse events

Study

Reason for exclusion

Aste 2004

Follow‐up under 12 wks and not focused on adverse events

Bos 2002

Not psoriasis, short review (letter)

Breneman 2007

Not a product included in our review (bexarotene gel 1%)

Carboni 2005

Not focused on adverse events

Feldman 2007a

Evaluated add‐on clobetasol for participants treated concurrently with topical or systemic therapy

Floden 1975

Inadequate reporting of adverse events

Franssen 1999

Small (N = 54) retrospective study using participant questionnaires ‐ aimed to identify teratogenetic effects of tar, but many women unable to recall whether tar used in pregnancy

Hong 2010; Hong 2011

Not chronic plaque psoriasis: paediatric dermatology participants had eczema or "eczema–psoriasis overlap (atopic dermatitis with associated features of psoriasis)"

Jacobi 2008

Small uncontrolled short‐term and already reflected in results from main review

Kang 1998

Short‐term and already reflected in results from main review

Lebwohl 1996

Follow‐up under 12 wks and not focused on adverse events

Park 2002

Case study

Senter 1983

Adverse events not reported

Singh 2000

Short‐term (4 weeks) and brief mention of adverse events

Stevanovic 1977

Short‐term, unclear if psoriasis, small numbers (N = 6)

Traulsen 2003

Participants were healthy volunteers

Uhoda 2003

Not about adverse events

Vissers 2004

Not about adverse events

Figuras y tablas -
Table 25. Excluded studies of adverse events
Table 26. Included studies of compliance

Study

Methods

Participants

Interventions

Outcomes (compliance

Summary findings

Notes

Allocation concealment

Balkrishnan 2003

DESIGN: uncontrolled study
patient delivery
ALLOCATION: non‐random
Method of randomisation: NA
Concealment: NA
BLINDING: single‐blind (participants unaware of electronic compliance assessment)
WITHDRAWAL/DROPOUT: described

N: 10
TD: 1 wk; FU: 1 wk
LF: 0 (0%)
BC: NA
Age: NR
Gender (per cent men): NR
Severity: NR
INCLUSION CRITERIA: participants with psoriasis who already enrolling in a study with salicylic acid and topical tacrolimus ointment (Protopic) combination therapy.
EXCLUSION CRITERIA: NR

Topical salicylic acid 6%

No control

Medication adherence:
(1) MEMS cap: medication bottle cap with microprocessor to record time/date of every opening of the bottle.
(2) Patient log (self report) of compliance
Mean adherence rate: method 1: 67% (32% SD); method 2: 92% (7% SD)

Medication adherence measured by method 1 (electronic) much lower than by method 2 (patient log)

Sponsorship not reported

D

Carroll 2004a; Carroll 2004b;
Carroll 2005

DESIGN: within‐patient
patient delivery
ALLOCATION: random
Method of randomisation: NR
Concealment: unclear
BLINDING:
Single‐blind (participants unaware of electronic compliance assessment)
WITHDRAWAL/DROPOUT:
described

N: 30
TD: 8 wks; FU: 12 wks
LF: 6 (20%)
BC: Yes
Age: 43.6 (range 18 to 70)
Gender (per cent men): 50%
Severity: TSS (0 to 8): 5.3
INCLUSION CRITERIA: participants aged ≥18; symmetrical plaque‐type psoriasis; BSA < = 10%; symmetrical target plaque 1cm² with each with a score of at least 1 for erythema, thickness, and scale
EXCLUSION CRITERIA: pregnancy or risk thereof; topical treatment within previous 2 wks; phototherapy or systemic therapy within previous 4 wks

Topical salicylic acid 6% plus 0.1% tacrolimus ointment BD

Topical salicylic acid 6% plus placebo BD

Medication adherence:
(1) MEMS cap: medication bottle cap with microprocessor to record time/date of every opening of the bottle.
(2) Patient log (self report) of compliance
(3) medication weights

Adherence decreased over time. On the intervention side, a decrease in adherence rate of 10% was associated with a 1‐point increase in severity (P < 0.05). For the placebo‐treated side, adherence was not significantly correlated with changes in severity.

Poor compliance appears to have an impact on treatment outcomes in psoriasis

Mean adherence (method 1):
% (doses taken/doses expected): 55%;
% (days with twice‐daily dose/total days): 39.1% Higher adherence rate for women and older participants

Sponsored by Fujisawa Healthcare, Inc. and by Wake Forest University School of Medicine.

Excluded from effectiveness review (comparator is not placebo)

B

Feldman 2007

DESIGN: uncontrolled study
patient delivery
ALLOCATION: non‐random
Method of randomisation: NA
Concealment: NA
BLINDING: single‐blind (participants unaware of electronic compliance assessment)
WITHDRAWAL/DROPOUT:
described

N: 29
TD: 8 wks; FU: 8 wks
LF: NR
BC: NA
Age: 43.5
Gender (per cent men): NR
Severity: NR
INCLUSION CRITERIA: NR
EXCLUSION CRITERIA: NR

6% salicylic acid gel BD

No control

Impact of office visits on participants' adherence to topical treatment.

Adherence assessed using MEMS cap: medication bottle cap

Adherence statistically significantly higher at time of office visit.

Mean adherence over the study duration was 55%.

Mean applications/day: 1.1 (range: 0.72 to 1.4)

Sponsored in part by Astellas Pharma US, Inc.
The Center for Dermatology Research is funded by a grant from GaldermaLaboratories, LP.

(see also Balkrishnan 2003; Carroll 2004a, 2004b, 2005)

D

Ferrandiz 1998

DESIGN: between‐patient
patient delivery (therapy)
Clinician delivery (programme)
ALLOCATION: random
Method of randomisation: NR
Concealment: unclear
BLINDING: open
WITHDRAWAL/DROPOUT: described

N: 881
TD: 16 wks; FU: 16 wks
LF: 127 (12.6%)
BC: Yes
Age: 43.3 (16.9SD)
Gender (per cent men): NR
Severity: mean PASI: 7.0
INCLUSION CRITERIA: moderately severe chronic plaque psoriasis; BSA < = 30%; aged 18 to 70; under specialist supervision
EXCLUSION CRITERIA: pregnancy or lactation; history of intolerance to calcipotriol/excipients; concurrent vitamin D (> 400 units/day) or calcium tablets; psoriasis mainly on face or hirsute areas

Calcipotriol plus reinforcement programme

Calcipotriol without reinforcement programme

Reinforcement therapeutic programme to enhance adherence: dermatologist provided participant education with explanation of disease characteristics and treatment efficacy and application, plus written information card

The reinforcement programme had no effect on treatment efficacy

Sponsorship not reported

B

Fouere 2005

DESIGN: questionnaire survey (observational cross‐sectional study)
ALLOCATION: non‐random
Method of randomisation: NA
Concealment: NA
BLINDING: open
WITHDRAWAL/DROPOUT:
response rate not reported

N: 1281
TD: NA; FU: NA
LF: NA
BC: NA
Age: 51.9 (SD 14.8)
Gender (per cent men): 48%
Severity: 74% considered their psoriasis as at least moderately severe
INCLUSION CRITERIA: members of the national psoriasis patient associations in France, UK, Belgium, Germany, and the Netherlands.
EXCLUSION CRITERIA: not stated

Any antipsoriatic therapy

Compliance measured against PMAQ‐3w scale (patient medication adherence questionnaire): strict adherence to prescribed regimen over previous 3 days and last weekend

Reasons for non‐compliance

Perceived necessary measures to increase compliance

73% reported non‐compliance with current treatment

Main reasons for non‐compliance: lack of efficacy, messiness, and time constraints

To improve compliance, patients suggested improved efficacy, less greasy, sticky and smelly treatment, and fewer side‐effects.

Sponsorship not reported.

70% of responders used topical therapy

D

Gokdemir 2008

DESIGN: open uncontrolled study
patient delivery
ALLOCATION: non‐random
Method of randomisation: NA
Concealment: NA
BLINDING: open WITHDRAWAL/DROPOUT: described

N: 109
TD: 8 wks; FU: 8 wks
LF: 6 (6%)
BC: NA
Age: 40 (range: 16 to 70)
Gender (per cent men): 43%
Severity: PASI: 9.1 (range: 1.2 to 35)
INCLUSION CRITERIA: chronic plaque psoriasis; received prescribed antipsoriatic therapy; aged ≥16; attending outpatient clinic in Istanbul.
EXCLUSION CRITERIA: other types of psoriasis; hospitalised; pregnancy

Any prescribed antipsoriatic therapy

Medication adherence: number prescribed doses taken/number prescribed doses prescribed (see Zaghloul 2004).

Mean adherence for topical therapy: 72% (31%SD)

Adherence rate was correlated with being unmarried, more highly educated, and being satisfied with treatment

Main reasons for non‐adherence were busyness and 'being fed up'

Findings relate to any treatment for psoriasis (not just topical therapy)

Sponsorship not reported

D

Richards 1999

DESIGN: questionnaire survey (cross‐sectional uncontrolled study)
patient delivery
ALLOCATION: non‐random
Method of randomisation: NA
Concealment: NA
BLINDING: open WITHDRAWAL/DROPOUT: Response rate not reported

N: 120
TD: NA; FU: NA
LF: NA
BC: NA
Age: 49 (18 to 84)
Gender (per cent men): 54%
Severity: Duration: range: 1 to 63 yrs
INCLUSION CRITERIA: consecutive participants attending tertiary psoriasis specialty clinic; psoriasis.
EXCLUSION CRITERIA: not stated

Any antipsoriatic therapy

Per cent complying with treatment (self report): scale not reported

39 per cent reported non‐compliance (sometimes/never complying) with prescribed treatment. The non‐compliant group had a higher self‐rated disease severity, were younger, and had a younger age at onset.
The non‐compliant group reported that psoriasis had a greater impact on daily life

Factors affecting compliance included the doctor‐participant relationship; optimism with the treatment prescribed; and a limited 'nuisance' value of treatment in terms of side‐effects and hassle of use

Sponsorship not reported

55% of participants were using topical therapies

D

van de Kerkhof 1998

DESIGN: questionnaire survey (uncontrolled study)
patient delivery
ALLOCATION: non‐random
Method of randomisation: NA
Concealment: NA

BLINDING: NA
WITHDRAWAL/DROPOUT: Response rate reported

N: 972
TD: NA; FU: NA
Response rate: 13%
BC: NA
Age: 45.8 (range: 5 to 87)
Gender (per cent men): 43%
Severity: duration of psoriasis > 10 yrs in 67% of responders
INCLUSION CRITERIA: subscribers to 'Psoriasis', the journal of the Dutch Psoriasis Patient Organisation
EXCLUSION CRITERIA: none stated

Any topical antipsoriatic therapy

Per cent complying with frequency of application of prescribed topical therapies

Reason for non‐compliance

29% of responders reported that the prescriber did not specify dosage frequency.
Where dosage frequency was specified, 33% (39%) complied with twice (once) daily regimens

Main reasons for non‐adherence were preference for less frequent dosage; greasiness; lack of efficacy; and higher‐than expected efficacy

Sponsorship not reported.

14‐item questionnaire mailed in 1996 to 6100 subscribers of Psoriasis, the Journal of the Dutch Psoriasis Patient Organisation

Responders asked to report on compliance over past 6 mths

D

van de Kerkhof 2000

DESIGN: questionnaire survey (uncontrolled study)
ALLOCATION: non‐random
Method of randomisation: NA
Concealment: NA
BLINDING: single‐blind
WITHDRAWAL/DROPOUT:
response rate reported

N: 839
TD: NA; FU: NA
LF: NA
Response rate: 14%
BC: NA
Age: 48.5 (range: 4 to 91)
Gender (per cent men): 46%
Severity: duration of psoriasis ≥ 11 years in 62% of responders

INCLUSION CRITERIA: subscribers to 'Psoriasis', the Journal of the Dutch Psoriasis Patient Organisation
EXCLUSION CRITERIA: none stated

Any antipsoriatic therapy including topical treatments, photo(chemo)therapy and systemic therapy

Per cent complying with duration of prescribed treatment (topical therapies)

Per cent complying with frequency of application of prescribed treatment (topical therapies)

Reason for non‐compliance

Per cent complying with duration of prescribed treatment (topical therapies): 71%

Per cent complying with frequency of application of prescribed treatment (topical therapies): 51%

Main reasons for non‐adherence were preference for minimum dosage; time constraints; and lack of confidence in efficacy

Sponsorship not reported

41‐item questionnaire mailed to 6100 subscribers of Psoriasis, the Journal of the Dutch Psoriasis Patient Organisation

Responders asked to report on compliance over past 6 mths

D

van de Kerkhof 2001

DESIGN: within‐patient (see Notes)
patient delivery
ALLOCATION: non‐random
Method of randomisation: NA
concealment: NA
BLINDING: open
WITHDRAWAL/DROPOUT:
described

N: 976
TD: 8 wks; FU: 8 wks
LF: 93 (9.5%)
BC: NR
Age: 45.6 (range: 7.4 to 88.4)
Gender (per cent men): 52% Severity: BSA ≥ 10% in 51% of participants

INCLUSION CRITERIA: psoriasis (type NR); eligible for treatment with calcipotriol

EXCLUSION CRITERIA:
concomitant topical or systemic antipsoriatic therapy; co‐existing skin disorder other than psoriasis

Calcipotriol cream OM plus calcipotriol ointment ON

Calcipotriol ointment BD

Compliance:
self‐reported number of days cream/ointment regimen applied

At wk 3, 72% of participants applied the regimen on most days. By wk 8, this statistic had fallen to 61%

51% of the 309 participants with previous experience of calcipotriol ointment monotherapy reported that their compliance with the cream/ointment regimen was higher

Sponsorship not reported

Control group comprised retrospective self‐reported experience of calcipotriol ointment monotherapy by 35% of participants in the intervention group

D

Zaghloul 2004

DESIGN: uncontrolled study
patient delivery
ALLOCATION: non‐random
Method of randomisation: NA
Concealment: NA
BLINDING: single‐blind (participants unaware that study focused on compliance)
WITHDRAWAL/DROPOUT:
described

N: 294
TD: 12 wks; FU: 12 wks
LF: 93 (31.6%)
BC: NA
Age: 45.1 (range: 20 to 65)
Gender (per cent men): 44.3%
Severity: NR
INCLUSION CRITERIA: psoriasis (unclear if chronic plaque only); aged 18 to 65; prescribed oral, topical or combined treatment
EXCLUSION CRITERIA: pregnancy, lactation, concomitant disease

Topical, oral, or combined antipsoriatic medication

No control

Medication adherence:
(1) number prescribed doses taken/number prescribed doses prescribed
(2) patient self‐report

Quality of Life (DLQI) (0 to 30; higher score implies lower quality of life)

Medication adherence measured by method 1 (objective) much lower than by method 2 (patient self report). Mean rate: 60.6% (33.0%SD); (range: 0% to169%)

Direct correlation observed between medication adherence and quality of life

Adherence rate higher for participants who were women, married, employed, or not paying for prescriptions

Adherence greater for topical (vs. systemic) therapy, once daily, or first‐time use

Authors report no relevant financial interests

D

per cent men: per cent male; AE(L): number local adverse events/number participants; AE(S): number systemic adverse events/number participants; AE: adverse events; BC: baseline comparability; BD: twice daily; BSA: body surface area; FU: follow up (includes TD); N: number enrolled; NA: not applicable; NR: not reported; OD: once daily; PASI: Psoriasis Area and Severity Index; PRN: as required; TD: treatment duration; TSS: Total Severity Score; WA: withdrawal due to adverse events

Figuras y tablas -
Table 26. Included studies of compliance
Table 27. Excluded studies of compliance

Study

Reason for exclusion

Atkinson 2004

Adherence not assessed

Chu 2000

Treatment guideline (not primary study)

Gupta 2007

Review/think piece

Lee 2006

Review

Osborne 2002

Study focused on non‐responsive participants rather than those that are specifically non‐compliant

Richards 2006

Review

Szeimies 2004

Think piece (not primary study)

Figuras y tablas -
Table 27. Excluded studies of compliance
Comparison 1. Vitamin D analogues versus placebo

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 IAGI Show forest plot

20

Std. Mean Difference (IV, Random, 95% CI)

Subtotals only

1.1 Calcipotriol

10

2287

Std. Mean Difference (IV, Random, 95% CI)

‐0.93 [‐1.17, ‐0.68]

1.2 Calcipotriol plus occlusion

0

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

1.3 Calcitriol

6

1120

Std. Mean Difference (IV, Random, 95% CI)

‐1.03 [‐1.71, ‐0.36]

1.4 Tacalcitol

2

433

Std. Mean Difference (IV, Random, 95% CI)

‐0.84 [‐1.41, ‐0.26]

1.5 Maxacalcitol

1

103

Std. Mean Difference (IV, Random, 95% CI)

‐1.43 [‐1.91, ‐0.96]

1.6 Paricalcitol OD

1

22

Std. Mean Difference (IV, Random, 95% CI)

‐1.66 [‐2.66, ‐0.67]

1.7 Becocalcidiol OD

1

121

Std. Mean Difference (IV, Random, 95% CI)

‐0.22 [‐0.58, 0.14]

1.8 Becocalcidiol twice daily

1

119

Std. Mean Difference (IV, Random, 95% CI)

‐0.67 [‐1.04, ‐0.30]

2 TSS Show forest plot

19

Std. Mean Difference (IV, Random, 95% CI)

Subtotals only

2.1 Calcipotriol

10

1208

Std. Mean Difference (IV, Random, 95% CI)

‐1.15 [‐1.41, ‐0.89]

2.2 Calcipotriol plus occlusion

1

187

Std. Mean Difference (IV, Random, 95% CI)

‐0.15 [‐0.44, 0.14]

2.3 Calcitriol

4

1027

Std. Mean Difference (IV, Random, 95% CI)

‐1.22 [‐2.38, ‐0.07]

2.4 Tacalcitol

3

496

Std. Mean Difference (IV, Random, 95% CI)

‐0.66 [‐0.95, ‐0.36]

2.5 Maxacalcitol

1

103

Std. Mean Difference (IV, Random, 95% CI)

‐1.61 [‐2.10, ‐1.12]

2.6 Paricalcitol OD

1

22

Std. Mean Difference (IV, Random, 95% CI)

‐2.15 [‐3.24, ‐1.06]

2.7 Becocalcidiol OD

1

121

Std. Mean Difference (IV, Random, 95% CI)

‐0.02 [‐0.37, 0.34]

2.8 Becocalcidiol twice daily

1

119

Std. Mean Difference (IV, Random, 95% CI)

‐0.46 [‐0.83, ‐0.10]

3 PASI Show forest plot

9

2422

Std. Mean Difference (IV, Random, 95% CI)

‐0.58 [‐0.71, ‐0.45]

3.1 Calcipotriol

8

2195

Std. Mean Difference (IV, Random, 95% CI)

‐0.65 [‐0.75, ‐0.55]

3.2 Calcipotriol plus occlusion

0

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

3.3 Calcitriol

0

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

3.4 Tacalcitol

1

227

Std. Mean Difference (IV, Random, 95% CI)

‐0.27 [‐0.56, 0.03]

3.5 Maxacalcitol

0

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

3.6 Paricalcitol OD

0

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

3.7 Becocalcidiol OD

0

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

3.8 Becocalcidiol twice daily

0

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

4 PAGI Show forest plot

5

1467

Std. Mean Difference (IV, Random, 95% CI)

‐0.54 [‐0.72, ‐0.36]

4.1 Calcipotriol

2

439

Std. Mean Difference (IV, Random, 95% CI)

‐0.64 [‐0.97, ‐0.30]

4.2 Calcipotriol plus occlusion

0

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

4.3 Calcitriol

2

801

Std. Mean Difference (IV, Random, 95% CI)

‐0.59 [‐0.76, ‐0.41]

4.4 Tacalcitol

1

227

Std. Mean Difference (IV, Random, 95% CI)

‐0.24 [‐0.53, 0.05]

4.5 Maxacalcitol

0

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

4.6 Paricalcitol OD

0

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

4.7 Becocalcidiol OD

0

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

4.8 Becocalcidiol twice daily

0

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

5 Combined end point (IAGI/TSS/PASI/PAGI) Show forest plot

30

Std. Mean Difference (IV, Random, 95% CI)

Subtotals only

5.1 Calcipotriol

17

3269

Std. Mean Difference (IV, Random, 95% CI)

‐0.96 [‐1.15, ‐0.77]

5.2 Calcipotriol plus occlusion

1

187

Std. Mean Difference (IV, Random, 95% CI)

‐0.15 [‐0.44, 0.14]

5.3 Calcitriol

7

1140

Std. Mean Difference (IV, Random, 95% CI)

‐0.92 [‐1.54, ‐0.29]

5.4 Tacalcitol

4

723

Std. Mean Difference (IV, Random, 95% CI)

‐0.73 [‐1.09, ‐0.37]

5.5 Maxacalcitol

1

103

Std. Mean Difference (IV, Random, 95% CI)

‐1.43 [‐1.91, ‐0.96]

5.6 Paricalcitol OD

1

22

Std. Mean Difference (IV, Random, 95% CI)

‐1.66 [‐2.66, ‐0.67]

5.7 Becocalcidiol OD

1

121

Std. Mean Difference (IV, Random, 95% CI)

‐0.22 [‐0.58, 0.14]

5.8 Becocalcidiol twice daily

1

119

Std. Mean Difference (IV, Random, 95% CI)

‐0.67 [‐1.04, ‐0.30]

6 Total withdrawals Show forest plot

25

4715

Risk Difference (M‐H, Random, 95% CI)

‐0.02 [‐0.05, 0.00]

6.1 Calcipotriol

14

3132

Risk Difference (M‐H, Random, 95% CI)

‐0.03 [‐0.06, 0.00]

6.2 Calcipotriol plus occlusion

0

0

Risk Difference (M‐H, Random, 95% CI)

0.0 [0.0, 0.0]

6.3 Calcitriol

5

339

Risk Difference (M‐H, Random, 95% CI)

‐0.00 [‐0.02, 0.02]

6.4 Tacalcitol

4

857

Risk Difference (M‐H, Random, 95% CI)

‐0.05 [‐0.14, 0.05]

6.5 Maxacalcitol

1

120

Risk Difference (M‐H, Random, 95% CI)

0.11 [‐0.01, 0.23]

6.6 Paricalcitol OD

1

22

Risk Difference (M‐H, Random, 95% CI)

0.0 [‐0.16, 0.16]

6.7 Becocalcidiol OD

1

124

Risk Difference (M‐H, Random, 95% CI)

‐0.01 [‐0.12, 0.11]

6.8 Becocalcidiol twice daily

1

121

Risk Difference (M‐H, Random, 95% CI)

‐0.01 [‐0.13, 0.10]

7 Withdrawals due to adverse events Show forest plot

23

4463

Risk Difference (M‐H, Random, 95% CI)

‐0.00 [‐0.02, 0.01]

7.1 Calcipotriol

12

2880

Risk Difference (M‐H, Random, 95% CI)

‐0.02 [‐0.04, 0.00]

7.2 Calcipotriol plus occlusion

0

0

Risk Difference (M‐H, Random, 95% CI)

0.0 [0.0, 0.0]

7.3 Calcitriol

5

339

Risk Difference (M‐H, Random, 95% CI)

‐0.00 [‐0.02, 0.02]

7.4 Tacalcitol

4

857

Risk Difference (M‐H, Random, 95% CI)

0.00 [‐0.01, 0.02]

7.5 Maxacalcitol

1

120

Risk Difference (M‐H, Random, 95% CI)

‐0.01 [‐0.08, 0.06]

7.6 Paricalcitol OD

1

22

Risk Difference (M‐H, Random, 95% CI)

0.0 [‐0.16, 0.16]

7.7 Becocalcidiol OD

1

124

Risk Difference (M‐H, Random, 95% CI)

0.03 [‐0.02, 0.08]

7.8 Becocalcidiol twice daily

1

121

Risk Difference (M‐H, Random, 95% CI)

0.05 [‐0.01, 0.11]

8 Withdrawals due to treatment failure Show forest plot

14

2752

Risk Difference (M‐H, Random, 95% CI)

‐0.03 [‐0.05, 0.00]

8.1 Calcipotriol

7

1770

Risk Difference (M‐H, Random, 95% CI)

‐0.03 [‐0.08, 0.01]

8.2 Calcipotriol plus occlusion

0

0

Risk Difference (M‐H, Random, 95% CI)

0.0 [0.0, 0.0]

8.3 Calcitriol

4

281

Risk Difference (M‐H, Random, 95% CI)

‐0.03 [‐0.12, 0.05]

8.4 Tacalcitol

1

314

Risk Difference (M‐H, Random, 95% CI)

0.0 [‐0.01, 0.01]

8.5 Maxacalcitol

1

120

Risk Difference (M‐H, Random, 95% CI)

‐0.03 [‐0.11, 0.04]

8.6 Paricalcitol OD

1

22

Risk Difference (M‐H, Random, 95% CI)

0.0 [‐0.16, 0.16]

8.7 Becocalcidiol OD

1

124

Risk Difference (M‐H, Random, 95% CI)

‐0.02 [‐0.07, 0.04]

8.8 Becocalcidiol twice daily

1

121

Risk Difference (M‐H, Random, 95% CI)

‐0.03 [‐0.09, 0.02]

9 Adverse events (local) Show forest plot

19

4402

Risk Difference (M‐H, Random, 95% CI)

0.00 [‐0.01, 0.02]

9.1 Calcipotriol

11

2652

Risk Difference (M‐H, Random, 95% CI)

0.01 [‐0.03, 0.05]

9.2 Calcipotriol plus occlusion

0

0

Risk Difference (M‐H, Random, 95% CI)

0.0 [0.0, 0.0]

9.3 Calcitriol

4

917

Risk Difference (M‐H, Random, 95% CI)

‐0.01 [‐0.03, 0.02]

9.4 Tacalcitol

2

566

Risk Difference (M‐H, Random, 95% CI)

‐0.00 [‐0.03, 0.03]

9.5 Maxacalcitol

0

0

Risk Difference (M‐H, Random, 95% CI)

0.0 [0.0, 0.0]

9.6 Paricalcitol OD

1

22

Risk Difference (M‐H, Random, 95% CI)

0.0 [‐0.16, 0.16]

9.7 Becocalcidiol OD

1

124

Risk Difference (M‐H, Random, 95% CI)

0.01 [‐0.06, 0.08]

9.8 Becocalcidiol twice daily

1

121

Risk Difference (M‐H, Random, 95% CI)

0.10 [0.00, 0.19]

10 Adverse events (systemic) Show forest plot

14

2463

Risk Difference (M‐H, Random, 95% CI)

0.0 [‐0.01, 0.01]

10.1 Calcipotriol

8

1182

Risk Difference (M‐H, Random, 95% CI)

0.0 [‐0.01, 0.01]

10.2 Calcipotriol plus occlusion

0

0

Risk Difference (M‐H, Random, 95% CI)

0.0 [0.0, 0.0]

10.3 Calcitriol

3

647

Risk Difference (M‐H, Random, 95% CI)

0.0 [‐0.01, 0.01]

10.4 Tacalcitol

1

244

Risk Difference (M‐H, Random, 95% CI)

0.0 [‐0.02, 0.02]

10.5 Maxacalcitol

1

120

Risk Difference (M‐H, Random, 95% CI)

0.0 [‐0.05, 0.05]

10.6 Paricalcitol OD

1

22

Risk Difference (M‐H, Random, 95% CI)

0.0 [‐0.16, 0.16]

10.7 Becocalcidiol OD

1

124

Risk Difference (M‐H, Random, 95% CI)

0.0 [‐0.03, 0.03]

10.8 Becocalcidiol twice daily

1

124

Risk Difference (M‐H, Random, 95% CI)

0.0 [‐0.03, 0.03]

Figuras y tablas -
Comparison 1. Vitamin D analogues versus placebo
Comparison 2. Corticosteroid (potent) versus placebo

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 IAGI Show forest plot

11

1904

Std. Mean Difference (IV, Random, 95% CI)

1.00 [‐1.18, ‐0.82]

1.1 Betamethasone dipropionate OD

2

739

Std. Mean Difference (IV, Random, 95% CI)

‐0.81 [‐0.98, ‐0.64]

1.2 Betamethasone dipropionate twice daily

4

537

Std. Mean Difference (IV, Random, 95% CI)

‐1.35 [‐1.56, ‐1.15]

1.3 Betamethasone dipropionate, maintenance

0

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

1.4 Betamethasone valerate

1

74

Std. Mean Difference (IV, Random, 95% CI)

‐1.41 [‐1.92, ‐0.90]

1.5 Budesonide

0

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

1.6 Desonide

1

76

Std. Mean Difference (IV, Random, 95% CI)

‐0.81 [‐1.34, ‐0.28]

1.7 Diflorasone diacetate

0

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

1.8 Fluticasone propionate

2

383

Std. Mean Difference (IV, Random, 95% CI)

‐0.93 [‐1.14, ‐0.72]

1.9 Hydrocortisone buteprate

0

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

1.10 Mometasone furoate

1

95

Std. Mean Difference (IV, Random, 95% CI)

‐0.75 [‐1.17, ‐0.34]

2 TSS Show forest plot

7

611

Std. Mean Difference (IV, Random, 95% CI)

‐0.77 [‐1.01, ‐0.52]

2.1 Betamethasone dipropionate OD

1

93

Std. Mean Difference (IV, Random, 95% CI)

‐0.74 [‐1.16, ‐0.32]

2.2 Betamethasone dipropionate twice daily

1

33

Std. Mean Difference (IV, Random, 95% CI)

‐0.77 [‐1.48, ‐0.06]

2.3 Betamethasone dipropionate, maintenance

1

38

Std. Mean Difference (IV, Random, 95% CI)

‐0.95 [‐1.62, ‐0.27]

2.4 Betamethasone valerate

1

22

Std. Mean Difference (IV, Random, 95% CI)

‐1.09 [‐2.00, ‐0.18]

2.5 Budesonide

0

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

2.6 Desonide

1

76

Std. Mean Difference (IV, Random, 95% CI)

‐1.16 [‐1.70, ‐0.61]

2.7 Diflorasone diacetate

1

93

Std. Mean Difference (IV, Random, 95% CI)

‐0.32 [‐0.73, 0.09]

2.8 Fluticasone propionate

0

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

2.9 Hydrocortisone buteprate

1

161

Std. Mean Difference (IV, Random, 95% CI)

‐0.46 [‐0.77, ‐0.15]

2.10 Mometasone furoate

1

95

Std. Mean Difference (IV, Random, 95% CI)

‐1.12 [‐1.55, ‐0.68]

3 PASI Show forest plot

3

1158

Std. Mean Difference (IV, Random, 95% CI)

‐0.97 [‐1.31, ‐0.62]

3.1 Betamethasone dipropionate OD

2

739

Std. Mean Difference (IV, Random, 95% CI)

‐0.79 [‐1.44, ‐0.14]

3.2 Betamethasone dipropionate twice daily

1

419

Std. Mean Difference (IV, Random, 95% CI)

‐1.21 [‐1.44, ‐0.97]

3.3 Betamethasone dipropionate, maintenance

0

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

3.4 Betamethasone valerate

0

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

3.5 Budesonide

0

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

3.6 Desonide

0

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

3.7 Diflorasone diacetate

0

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

3.8 Fluticasone propionate

0

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

3.9 Hydrocortisone buteprate

0

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

3.10 Mometasone furoate

0

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

4 PAGI

0

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

4.1 Betamethasone dipropionate OD

0

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

4.2 Betamethasone dipropionate twice daily

0

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

4.3 Betamethasone dipropionate, maintenance

0

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

4.4 Betamethasone valerate

0

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

4.5 Budesonide

0

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

4.6 Desonide

0

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

4.7 Diflorasone diacetate

0

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

4.8 Fluticasone propionate

0

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

4.9 Hydrocortisone buteprate

0

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

4.10 Mometasone furoate

0

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

5 Combined end point (IAGI/TSS/PASI/PAGI) Show forest plot

15

2311

Std. Mean Difference (IV, Random, 95% CI)

‐0.89 [‐1.06, ‐0.72]

5.1 Betamethasone dipropionate OD

3

832

Std. Mean Difference (IV, Random, 95% CI)

‐0.80 [‐0.96, ‐0.64]

5.2 Betamethasone dipropionate twice daily

4

537

Std. Mean Difference (IV, Random, 95% CI)

‐1.35 [‐1.56, ‐1.15]

5.3 Betamethasone dipropionate, maintenance

1

38

Std. Mean Difference (IV, Random, 95% CI)

‐0.95 [‐1.62, ‐0.27]

5.4 Betamethasone valerate

2

96

Std. Mean Difference (IV, Random, 95% CI)

‐1.33 [‐1.78, ‐0.89]

5.5 Budesonide

0

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

5.6 Desonide

1

76

Std. Mean Difference (IV, Random, 95% CI)

‐0.81 [‐1.34, ‐0.28]

5.7 Diflorasone diacetate

1

93

Std. Mean Difference (IV, Random, 95% CI)

‐0.32 [‐0.73, 0.09]

5.8 Fluticasone propionate

2

383

Std. Mean Difference (IV, Random, 95% CI)

‐0.93 [‐1.14, ‐0.72]

5.9 Hydrocortisone buteprate

1

161

Std. Mean Difference (IV, Random, 95% CI)

‐0.46 [‐0.77, ‐0.15]

5.10 Mometasone furoate

1

95

Std. Mean Difference (IV, Random, 95% CI)

‐0.75 [‐1.17, ‐0.34]

6 Total withdrawals Show forest plot

9

1673

Risk Difference (M‐H, Random, 95% CI)

‐0.14 [‐0.22, ‐0.05]

6.1 Betamethasone dipropionate OD

2

756

Risk Difference (M‐H, Random, 95% CI)

‐0.16 [‐0.28, ‐0.04]

6.2 Betamethasone dipropionate twice daily

1

421

Risk Difference (M‐H, Random, 95% CI)

‐0.06 [‐0.12, 0.01]

6.3 Betamethasone dipropionate, maintenance

2

134

Risk Difference (M‐H, Random, 95% CI)

‐0.45 [‐0.60, ‐0.30]

6.4 Betamethasone valerate

1

80

Risk Difference (M‐H, Random, 95% CI)

0.0 [‐0.12, 0.12]

6.5 Budesonide

1

22

Risk Difference (M‐H, Random, 95% CI)

0.0 [‐0.16, 0.16]

6.6 Desonide

1

80

Risk Difference (M‐H, Random, 95% CI)

‐0.18 [‐0.38, 0.02]

6.7 Diflorasone diacetate

0

0

Risk Difference (M‐H, Random, 95% CI)

0.0 [0.0, 0.0]

6.8 Fluticasone propionate

0

0

Risk Difference (M‐H, Random, 95% CI)

0.0 [0.0, 0.0]

6.9 Hydrocortisone buteprate

1

180

Risk Difference (M‐H, Random, 95% CI)

0.00 [‐0.09, 0.10]

6.10 Mometasone furoate

0

0

Risk Difference (M‐H, Random, 95% CI)

0.0 [0.0, 0.0]

7 Withdrawals due to adverse events Show forest plot

9

1292

Risk Difference (M‐H, Random, 95% CI)

‐0.01 [‐0.05, 0.02]

7.1 Betamethasone dipropionate OD

1

633

Risk Difference (M‐H, Random, 95% CI)

‐0.07 [‐0.11, ‐0.02]

7.2 Betamethasone dipropionate twice daily

1

33

Risk Difference (M‐H, Random, 95% CI)

0.0 [‐0.11, 0.11]

7.3 Betamethasone dipropionate, maintenance

2

134

Risk Difference (M‐H, Random, 95% CI)

0.0 [‐0.04, 0.04]

7.4 Betamethasone valerate

1

80

Risk Difference (M‐H, Random, 95% CI)

0.08 [‐0.02, 0.17]

7.5 Budesonide

1

22

Risk Difference (M‐H, Random, 95% CI)

0.0 [‐0.16, 0.16]

7.6 Desonide

1

80

Risk Difference (M‐H, Random, 95% CI)

‐0.1 [‐0.24, 0.04]

7.7 Diflorasone diacetate

0

0

Risk Difference (M‐H, Random, 95% CI)

0.0 [0.0, 0.0]

7.8 Fluticasone propionate

0

0

Risk Difference (M‐H, Random, 95% CI)

0.0 [0.0, 0.0]

7.9 Hydrocortisone buteprate

1

190

Risk Difference (M‐H, Random, 95% CI)

0.01 [‐0.02, 0.04]

7.10 Mometasone furoate

1

120

Risk Difference (M‐H, Random, 95% CI)

‐0.05 [‐0.11, 0.01]

8 Withdrawals due to treatment failure Show forest plot

6

Risk Difference (M‐H, Random, 95% CI)

Subtotals only

8.1 Betamethasone dipropionate OD

0

0

Risk Difference (M‐H, Random, 95% CI)

0.0 [0.0, 0.0]

8.2 Betamethasone dipropionate twice daily

0

0

Risk Difference (M‐H, Random, 95% CI)

0.0 [0.0, 0.0]

8.3 Betamethasone dipropionate, maintenance

2

130

Risk Difference (M‐H, Random, 95% CI)

‐0.46 [‐0.61, ‐0.31]

8.4 Betamethasone valerate

1

80

Risk Difference (M‐H, Random, 95% CI)

0.0 [‐0.05, 0.05]

8.5 Budesonide

1

22

Risk Difference (M‐H, Random, 95% CI)

0.0 [‐0.16, 0.16]

8.6 Desonide

1

80

Risk Difference (M‐H, Random, 95% CI)

0.0 [‐0.07, 0.07]

8.7 Diflorasone diacetate

0

0

Risk Difference (M‐H, Random, 95% CI)

0.0 [0.0, 0.0]

8.8 Fluticasone propionate

0

0

Risk Difference (M‐H, Random, 95% CI)

0.0 [0.0, 0.0]

8.9 Hydrocortisone buteprate

1

190

Risk Difference (M‐H, Random, 95% CI)

0.0 [‐0.02, 0.02]

8.10 Mometasone furoate

0

0

Risk Difference (M‐H, Random, 95% CI)

0.0 [0.0, 0.0]

9 Adverse events (local) Show forest plot

10

2117

Risk Difference (M‐H, Random, 95% CI)

‐0.04 [‐0.08, ‐0.00]

9.1 Betamethasone dipropionate OD

2

756

Risk Difference (M‐H, Random, 95% CI)

‐0.10 [‐0.15, ‐0.04]

9.2 Betamethasone dipropionate twice daily

2

454

Risk Difference (M‐H, Random, 95% CI)

‐0.05 [‐0.12, 0.03]

9.3 Betamethasone dipropionate, maintenance

2

134

Risk Difference (M‐H, Random, 95% CI)

0.0 [‐0.04, 0.04]

9.4 Betamethasone valerate

0

0

Risk Difference (M‐H, Random, 95% CI)

0.0 [0.0, 0.0]

9.5 Budesonide

0

0

Risk Difference (M‐H, Random, 95% CI)

0.0 [0.0, 0.0]

9.6 Desonide

1

80

Risk Difference (M‐H, Random, 95% CI)

0.0 [‐0.11, 0.11]

9.7 Diflorasone diacetate

0

0

Risk Difference (M‐H, Random, 95% CI)

0.0 [0.0, 0.0]

9.8 Fluticasone propionate

1

383

Risk Difference (M‐H, Random, 95% CI)

0.00 [‐0.05, 0.05]

9.9 Hydrocortisone buteprate

1

190

Risk Difference (M‐H, Random, 95% CI)

‐0.06 [‐0.18, 0.07]

9.10 Mometasone furoate

1

120

Risk Difference (M‐H, Random, 95% CI)

‐0.10 [‐0.23, 0.02]

10 Adverse events (systemic) Show forest plot

4

675

Risk Difference (M‐H, Random, 95% CI)

0.00 [‐0.01, 0.01]

10.1 Betamethasone dipropionate OD

0

0

Risk Difference (M‐H, Random, 95% CI)

0.0 [0.0, 0.0]

10.2 Betamethasone dipropionate twice daily

1

421

Risk Difference (M‐H, Random, 95% CI)

0.0 [‐0.01, 0.01]

10.3 Betamethasone dipropionate, maintenance

2

134

Risk Difference (M‐H, Random, 95% CI)

0.01 [‐0.07, 0.10]

10.4 Budesonide

0

0

Risk Difference (M‐H, Random, 95% CI)

0.0 [0.0, 0.0]

10.5 Desonide

0

0

Risk Difference (M‐H, Random, 95% CI)

0.0 [0.0, 0.0]

10.6 Diflorasone diacetate

0

0

Risk Difference (M‐H, Random, 95% CI)

0.0 [0.0, 0.0]

10.7 Fluticasone propionate

0

0

Risk Difference (M‐H, Random, 95% CI)

0.0 [0.0, 0.0]

10.8 Hydrocortisone buteprate

0

0

Risk Difference (M‐H, Random, 95% CI)

0.0 [0.0, 0.0]

10.9 Betamethasone valerate

0

0

Risk Difference (M‐H, Random, 95% CI)

0.0 [0.0, 0.0]

10.10 Mometasone furoate

1

120

Risk Difference (M‐H, Random, 95% CI)

0.0 [‐0.03, 0.03]

Figuras y tablas -
Comparison 2. Corticosteroid (potent) versus placebo
Comparison 3. Corticosteroid (very potent) versus placebo

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 IAGI Show forest plot

5

540

Std. Mean Difference (IV, Random, 95% CI)

‐1.87 [‐2.38, ‐1.36]

1.1 Clobetasol propionate

4

471

Std. Mean Difference (IV, Random, 95% CI)

‐1.89 [‐2.53, ‐1.24]

1.2 Halcinonide

0

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

1.3 Halobetasol

1

69

Std. Mean Difference (IV, Random, 95% CI)

‐1.81 [‐2.37, ‐1.24]

2 TSS Show forest plot

3

545

Std. Mean Difference (IV, Random, 95% CI)

‐1.35 [‐1.80, ‐0.89]

2.1 Clobetasol propionate

3

545

Std. Mean Difference (IV, Random, 95% CI)

‐1.35 [‐1.80, ‐0.89]

2.2 Halcinonide

0

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

2.3 Halobetasol

0

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

3 PASI

0

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

3.1 Clobetasol propionate

0

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

3.2 Halcinonide

0

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

3.3 Halobetasol

0

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

4 PAGI Show forest plot

3

487

Std. Mean Difference (IV, Random, 95% CI)

‐1.22 [‐1.42, ‐1.02]

4.1 Clobetasol propionate

1

79

Std. Mean Difference (IV, Random, 95% CI)

‐1.01 [‐1.55, ‐0.47]

4.2 Halcinonide

0

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

4.3 Halobetasol

2

408

Std. Mean Difference (IV, Random, 95% CI)

‐1.25 [‐1.46, ‐1.04]

5 Combined end point (IAGI/TSS/PASI/PAGI) Show forest plot

10

1493

Std. Mean Difference (IV, Random, 95% CI)

‐1.56 [‐1.87, ‐1.26]

5.1 Clobetasol propionate

7

1016

Std. Mean Difference (IV, Random, 95% CI)

‐1.65 [‐2.10, ‐1.20]

5.2 Halcinonide

0

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

5.3 Halobetasol

3

477

Std. Mean Difference (IV, Random, 95% CI)

‐1.36 [‐1.65, ‐1.07]

6 Total withdrawals Show forest plot

8

1181

Risk Difference (M‐H, Random, 95% CI)

‐0.05 [‐0.10, 0.01]

6.1 Clobetasol propionate

7

1037

Risk Difference (M‐H, Random, 95% CI)

‐0.06 [‐0.13, 0.01]

6.2 Halcinonide

0

0

Risk Difference (M‐H, Random, 95% CI)

0.0 [0.0, 0.0]

6.3 Halobetasol

1

144

Risk Difference (M‐H, Random, 95% CI)

0.0 [‐0.03, 0.03]

7 Withdrawals due to adverse events Show forest plot

10

1601

Risk Difference (M‐H, Random, 95% CI)

‐0.00 [‐0.01, 0.01]

7.1 Clobetasol propionate

7

1037

Risk Difference (M‐H, Random, 95% CI)

‐0.00 [‐0.02, 0.01]

7.2 Halcinonide

0

0

Risk Difference (M‐H, Random, 95% CI)

0.0 [0.0, 0.0]

7.3 Halobetasol

3

564

Risk Difference (M‐H, Random, 95% CI)

0.0 [‐0.01, 0.01]

8 Withdrawals due to treatment failure Show forest plot

8

1189

Risk Difference (M‐H, Random, 95% CI)

‐0.00 [‐0.02, 0.01]

8.1 Clobetasol propionate

6

845

Risk Difference (M‐H, Random, 95% CI)

‐0.01 [‐0.03, 0.01]

8.2 Halcinonide

0

0

Risk Difference (M‐H, Random, 95% CI)

0.0 [0.0, 0.0]

8.3 Halobetasol

2

344

Risk Difference (M‐H, Random, 95% CI)

0.0 [‐0.02, 0.02]

9 Adverse events (local) Show forest plot

8

1265

Risk Difference (M‐H, Random, 95% CI)

0.00 [‐0.02, 0.02]

9.1 Clobetasol propionate

6

845

Risk Difference (M‐H, Random, 95% CI)

0.00 [‐0.03, 0.03]

9.2 Halcinonide

0

0

Risk Difference (M‐H, Random, 95% CI)

0.0 [0.0, 0.0]

9.3 Halobetasol

2

420

Risk Difference (M‐H, Random, 95% CI)

0.0 [‐0.02, 0.02]

10 Adverse events (systemic) Show forest plot

6

1056

Risk Difference (M‐H, Random, 95% CI)

‐0.00 [‐0.01, 0.01]

10.1 Clobetasol propionate

3

480

Risk Difference (M‐H, Random, 95% CI)

‐0.01 [‐0.02, 0.01]

10.2 Halcinonide

1

156

Risk Difference (M‐H, Random, 95% CI)

0.0 [‐0.02, 0.02]

10.3 Halobetasol

2

420

Risk Difference (M‐H, Random, 95% CI)

0.0 [‐0.01, 0.01]

Figuras y tablas -
Comparison 3. Corticosteroid (very potent) versus placebo
Comparison 4. Dithranol versus placebo

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 IAGI

0

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

2 TSS Show forest plot

3

94

Std. Mean Difference (IV, Random, 95% CI)

‐1.06 [‐1.66, ‐0.46]

3 PASI

0

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

4 PAGI

0

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

5 Combined end point (IAGI/TSS/PASI/PAGI) Show forest plot

3

94

Std. Mean Difference (IV, Random, 95% CI)

‐1.06 [‐1.66, ‐0.46]

6 Total withdrawals Show forest plot

4

124

Risk Difference (M‐H, Random, 95% CI)

0.0 [‐0.09, 0.09]

7 Withdrawals due to adverse events Show forest plot

3

104

Risk Difference (M‐H, Random, 95% CI)

0.0 [‐0.05, 0.05]

8 Withdrawals due to treatment failure Show forest plot

2

44

Risk Difference (M‐H, Random, 95% CI)

0.0 [‐0.11, 0.11]

9 Adverse events (local) Show forest plot

3

94

Risk Difference (M‐H, Random, 95% CI)

0.26 [‐0.30, 0.82]

10 Adverse events (systemic) Show forest plot

1

20

Risk Difference (M‐H, Random, 95% CI)

0.0 [‐0.35, 0.35]

Figuras y tablas -
Comparison 4. Dithranol versus placebo
Comparison 5. Vitamin D combination products versus placebo

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 IAGI Show forest plot

5

2264

Std. Mean Difference (IV, Random, 95% CI)

‐1.44 [‐1.76, ‐1.12]

1.1 Combination calcipotriol/betamethasone dipropionate, once daily

4

1416

Std. Mean Difference (IV, Random, 95% CI)

‐1.21 [‐1.50, ‐0.91]

1.2 Combination calcipotriol/betamethasone dipropionate, twice daily

2

848

Std. Mean Difference (IV, Random, 95% CI)

‐1.90 [‐2.09, ‐1.71]

2 TSS

0

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

2.1 Combination calcipotriol/betamethasone dipropionate, once daily

0

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

2.2 Combination calcipotriol/betamethasone dipropionate, twice daily

0

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

3 PASI Show forest plot

5

2263

Std. Mean Difference (IV, Random, 95% CI)

‐1.24 [‐1.53, ‐0.95]

3.1 Combination calcipotriol/betamethasone dipropionate, once daily

4

1414

Std. Mean Difference (IV, Random, 95% CI)

‐1.14 [‐1.57, ‐0.70]

3.2 Combination calcipotriol/betamethasone dipropionate, twice daily

2

849

Std. Mean Difference (IV, Random, 95% CI)

‐1.41 [‐1.86, ‐0.97]

4 PAGI Show forest plot

1

Std. Mean Difference (IV, Random, 95% CI)

Totals not selected

4.1 Combination calcipotriol/betamethasone dipropionate, once daily

1

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

4.2 Combination calcipotriol/betamethasone dipropionate, twice daily

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

5 Combined end point (IAGI/TSS/PASI/PAGI) Show forest plot

5

2264

Std. Mean Difference (IV, Random, 95% CI)

‐1.44 [‐1.76, ‐1.12]

5.1 Combination calcipotriol/betamethasone dipropionate, once daily

4

1416

Std. Mean Difference (IV, Random, 95% CI)

‐1.21 [‐1.50, ‐0.91]

5.2 Combination calcipotriol/betamethasone dipropionate, twice daily

2

848

Std. Mean Difference (IV, Random, 95% CI)

‐1.90 [‐2.09, ‐1.71]

6 Total withdrawals Show forest plot

5

2340

Risk Difference (M‐H, Random, 95% CI)

‐0.12 [‐0.17, ‐0.07]

6.1 Combination calcipotriol/betamethasone dipropionate, once daily

4

1483

Risk Difference (M‐H, Random, 95% CI)

‐0.15 [‐0.22, ‐0.09]

6.2 Combination calcipotriol/betamethasone dipropionate, twice daily

2

857

Risk Difference (M‐H, Random, 95% CI)

‐0.07 [‐0.12, ‐0.03]

7 Withdrawals due to adverse events Show forest plot

3

1723

Risk Difference (M‐H, Random, 95% CI)

‐0.07 [‐0.11, ‐0.04]

7.1 Combination calcipotriol/betamethasone dipropionate, once daily

3

1280

Risk Difference (M‐H, Random, 95% CI)

‐0.07 [‐0.11, ‐0.03]

7.2 Combination calcipotriol/betamethasone dipropionate, twice daily

1

443

Risk Difference (M‐H, Random, 95% CI)

‐0.10 [‐0.14, ‐0.05]

8 Withdrawals due to treatment failure Show forest plot

1

802

Risk Difference (M‐H, Random, 95% CI)

‐0.09 [‐0.12, ‐0.06]

8.1 Combination calcipotriol/betamethasone dipropionate, once daily

1

359

Risk Difference (M‐H, Random, 95% CI)

‐0.09 [‐0.13, ‐0.05]

8.2 Combination calcipotriol/betamethasone dipropionate, twice daily

1

443

Risk Difference (M‐H, Random, 95% CI)

‐0.09 [‐0.13, ‐0.05]

9 Adverse events (local) Show forest plot

5

2334

Risk Difference (M‐H, Random, 95% CI)

‐0.05 [‐0.08, ‐0.02]

9.1 Combination calcipotriol/betamethasone dipropionate, once daily

4

1479

Risk Difference (M‐H, Random, 95% CI)

‐0.07 [‐0.11, ‐0.02]

9.2 Combination calcipotriol/betamethasone dipropionate, twice daily

2

855

Risk Difference (M‐H, Random, 95% CI)

‐0.03 [‐0.08, 0.01]

10 Adverse events (systemic) Show forest plot

1

412

Risk Difference (M‐H, Random, 95% CI)

0.0 [‐0.01, 0.01]

10.1 Combination calcipotriol/betamethasone dipropionate, once daily

0

0

Risk Difference (M‐H, Random, 95% CI)

0.0 [0.0, 0.0]

10.2 Combination calcipotriol/betamethasone dipropionate, twice daily

1

412

Risk Difference (M‐H, Random, 95% CI)

0.0 [‐0.01, 0.01]

Figuras y tablas -
Comparison 5. Vitamin D combination products versus placebo
Comparison 6. Other treatment versus placebo

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 IAGI Show forest plot

8

Std. Mean Difference (IV, Random, 95% CI)

Totals not selected

1.1 Aloe vera extract 0.5% hydrophilic cream, three times per day

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

1.2 Anti‐IL‐8 monoclonal antibody cream

1

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

1.3 Betamethasone 17‐valerate 21‐acetate plus tretinoin plus salicylic acid

1

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

1.4 Caffeine (topical) 10%, TD

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

1.5 Calcipotriene 0.005% ointment + nicotinamide 0.05% or 0.1% or 0.7% or 1.4%, twice daily

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

1.6 Dead Sea salts emollient lotion

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

1.7 Fish oil plus occlusion

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

1.8 Herbal skin care (Dr Michaels® cleansing gel, ointment and skin conditioner), twice daily

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

1.9 Hexafluoro‐1,25‐dihydroxyvitamin D3

1

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

1.10 Indigo naturalis 1.4% ointment

1

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

1.11 Kukui nut oil, TD

1

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

1.12 Mahonia aquifolium (Reliéva™), twice daily

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

1.13 Methotrexate gel

1

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

1.14 Mycophenolic acid ointment

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

1.15 NG‐monomethyl‐L‐arginine (L‐NMMA) cream

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

1.16 Nicotinamide 1.4%, twice daily

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

1.17 Oleum horwathiensis (Psoricur®)

1

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

1.18 Omega‐3‐polyunsaturated fatty acids ointment

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

1.19 Platelet aggregation activating factor (PAF)(Ro 24‐0238)

1

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

1.20 Polymyxin B cream 200,000 U/g

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

1.21 PTH (1‐34) in Novasome A® liposomal cream, twice daily

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

1.22 Sirolimus (topical), 2.2% for 6 wks, then 8% for a further 6 wks

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

1.23 Tacrolimus ointment

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

1.24 Tar

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

1.25 Tazarotene

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

1.26 Theophylline 1% ointment, twice daily

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

2 TSS Show forest plot

17

Std. Mean Difference (IV, Random, 95% CI)

Subtotals only

2.1 Aloe vera extract 0.5% hydrophilic cream, three times per day

0

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

2.2 Anti‐IL‐8 monoclonal antibody cream

1

89

Std. Mean Difference (IV, Random, 95% CI)

‐0.70 [‐1.13, ‐0.27]

2.3 Betamethasone 17‐valerate 21‐acetate plus tretinoin plus salicylic acid

0

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

2.4 Caffeine (topical) 10%, TD

0

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

2.5 Calcipotriene 0.005% ointment + nicotinamide 0.05% or 0.1% or 0.7% or 1.4%, twice daily

1

192

Std. Mean Difference (IV, Random, 95% CI)

‐0.48 [‐0.81, ‐0.15]

2.6 Dead Sea salts emollient lotion

0

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

2.7 Fish oil plus occlusion

1

50

Std. Mean Difference (IV, Random, 95% CI)

‐1.05 [‐1.64, ‐0.46]

2.8 Herbal skin care (Dr Michaels® cleansing gel, ointment and skin conditioner), twice daily

0

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

2.9 Hexafluoro‐1,25‐dihydroxyvitamin D3, twice daily

1

30

Std. Mean Difference (IV, Random, 95% CI)

‐1.13 [‐1.91, ‐0.35]

2.10 Indigo naturalis 1.4% ointment

2

88

Std. Mean Difference (IV, Random, 95% CI)

‐1.64 [‐2.13, ‐1.15]

2.11 Kukui nut oil, TD

1

24

Std. Mean Difference (IV, Random, 95% CI)

0.33 [‐0.48, 1.14]

2.12 Mahonia aquifolium (Reliéva™), twice daily

0

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

2.13 Methotrexate gel

1

82

Std. Mean Difference (IV, Random, 95% CI)

‐0.48 [‐0.92, ‐0.04]

2.14 Mycophenolic acid ointment

1

14

Std. Mean Difference (IV, Random, 95% CI)

‐1.44 [‐2.67, ‐0.22]

2.15 NG‐monomethyl‐L‐arginine (L‐NMMA) cream

1

34

Std. Mean Difference (IV, Random, 95% CI)

0.08 [‐0.60, 0.75]

2.16 Nicotinamide 1.4%, twice daily

1

96

Std. Mean Difference (IV, Random, 95% CI)

‐0.20 [‐0.60, 0.20]

2.17 Oleum horwathiensis (Psoricur®)

1

42

Std. Mean Difference (IV, Random, 95% CI)

‐0.77 [‐1.40, ‐0.14]

2.18 Omega‐3‐polyunsaturated fatty acids ointment

0

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

2.19 Platelet aggregation activating factor (PAF)(Ro 24‐0238)

0

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

2.20 Polymyxin B cream 200,000 U/g

1

30

Std. Mean Difference (IV, Random, 95% CI)

0.13 [‐0.59, 0.85]

2.21 PTH (1‐34) in Novasome A® liposomal cream, twice daily

1

30

Std. Mean Difference (IV, Random, 95% CI)

‐2.31 [‐3.26, ‐1.36]

2.22 Sirolimus (topical), 2.2% for 6 wks, then 8% for a further 6 wks

1

44

Std. Mean Difference (IV, Random, 95% CI)

‐0.39 [‐0.98, 0.21]

2.23 Tacrolimus ointment

1

47

Std. Mean Difference (IV, Random, 95% CI)

0.06 [‐0.52, 0.63]

2.24 Tar

1

36

Std. Mean Difference (IV, Random, 95% CI)

‐0.45 [‐1.11, 0.22]

2.25 Tazarotene

1

318

Std. Mean Difference (IV, Random, 95% CI)

‐0.86 [‐1.11, ‐0.62]

2.26 Theophylline 1% ointment, twice daily

0

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

3 PASI Show forest plot

9

Std. Mean Difference (IV, Random, 95% CI)

Totals not selected

3.1 Aloe vera extract 0.5% hydrophilic cream, three times per day

1

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

3.2 Anti‐IL‐8 monoclonal antibody cream

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

3.3 Betamethasone 17‐valerate 21‐acetate plus tretinoin plus salicylic acid

1

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

3.4 Caffeine (topical) 10%, TD

1

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

3.5 Calcipotriene 0.005% ointment + nicotinamide 0.05% or 0.1% or 0.7% or 1.4%, twice daily

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

3.6 Dead Sea salts emollient lotion, 30%

1

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

3.7 Fish oil plus occlusion

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

3.8 Herbal skin care (Dr Michaels® cleansing gel, ointment and skin conditioner), twice daily

1

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

3.9 Hexafluoro‐1,25‐dihydroxyvitamin D3, twice daily

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

3.10 Indigo naturalis 1.4% ointment

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

3.11 Kukui nut oil, twice daily

1

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

3.12 Mahonia aquifolium (Reliéva™), twice daily

1

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

3.13 Methotrexate gel

1

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

3.14 Mycophenolic acid ointment

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

3.15 NG‐monomethyl‐L‐arginine (L‐NMMA) cream

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

3.16 Nicotinamide 1.4%, twice daily

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

3.17 Oleum horwathiensis (Psoricur®)

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

3.18 Omega‐3‐polyunsaturated fatty acids ointment

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

3.19 Platelet aggregation activating factor (PAF)(Ro 24‐0238)

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

3.20 Polymyxin B cream 200,000 U/g

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

3.21 PTH (1‐34) in Novasome A® liposomal cream, twice daily

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

3.22 Sirolimus (topical), 2.2% for 6 wks, then 8% for a further 6 wks

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

3.23 Tacrolimus ointment

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

3.24 Tar

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

3.25 Tazarotene

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

3.26 Theophylline 1% ointment, twice daily

1

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

4 PAGI Show forest plot

2

Std. Mean Difference (IV, Random, 95% CI)

Totals not selected

4.1 Aloe vera extract 0.5% hydrophilic cream, three times per day

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

4.2 Anti‐IL‐8 monoclonal antibody cream

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

4.3 Betamethasone 17‐valerate 21‐acetate plus tretinoin plus salicylic acid

1

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

4.4 Caffeine (topical) 10%, TD

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

4.5 Calcipotriene 0.005% ointment + nicotinamide 0.05% or 0.1% or 0.7% or 1.4%, twice daily

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

4.6 Dead Sea salts emollient lotion, 30%

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

4.7 Fish oil plus occlusion

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

4.8 Herbal skin care (Dr Michaels® cleansing gel, ointment and skin conditioner), twice daily

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

4.9 Hexafluoro‐1,25‐dihydroxyvitamin D3, twice daily

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

4.10 Indigo naturalis 1.4% ointment

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

4.11 Kukui nut oil, TD

1

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

4.12 Mahonia aquifolium (Reliéva™), twice daily

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

4.13 Methotrexate gel

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

4.14 Mycophenolic acid ointment

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

4.15 NG‐monomethyl‐L‐arginine (L‐NMMA) cream

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

4.16 Nicotinamide 1.4%, twice daily

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

4.17 Oleum horwathiensis (Psoricur®)

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

4.18 Omega‐3‐polyunsaturated fatty acids ointment

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

4.19 Platelet aggregation activating factor (PAF)(Ro 24‐0238)

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

4.20 Polymyxin B cream 200,000 U/g

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

4.21 PTH (1‐34) in Novasome A® liposomal cream, twice daily

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

4.22 Sirolimus (topical), 2.2% for 6 wks, then 8% for a further 6 wks

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

4.23 Tacrolimus ointment

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

4.24 Tar

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

4.25 Tazarotene

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

4.26 Theophylline 1% ointment, twice daily

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

5 Combined end point (IAGI/TSS/PASI/PAGI) Show forest plot

26

Std. Mean Difference (IV, Random, 95% CI)

Subtotals only

5.1 Aloe vera extract 0.5% hydrophilic cream, three times per day

1

60

Std. Mean Difference (IV, Random, 95% CI)

‐1.58 [‐2.16, ‐0.99]

5.2 Anti‐IL‐8 monoclonal antibody cream

1

89

Std. Mean Difference (IV, Random, 95% CI)

‐0.59 [‐1.01, ‐0.16]

5.3 Betamethasone 17‐valerate 21‐acetate plus tretinoin plus salicylic acid

1

81

Std. Mean Difference (IV, Random, 95% CI)

‐0.76 [‐1.21, ‐0.31]

5.4 Caffeine (topical) 10%, TD

1

78

Std. Mean Difference (IV, Random, 95% CI)

‐0.39 [‐0.84, 0.06]

5.5 Calcipotriene 0.005% ointment + nicotinamide 0.05% or 0.1% or 0.7% or 1.4%, twice daily

1

192

Std. Mean Difference (IV, Random, 95% CI)

‐0.48 [‐0.81, ‐0.15]

5.6 Dead Sea salts emollient lotion, 30%

1

19

Std. Mean Difference (IV, Random, 95% CI)

0.57 [‐0.36, 1.51]

5.7 Fish oil plus occlusion

1

50

Std. Mean Difference (IV, Random, 95% CI)

‐1.05 [‐1.64, ‐0.46]

5.8 Herbal skin care (Dr Michaels® cleansing gel, ointment and skin conditioner), twice daily

1

24

Std. Mean Difference (IV, Random, 95% CI)

‐2.96 [‐4.19, ‐1.74]

5.9 Hexafluoro‐1,25‐dihydroxyvitamin D3

1

30

Std. Mean Difference (IV, Random, 95% CI)

‐0.62 [‐1.35, 0.12]

5.10 Indigo naturalis 1.4% ointment

2

88

Std. Mean Difference (IV, Random, 95% CI)

‐2.09 [‐2.62, ‐1.56]

5.11 Kukui nut oil, TD

1

24

Std. Mean Difference (IV, Random, 95% CI)

0.0 [‐0.80, 0.80]

5.12 Mahonia aquifolium (Reliéva™), twice daily

1

200

Std. Mean Difference (IV, Random, 95% CI)

‐0.77 [‐1.06, ‐0.48]

5.13 Methotrexate gel

2

142

Std. Mean Difference (IV, Random, 95% CI)

‐1.05 [‐2.04, ‐0.06]

5.14 Mycophenolic acid ointment

1

14

Std. Mean Difference (IV, Random, 95% CI)

‐1.44 [‐2.67, ‐0.22]

5.15 NG‐monomethyl‐L‐arginine (L‐NMMA) cream

1

34

Std. Mean Difference (IV, Random, 95% CI)

0.08 [‐0.60, 0.75]

5.16 Nicotinamide 1.4%, twice daily

1

96

Std. Mean Difference (IV, Random, 95% CI)

‐0.20 [‐0.60, 0.20]

5.17 Oleum horwathiensis (Psoricur®)

1

42

Std. Mean Difference (IV, Random, 95% CI)

‐0.02 [‐0.63, 0.58]

5.18 Omega‐3‐polyunsaturated fatty acids ointment

0

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

5.19 Platelet aggregation activating factor (PAF)(Ro 24‐0238)

1

80

Std. Mean Difference (IV, Random, 95% CI)

‐0.07 [‐0.50, 0.37]

5.20 Polymyxin B cream 200,000 U/g

1

30

Std. Mean Difference (IV, Random, 95% CI)

0.13 [‐0.59, 0.85]

5.21 PTH (1‐34) in Novasome A® liposomal cream, twice daily

1

30

Std. Mean Difference (IV, Random, 95% CI)

‐2.31 [‐3.26, ‐1.36]

5.22 Sirolimus (topical), 2.2% for 6 wks, then 8% for a further 6 wks

1

44

Std. Mean Difference (IV, Random, 95% CI)

‐0.39 [‐0.98, 0.21]

5.23 Tacrolimus ointment

1

47

Std. Mean Difference (IV, Random, 95% CI)

0.06 [‐0.52, 0.63]

5.24 Tar

1

36

Std. Mean Difference (IV, Random, 95% CI)

‐0.45 [‐1.11, 0.22]

5.25 Tazarotene

1

318

Std. Mean Difference (IV, Random, 95% CI)

‐0.86 [‐1.11, ‐0.62]

5.26 Theophylline 1% ointment, twice daily

1

22

Std. Mean Difference (IV, Random, 95% CI)

‐2.87 [‐4.13, ‐1.62]

6 Total withdrawals Show forest plot

23

Risk Difference (M‐H, Random, 95% CI)

Subtotals only

6.1 Aloe vera extract 0.5% hydrophilic cream, three times per day

1

60

Risk Difference (M‐H, Random, 95% CI)

0.0 [‐0.06, 0.06]

6.2 Anti‐IL‐8 monoclonal antibody cream

1

96

Risk Difference (M‐H, Random, 95% CI)

‐0.02 [‐0.12, 0.08]

6.3 Betamethasone 17‐valerate 21‐acetate plus tretinoin plus salicylic acid

1

85

Risk Difference (M‐H, Random, 95% CI)

‐0.00 [‐0.09, 0.09]

6.4 Caffeine (topical) 10%, TD

1

78

Risk Difference (M‐H, Random, 95% CI)

0.0 [‐0.12, 0.12]

6.5 Calcipotriene 0.005% ointment + nicotinamide 0.05% or 0.1% or 0.7% or 1.4%, twice daily

1

192

Risk Difference (M‐H, Random, 95% CI)

0.03 [‐0.01, 0.08]

6.6 Dead Sea salts emollient lotion

1

24

Risk Difference (M‐H, Random, 95% CI)

0.25 [‐0.06, 0.56]

6.7 Fish oil plus occlusion

1

50

Risk Difference (M‐H, Random, 95% CI)

0.0 [‐0.07, 0.07]

6.8 Herbal skin care (Dr Michaels® cleansing gel, ointment and skin conditioner), twice daily

0

0

Risk Difference (M‐H, Random, 95% CI)

0.0 [0.0, 0.0]

6.9 Hexafluoro‐1,25‐dihydroxyvitamin D3

1

30

Risk Difference (M‐H, Random, 95% CI)

0.0 [‐0.12, 0.12]

6.10 Indigo naturalis 1.4% ointment

2

112

Risk Difference (M‐H, Random, 95% CI)

0.0 [‐0.15, 0.15]

6.11 Kukui nut oil, TD

1

30

Risk Difference (M‐H, Random, 95% CI)

‐0.13 [‐0.42, 0.15]

6.12 Mahonia aquifolium (Reliéva™), twice daily

1

200

Risk Difference (M‐H, Random, 95% CI)

‐0.23 [‐0.32, ‐0.14]

6.13 Methotrexate gel

1

60

Risk Difference (M‐H, Random, 95% CI)

0.0 [‐0.06, 0.06]

6.14 Mycophenolic acid ointment

1

14

Risk Difference (M‐H, Random, 95% CI)

0.0 [‐0.24, 0.24]

6.15 NG‐monomethyl‐L‐arginine (L‐NMMA) cream

1

34

Risk Difference (M‐H, Random, 95% CI)

0.0 [‐0.11, 0.11]

6.16 Nicotinamide 1.4%, twice daily

1

96

Risk Difference (M‐H, Random, 95% CI)

0.02 [‐0.04, 0.08]

6.17 Oleum horwathiensis

1

50

Risk Difference (M‐H, Random, 95% CI)

0.16 [‐0.04, 0.36]

6.18 Omega‐3‐polyunsaturated fatty acids ointment

1

146

Risk Difference (M‐H, Random, 95% CI)

0.0 [‐0.15, 0.15]

6.19 Platelet aggregation activating factor (PAF)(Ro 24‐0238)

1

104

Risk Difference (M‐H, Random, 95% CI)

0.0 [‐0.16, 0.16]

6.20 Polymyxin B cream 200,000 U/g

1

30

Risk Difference (M‐H, Random, 95% CI)

0.0 [‐0.24, 0.24]

6.21 PTH (1‐34) in Novasome A® liposomal cream, twice daily

1

30

Risk Difference (M‐H, Random, 95% CI)

0.0 [‐0.12, 0.12]

6.22 Sirolimus (topical)

0

0

Risk Difference (M‐H, Random, 95% CI)

0.0 [0.0, 0.0]

6.23 Tacrolimus ointment

0

0

Risk Difference (M‐H, Random, 95% CI)

0.0 [0.0, 0.0]

6.24 Tar

0

0

Risk Difference (M‐H, Random, 95% CI)

0.0 [0.0, 0.0]

6.25 Tazarotene

2

1627

Risk Difference (M‐H, Random, 95% CI)

0.04 [‐0.01, 0.09]

6.26 Theophylline 1% ointment, twice daily

1

22

Risk Difference (M‐H, Random, 95% CI)

0.0 [‐0.16, 0.16]

7 Withdrawals due to adverse events Show forest plot

19

Risk Difference (M‐H, Random, 95% CI)

Subtotals only

7.1 Aloe vera extract 0.5% hydrophilic cream, three times per day

1

60

Risk Difference (M‐H, Random, 95% CI)

0.0 [‐0.06, 0.06]

7.2 Anti‐IL‐8 monoclonal antibody cream

0

0

Risk Difference (M‐H, Random, 95% CI)

0.0 [0.0, 0.0]

7.3 Betamethasone 17‐valerate 21‐acetate plus tretinoin plus salicylic acid

1

85

Risk Difference (M‐H, Random, 95% CI)

‐0.00 [‐0.07, 0.06]

7.4 Caffeine (topical) 10%, TD

1

78

Risk Difference (M‐H, Random, 95% CI)

0.0 [‐0.05, 0.05]

7.5 Calcipotriene 0.005% ointment + nicotinamide 0.05% or 0.1% or 0.7% or 1.4%, twice daily

1

192

Risk Difference (M‐H, Random, 95% CI)

0.0 [‐0.03, 0.03]

7.6 Dead Sea salts emollient lotion

1

24

Risk Difference (M‐H, Random, 95% CI)

0.08 [‐0.18, 0.35]

7.7 Fish oil plus occlusion

1

50

Risk Difference (M‐H, Random, 95% CI)

0.0 [‐0.07, 0.07]

7.8 Herbal skin care (Dr Michaels® cleansing gel, ointment and skin conditioner), twice daily

0

0

Risk Difference (M‐H, Random, 95% CI)

0.0 [0.0, 0.0]

7.9 Hexafluoro‐1,25‐dihydroxyvitamin D3

1

30

Risk Difference (M‐H, Random, 95% CI)

0.0 [‐0.12, 0.12]

7.10 Indigo naturalis 1.4% ointment

2

112

Risk Difference (M‐H, Random, 95% CI)

0.0 [‐0.04, 0.04]

7.11 Kukui nut oil, TD

1

30

Risk Difference (M‐H, Random, 95% CI)

0.0 [‐0.12, 0.12]

7.12 Mahonia aquifolium (Reliéva™), twice daily

0

0

Risk Difference (M‐H, Random, 95% CI)

0.0 [0.0, 0.0]

7.13 Methotrexate gel

1

60

Risk Difference (M‐H, Random, 95% CI)

0.0 [‐0.06, 0.06]

7.14 Mycophenolic acid ointment

1

14

Risk Difference (M‐H, Random, 95% CI)

0.0 [‐0.24, 0.24]

7.15 NG‐monomethyl‐L‐arginine (L‐NMMA) cream

1

34

Risk Difference (M‐H, Random, 95% CI)

0.0 [‐0.11, 0.11]

7.16 Nicotinamide 1.4%, twice daily

1

96

Risk Difference (M‐H, Random, 95% CI)

0.0 [‐0.04, 0.04]

7.17 Oleum horwathiensis

1

50

Risk Difference (M‐H, Random, 95% CI)

0.0 [‐0.07, 0.07]

7.18 Omega‐3‐polyunsaturated fatty acids ointment

1

146

Risk Difference (M‐H, Random, 95% CI)

0.0 [‐0.03, 0.03]

7.19 Platelet aggregation activating factor (PAF)(Ro 24‐0238)

0

0

Risk Difference (M‐H, Random, 95% CI)

0.0 [0.0, 0.0]

7.20 Polymyxin B cream 200,000 U/g

0

0

Risk Difference (M‐H, Random, 95% CI)

0.0 [0.0, 0.0]

7.21 PTH (1‐34) in Novasome A® liposomal cream, twice daily

1

30

Risk Difference (M‐H, Random, 95% CI)

0.0 [‐0.12, 0.12]

7.22 Sirolimus (topical)

0

0

Risk Difference (M‐H, Random, 95% CI)

0.0 [0.0, 0.0]

7.23 Tacrolimus ointment

0

0

Risk Difference (M‐H, Random, 95% CI)

0.0 [0.0, 0.0]

7.24 Tar

0

0

Risk Difference (M‐H, Random, 95% CI)

0.0 [0.0, 0.0]

7.25 Tazarotene

2

1627

Risk Difference (M‐H, Random, 95% CI)

0.07 [0.05, 0.10]

7.26 Theophylline 1% ointment, twice daily

1

22

Risk Difference (M‐H, Random, 95% CI)

0.0 [‐0.16, 0.16]

8 Withdrawals due to treatment failure Show forest plot

18

Risk Difference (M‐H, Random, 95% CI)

Subtotals only

8.1 Aloe vera extract 0.5% hydrophilic cream, three times per day

1

60

Risk Difference (M‐H, Random, 95% CI)

0.0 [‐0.06, 0.06]

8.2 Anti‐IL‐8 monoclonal antibody cream

0

0

Risk Difference (M‐H, Random, 95% CI)

0.0 [0.0, 0.0]

8.3 Betamethasone 17‐valerate 21‐acetate plus tretinoin plus salicylic acid

1

85

Risk Difference (M‐H, Random, 95% CI)

0.02 [‐0.04, 0.08]

8.4 Caffeine (topical) 10%, TD

1

78

Risk Difference (M‐H, Random, 95% CI)

0.0 [‐0.05, 0.05]

8.5 Calcipotriene 0.005% ointment + nicotinamide 0.05% or 0.1% or 0.7% or 1.4%, twice daily

1

192

Risk Difference (M‐H, Random, 95% CI)

0.0 [‐0.03, 0.03]

8.6 Dead Sea salts emollient lotion

1

24

Risk Difference (M‐H, Random, 95% CI)

0.08 [‐0.12, 0.29]

8.7 Fish oil plus occlusion

1

50

Risk Difference (M‐H, Random, 95% CI)

0.0 [‐0.07, 0.07]

8.8 Herbal skin care (Dr Michaels® cleansing gel, ointment and skin conditioner), twice daily

0

0

Risk Difference (M‐H, Random, 95% CI)

0.0 [0.0, 0.0]

8.9 Hexafluoro‐1,25‐dihydroxyvitamin D3

1

30

Risk Difference (M‐H, Random, 95% CI)

0.0 [‐0.12, 0.12]

8.10 Indigo naturalis 1.4% ointment

1

28

Risk Difference (M‐H, Random, 95% CI)

0.0 [‐0.13, 0.13]

8.11 Kukui nut oil, TD

1

30

Risk Difference (M‐H, Random, 95% CI)

0.0 [‐0.12, 0.12]

8.12 Mahonia aquifolium (Reliéva™), twice daily

0

0

Risk Difference (M‐H, Random, 95% CI)

0.0 [0.0, 0.0]

8.13 Methotrexate gel

1

60

Risk Difference (M‐H, Random, 95% CI)

0.0 [‐0.06, 0.06]

8.14 Mycophenolic acid ointment

1

14

Risk Difference (M‐H, Random, 95% CI)

0.0 [‐0.24, 0.24]

8.15 NG‐monomethyl‐L‐arginine (L‐NMMA) cream

1

34

Risk Difference (M‐H, Random, 95% CI)

0.0 [‐0.11, 0.11]

8.16 Nicotinamide 1.4%, twice daily

1

96

Risk Difference (M‐H, Random, 95% CI)

0.0 [‐0.04, 0.04]

8.17 Oleum horwathiensis

1

50

Risk Difference (M‐H, Random, 95% CI)

0.0 [‐0.07, 0.07]

8.18 Omega‐3‐polyunsaturated fatty acids ointment

1

146

Risk Difference (M‐H, Random, 95% CI)

0.0 [‐0.03, 0.03]

8.19 Platelet aggregation activating factor (PAF)(Ro 24‐0238)

0

0

Risk Difference (M‐H, Random, 95% CI)

0.0 [0.0, 0.0]

8.20 Polymyxin B cream 200,000 U/g

0

0

Risk Difference (M‐H, Random, 95% CI)

0.0 [0.0, 0.0]

8.21 PTH (1‐34) in Novasome A® liposomal cream, twice daily

1

30

Risk Difference (M‐H, Random, 95% CI)

0.0 [‐0.12, 0.12]

8.22 Sirolimus (topical)

0

0

Risk Difference (M‐H, Random, 95% CI)

0.0 [0.0, 0.0]

8.23 Tacrolimus ointment

0

0

Risk Difference (M‐H, Random, 95% CI)

0.0 [0.0, 0.0]

8.24 Tar

0

0

Risk Difference (M‐H, Random, 95% CI)

0.0 [0.0, 0.0]

8.25 Tazarotene

2

1627

Risk Difference (M‐H, Random, 95% CI)

‐0.02 [‐0.04, 0.01]

8.26 Theophylline 1% ointment, twice daily

1

22

Risk Difference (M‐H, Random, 95% CI)

0.0 [‐0.16, 0.16]

9 Adverse events (local) Show forest plot

21

Risk Difference (M‐H, Random, 95% CI)

Subtotals only

9.1 Aloe vera extract 0.5% hydrophilic cream, three times per day

1

60

Risk Difference (M‐H, Random, 95% CI)

0.0 [‐0.06, 0.06]

9.2 Anti‐IL‐8 monoclonal antibody cream

1

92

Risk Difference (M‐H, Random, 95% CI)

0.02 [‐0.10, 0.14]

9.3 Betamethasone 17‐valerate 21‐acetate plus tretinoin plus salicylic acid

1

85

Risk Difference (M‐H, Random, 95% CI)

‐0.00 [‐0.07, 0.06]

9.4 Caffeine (topical) 10%, TD

1

78

Risk Difference (M‐H, Random, 95% CI)

0.05 [‐0.03, 0.13]

9.5 Calcipotriene 0.005% ointment + nicotinamide 0.05% or 0.1% or 0.7% or 1.4%, twice daily

1

192

Risk Difference (M‐H, Random, 95% CI)

0.13 [‐0.02, 0.27]

9.6 Dead Sea salts emollient lotion

1

24

Risk Difference (M‐H, Random, 95% CI)

0.08 [‐0.18, 0.35]

9.7 Fish oil plus occlusion

1

50

Risk Difference (M‐H, Random, 95% CI)

0.04 [‐0.06, 0.14]

9.8 Herbal skin care (Dr Michaels® cleansing gel, ointment and skin conditioner), twice daily

1

24

Risk Difference (M‐H, Random, 95% CI)

‐0.09 [‐0.44, 0.27]

9.9 Hexafluoro‐1,25‐dihydroxyvitamin D3

1

30

Risk Difference (M‐H, Random, 95% CI)

0.13 [‐0.06, 0.33]

9.10 Indigo naturalis 1.4% ointment

2

88

Risk Difference (M‐H, Random, 95% CI)

0.0 [‐0.05, 0.05]

9.11 Kukui nut oil, TD

1

30

Risk Difference (M‐H, Random, 95% CI)

0.0 [‐0.12, 0.12]

9.12 Mahonia aquifolium (Reliéva™), twice daily

1

200

Risk Difference (M‐H, Random, 95% CI)

‐0.02 [‐0.06, 0.02]

9.13 Methotrexate gel

1

60

Risk Difference (M‐H, Random, 95% CI)

0.0 [‐0.06, 0.06]

9.14 Mycophenolic acid ointment

1

14

Risk Difference (M‐H, Random, 95% CI)

0.0 [‐0.24, 0.24]

9.15 NG‐monomethyl‐L‐arginine (L‐NMMA) cream

1

34

Risk Difference (M‐H, Random, 95% CI)

0.0 [‐0.11, 0.11]

9.16 Nicotinamide 1.4%, twice daily

1

96

Risk Difference (M‐H, Random, 95% CI)

0.10 [‐0.07, 0.28]

9.17 Oleum horwathiensis

1

50

Risk Difference (M‐H, Random, 95% CI)

0.04 [‐0.06, 0.14]

9.18 Omega‐3‐polyunsaturated fatty acids ointment

1

146

Risk Difference (M‐H, Random, 95% CI)

0.01 [‐0.02, 0.05]

9.19 Platelet aggregation activating factor (PAF)(Ro 24‐0238)

1

104

Risk Difference (M‐H, Random, 95% CI)

0.0 [‐0.19, 0.19]

9.20 Polymyxin B cream 200,000 U/g

0

0

Risk Difference (M‐H, Random, 95% CI)

0.0 [0.0, 0.0]

9.21 PTH (1‐34) in Novasome A® liposomal cream, twice daily

1

30

Risk Difference (M‐H, Random, 95% CI)

0.0 [‐0.12, 0.12]

9.22 Sirolimus (topical)

0

0

Risk Difference (M‐H, Random, 95% CI)

0.0 [0.0, 0.0]

9.23 Tacrolimus ointment

0

0

Risk Difference (M‐H, Random, 95% CI)

0.0 [0.0, 0.0]

9.24 Tar

0

0

Risk Difference (M‐H, Random, 95% CI)

0.0 [0.0, 0.0]

9.25 Tazarotene

0

0

Risk Difference (M‐H, Random, 95% CI)

0.0 [0.0, 0.0]

9.26 Theophylline 1% ointment, twice daily

1

22

Risk Difference (M‐H, Random, 95% CI)

0.0 [‐0.16, 0.16]

10 Adverse events (systemic) Show forest plot

12

Risk Difference (M‐H, Random, 95% CI)

Subtotals only

10.1 Aloe vera extract 0.5% hydrophilic cream, three times per day

0

0

Risk Difference (M‐H, Random, 95% CI)

0.0 [0.0, 0.0]

10.2 Anti‐IL‐8 monoclonal antibody cream

0

0

Risk Difference (M‐H, Random, 95% CI)

0.0 [0.0, 0.0]

10.3 Betamethasone 17‐valerate 21‐acetate plus tretinoin plus salicylic acid

1

85

Risk Difference (M‐H, Random, 95% CI)

0.0 [‐0.04, 0.04]

10.4 Caffeine (topical) 10%, TD

0

0

Risk Difference (M‐H, Random, 95% CI)

0.0 [0.0, 0.0]

10.5 Calcipotriene 0.005% ointment + nicotinamide 0.05% or 0.1% or 0.7% or 1.4%, twice daily

0

0

Risk Difference (M‐H, Random, 95% CI)

0.0 [0.0, 0.0]

10.6 Dead Sea salts emollient lotion

0

0

Risk Difference (M‐H, Random, 95% CI)

0.0 [0.0, 0.0]

10.7 Fish oil plus occlusion

0

0

Risk Difference (M‐H, Random, 95% CI)

0.0 [0.0, 0.0]

10.8 Herbal skin care (Dr Michaels® cleansing gel, ointment and skin conditioner), twice daily

0

0

Risk Difference (M‐H, Random, 95% CI)

0.0 [0.0, 0.0]

10.9 Hexafluoro‐1,25‐dihydroxyvitamin D3

1

30

Risk Difference (M‐H, Random, 95% CI)

0.0 [‐0.12, 0.12]

10.10 Indigo naturalis 1.4% ointment

2

88

Risk Difference (M‐H, Random, 95% CI)

0.0 [‐0.05, 0.05]

10.11 Kukui nut oil, TD

0

0

Risk Difference (M‐H, Random, 95% CI)

0.0 [0.0, 0.0]

10.12 Mahonia aquifolium (Reliéva™), twice daily

0

0

Risk Difference (M‐H, Random, 95% CI)

0.0 [0.0, 0.0]

10.13 Methotrexate gel

2

166

Risk Difference (M‐H, Random, 95% CI)

0.0 [‐0.03, 0.03]

10.14 Mycophenolic acid ointment

0

0

Risk Difference (M‐H, Random, 95% CI)

0.0 [0.0, 0.0]

10.15 NG‐monomethyl‐L‐arginine (L‐NMMA) cream

1

34

Risk Difference (M‐H, Random, 95% CI)

0.0 [‐0.11, 0.11]

10.16 Nicotinamide 1.4%, twice daily

0

0

Risk Difference (M‐H, Random, 95% CI)

0.0 [0.0, 0.0]

10.17 Oleum horwathiensis

1

50

Risk Difference (M‐H, Random, 95% CI)

0.0 [‐0.07, 0.07]

10.18 Omega‐3‐polyunsaturated fatty acids ointment

0

0

Risk Difference (M‐H, Random, 95% CI)

0.0 [0.0, 0.0]

10.19 Platelet aggregation activating factor (PAF)(Ro 24‐0238)

1

104

Risk Difference (M‐H, Random, 95% CI)

0.0 [‐0.04, 0.04]

10.20 Polymyxin B cream 200,000 U/g

0

0

Risk Difference (M‐H, Random, 95% CI)

0.0 [0.0, 0.0]

10.21 PTH (1‐34) in Novasome A® liposomal cream, twice daily

1

30

Risk Difference (M‐H, Random, 95% CI)

0.0 [‐0.12, 0.12]

10.22 Sirolimus (topical)

0

0

Risk Difference (M‐H, Random, 95% CI)

0.0 [0.0, 0.0]

10.23 Tacrolimus ointment

0

0

Risk Difference (M‐H, Random, 95% CI)

0.0 [0.0, 0.0]

10.24 Tar

0

0

Risk Difference (M‐H, Random, 95% CI)

0.0 [0.0, 0.0]

10.25 Tazarotene

2

414

Risk Difference (M‐H, Random, 95% CI)

0.0 [‐0.01, 0.01]

10.26 Theophylline 1% ointment, twice daily

0

0

Risk Difference (M‐H, Random, 95% CI)

0.0 [0.0, 0.0]

Figuras y tablas -
Comparison 6. Other treatment versus placebo
Comparison 7. Vitamin D analogues versus corticosteroid (potent)

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 IAGI Show forest plot

8

Std. Mean Difference (IV, Random, 95% CI)

Subtotals only

1.1 Calcipotriol vs. betamethasone dipropionate

3

1728

Std. Mean Difference (IV, Random, 95% CI)

0.43 [0.28, 0.58]

1.2 Calcipotriol vs. betamethasone valerate

1

412

Std. Mean Difference (IV, Random, 95% CI)

‐0.02 [‐0.21, 0.17]

1.3 Calcipotriol vs. desoxymetasone

0

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

1.4 Calcipotriol vs. diflorasone diacetate

1

256

Std. Mean Difference (IV, Random, 95% CI)

0.27 [0.02, 0.52]

1.5 Calcipotriol vs. fluocinonide

1

99

Std. Mean Difference (IV, Random, 95% CI)

‐0.58 [‐0.99, ‐0.18]

1.6 Calcitriol vs. betamethasone dipropionate

1

258

Std. Mean Difference (IV, Random, 95% CI)

0.21 [‐0.04, 0.45]

1.7 Calcitriol vs. betamethasone valerate

1

30

Std. Mean Difference (IV, Random, 95% CI)

‐0.19 [‐0.91, 0.53]

1.8 Tacalcitol vs. betamethasone valerate

0

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

2 TSS Show forest plot

6

Std. Mean Difference (IV, Random, 95% CI)

Subtotals only

2.1 Calcipotriol vs. betamethasone dipropionate

0

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

2.2 Calcipotriol vs. betamethasone valerate

1

684

Std. Mean Difference (IV, Random, 95% CI)

‐0.26 [‐0.41, ‐0.11]

2.3 Calcipotriol vs. desoxymetasone

0

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

2.4 Calcipotriol vs. diflorasone diacetate

1

256

Std. Mean Difference (IV, Random, 95% CI)

0.40 [0.15, 0.65]

2.5 Calcipotriol vs. fluocinonide

1

89

Std. Mean Difference (IV, Random, 95% CI)

‐0.50 [‐0.92, ‐0.07]

2.6 Calcitriol vs. betamethasone dipropionate

1

258

Std. Mean Difference (IV, Random, 95% CI)

0.27 [0.02, 0.51]

2.7 Calcitriol vs. betamethasone valerate

0

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

2.8 Tacalcitol vs. betamethasone valerate

2

148

Std. Mean Difference (IV, Random, 95% CI)

0.41 [0.09, 0.74]

3 PASI Show forest plot

9

Std. Mean Difference (IV, Random, 95% CI)

Subtotals only

3.1 Calcipotriol vs. betamethasone dipropionate

3

1728

Std. Mean Difference (IV, Random, 95% CI)

0.36 [0.22, 0.51]

3.2 Calcipotriol vs. betamethasone valerate

4

1505

Std. Mean Difference (IV, Random, 95% CI)

‐0.12 [‐0.22, ‐0.02]

3.3 Calcipotriol vs. desoxymetasone

1

20

Std. Mean Difference (IV, Random, 95% CI)

0.15 [‐0.73, 1.02]

3.4 Calcipotriol vs. diflorasone diacetate

0

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

3.5 Calcipotriol vs. fluocinonide

0

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

3.6 Calcitriol vs. betamethasone dipropionate

1

258

Std. Mean Difference (IV, Random, 95% CI)

0.39 [0.14, 0.63]

3.7 Calcitriol vs. betamethasone valerate

0

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

3.8 Tacalcitol vs. betamethasone valerate

0

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

4 PAGI Show forest plot

2

1080

Std. Mean Difference (IV, Random, 95% CI)

‐0.26 [‐0.38, ‐0.14]

4.1 Calcipotriol vs. betamethasone dipropionate

0

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

4.2 Calcipotriol vs. betamethasone valerate

2

1080

Std. Mean Difference (IV, Random, 95% CI)

‐0.26 [‐0.38, ‐0.14]

4.3 Calcipotriol vs. desoxymetasone

0

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

4.4 Calcipotriol vs. diflorasone diacetate

0

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

4.5 Calcipotriol vs. fluocinonide

0

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

4.6 Calcitriol vs. betamethasone dipropionate

0

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

4.7 Calcitriol vs. betamethasone valerate

0

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

4.8 Tacalcitol vs. betamethasone valerate

0

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

5 Combined end point (IAGI/TSS/PASI/PAGI) Show forest plot

14

Std. Mean Difference (IV, Random, 95% CI)

Subtotals only

5.1 Calcipotriol vs. betamethasone dipropionate

3

1728

Std. Mean Difference (IV, Random, 95% CI)

0.43 [0.28, 0.58]

5.2 Calcipotriol vs. betamethasone valerate

4

1557

Std. Mean Difference (IV, Random, 95% CI)

‐0.12 [‐0.26, 0.02]

5.3 Calcipotriol vs. desoxymetasone

1

20

Std. Mean Difference (IV, Random, 95% CI)

0.15 [‐0.73, 1.02]

5.4 Calcipotriol vs. diflorasone diacetate

1

256

Std. Mean Difference (IV, Random, 95% CI)

0.27 [0.02, 0.52]

5.5 Calcipotriol vs. fluocinonide

1

99

Std. Mean Difference (IV, Random, 95% CI)

‐0.58 [‐0.99, ‐0.18]

5.6 Calcitriol vs. betamethasone dipropionate

1

258

Std. Mean Difference (IV, Random, 95% CI)

0.21 [‐0.04, 0.45]

5.7 Calcitriol vs. betamethasone valerate

1

30

Std. Mean Difference (IV, Random, 95% CI)

‐0.19 [‐0.91, 0.53]

5.8 Tacalcitol vs. betamethasone valerate

2

148

Std. Mean Difference (IV, Random, 95% CI)

0.41 [0.09, 0.74]

6 Total withdrawals Show forest plot

11

3995

Risk Difference (M‐H, Random, 95% CI)

0.02 [0.00, 0.03]

6.1 Calcipotriol vs. betamethasone dipropionate

3

1739

Risk Difference (M‐H, Random, 95% CI)

0.03 [0.01, 0.06]

6.2 Calcipotriol vs. betamethasone valerate

3

1520

Risk Difference (M‐H, Random, 95% CI)

0.01 [‐0.01, 0.04]

6.3 Calcipotriol vs. desoxymetasone

0

0

Risk Difference (M‐H, Random, 95% CI)

0.0 [0.0, 0.0]

6.4 Calcipotriol vs. diflorasone diacetate

1

268

Risk Difference (M‐H, Random, 95% CI)

0.0 [‐0.05, 0.05]

6.5 Calcipotriol vs. fluocinonide

0

0

Risk Difference (M‐H, Random, 95% CI)

0.0 [0.0, 0.0]

6.6 Calcitriol vs. betamethasone dipropionate

1

258

Risk Difference (M‐H, Random, 95% CI)

‐0.02 [‐0.08, 0.03]

6.7 Calcitriol vs. betamethasone valerate

1

30

Risk Difference (M‐H, Random, 95% CI)

0.07 [‐0.10, 0.23]

6.8 Tacalcitol vs. betamethasone valerate

2

180

Risk Difference (M‐H, Random, 95% CI)

0.0 [‐0.11, 0.11]

7 Withdrawals due to adverse events Show forest plot

9

3058

Risk Difference (M‐H, Random, 95% CI)

0.01 [‐0.00, 0.01]

7.1 Calcipotriol vs. betamethasone dipropionate

1

956

Risk Difference (M‐H, Random, 95% CI)

0.02 [0.00, 0.04]

7.2 Calcipotriol vs. betamethasone valerate

3

1520

Risk Difference (M‐H, Random, 95% CI)

0.00 [‐0.00, 0.01]

7.3 Calcipotriol vs. desoxymetasone

0

0

Risk Difference (M‐H, Random, 95% CI)

0.0 [0.0, 0.0]

7.4 Calcipotriol vs. diflorasone diacetate

0

0

Risk Difference (M‐H, Random, 95% CI)

0.0 [0.0, 0.0]

7.5 Calcipotriol vs. fluocinonide

1

114

Risk Difference (M‐H, Random, 95% CI)

‐0.02 [‐0.06, 0.03]

7.6 Calcitriol vs. betamethasone dipropionate

1

258

Risk Difference (M‐H, Random, 95% CI)

0.01 [‐0.02, 0.03]

7.7 Calcitriol vs. betamethasone valerate

1

30

Risk Difference (M‐H, Random, 95% CI)

0.07 [‐0.10, 0.23]

7.8 Tacalcitol vs. betamethasone valerate

2

180

Risk Difference (M‐H, Random, 95% CI)

0.0 [‐0.02, 0.02]

8 Withdrawals due to treatment failure Show forest plot

5

1500

Risk Difference (M‐H, Random, 95% CI)

‐0.00 [‐0.01, 0.01]

8.1 Calcipotriol vs. betamethasone dipropionate

0

0

Risk Difference (M‐H, Random, 95% CI)

0.0 [0.0, 0.0]

8.2 Calcipotriol vs. betamethasone valerate

2

1099

Risk Difference (M‐H, Random, 95% CI)

‐0.00 [‐0.01, 0.01]

8.3 Calcipotriol vs. desoxymetasone

0

0

Risk Difference (M‐H, Random, 95% CI)

0.0 [0.0, 0.0]

8.4 Calcipotriol vs. diflorasone diacetate

0

0

Risk Difference (M‐H, Random, 95% CI)

0.0 [0.0, 0.0]

8.5 Calcipotriol vs. fluocinonide

1

113

Risk Difference (M‐H, Random, 95% CI)

0.0 [‐0.03, 0.03]

8.6 Calcitriol vs. betamethasone dipropionate

1

258

Risk Difference (M‐H, Random, 95% CI)

0.01 [‐0.03, 0.05]

8.7 Calcitriol vs. betamethasone valerate

1

30

Risk Difference (M‐H, Random, 95% CI)

0.0 [‐0.12, 0.12]

8.8 Tacalcitol vs. betamethasone valerate

0

0

Risk Difference (M‐H, Random, 95% CI)

0.0 [0.0, 0.0]

9 Adverse events (local) Show forest plot

9

3778

Risk Difference (M‐H, Random, 95% CI)

0.07 [0.02, 0.11]

9.1 Calcipotriol vs. betamethasone dipropionate

3

1739

Risk Difference (M‐H, Random, 95% CI)

0.07 [0.04, 0.09]

9.2 Calcipotriol vs. betamethasone valerate

3

1516

Risk Difference (M‐H, Random, 95% CI)

0.12 [‐0.02, 0.26]

9.3 Calcipotriol vs. desoxymetasone

0

0

Risk Difference (M‐H, Random, 95% CI)

0.0 [0.0, 0.0]

9.4 Calcipotriol vs. diflorasone diacetate

0

0

Risk Difference (M‐H, Random, 95% CI)

0.0 [0.0, 0.0]

9.5 Calcipotriol vs. fluocinonide

1

113

Risk Difference (M‐H, Random, 95% CI)

0.10 [‐0.02, 0.22]

9.6 Calcitriol vs. betamethasone dipropionate

1

258

Risk Difference (M‐H, Random, 95% CI)

0.00 [‐0.05, 0.06]

9.7 Calcitriol vs. betamethasone valerate

0

0

Risk Difference (M‐H, Random, 95% CI)

0.0 [0.0, 0.0]

9.8 Tacalcitol vs. betamethasone valerate

1

152

Risk Difference (M‐H, Random, 95% CI)

‐0.01 [‐0.07, 0.04]

10 Adverse events (systemic) Show forest plot

6

2547

Risk Difference (M‐H, Random, 95% CI)

‐0.00 [‐0.00, 0.00]

10.1 Calcipotriol vs. betamethasone dipropionate

1

621

Risk Difference (M‐H, Random, 95% CI)

0.0 [‐0.01, 0.01]

10.2 Calcipotriol vs. betamethasone valerate

3

1516

Risk Difference (M‐H, Random, 95% CI)

‐0.00 [‐0.00, 0.00]

10.3 Calcipotriol vs. desoxymetasone

0

0

Risk Difference (M‐H, Random, 95% CI)

0.0 [0.0, 0.0]

10.4 Calcipotriol vs. diflorasone diacetate

0

0

Risk Difference (M‐H, Random, 95% CI)

0.0 [0.0, 0.0]

10.5 Calcipotriol vs. fluocinonide

0

0

Risk Difference (M‐H, Random, 95% CI)

0.0 [0.0, 0.0]

10.6 Calcitriol vs. betamethasone dipropionate

1

258

Risk Difference (M‐H, Random, 95% CI)

‐0.01 [‐0.04, 0.03]

10.7 Calcitriol vs. betamethasone valerate

0

0

Risk Difference (M‐H, Random, 95% CI)

0.0 [0.0, 0.0]

10.8 Tacalcitol vs. betamethasone valerate

1

152

Risk Difference (M‐H, Random, 95% CI)

0.0 [‐0.09, 0.09]

Figuras y tablas -
Comparison 7. Vitamin D analogues versus corticosteroid (potent)
Comparison 8. Vitamin D analogues versus corticosteroid (very potent)

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 IAGI Show forest plot

1

Std. Mean Difference (IV, Random, 95% CI)

Totals not selected

1.1 Calcipotriol vs. Clobetasol propionate

1

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

2 TSS

0

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

2.1 Calcipotriol vs. Clobetasol propionate

0

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

3 PASI Show forest plot

1

Std. Mean Difference (IV, Random, 95% CI)

Totals not selected

3.1 Calcipotriol vs. Clobetasol propionate

1

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

4 PAGI Show forest plot

1

Std. Mean Difference (IV, Random, 95% CI)

Totals not selected

4.1 Calcipotriol vs. Clobetasol propionate

1

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

5 Combined end point (IAGI/TSS/PASI/PAGI) Show forest plot

2

82

Std. Mean Difference (IV, Random, 95% CI)

‐0.06 [‐0.57, 0.44]

5.1 Calcipotriol vs. Clobetasol propionate

2

82

Std. Mean Difference (IV, Random, 95% CI)

‐0.06 [‐0.57, 0.44]

6 Total withdrawals Show forest plot

1

Risk Difference (M‐H, Random, 95% CI)

Totals not selected

6.1 Calcipotriol vs. Clobetasol propionate

1

Risk Difference (M‐H, Random, 95% CI)

0.0 [0.0, 0.0]

7 Withdrawals due to adverse events Show forest plot

1

Risk Difference (M‐H, Random, 95% CI)

Totals not selected

7.1 Calcipotriol vs. Clobetasol propionate

1

Risk Difference (M‐H, Random, 95% CI)

0.0 [0.0, 0.0]

8 Withdrawals due to treatment failure Show forest plot

1

Risk Difference (M‐H, Random, 95% CI)

Totals not selected

8.1 Calcipotriol vs. Clobetasol propionate

1

Risk Difference (M‐H, Random, 95% CI)

0.0 [0.0, 0.0]

9 Adverse events (local) Show forest plot

1

Risk Difference (M‐H, Random, 95% CI)

Totals not selected

9.1 Calcipotriol vs. Clobetasol propionate

1

Risk Difference (M‐H, Random, 95% CI)

0.0 [0.0, 0.0]

10 Adverse events (systemic) Show forest plot

1

Risk Difference (M‐H, Random, 95% CI)

Totals not selected

10.1 Calcipotriol vs. Clobetasol propionate

1

Risk Difference (M‐H, Random, 95% CI)

0.0 [0.0, 0.0]

Figuras y tablas -
Comparison 8. Vitamin D analogues versus corticosteroid (very potent)
Comparison 9. Vitamin D combined with corticosteroid versus corticosteroid

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 IAGI Show forest plot

4

Std. Mean Difference (IV, Random, 95% CI)

Subtotals only

1.1 Calcipotriol + betamethasone dipropionate vs. betamethasone dipropionate

3

1926

Std. Mean Difference (IV, Random, 95% CI)

‐0.40 [‐0.52, ‐0.27]

1.2 Calcipotriol + betamethasone dipropionate vs. clobetasol propionate

0

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

1.3 Calcipotriol + clobetasol propionate vs. clobetasol propionate

1

65

Std. Mean Difference (IV, Random, 95% CI)

‐0.69 [‐1.22, ‐0.15]

2 TSS Show forest plot

1

Std. Mean Difference (IV, Random, 95% CI)

Totals not selected

2.1 Calcipotriol + betamethasone dipropionate vs. betamethasone dipropionate

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

2.2 Calcipotriol + betamethasone dipropionate vs. clobetasol propionate

1

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

2.3 Calcipotriol + clobetasol propionate vs. clobetasol propionate

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

3 PASI Show forest plot

3

1876

Std. Mean Difference (IV, Random, 95% CI)

‐0.44 [‐0.55, ‐0.33]

3.1 Calcipotriol + betamethasone dipropionate vs. betamethasone dipropionate

3

1876

Std. Mean Difference (IV, Random, 95% CI)

‐0.44 [‐0.55, ‐0.33]

3.2 Calcipotriol + betamethasone dipropionate vs. clobetasol propionate

0

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

3.3 Calcipotriol + clobetasol propionate vs. clobetasol propionate

0

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

4 PAGI Show forest plot

1

Std. Mean Difference (IV, Random, 95% CI)

Totals not selected

4.1 Calcipotriol + betamethasone dipropionate vs. betamethasone dipropionate

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

4.2 Calcipotriol + betamethasone dipropionate vs. clobetasol propionate

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

4.3 Calcipotriol + clobetasol propionate vs. clobetasol propionate

1

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

5 Combined end point (IAGI/TSS/PASI/PAGI) Show forest plot

5

Std. Mean Difference (IV, Random, 95% CI)

Subtotals only

5.1 Calcipotriol + betamethasone dipropionate vs. betamethasone dipropionate

3

1926

Std. Mean Difference (IV, Random, 95% CI)

‐0.40 [‐0.52, ‐0.27]

5.2 Calcipotriol + betamethasone dipropionate vs. clobetasol propionate

1

122

Std. Mean Difference (IV, Random, 95% CI)

0.45 [0.09, 0.81]

5.3 Calcipotriol + clobetasol propionate vs. clobetasol propionate

1

65

Std. Mean Difference (IV, Random, 95% CI)

‐0.69 [‐1.22, ‐0.15]

6 Total withdrawals Show forest plot

5

2135

Risk Difference (M‐H, Random, 95% CI)

‐0.00 [‐0.02, 0.01]

6.1 Calcipotriol + betamethasone dipropionate vs. betamethasone dipropionate

3

1948

Risk Difference (M‐H, Random, 95% CI)

‐0.00 [‐0.03, 0.03]

6.2 Calcipotriol + betamethasone dipropionate vs. clobetasol propionate

1

122

Risk Difference (M‐H, Random, 95% CI)

0.0 [‐0.03, 0.03]

6.3 Calcipotriol + clobetasol propionate vs. clobetasol propionate

1

65

Risk Difference (M‐H, Random, 95% CI)

0.0 [‐0.07, 0.07]

7 Withdrawals due to adverse events Show forest plot

3

Risk Difference (M‐H, Random, 95% CI)

Totals not selected

7.1 Calcipotriol + betamethasone dipropionate vs. betamethasone dipropionate

1

Risk Difference (M‐H, Random, 95% CI)

0.0 [0.0, 0.0]

7.2 Calcipotriol + betamethasone dipropionate vs. clobetasol propionate

1

Risk Difference (M‐H, Random, 95% CI)

0.0 [0.0, 0.0]

7.3 Calcipotriol + clobetasol propionate vs. clobetasol propionate

1

Risk Difference (M‐H, Random, 95% CI)

0.0 [0.0, 0.0]

8 Withdrawals due to treatment failure Show forest plot

2

Risk Difference (M‐H, Random, 95% CI)

Totals not selected

8.1 Calcipotriol + betamethasone dipropionate vs. betamethasone dipropionate

0

Risk Difference (M‐H, Random, 95% CI)

0.0 [0.0, 0.0]

8.2 Calcipotriol + betamethasone dipropionate vs. clobetasol propionate

1

Risk Difference (M‐H, Random, 95% CI)

0.0 [0.0, 0.0]

8.3 Calcipotriol + clobetasol propionate vs. clobetasol propionate

1

Risk Difference (M‐H, Random, 95% CI)

0.0 [0.0, 0.0]

9 Adverse events (local) Show forest plot

4

Risk Difference (M‐H, Random, 95% CI)

Subtotals only

9.1 Calcipotriol + betamethasone dipropionate vs. betamethasone dipropionate

3

1946

Risk Difference (M‐H, Random, 95% CI)

0.02 [‐0.00, 0.04]

9.2 Calcipotriol + betamethasone dipropionate vs. clobetasol propionate

1

122

Risk Difference (M‐H, Random, 95% CI)

‐0.04 [‐0.13, 0.06]

9.3 Calcipotriol + clobetasol propionate vs. clobetasol propionate

0

0

Risk Difference (M‐H, Random, 95% CI)

0.0 [0.0, 0.0]

10 Adverse events (systemic) Show forest plot

1

Risk Difference (M‐H, Random, 95% CI)

Totals not selected

10.1 Calcipotriol + betamethasone dipropionate vs. betamethasone dipropionate

1

Risk Difference (M‐H, Random, 95% CI)

0.0 [0.0, 0.0]

10.2 Calcipotriol + betamethasone dipropionate vs. clobetasol propionate

0

Risk Difference (M‐H, Random, 95% CI)

0.0 [0.0, 0.0]

10.3 Calcipotriol + clobetasol propionate vs. clobetasol propionate

0

Risk Difference (M‐H, Random, 95% CI)

0.0 [0.0, 0.0]

Figuras y tablas -
Comparison 9. Vitamin D combined with corticosteroid versus corticosteroid
Comparison 10. Vitamin D alone or in combination versus dithranol

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 IAGI Show forest plot

5

Std. Mean Difference (IV, Random, 95% CI)

Subtotals only

1.1 Calcipotriol vs. dithranol

4

994

Std. Mean Difference (IV, Random, 95% CI)

‐0.43 [‐0.85, ‐0.01]

1.2 Calcitriol vs. dithranol

1

114

Std. Mean Difference (IV, Random, 95% CI)

0.51 [0.13, 0.88]

1.3 Tacalcitol vs. dithranol

0

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

2 TSS Show forest plot

4

Std. Mean Difference (IV, Random, 95% CI)

Subtotals only

2.1 Calcipotriol vs. dithranol

2

210

Std. Mean Difference (IV, Random, 95% CI)

‐0.54 [‐1.16, 0.08]

2.2 Calcitriol vs. dithranol

1

114

Std. Mean Difference (IV, Random, 95% CI)

0.13 [‐0.24, 0.50]

2.3 Tacalcitol vs. dithranol

1

84

Std. Mean Difference (IV, Random, 95% CI)

‐0.18 [‐0.60, 0.25]

3 PASI Show forest plot

5

Std. Mean Difference (IV, Random, 95% CI)

Totals not selected

3.1 Calcipotriol vs. dithranol

3

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

3.2 Calcitriol vs. dithranol

1

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

3.3 Tacalcitol vs. dithranol

1

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

4 PAGI Show forest plot

2

Std. Mean Difference (IV, Random, 95% CI)

Subtotals only

4.1 Calcipotriol vs. dithranol

2

544

Std. Mean Difference (IV, Random, 95% CI)

‐0.05 [‐0.90, 0.80]

4.2 Calcitriol vs. dithranol

0

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

4.3 Tacalcitol vs. dithranol

0

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

5 Combined end point (IAGI/TSS/PASI/PAGI) Show forest plot

8

Std. Mean Difference (IV, Random, 95% CI)

Totals not selected

5.1 Calcipotriol vs. dithranol

6

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

5.2 Calcitriol vs. dithranol

1

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

5.3 Tacalcitol vs. dithranol

1

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

6 Total withdrawals Show forest plot

7

615

Risk Difference (M‐H, Random, 95% CI)

‐0.02 [‐0.06, 0.01]

6.1 Calcipotriol vs. dithranol

5

417

Risk Difference (M‐H, Random, 95% CI)

‐0.01 [‐0.07, 0.04]

6.2 Calcitriol vs. dithranol

1

114

Risk Difference (M‐H, Random, 95% CI)

‐0.10 [‐0.25, 0.06]

6.3 Tacalcitol vs. dithranol

1

84

Risk Difference (M‐H, Random, 95% CI)

‐0.02 [‐0.16, 0.11]

7 Withdrawals due to adverse events Show forest plot

7

1265

Risk Difference (M‐H, Random, 95% CI)

‐0.03 [‐0.06, ‐0.00]

7.1 Calcipotriol vs. dithranol

6

1151

Risk Difference (M‐H, Random, 95% CI)

‐0.03 [‐0.06, 0.00]

7.2 Calcitriol vs. dithranol

1

114

Risk Difference (M‐H, Random, 95% CI)

‐0.06 [‐0.13, 0.02]

7.3 Tacalcitol vs. dithranol

0

0

Risk Difference (M‐H, Random, 95% CI)

0.0 [0.0, 0.0]

8 Withdrawals due to treatment failure Show forest plot

5

788

Risk Difference (M‐H, Random, 95% CI)

‐0.00 [‐0.02, 0.02]

8.1 Calcipotriol vs. dithranol

4

674

Risk Difference (M‐H, Random, 95% CI)

0.00 [‐0.02, 0.02]

8.2 Calcitriol vs. dithranol

1

114

Risk Difference (M‐H, Random, 95% CI)

‐0.02 [‐0.08, 0.04]

8.3 Tacalcitol vs. dithranol

0

0

Risk Difference (M‐H, Random, 95% CI)

0.0 [0.0, 0.0]

9 Adverse events (local) Show forest plot

9

1543

Risk Difference (M‐H, Random, 95% CI)

‐0.32 [‐0.43, ‐0.20]

9.1 Calcipotriol vs. dithranol

7

1345

Risk Difference (M‐H, Random, 95% CI)

‐0.25 [‐0.32, ‐0.17]

9.2 Calcitriol vs. dithranol

1

114

Risk Difference (M‐H, Random, 95% CI)

‐0.67 [‐0.80, ‐0.54]

9.3 Tacalcitol vs. dithranol

1

84

Risk Difference (M‐H, Random, 95% CI)

‐0.36 [‐0.52, ‐0.20]

10 Adverse events (systemic) Show forest plot

4

746

Risk Difference (M‐H, Random, 95% CI)

‐0.00 [‐0.01, 0.01]

10.1 Calcipotriol vs. dithranol

2

548

Risk Difference (M‐H, Random, 95% CI)

‐0.00 [‐0.02, 0.01]

10.2 Calcitriol vs. dithranol

1

114

Risk Difference (M‐H, Random, 95% CI)

0.0 [‐0.03, 0.03]

10.3 Tacalcitol vs. dithranol

1

84

Risk Difference (M‐H, Random, 95% CI)

0.0 [‐0.05, 0.05]

Figuras y tablas -
Comparison 10. Vitamin D alone or in combination versus dithranol
Comparison 11. Vitamin D alone or in combination versus other vitamin D analogue

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 IAGI Show forest plot

3

Std. Mean Difference (IV, Random, 95% CI)

Subtotals only

1.1 Calcipotriol vs. calcitriol

1

246

Std. Mean Difference (IV, Random, 95% CI)

0.0 [‐0.25, 0.25]

1.2 Calcipotriol vs. tacalcitol

1

226

Std. Mean Difference (IV, Random, 95% CI)

‐0.47 [‐0.73, ‐0.21]

1.3 Calcipotriol vs. maxacalcitol

1

52

Std. Mean Difference (IV, Random, 95% CI)

0.43 [‐0.12, 0.98]

2 TSS Show forest plot

3

589

Std. Mean Difference (IV, Random, 95% CI)

‐0.31 [‐0.55, ‐0.06]

2.1 Calcipotriol vs. calcitriol

1

250

Std. Mean Difference (IV, Random, 95% CI)

‐0.32 [‐0.57, ‐0.07]

2.2 Calcipotriol vs. tacalcitol

1

287

Std. Mean Difference (IV, Random, 95% CI)

‐0.45 [‐0.68, ‐0.22]

2.3 Calcipotriol vs. maxacalcitol

1

52

Std. Mean Difference (IV, Random, 95% CI)

0.13 [‐0.41, 0.68]

3 PASI Show forest plot

1

Std. Mean Difference (IV, Random, 95% CI)

Totals not selected

3.1 Calcipotriol vs. calcitriol

1

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

3.2 Calcipotriol vs. tacalcitol

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

3.3 Calcipotriol vs. maxacalcitol

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

4 PAGI Show forest plot

1

Std. Mean Difference (IV, Random, 95% CI)

Totals not selected

4.1 Calcipotriol vs. calcitriol

1

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

4.2 Calcipotriol vs. tacalcitol

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

4.3 Calcipotriol vs. maxacalcitol

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

5 Combined end point (IAGI/TSS/PASI/PAGI) Show forest plot

4

539

Std. Mean Difference (IV, Random, 95% CI)

‐0.17 [‐0.62, 0.27]

5.1 Calcipotriol vs. calcitriol

2

261

Std. Mean Difference (IV, Random, 95% CI)

‐0.41 [‐1.46, 0.64]

5.2 Calcipotriol vs. tacalcitol

1

226

Std. Mean Difference (IV, Random, 95% CI)

‐0.47 [‐0.73, ‐0.21]

5.3 Calcipotriol vs. maxacalcitol

1

52

Std. Mean Difference (IV, Random, 95% CI)

0.43 [‐0.12, 0.98]

6 Total withdrawals Show forest plot

3

334

Risk Difference (M‐H, Random, 95% CI)

0.02 [‐0.04, 0.08]

6.1 Calcipotriol vs. calcitriol

2

274

Risk Difference (M‐H, Random, 95% CI)

0.02 [‐0.04, 0.09]

6.2 Calcipotriol vs. tacalcitol

0

0

Risk Difference (M‐H, Random, 95% CI)

0.0 [0.0, 0.0]

6.3 Calcipotriol vs. maxacalcitol

1

60

Risk Difference (M‐H, Random, 95% CI)

0.0 [‐0.17, 0.17]

7 Withdrawals due to adverse events Show forest plot

3

334

Risk Difference (M‐H, Random, 95% CI)

0.02 [‐0.01, 0.06]

7.1 Calcipotriol vs. calcitriol

2

274

Risk Difference (M‐H, Random, 95% CI)

0.03 [‐0.01, 0.07]

7.2 Calcipotriol vs. tacalcitol

0

0

Risk Difference (M‐H, Random, 95% CI)

0.0 [0.0, 0.0]

7.3 Calcipotriol vs. maxacalcitol

1

60

Risk Difference (M‐H, Random, 95% CI)

0.0 [‐0.06, 0.06]

8 Withdrawals due to treatment failure Show forest plot

3

334

Risk Difference (M‐H, Random, 95% CI)

‐0.00 [‐0.02, 0.01]

8.1 Calcipotriol vs. calcitriol

2

274

Risk Difference (M‐H, Random, 95% CI)

‐0.01 [‐0.08, 0.07]

8.2 Calcipotriol vs. tacalcitol

0

0

Risk Difference (M‐H, Random, 95% CI)

0.0 [0.0, 0.0]

8.3 Calcipotriol vs. maxacalcitol

1

60

Risk Difference (M‐H, Random, 95% CI)

0.0 [‐0.06, 0.06]

9 Adverse events (local) Show forest plot

2

537

Risk Difference (M‐H, Random, 95% CI)

0.03 [‐0.05, 0.12]

9.1 Calcipotriol vs. calcitriol

1

250

Risk Difference (M‐H, Random, 95% CI)

0.07 [0.01, 0.14]

9.2 Calcipotriol vs. tacalcitol

1

287

Risk Difference (M‐H, Random, 95% CI)

‐0.01 [‐0.09, 0.07]

9.3 Calcipotriol vs. maxacalcitol

0

0

Risk Difference (M‐H, Random, 95% CI)

0.0 [0.0, 0.0]

10 Adverse events (systemic) Show forest plot

3

597

Risk Difference (M‐H, Random, 95% CI)

0.0 [‐0.01, 0.01]

10.1 Calcipotriol vs. calcitriol

1

250

Risk Difference (M‐H, Random, 95% CI)

0.0 [‐0.02, 0.02]

10.2 Calcipotriol vs. tacalcitol

1

287

Risk Difference (M‐H, Random, 95% CI)

0.0 [‐0.01, 0.01]

10.3 Calcipotriol vs. maxacalcitol

1

60

Risk Difference (M‐H, Random, 95% CI)

0.0 [‐0.06, 0.06]

Figuras y tablas -
Comparison 11. Vitamin D alone or in combination versus other vitamin D analogue
Comparison 12. Vitamin D alone or in combination versus vitamin D + corticosteroid

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 IAGI Show forest plot

11

Std. Mean Difference (IV, Random, 95% CI)

Subtotals only

1.1 Calcipotriol twice daily vs. calcipotriol OM, BMD ON

1

154

Std. Mean Difference (IV, Random, 95% CI)

0.56 [0.23, 0.88]

1.2 Calcipotriol OD vs. combined calcipotriol + BMD OD

2

1194

Std. Mean Difference (IV, Random, 95% CI)

0.66 [0.31, 1.02]

1.3 Calcipotriol twice daily vs. combined calcipotriol + BMD OD

1

377

Std. Mean Difference (IV, Random, 95% CI)

0.27 [0.06, 0.48]

1.4 Calcipotriol twice daily vs. combined calcipotriol + BMD twice daily

3

1804

Std. Mean Difference (IV, Random, 95% CI)

0.66 [0.40, 0.93]

1.5 Calcipotriol twice daily vs. calcipotriol OM, BMV ON

2

510

Std. Mean Difference (IV, Random, 95% CI)

0.27 [‐0.19, 0.74]

1.6 Calcipotriol twice daily vs. calcipotriol OM, clobetasone butyrate ON

1

344

Std. Mean Difference (IV, Random, 95% CI)

0.27 [0.05, 0.48]

1.7 Calcipotriol twice daily vs. calcipotriol twice daily + clobetasol propionate twice daily

1

65

Std. Mean Difference (IV, Random, 95% CI)

0.88 [0.34, 1.42]

1.8 Calcipotriol twice daily vs. calcipotriol OM, diflucortolone valerate ON

0

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

1.9 Calcipotriol OD vs. calcipotriol OM, fluocinonide acetonide ON

0

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

1.10 Calcipotriol OD vs. combined calcipotriol + hydrocortisone OD

1

408

Std. Mean Difference (IV, Random, 95% CI)

0.14 [‐0.06, 0.33]

1.11 Calcitriol twice daily vs. diflucortolone valerate OM, calcitriol ON

0

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

1.12 Tacalcitol OD vs. combined calcipotriol + BMD OD

1

334

Std. Mean Difference (IV, Random, 95% CI)

0.48 [0.26, 0.70]

2 TSS Show forest plot

1

Std. Mean Difference (IV, Random, 95% CI)

Totals not selected

2.1 Calcipotriol twice daily vs. calcipotriol OM, BMD ON

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

2.2 Calcipotriol OD vs. combined calcipotriol + BMD OD

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

2.3 Calcipotriol twice daily vs. combined calcipotriol + BMD OD

1

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

2.4 Calcipotriol twice daily vs. combined calcipotriol + BMD twice daily

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

2.5 Calcipotriol twice daily vs. calcipotriol OM, BMV ON

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

2.6 Calcipotriol twice daily vs. calcipotriol OM, clobetasone butyrate ON

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

2.7 Calcipotriol twice daily vs. calcipotriol twice daily + clobetasol propionate twice daily

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

2.8 Calcipotriol twice daily vs. calcipotriol OM, diflucortolone valerate ON

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

2.9 Calcipotriol OD vs. calcipotriol OM, fluocinonide acetonide ON

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

2.10 Calcipotriol OD vs. combined calcipotriol + hydrocortisone OD

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

2.11 Calcitriol twice daily vs. diflucortolone valerate OM, calcitriol ON

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

2.12 Tacalcitol OD vs. combined calcipotriol + BMD OD

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

3 PASI Show forest plot

16

Std. Mean Difference (IV, Random, 95% CI)

Subtotals only

3.1 Calcipotriol twice daily vs. calcipotriol OM, BMD ON

1

124

Std. Mean Difference (IV, Random, 95% CI)

0.46 [0.10, 0.82]

3.2 Calcipotriol OD vs. combined calcipotriol + BMD OD

2

1191

Std. Mean Difference (IV, Random, 95% CI)

0.67 [0.23, 1.11]

3.3 Calcipotriol twice daily vs. combined calcipotriol + BMD OD

4

1204

Std. Mean Difference (IV, Random, 95% CI)

0.52 [0.38, 0.67]

3.4 Calcipotriol twice daily vs. combined calcipotriol + BMD twice daily

3

1744

Std. Mean Difference (IV, Random, 95% CI)

0.64 [0.46, 0.83]

3.5 Calcipotriol twice daily vs. calcipotriol OM, BMV ON

2

515

Std. Mean Difference (IV, Random, 95% CI)

0.43 [‐0.07, 0.93]

3.6 Calcipotriol twice daily vs. calcipotriol OM, clobetasone butyrate ON

1

344

Std. Mean Difference (IV, Random, 95% CI)

0.17 [‐0.04, 0.38]

3.7 Calcipotriol twice daily vs. calcipotriol twice daily + clobetasol propionate twice daily

0

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

3.8 Calcipotriol twice daily vs. calcipotriol OM, diflucortolone valerate ON

1

116

Std. Mean Difference (IV, Random, 95% CI)

0.08 [‐0.29, 0.44]

3.9 Calcipotriol OD vs. calcipotriol OM, fluocinonide acetonide ON

1

38

Std. Mean Difference (IV, Random, 95% CI)

0.53 [‐0.11, 1.18]

3.10 Calcipotriol OD vs. combined calcipotriol + hydrocortisone OD

1

408

Std. Mean Difference (IV, Random, 95% CI)

0.08 [‐0.11, 0.28]

3.11 Calcitriol twice daily vs. diflucortolone valerate OM, calcitriol ON

1

142

Std. Mean Difference (IV, Random, 95% CI)

0.24 [‐0.09, 0.57]

3.12 Tacalcitol OD vs. combined calcipotriol + BMD OD

1

334

Std. Mean Difference (IV, Random, 95% CI)

0.47 [0.25, 0.69]

4 PAGI Show forest plot

2

399

Std. Mean Difference (IV, Random, 95% CI)

0.49 [0.29, 0.69]

4.1 Calcipotriol twice daily vs. calcipotriol OM, BMD ON

0

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

4.2 Calcipotriol OD vs. combined calcipotriol + BMD OD

0

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

4.3 Calcipotriol twice daily vs. combined calcipotriol + BMD OD

0

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

4.4 Calcipotriol twice daily vs. combined calcipotriol + BMD twice daily

0

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

4.5 Calcipotriol twice daily vs. calcipotriol OM, BMV ON

0

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

4.6 Calcipotriol twice daily vs. calcipotriol OM, clobetasone butyrate ON

0

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

4.7 Calcipotriol twice daily vs. calcipotriol twice daily + clobetasol propionate twice daily

1

65

Std. Mean Difference (IV, Random, 95% CI)

0.70 [0.16, 1.23]

4.8 Calcipotriol twice daily vs. calcipotriol OM, diflucortolone valerate ON

0

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

4.9 Calcipotriol OD vs. calcipotriol OM, fluocinonide acetonide ON

0

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

4.10 Calcipotriol OD vs. combined calcipotriol + hydrocortisone OD

0

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

4.11 Calcitriol twice daily vs. diflucortolone valerate OM, calcitriol ON

0

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

4.12 Tacalcitol OD vs. combined calcipotriol + BMD OD

1

334

Std. Mean Difference (IV, Random, 95% CI)

0.46 [0.24, 0.68]

5 Combined end point (IAGI/TSS/PASI/PAGI) Show forest plot

17

Std. Mean Difference (IV, Random, 95% CI)

Subtotals only

5.1 Calcipotriol twice daily vs. calcipotriol OM, BMD ON

1

154

Std. Mean Difference (IV, Random, 95% CI)

0.56 [0.23, 0.88]

5.2 Calcipotriol OD vs. combined calcipotriol + BMD OD

2

1194

Std. Mean Difference (IV, Random, 95% CI)

0.66 [0.31, 1.02]

5.3 Calcipotriol twice daily vs. combined calcipotriol + BMD OD

4

1204

Std. Mean Difference (IV, Random, 95% CI)

0.43 [0.20, 0.66]

5.4 Calcipotriol twice daily vs. combined calcipotriol + BMD twice daily

3

1804

Std. Mean Difference (IV, Random, 95% CI)

0.66 [0.40, 0.93]

5.5 Calcipotriol twice daily vs. calcipotriol OM, BMV ON

2

510

Std. Mean Difference (IV, Random, 95% CI)

0.27 [‐0.19, 0.74]

5.6 Calcipotriol twice daily vs. calcipotriol OM, clobetasone butyrate ON

1

344

Std. Mean Difference (IV, Random, 95% CI)

0.27 [0.05, 0.48]

5.7 Calcipotriol twice daily vs. calcipotriol twice daily + clobetasol propionate twice daily

1

65

Std. Mean Difference (IV, Random, 95% CI)

0.88 [0.34, 1.42]

5.8 Calcipotriol twice daily vs. calcipotriol OM, diflucortolone valerate ON

1

116

Std. Mean Difference (IV, Random, 95% CI)

0.08 [‐0.29, 0.44]

5.9 Calcipotriol OD vs. calcipotriol OM, fluocinonide acetonide ON

1

38

Std. Mean Difference (IV, Random, 95% CI)

0.53 [‐0.11, 1.18]

5.10 Calcipotriol OD vs. combined calcipotriol + hydrocortisone OD

1

408

Std. Mean Difference (IV, Random, 95% CI)

0.14 [‐0.06, 0.33]

5.11 Calcitriol twice daily vs. diflucortolone valerate OM, calcitriol ON

1

142

Std. Mean Difference (IV, Random, 95% CI)

0.24 [‐0.09, 0.57]

5.12 Tacalcitol OD vs. combined calcipotriol + BMD OD

1

334

Std. Mean Difference (IV, Random, 95% CI)

0.48 [0.26, 0.70]

6 Total withdrawals Show forest plot

15

5494

Risk Difference (M‐H, Random, 95% CI)

0.03 [0.02, 0.05]

6.1 Talcipotriol vs. calcipotriol and corticosteroid

13

4985

Risk Difference (M‐H, Random, 95% CI)

0.03 [0.01, 0.05]

6.2 Calcitriol vs. calcitriol and corticosteroid

1

142

Risk Difference (M‐H, Random, 95% CI)

0.01 [‐0.08, 0.10]

6.3 Tacalcitol vs. calcipotriol and corticosteroid

1

367

Risk Difference (M‐H, Random, 95% CI)

0.05 [‐0.01, 0.11]

7 Withdrawals due to adverse events Show forest plot

13

4081

Risk Difference (M‐H, Random, 95% CI)

0.02 [0.01, 0.03]

7.1 Calcipotriol vs. calcipotriol and corticosteroid

11

3572

Risk Difference (M‐H, Random, 95% CI)

0.02 [0.01, 0.03]

7.2 Calcitriol vs. calcitriol and corticosteroid

1

142

Risk Difference (M‐H, Random, 95% CI)

0.03 [‐0.02, 0.07]

7.3 Tacalcitol vs. calcipotriol and corticosteroid

1

367

Risk Difference (M‐H, Random, 95% CI)

0.01 [‐0.02, 0.03]

8 Withdrawals due to treatment failure Show forest plot

7

1925

Risk Difference (M‐H, Random, 95% CI)

0.01 [‐0.00, 0.02]

8.1 Calcipotriol vs. calcipotriol and corticosteroid

7

1925

Risk Difference (M‐H, Random, 95% CI)

0.01 [‐0.00, 0.02]

8.2 Calcitriol vs. calcitriol and corticosteroid

0

0

Risk Difference (M‐H, Random, 95% CI)

0.0 [0.0, 0.0]

8.3 Tacalcitol vs. calcipotriol and corticosteroid

0

0

Risk Difference (M‐H, Random, 95% CI)

0.0 [0.0, 0.0]

9 Adverse events (local) Show forest plot

15

5581

Risk Difference (M‐H, Random, 95% CI)

0.06 [0.05, 0.08]

9.1 Calcipotriol vs. calcipotriol and corticosteroid

13

5084

Risk Difference (M‐H, Random, 95% CI)

0.06 [0.04, 0.08]

9.2 Calcitriol vs. calcitriol and corticosteroid

1

131

Risk Difference (M‐H, Random, 95% CI)

0.10 [0.02, 0.19]

9.3 Tacalcitol vs. calcipotriol and corticosteroid

1

366

Risk Difference (M‐H, Random, 95% CI)

0.09 [0.02, 0.15]

10 Adverse events (systemic) Show forest plot

6

2099

Risk Difference (M‐H, Random, 95% CI)

0.00 [‐0.00, 0.00]

10.1 Calcipotriol vs. calcipotriol and corticosteroid

5

1968

Risk Difference (M‐H, Random, 95% CI)

0.00 [‐0.00, 0.00]

10.2 Calcitriol vs. calcitriol and corticosteroid

1

131

Risk Difference (M‐H, Random, 95% CI)

0.0 [‐0.03, 0.03]

10.3 Tacalcitol vs. calcipotriol and corticosteroid

0

0

Risk Difference (M‐H, Random, 95% CI)

0.0 [0.0, 0.0]

Figuras y tablas -
Comparison 12. Vitamin D alone or in combination versus vitamin D + corticosteroid
Comparison 13. Vitamin D alone or in combination versus other treatments: complex regimens

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 IAGI Show forest plot

7

Std. Mean Difference (IV, Random, 95% CI)

Subtotals only

1.1 Calcipotriol (12 wks) vs. combined calcipotriol + BMD (8 wks); then calcipotriol (4 wks)

1

577

Std. Mean Difference (IV, Random, 95% CI)

‐0.12 [‐0.29, 0.04]

1.2 Calcipotriol (12 wks) vs. combined calcipotriol + BMD (4 wks); then calcipotriol (8 wks)

0

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

1.3 Calcipotriol (12 wks) vs. combined calcipotriol + BMD (4 wks); then calcipotriol (w/dy) & combined calcipotriol + BMD (w/e) (8 wks)

1

585

Std. Mean Difference (IV, Random, 95% CI)

0.13 [‐0.04, 0.29]

1.4 Calcipotriol (6 wks) vs. clobetasol propionate (2 wks); then calcipotriol (4 wks)

1

92

Std. Mean Difference (IV, Random, 95% CI)

0.60 [0.18, 1.02]

1.5 Calcipotriol (6 wks) vs. calcipotriol OM, fluocinonide acetonide ON (2 wks); then calcipotriol twice daily (4 wks)

0

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

1.6 Calcipotriol (6 wks) vs. halometasone OM, calcipotriol ON (2 wks); then calcipotriol twice daily (w/dy), halometasone (w/e) (2 wks); then calcipotriol twice daily (2wks)

1

76

Std. Mean Difference (IV, Random, 95% CI)

0.41 [‐0.05, 0.86]

1.7 Calcipotriol ON, clobetasol propionate OM (2 to 4 wks); then calcipotriol twice daily (to wk 12) vs. calcitriol ON, clobetasol propionate OM (2 to 4 wks); then calcitriol twice daily (to wk 12)

1

125

Std. Mean Difference (IV, Random, 95% CI)

‐0.19 [‐0.54, 0.16]

1.8 Combined calcipotriol + BMD (4 wks); then placebo ointment twice daily (8 wks) vs. combined calcipotriol + BMD (4 wks); then calcipotriol ointment twice daily (8 wks)

1

759

Std. Mean Difference (IV, Random, 95% CI)

0.27 [0.12, 0.41]

1.9 Combined calcipotriol + BMD (4 wks); then placebo ointment twice daily (8 wks) vs. combined calcipotriol + BMD (4 wks); then calcipotriol (w/dy)+ combined calcipotriol + BMD (w/e) (8 wks)

1

753

Std. Mean Difference (IV, Random, 95% CI)

0.51 [0.37, 0.66]

1.10 Combined calcipotriol + BMD (4 wks); then calcipotriol ointment twice daily (8 wks) vs. combined calcipotriol + BMD (4 wks); then calcipotriol (w/dy)+ combined calcipotriol + BMD (w/e) (8 wks)

1

760

Std. Mean Difference (IV, Random, 95% CI)

0.26 [0.11, 0.40]

1.11 Combined calcipotriol + BMD (8 wks); then calcipotriol (4 wks) vs. combined calcipotriol + BMD (4 wks); then calcipotriol (w/dy) & combined calcipotriol + BMD (w/e) (8 wks)

1

596

Std. Mean Difference (IV, Random, 95% CI)

0.24 [0.08, 0.40]

1.12 Tacalcitol (8 wks) vs. combined calcipotriol + BMD (4 wks); then calcipotriol (4 wks)

1

493

Std. Mean Difference (IV, Random, 95% CI)

0.54 [0.36, 0.72]

2 TSS Show forest plot

1

Std. Mean Difference (IV, Random, 95% CI)

Subtotals only

2.1 Calcipotriol (12 wks) vs. combined calcipotriol + BMD (8 wks); then calcipotriol (4 wks)

0

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

2.2 Calcipotriol (12 wks) vs. combined calcipotriol + BMD (4 wks); then calcipotriol (8 wks)

0

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

2.3 Calcipotriol (12 wks) vs. combined calcipotriol + BMD (4 wks); then calcipotriol (w/dy) & combined calcipotriol + BMD (w/e) (8 wks)

0

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

2.4 Calcipotriol (6 wks) vs. clobetasol propionate (2wks); then calcipotriol (4 wks)

1

92

Std. Mean Difference (IV, Random, 95% CI)

0.63 [0.21, 1.05]

2.5 Calcipotriol (6 wks) vs. calcipotriol OM, fluocinonide acetonide ON (2 wks); then calcipotriol twice daily (4 wks)

0

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

2.6 Calcipotriol (6 wks) vs. halometasone OM, calcipotriol ON (2 wks); then calcipotriol twice daily (w/dy), halometasone (w/e) (2 wks); then calcipotriol twice daily (2 wks)

0

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

2.7 Calcipotriol ON, clobetasol propionate OM (2 to 4 wks); then calcipotriol twice daily (to wk 12) vs. calcitriol ON, clobetasol propionate OM (2 to 4 wks); then calcitriol twice daily (to wk 12)

0

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

2.8 Combined calcipotriol + BMD (4 wks); then placebo ointment twice daily (8 wks) vs. combined calcipotriol + BMD (4 wks); then calcipotriol ointment twice daily (8 wks)

0

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

2.9 Combined calcipotriol + BMD (4 wks); then placebo ointment twice daily (8 wks) vs. combined calcipotriol + BMD (4 wks); then calcipotriol (w/dy) + combined calcipotriol + BMD (w/e) (8 wks)

0

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

2.10 Combined calcipotriol + BMD (4 wks); then calcipotriol ointment twice daily (8 wks) vs. combined calcipotriol + BMD (4 wks); then calcipotriol (w/dy) + combined calcipotriol + BMD (w/e) (8 wks)

0

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

2.11 Combined calcipotriol + BMD (8 wks); then calcipotriol (4 wks) vs. combined calcipotriol + BMD (4 wks); then calcipotriol (w/dy) & combined calcipotriol + BMD (w/e) (8 wks)

0

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

2.12 Tacalcitol (8 wks) vs. combined calcipotriol + BMD (4 wks); then calcipotriol (4 wks)

0

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

3 PASI Show forest plot

8

Std. Mean Difference (IV, Random, 95% CI)

Subtotals only

3.1 Calcipotriol (12 wks) vs. combined calcipotriol + BMD (8 wks); then calcipotriol (4 wks)

1

649

Std. Mean Difference (IV, Random, 95% CI)

‐0.04 [‐0.19, 0.11]

3.2 Calcipotriol (12 wks) vs. combined calcipotriol + BMD (4 wks); then calcipotriol (8 wks)

1

143

Std. Mean Difference (IV, Random, 95% CI)

0.29 [‐0.04, 0.62]

3.3 Calcipotriol (12 wks) vs. combined calcipotriol + BMD (4 wks); then calcipotriol (w/dy) & combined calcipotriol + BMD (w/e) (8 wks)

1

650

Std. Mean Difference (IV, Random, 95% CI)

0.10 [‐0.05, 0.25]

3.4 Calcipotriol (6 wks) vs. clobetasol propionate (2 wks); then calcipotriol (4 wks)

0

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

3.5 Calcipotriol (6 wks) vs. calcipotriol OM, fluocinonide acetonide ON (2 wks); then calcipotriol twice daily (4 wks)

1

38

Std. Mean Difference (IV, Random, 95% CI)

0.66 [0.01, 1.32]

3.6 Calcipotriol (6 wks) vs. halometasone OM, calcipotriol ON (2 wks); then calcipotriol twice daily (w/dy), halometasone (w/e) (2 wks); then calcipotriol twice daily (2 wks)

1

76

Std. Mean Difference (IV, Random, 95% CI)

1.13 [0.64, 1.62]

3.7 Calcipotriol ON, clobetasol propionate OM (2 to 4 wks); then calcipotriol twice daily (to wk 12) vs. calcitriol ON, clobetasol propionate OM (2 to 4 wks); then calcitriol twice daily (to wk 12)

1

125

Std. Mean Difference (IV, Random, 95% CI)

‐0.27 [‐0.62, 0.09]

3.8 Combined calcipotriol + BMD (4 wks); then placebo ointment twice daily (8 wks) vs. combined calcipotriol + BMD (4 wks); then calcipotriol ointment twice daily (8 wks)

1

759

Std. Mean Difference (IV, Random, 95% CI)

0.25 [0.10, 0.39]

3.9 Combined calcipotriol + BMD (4 wks); then placebo ointment twice daily (8 wks) vs. combined calcipotriol + BMD (4 wks); then calcipotriol (w/dy) + combined calcipotriol + BMD (w/e) (8 wks)

1

753

Std. Mean Difference (IV, Random, 95% CI)

0.59 [0.45, 0.74]

3.10 Combined calcipotriol + BMD (4 wks); then calcipotriol ointment twice daily (8 wks) vs. combined calcipotriol + BMD (4 wks); then calcipotriol (w/dy) + combined calcipotriol + BMD (w/e) (8 wks)

1

760

Std. Mean Difference (IV, Random, 95% CI)

0.30 [0.16, 0.45]

3.11 Combined calcipotriol + BMD (8 wks); then calcipotriol (4 wks) vs. combined calcipotriol + BMD (4 wks); then calcipotriol (w/dy) & combined calcipotriol + BMD (w/e) (8 wks)

1

645

Std. Mean Difference (IV, Random, 95% CI)

0.15 [‐0.01, 0.30]

3.12 Tacalcitol (8 wks) vs. combined calcipotriol + BMD (4 wks); then calcipotriol (4 wks)

1

501

Std. Mean Difference (IV, Random, 95% CI)

0.49 [0.31, 0.67]

4 PAGI Show forest plot

4

Std. Mean Difference (IV, Random, 95% CI)

Subtotals only

4.1 Calcipotriol (12 wks) vs. combined calcipotriol + BMD (8 wks); then calcipotriol (4 wks)

1

577

Std. Mean Difference (IV, Random, 95% CI)

‐0.14 [‐0.30, 0.02]

4.2 Calcipotriol (12 wks) vs. combined calcipotriol + BMD (4 wks); then calcipotriol (8 wks)

0

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

4.3 Calcipotriol (12 wks) vs. combined calcipotriol + BMD (4 wks); then calcipotriol (w/dy) & combined calcipotriol + BMD (w/e) (8 wks)

1

585

Std. Mean Difference (IV, Random, 95% CI)

0.10 [‐0.06, 0.26]

4.4 Calcipotriol (6 wks) vs. clobetasol propionate (2 wks); then calcipotriol (4 wks)

0

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

4.5 Calcipotriol (6 wks) vs. calcipotriol OM, fluocinonide acetonide ON (2 wks); then calcipotriol twice daily (4 wks)

0

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

4.6 Calcipotriol (6 wks) vs. halometasone OM, calcipotriol ON (2 wks); then calcipotriol twice daily (w/dy), halometasone (w/e) (2 wks); then calcipotriol twice daily (2 wks)

0

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

4.7 Calcipotriol ON, clobetasol propionate OM (2 to 4 wks); then calcipotriol twice daily (to wk 12) vs. calcitriol ON, clobetasol propionate OM (2 to 4 wks); then calcitriol twice daily (to wk 12)

0

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

4.8 Combined calcipotriol + BMD (4 wks); then placebo ointment twice daily (8 wks) vs. combined calcipotriol + BMD (4 wks); then calcipotriol ointment twice daily (8 wks)

1

759

Std. Mean Difference (IV, Random, 95% CI)

0.28 [0.13, 0.42]

4.9 Combined calcipotriol + BMD (4 wks); then placebo ointment twice daily (8 wks) vs. combined calcipotriol + BMD (4 wks); then calcipotriol (w/dy) + combined calcipotriol + BMD (w/e) (8 wks)

1

753

Std. Mean Difference (IV, Random, 95% CI)

0.71 [0.56, 0.85]

4.10 Combined calcipotriol + BMD (4 wks); then calcipotriol ointment twice daily (8 wks) vs. combined calcipotriol + BMD (4 wks); then calcipotriol (w/dy) + combined calcipotriol + BMD (w/e) (8 wks)

1

760

Std. Mean Difference (IV, Random, 95% CI)

0.44 [0.29, 0.58]

4.11 Combined calcipotriol + BMD (8 wks); then calcipotriol (4 wks) vs. combined calcipotriol + BMD (4 wks); then calcipotriol (w/dy) & combined calcipotriol + BMD (w/e) (8 wks)

1

596

Std. Mean Difference (IV, Random, 95% CI)

0.23 [0.07, 0.39]

4.12 Tacalcitol (8 wks) vs. combined calcipotriol + BMD (4 wks); then calcipotriol (4 wks)

1

493

Std. Mean Difference (IV, Random, 95% CI)

0.54 [0.36, 0.72]

5 Combined end point (IAGI/TSS/PASI/PAGI) Show forest plot

9

Std. Mean Difference (IV, Random, 95% CI)

Subtotals only

5.1 Calcipotriol (12 wks) vs. combined calcipotriol + BMD (8 wks); then calcipotriol (4 wks)

1

577

Std. Mean Difference (IV, Random, 95% CI)

‐0.12 [‐0.29, 0.04]

5.2 Calcipotriol (12 wks) vs. combined calcipotriol + BMD (4 wks); then calcipotriol (8 wks)

1

143

Std. Mean Difference (IV, Random, 95% CI)

0.29 [‐0.04, 0.62]

5.3 Calcipotriol (12 wks) vs. combined calcipotriol + BMD (4 wks); then calcipotriol (w/dy) & combined calcipotriol + BMD (w/e) (8 wks)

1

585

Std. Mean Difference (IV, Random, 95% CI)

0.13 [‐0.04, 0.29]

5.4 Calcipotriol (6 wks) vs. clobetasol propionate (2 wks); then calcipotriol (4 wks)

1

92

Std. Mean Difference (IV, Random, 95% CI)

0.60 [0.18, 1.02]

5.5 Calcipotriol (6 wks) vs. calcipotriol OM, fluocinonide acetonide ON (2 wks); then calcipotriol twice daily (4 wks)

1

38

Std. Mean Difference (IV, Random, 95% CI)

0.66 [0.01, 1.32]

5.6 Calcipotriol (6 wks) vs. halometasone OM, calcipotriol ON (2 wks); then calcipotriol twice daily (w/dy), halometasone (w/e) (2 wks); then calcipotriol twice daily (2 wks)

1

76

Std. Mean Difference (IV, Random, 95% CI)

0.41 [‐0.05, 0.86]

5.7 Calcipotriol ON, clobetasol propionate OM (2 to 4 wks); then calcipotriol twice daily (to wk 12) vs. calcitriol ON, clobetasol propionate OM (2 to 4 wks); then calcitriol twice daily (to wk 12)

1

125

Std. Mean Difference (IV, Random, 95% CI)

‐0.19 [‐0.54, 0.16]

5.8 Combined calcipotriol + BMD (4 wks); then placebo ointment twice daily (8 wks) vs. combined calcipotriol + BMD (4 wks); then calcipotriol ointment twice daily (8 wks)

1

759

Std. Mean Difference (IV, Random, 95% CI)

0.27 [0.12, 0.41]

5.9 Combined calcipotriol + BMD (4 wks); then placebo ointment twice daily (8 wks) vs. combined calcipotriol + BMD (4 wks); then calcipotriol (w/dy)+ combined calcipotriol + BMD (w/e) (8 wks)

1

753

Std. Mean Difference (IV, Random, 95% CI)

0.51 [0.37, 0.66]

5.10 Combined calcipotriol + BMD (4 wks); then calcipotriol ointment twice daily (8 wks) vs. combined calcipotriol + BMD (4 wks); then calcipotriol (w/dy) + combined calcipotriol + BMD (w/e) (8 wks)

1

760

Std. Mean Difference (IV, Random, 95% CI)

0.26 [0.11, 0.40]

5.11 Combined calcipotriol + BMD (8 wks); then calcipotriol (4 wks) vs. combined calcipotriol + BMD (4 wks); then calcipotriol (w/dy) & combined calcipotriol + BMD (w/e) (8 wks)

1

596

Std. Mean Difference (IV, Random, 95% CI)

0.24 [0.08, 0.40]

5.12 Tacalcitol (8 wks) vs. combined calcipotriol + BMD (4 wks); then calcipotriol (4 wks)

1

493

Std. Mean Difference (IV, Random, 95% CI)

0.54 [0.36, 0.72]

6 Total withdrawals Show forest plot

9

Risk Difference (M‐H, Random, 95% CI)

Subtotals only

6.1 Calcipotriol (12 wks) vs. combined calcipotriol + BMD (8 wks); then calcipotriol (4 wks)

1

649

Risk Difference (M‐H, Random, 95% CI)

0.05 [0.00, 0.10]

6.2 Calcipotriol (12 wks) vs. combined calcipotriol + BMD (4 wks); then calcipotriol (8 wks)

1

150

Risk Difference (M‐H, Random, 95% CI)

0.04 [‐0.09, 0.17]

6.3 Calcipotriol (12 wks) vs. combined calcipotriol + BMD (4 wks); then calcipotriol (w/dy) & combined calcipotriol + BMD (w/e) (8 wks)

1

649

Risk Difference (M‐H, Random, 95% CI)

0.08 [0.03, 0.13]

6.4 Calcipotriol (6 wks) vs. clobetasol propionate (2 wks); then calcipotriol (4 wks)

1

98

Risk Difference (M‐H, Random, 95% CI)

0.0 [‐0.09, 0.09]

6.5 Calcipotriol (6 wks) vs. calcipotriol OM, fluocinonide acetonide ON (2 wks); then calcipotriol twice daily (4 wks)

1

38

Risk Difference (M‐H, Random, 95% CI)

0.0 [‐0.10, 0.10]

6.6 Calcipotriol (6 wks) vs. halometasone OM, calcipotriol ON (2 wks); then calcipotriol twice daily (w/dy), halometasone (w/e) (2 wks); then calcipotriol twice daily (2 wks)

1

76

Risk Difference (M‐H, Random, 95% CI)

0.0 [‐0.05, 0.05]

6.7 Calcipotriol ON, clobetasol propionate OM (2 to 4 wks); then calcipotriol twice daily (to wk 12) vs. calcitriol ON, clobetasol propionate OM (2 to 4 wks); then calcitriol twice daily (to wk 12)

1

125

Risk Difference (M‐H, Random, 95% CI)

‐0.01 [‐0.12, 0.11]

6.8 Combined calcipotriol + BMD (4 wks); then placebo ointment twice daily (8 wks) vs. combined calcipotriol + BMD (4 wks); then calcipotriol ointment twice daily (8 wks)

1

759

Risk Difference (M‐H, Random, 95% CI)

0.08 [0.03, 0.14]

6.9 Combined calcipotriol + BMD (4 wks); then placebo ointment twice daily (8 wks) vs. combined calcipotriol + BMD (4 wks); then calcipotriol (w/dy) + combined calcipotriol + BMD (w/e) (8 wks)

1

753

Risk Difference (M‐H, Random, 95% CI)

0.11 [0.06, 0.17]

6.10 Combined calcipotriol + BMD (4 wks); then calcipotriol ointment twice daily (8 wks) vs. combined calcipotriol + BMD (4 wks); then calcipotriol (w/dy) + combined calcipotriol + BMD (w/e) (8 wks)

1

760

Risk Difference (M‐H, Random, 95% CI)

0.03 [‐0.01, 0.07]

6.11 Combined calcipotriol + BMD (8 wks); then calcipotriol (4 wks) vs. combined calcipotriol + BMD (4 wks); then calcipotriol (w/dy) & combined calcipotriol + BMD (w/e) (8 wks)

1

644

Risk Difference (M‐H, Random, 95% CI)

0.03 [‐0.01, 0.07]

6.12 Tacalcitol (8 wks) vs. combined calcipotriol + BMD (4 wks); then calcipotriol (4 wks)

1

501

Risk Difference (M‐H, Random, 95% CI)

0.05 [‐0.01, 0.12]

7 Withdrawals due to adverse events Show forest plot

8

Risk Difference (M‐H, Random, 95% CI)

Subtotals only

7.1 Calcipotriol (12 wks) vs. combined calcipotriol + BMD (8 wks); then calcipotriol (4 wks)

0

0

Risk Difference (M‐H, Random, 95% CI)

0.0 [0.0, 0.0]

7.2 Calcipotriol (12 wks) vs. combined calcipotriol + BMD (4 wks); then calcipotriol (8 wks)

1

150

Risk Difference (M‐H, Random, 95% CI)

‐0.04 [‐0.09, 0.01]

7.3 Calcipotriol (12 wks) vs. combined calcipotriol + BMD (4 wks); then calcipotriol (w/dy) & combined calcipotriol + BMD (w/e) (8 wks)

0

0

Risk Difference (M‐H, Random, 95% CI)

0.0 [0.0, 0.0]

7.4 Calcipotriol (6 wks) vs. clobetasol propionate (2 wks); then calcipotriol (4 wks)

1

98

Risk Difference (M‐H, Random, 95% CI)

0.0 [‐0.04, 0.04]

7.5 Calcipotriol (6 wks) vs. calcipotriol OM, fluocinonide acetonide ON (2 wks); then calcipotriol twice daily (4 wks)

1

38

Risk Difference (M‐H, Random, 95% CI)

0.0 [‐0.10, 0.10]

7.6 Calcipotriol (6 wks) vs. halometasone OM, calcipotriol ON (2 wks); then calcipotriol twice daily (w/dy), halometasone (w/e) (2 wks); then calcipotriol twice daily (2 wks)

1

76

Risk Difference (M‐H, Random, 95% CI)

0.0 [‐0.05, 0.05]

7.7 Calcipotriol ON, clobetasol propionate OM (2 to 4 wks); then calcipotriol twice daily (to wk 12) vs. calcitriol ON, clobetasol propionate OM (2 to 4 wks); then calcitriol twice daily (to wk 12)

1

125

Risk Difference (M‐H, Random, 95% CI)

‐0.02 [‐0.06, 0.03]

7.8 Combined calcipotriol + BMD (4 wks); then placebo ointment twice daily (8 wks) vs. combined calcipotriol + BMD (4 wks); then calcipotriol ointment twice daily (8 wks)

1

759

Risk Difference (M‐H, Random, 95% CI)

0.01 [‐0.01, 0.02]

7.9 Combined calcipotriol + BMD (4 wks); then placebo ointment twice daily (8 wks) vs. combined calcipotriol + BMD (4 wks); then calcipotriol (w/dy) + combined calcipotriol + BMD (w/e) (8 wks)

1

753

Risk Difference (M‐H, Random, 95% CI)

‐0.00 [‐0.02, 0.02]

7.10 Combined calcipotriol + BMD (4 wks); then calcipotriol ointment twice daily (8 wks) vs. combined calcipotriol + BMD (4 wks); then calcipotriol (w/dy) + combined calcipotriol + BMD (w/e) (8 wks)

1

760

Risk Difference (M‐H, Random, 95% CI)

‐0.01 [‐0.03, 0.01]

7.11 Combined calcipotriol + BMD (8 wks); then calcipotriol (4 wks) vs. combined calcipotriol + BMD (4 wks); then calcipotriol (w/dy) & combined calcipotriol + BMD (w/e) (8 wks)

0

0

Risk Difference (M‐H, Random, 95% CI)

0.0 [0.0, 0.0]

7.12 Tacalcitol (8 wks) vs. combined calcipotriol + BMD (4 wks); then calcipotriol (4 wks)

1

501

Risk Difference (M‐H, Random, 95% CI)

0.02 [‐0.01, 0.05]

8 Withdrawals due to treatment failure Show forest plot

6

Risk Difference (M‐H, Random, 95% CI)

Subtotals only

8.1 Calcipotriol (12 wks) vs. combined calcipotriol + BMD (8 wks); then calcipotriol (4 wks)

0

0

Risk Difference (M‐H, Random, 95% CI)

0.0 [0.0, 0.0]

8.2 Calcipotriol (12 wks) vs. combined calcipotriol + BMD (4 wks); then calcipotriol (8 wks)

1

150

Risk Difference (M‐H, Random, 95% CI)

0.21 [0.10, 0.33]

8.3 Calcipotriol (12 wks) vs. combined calcipotriol + BMD (4 wks); then calcipotriol (w/dy) & combined calcipotriol + BMD (w/e) (8 wks)

0

0

Risk Difference (M‐H, Random, 95% CI)

0.0 [0.0, 0.0]

8.4 Calcipotriol (6 wks) vs. clobetasol propionate (2 wks); then calcipotriol (4 wks)

1

98

Risk Difference (M‐H, Random, 95% CI)

0.0 [‐0.04, 0.04]

8.5 Calcipotriol (6 wks) vs. calcipotriol OM, fluocinonide acetonide ON (2 wks); then calcipotriol twice daily (4 wks)

1

38

Risk Difference (M‐H, Random, 95% CI)

0.0 [‐0.10, 0.10]

8.6 Calcipotriol (6 wks) vs. halometasone OM, calcipotriol ON (2 wks); then calcipotriol twice daily (w/dy), halometasone (w/e) (2 wks); then calcipotriol twice daily (2 wks)

1

76

Risk Difference (M‐H, Random, 95% CI)

0.0 [‐0.05, 0.05]

8.7 Calcipotriol ON, clobetasol propionate OM (2 to 4 wks); then calcipotriol twice daily (to wk 12) vs. calcitriol ON, clobetasol propionate OM (2 to 4 wks); then calcitriol twice daily (to wk 12)

1

125

Risk Difference (M‐H, Random, 95% CI)

0.03 [‐0.04, 0.10]

8.8 Combined calcipotriol + BMD (4 wks); then placebo ointment twice daily (8 wks) vs. combined calcipotriol + BMD (4 wks); then calcipotriol ointment twice daily (8 wks)

0

0

Risk Difference (M‐H, Random, 95% CI)

0.0 [0.0, 0.0]

8.9 Combined calcipotriol + BMD (4 wks); then placebo ointment twice daily (8 wks) vs. combined calcipotriol + BMD (4 wks); then calcipotriol (w/dy) + combined calcipotriol + BMD (w/e) (8 wks)

0

0

Risk Difference (M‐H, Random, 95% CI)

0.0 [0.0, 0.0]

8.10 Combined calcipotriol + BMD (4 wks); then calcipotriol ointment twice daily (8 wks) vs. combined calcipotriol + BMD (4 wks); then calcipotriol (w/dy)+ combined calcipotriol + BMD (w/e) (8 wks)

0

0

Risk Difference (M‐H, Random, 95% CI)

0.0 [0.0, 0.0]

8.11 Combined calcipotriol + BMD (8 wks); then calcipotriol (4 wks) vs. combined calcipotriol + BMD (4 wks); then calcipotriol (w/dy) & combined calcipotriol + BMD (w/e) (8 wks)

0

0

Risk Difference (M‐H, Random, 95% CI)

0.0 [0.0, 0.0]

8.12 Tacalcitol (8 wks) vs. combined calcipotriol + BMD (4 wks); then calcipotriol (4 wks)

1

501

Risk Difference (M‐H, Random, 95% CI)

0.05 [0.02, 0.08]

9 Adverse events (local) Show forest plot

8

Risk Difference (M‐H, Random, 95% CI)

Subtotals only

9.1 Calcipotriol (12 wks) vs. combined calcipotriol + BMD (8 wks); then calcipotriol (4 wks)

1

649

Risk Difference (M‐H, Random, 95% CI)

0.11 [0.06, 0.17]

9.2 Calcipotriol (12 wks) vs. combined calcipotriol + BMD (4 wks); then calcipotriol (8 wks)

0

0

Risk Difference (M‐H, Random, 95% CI)

0.0 [0.0, 0.0]

9.3 Calcipotriol (12 wks) vs. combined calcipotriol + BMD (4 wks); then calcipotriol (w/dy) & combined calcipotriol + BMD (w/e) (8 wks)

1

649

Risk Difference (M‐H, Random, 95% CI)

0.11 [0.05, 0.17]

9.4 Calcipotriol (6 wks) vs. clobetasol propionate (2 wks); then calcipotriol (4 wks)

1

98

Risk Difference (M‐H, Random, 95% CI)

0.02 [‐0.08, 0.12]

9.5 Calcipotriol (6 wks) vs. calcipotriol OM, fluocinonide acetonide ON (2 wks); then calcipotriol twice daily (4 wks)

1

38

Risk Difference (M‐H, Random, 95% CI)

0.0 [‐0.14, 0.14]

9.6 Calcipotriol (6 wks) vs. halometasone OM, calcipotriol ON (2 wks); then calcipotriol twice daily (w/dy), halometasone (w/e) (2 wks); then calcipotriol twice daily (2 wks)

1

76

Risk Difference (M‐H, Random, 95% CI)

0.26 [0.07, 0.45]

9.7 Calcipotriol ON, clobetasol propionate OM (2 to 4 wks); then calcipotriol twice daily (to wk 12) vs. calcitriol ON, clobetasol propionate OM (2 to 4 wks); then calcitriol twice daily (to wk 12)

1

125

Risk Difference (M‐H, Random, 95% CI)

‐0.02 [‐0.10, 0.06]

9.8 Combined calcipotriol + BMD (4 wks); then placebo ointment twice daily (8 wks) vs. combined calcipotriol + BMD (4 wks); then calcipotriol ointment twice daily (8 wks)

1

752

Risk Difference (M‐H, Random, 95% CI)

‐0.03 [‐0.07, 0.02]

9.9 Combined calcipotriol + BMD (4 wks); then placebo ointment twice daily (8 wks) vs. combined calcipotriol + BMD (4 wks); then calcipotriol (w/dy) + combined calcipotriol + BMD (w/e) (8 wks)

1

743

Risk Difference (M‐H, Random, 95% CI)

0.01 [‐0.03, 0.05]

9.10 Combined calcipotriol + BMD (4 wks); then calcipotriol ointment twice daily (8 wks) vs. combined calcipotriol + BMD (4 wks); then calcipotriol (w/dy) + combined calcipotriol + BMD (w/e) (8 wks)

1

749

Risk Difference (M‐H, Random, 95% CI)

0.04 [‐0.00, 0.08]

9.11 Combined calcipotriol + BMD (8 wks); then calcipotriol (4 wks) vs. combined calcipotriol + BMD (4 wks); then calcipotriol (w/dy) & combined calcipotriol + BMD (w/e) (8 wks)

1

644

Risk Difference (M‐H, Random, 95% CI)

‐0.01 [‐0.05, 0.04]

9.12 Tacalcitol (8 wks) vs. combined calcipotriol + BMD (4 wks); then calcipotriol (4 wks)

1

501

Risk Difference (M‐H, Random, 95% CI)

0.06 [0.01, 0.11]

10 Adverse events (systemic)

0

0

Risk Difference (M‐H, Random, 95% CI)

0.0 [0.0, 0.0]

10.1 Calcipotriol (12 wks) vs. combined calcipotriol + BMD (8 wks); then calcipotriol (4 wks)

0

0

Risk Difference (M‐H, Random, 95% CI)

0.0 [0.0, 0.0]

10.2 Calcipotriol (12 wks) vs. combined calcipotriol + BMD (4 wks); then calcipotriol (8 wks)

0

0

Risk Difference (M‐H, Random, 95% CI)

0.0 [0.0, 0.0]

10.3 Calcipotriol (12 wks) vs. combined calcipotriol + BMD (4 wks); then calcipotriol (w/dy) & combined calcipotriol + BMD (w/e) (8 wks)

0

0

Risk Difference (M‐H, Random, 95% CI)

0.0 [0.0, 0.0]

10.4 Calcipotriol (6 wks) vs. clobetasol propionate (2 wks); then calcipotriol (4 wks)

0

0

Risk Difference (M‐H, Random, 95% CI)

0.0 [0.0, 0.0]

10.5 Calcipotriol (6 wks) vs. calcipotriol OM, fluocinonide acetonide ON (2 wks); then calcipotriol twice daily (4 wks)

0

0

Risk Difference (M‐H, Random, 95% CI)

0.0 [0.0, 0.0]

10.6 Calcipotriol (6 wks) vs. halometasone OM, calcipotriol ON (2 wks); then calcipotriol twice daily (w/dy), halometasone (w/e) (2 wks); then calcipotriol twice daily (2 wks)

0

0

Risk Difference (M‐H, Random, 95% CI)

0.0 [0.0, 0.0]

10.7 Calcipotriol ON, clobetasol propionate OM (2 to 4 wks); then calcipotriol twice daily (to wk 12) vs. calcitriol ON, clobetasol propionate OM (2 to 4 wks); then calcitriol twice daily (to wk 12)

0

0

Risk Difference (M‐H, Random, 95% CI)

0.0 [0.0, 0.0]

10.8 Combined calcipotriol + BMD (4 wks); then placebo ointment twice daily (8 wks) vs. combined calcipotriol + BMD (4 wks); then calcipotriol ointment twice daily (8 wks)

0

0

Risk Difference (M‐H, Random, 95% CI)

0.0 [0.0, 0.0]

10.9 Combined calcipotriol + BMD (4 wks); then placebo ointment twice daily (8 wks) vs. combined calcipotriol + BMD (4 wks); then calcipotriol (w/dy) + combined calcipotriol + BMD (w/e) (8 wks)

0

0

Risk Difference (M‐H, Random, 95% CI)

0.0 [0.0, 0.0]

10.10 Combined calcipotriol + BMD (4 wks); then calcipotriol ointment twice daily (8 wks) vs. combined calcipotriol + BMD (4 wks); then calcipotriol (w/dy) + combined calcipotriol + BMD (w/e) (8 wks)

0

0

Risk Difference (M‐H, Random, 95% CI)

0.0 [0.0, 0.0]

10.11 Combined calcipotriol + BMD (8 wks); then calcipotriol (4 wks) vs. combined calcipotriol + BMD (4 wks); then calcipotriol (w/dy) & combined calcipotriol + BMD (w/e) (8 wks)

0

0

Risk Difference (M‐H, Random, 95% CI)

0.0 [0.0, 0.0]

10.12 Tacalcitol (8 wks) vs. combined calcipotriol + BMD (4 wks); then calcipotriol (4 wks)

0

0

Risk Difference (M‐H, Random, 95% CI)

0.0 [0.0, 0.0]

Figuras y tablas -
Comparison 13. Vitamin D alone or in combination versus other treatments: complex regimens
Comparison 14. Vitamin D alone or in combination versus other treatment: long‐term studies (> 24 wks)

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 IAGI Show forest plot

1

Std. Mean Difference (IV, Random, 95% CI)

Totals not selected

1.1 Combined calcipotriol + BMD (52 wks) vs. alternating: combined calcipotriol + BMD (4 wks); then calcipotriol (4 wks)

1

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

1.2 Combined calcipotriol + BMD (52 wks) vs. combined calcipotriol + BMD (4 wks); then calcipotriol (48 wks)

1

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

1.3 Alternating: combined calcipotriol + BMD (4 wks); then calcipotriol (4 wks) vs. combined calcipotriol + BMD (4 wks); then calcipotriol (48 wks)

1

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

2 TSS

0

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

2.1 Combined calcipotriol + BMD (52 wks) vs. alternating: combined calcipotriol + BMD (4 wks); then calcipotriol (4 wks)

0

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

2.2 Combined calcipotriol + BMD (52 wks) vs. combined calcipotriol + BMD (4 wks); then calcipotriol (48 wks)

0

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

2.3 Alternating: combined calcipotriol + BMD (4 wks); then calcipotriol (4 wks) vs. combined calcipotriol + BMD (4 wks); then calcipotriol (48 wks)

0

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

3 PASI

0

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

3.1 Combined calcipotriol + BMD (52 wks) vs. alternating: combined calcipotriol + BMD (4 wks); then calcipotriol (4 wks)

0

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

3.2 Combined calcipotriol + BMD (52 wks) vs. combined calcipotriol + BMD (4 wks); then calcipotriol (48 wks)

0

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

3.3 Alternating: combined calcipotriol + BMD (4 wks); then calcipotriol (4 wks) vs. combined calcipotriol + BMD (4 wks); then calcipotriol (48 wks)

0

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

4 PAGI

0

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

4.1 Combined calcipotriol + BMD (52 wks) vs. alternating: combined calcipotriol + BMD (4 wks); then calcipotriol (4 wks)

0

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

4.2 Combined calcipotriol + BMD (52 wks) vs. combined calcipotriol + BMD (4 wks); then calcipotriol (48 wks)

0

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

4.3 Alternating: combined calcipotriol + BMD (4 wks); then calcipotriol (4 wks) vs. combined calcipotriol + BMD (4 wks); then calcipotriol (48 wks)

0

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

5 Combined end point (IAGI/TSS/PASI/PAGI) Show forest plot

1

Std. Mean Difference (IV, Random, 95% CI)

Totals not selected

5.1 Combined calcipotriol + BMD (52 wks) vs. alternating: combined calcipotriol + BMD (4 wks); then calcipotriol (4 wks)

1

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

5.2 Combined calcipotriol + BMD (52 wks) vs. combined calcipotriol + BMD (4 wks); then calcipotriol (48 wks)

1

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

5.3 Alternating: combined calcipotriol + BMD (4 wks); then calcipotriol (4 wks) vs. combined calcipotriol + BMD (4 wks); then calcipotriol (48 wks)

1

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

6 Total withdrawals Show forest plot

1

Risk Difference (M‐H, Random, 95% CI)

Totals not selected

6.1 Combined calcipotriol + BMD (52 wks) vs. alternating: combined calcipotriol + BMD (4 wks); then calcipotriol (4 wks)

1

Risk Difference (M‐H, Random, 95% CI)

0.0 [0.0, 0.0]

6.2 Combined calcipotriol + BMD (52 wks) vs. combined calcipotriol + BMD (4 wks); then calcipotriol (48 wks)

1

Risk Difference (M‐H, Random, 95% CI)

0.0 [0.0, 0.0]

6.3 Alternating: combined calcipotriol + BMD (4 wks); then calcipotriol (4 wks) vs. combined calcipotriol + BMD (4 wks); then calcipotriol (48 wks)

1

Risk Difference (M‐H, Random, 95% CI)

0.0 [0.0, 0.0]

7 Withdrawals due to adverse events Show forest plot

1

Risk Difference (M‐H, Random, 95% CI)

Totals not selected

7.1 Combined calcipotriol + BMD (52 wks) vs. alternating: combined calcipotriol + BMD (4 wks); then calcipotriol (4 wks)

1

Risk Difference (M‐H, Random, 95% CI)

0.0 [0.0, 0.0]

7.2 Combined calcipotriol + BMD (52 wks) vs. combined calcipotriol + BMD (4 wks); then calcipotriol (48 wks)

1

Risk Difference (M‐H, Random, 95% CI)

0.0 [0.0, 0.0]

7.3 Alternating: combined calcipotriol + BMD (4 wks); then calcipotriol (4 wks) vs. combined calcipotriol + BMD (4 wks); then calcipotriol (48 wks)

1

Risk Difference (M‐H, Random, 95% CI)

0.0 [0.0, 0.0]

8 Withdrawals due to treatment failure Show forest plot

1

Risk Difference (M‐H, Random, 95% CI)

Totals not selected

8.1 Combined calcipotriol + BMD (52 wks) vs. alternating: combined calcipotriol + BMD (4 wks); then calcipotriol (4 wks)

1

Risk Difference (M‐H, Random, 95% CI)

0.0 [0.0, 0.0]

8.2 Combined calcipotriol + BMD (52 wks) vs. combined calcipotriol + BMD (4 wks); then calcipotriol (48 wks)

1

Risk Difference (M‐H, Random, 95% CI)

0.0 [0.0, 0.0]

8.3 Alternating: combined calcipotriol + BMD (4 wks); then calcipotriol (4 wks) vs. combined calcipotriol + BMD (4 wks); then calcipotriol (48 wks)

1

Risk Difference (M‐H, Random, 95% CI)

0.0 [0.0, 0.0]

9 Adverse events (local) Show forest plot

1

Risk Difference (M‐H, Random, 95% CI)

Totals not selected

9.1 Combined calcipotriol + BMD (52 wks) vs. alternating: combined calcipotriol + BMD (4 wks); then calcipotriol (4 wks)

1

Risk Difference (M‐H, Random, 95% CI)

0.0 [0.0, 0.0]

9.2 Combined calcipotriol + BMD (52 wks) vs. combined calcipotriol + BMD (4 wks); then calcipotriol (48 wks)

1

Risk Difference (M‐H, Random, 95% CI)

0.0 [0.0, 0.0]

9.3 Alternating: combined calcipotriol + BMD (4 wks); then calcipotriol (4 wks) vs. combined calcipotriol + BMD (4 wks); then calcipotriol (48 wks)

1

Risk Difference (M‐H, Random, 95% CI)

0.0 [0.0, 0.0]

10 Adverse events (systemic)

0

Risk Difference (M‐H, Random, 95% CI)

Subtotals only

10.1 Combined calcipotriol + BMD (52 wks) vs. alternating: combined calcipotriol + BMD (4 wks); then calcipotriol (4 wks)

0

0

Risk Difference (M‐H, Random, 95% CI)

0.0 [0.0, 0.0]

10.2 Combined calcipotriol + BMD (52 wks) vs. combined calcipotriol + BMD (4 wks); then calcipotriol (48 wks)

0

0

Risk Difference (M‐H, Random, 95% CI)

0.0 [0.0, 0.0]

10.3 Alternating: combined calcipotriol + BMD (4 wks); then calcipotriol (4 wks) vs. combined calcipotriol + BMD (4 wks); then calcipotriol (48 wks)

0

0

Risk Difference (M‐H, Random, 95% CI)

0.0 [0.0, 0.0]

Figuras y tablas -
Comparison 14. Vitamin D alone or in combination versus other treatment: long‐term studies (> 24 wks)
Comparison 15. Vitamin D analogues versus other treatment

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 IAGI Show forest plot

10

Std. Mean Difference (IV, Random, 95% CI)

Subtotals only

1.1 Calcipotriol vs. coal tar

3

139

Std. Mean Difference (IV, Random, 95% CI)

‐0.53 [‐1.74, 0.68]

1.2 Calcipotriol vs. coal tar polytherapy

2

209

Std. Mean Difference (IV, Random, 95% CI)

‐0.59 [‐0.87, ‐0.31]

1.3 Calcipotriol vs. nicotinamide 1.4%, twice daily

0

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

1.4 Calcipotriol vs. calcipotriol + nicotinamide 1.4%, twice daily

0

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

1.5 Calcipotriol vs. corticosteroid + salicylic acid

1

200

Std. Mean Difference (IV, Random, 95% CI)

‐0.06 [‐0.33, 0.22]

1.6 Calcipotriol vs. propylthiouracil cream

0

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

1.7 Calcipotriol vs. tazarotene

0

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

1.8 Calcipotriol vs. tacrolimus ointment

1

124

Std. Mean Difference (IV, Random, 95% CI)

‐0.22 [‐0.60, 0.16]

1.9 Calcipotriol vs. tazarotene gel plus mometasone furoate cream

0

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

1.10 Calcipotriol vs. vitamin B12 cream

1

26

Std. Mean Difference (IV, Random, 95% CI)

‐0.55 [‐1.33, 0.24]

1.11 Head‐to‐head vitamin D alone or in combination: twice daily vs OD

2

728

Std. Mean Difference (IV, Random, 95% CI)

‐0.24 [‐0.38, ‐0.09]

1.12 Head‐to‐head vitamin D alone or in combination: no occlusion vs. occlusion

0

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

2 TSS Show forest plot

7

Std. Mean Difference (IV, Random, 95% CI)

Subtotals only

2.1 Calcipotriol vs. coal tar

0

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

2.2 Calcipotriol vs. coal tar polytherapy

1

132

Std. Mean Difference (IV, Random, 95% CI)

‐0.51 [‐0.86, ‐0.16]

2.3 Calcipotriol vs. nicotinamide 1.4%, twice daily

1

96

Std. Mean Difference (IV, Random, 95% CI)

‐0.09 [‐0.49, 0.31]

2.4 Calcipotriol vs. calcipotriol+nicotinamide (0.05%, 0.1%, 0.7%, or 1.4%), twice daily

1

192

Std. Mean Difference (IV, Random, 95% CI)

0.19 [‐0.14, 0.52]

2.5 Calcipotriol vs. corticosteroid + salicylic acid

0

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

2.6 Calcipotriol vs. propylthiouracil cream

0

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

2.7 Calcipotriol vs. tacrolimus ointment

2

171

Std. Mean Difference (IV, Random, 95% CI)

‐0.35 [‐1.51, 0.81]

2.8 Calcipotriol vs. tazarotene

1

199

Std. Mean Difference (IV, Random, 95% CI)

‐0.05 [‐0.33, 0.23]

2.9 Calcipotriol vs. tazarotene gel plus mometasone furoate cream

0

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

2.10 Calcipotriol vs. vitamin B12 cream

0

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

2.11 Head‐to‐head vitamin D alone or in combination: twice daily vs OD

0

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

2.12 Head‐to‐head vitamin D alone or in combination: no occlusion vs. occlusion

2

247

Std. Mean Difference (IV, Random, 95% CI)

‐0.18 [‐2.04, 1.68]

3 PASI Show forest plot

9

Std. Mean Difference (IV, Random, 95% CI)

Subtotals only

3.1 Calcipotriol vs. coal tar

2

109

Std. Mean Difference (IV, Random, 95% CI)

‐0.10 [‐1.54, 1.35]

3.2 Calcipotriol vs. coal tar polytherapy

1

87

Std. Mean Difference (IV, Random, 95% CI)

‐0.63 [‐1.06, ‐0.20]

3.3 Calcipotriol vs. nicotinamide 1.4%, twice daily

0

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

3.4 Calcipotriol vs. calcipotriol + nicotinamide 1.4%, twice daily

0

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

3.5 Calcipotriol vs. corticosteroid + salicylic acid

1

160

Std. Mean Difference (IV, Random, 95% CI)

‐0.05 [‐0.36, 0.26]

3.6 Calcipotriol vs. propylthiouracil cream

1

27

Std. Mean Difference (IV, Random, 95% CI)

‐2.24 [‐3.23, ‐1.25]

3.7 Calcipotriol vs. tacrolimus ointment

0

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

3.8 Calcipotriol vs. tazarotene

0

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

3.9 Calcipotriol vs. tazarotene gel plus mometasone furoate cream

0

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

3.10 Calcipotriol vs. vitamin B12 cream

1

26

Std. Mean Difference (IV, Random, 95% CI)

‐0.01 [‐0.78, 0.75]

3.11 Head‐to‐head vitamin D alone or in combination: twice daily vs OD

3

989

Std. Mean Difference (IV, Random, 95% CI)

‐0.12 [‐0.25, 0.00]

3.12 Head‐to‐head vitamin D alone or in combination: no occlusion vs. occlusion

0

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

4 PAGI Show forest plot

6

Std. Mean Difference (IV, Random, 95% CI)

Subtotals only

4.1 Calcipotriol vs. coal tar

1

54

Std. Mean Difference (IV, Random, 95% CI)

‐1.51 [‐2.12, ‐0.90]

4.2 Calcipotriol vs. coal tar polytherapy

1

87

Std. Mean Difference (IV, Random, 95% CI)

‐0.56 [‐0.99, ‐0.13]

4.3 Calcipotriol vs. nicotinamide 1.4%, twice daily

0

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

4.4 Calcipotriol vs. calcipotriol + nicotinamide 1.4%, twice daily

0

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

4.5 Calcipotriol vs. corticosteroid + salicylic acid

1

186

Std. Mean Difference (IV, Random, 95% CI)

‐0.49 [‐0.79, ‐0.20]

4.6 Calcipotriol vs. propylthiouracil cream

0

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

4.7 Calcipotriol vs. tacrolimus ointment

1

124

Std. Mean Difference (IV, Random, 95% CI)

‐0.13 [‐0.51, 0.24]

4.8 Calcipotriol vs. tazarotene

1

38

Std. Mean Difference (IV, Random, 95% CI)

‐0.35 [‐0.99, 0.29]

4.9 Calcipotriol vs. tazarotene gel plus mometasone furoate cream

0

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

4.10 Calcipotriol vs. vitamin B12 cream

1

26

Std. Mean Difference (IV, Random, 95% CI)

‐0.55 [‐1.33, 0.24]

4.11 Head‐to‐head vitamin D alone or in combination: twice daily vs OD

0

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

4.12 Head‐to‐head vitamin D alone or in combination: no occlusion vs. occlusion

0

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

5 Combined end point (IAGI/TSS/PASI/PAGI) Show forest plot

19

Std. Mean Difference (IV, Random, 95% CI)

Subtotals only

5.1 Calcipotriol vs. coal tar

3

139

Std. Mean Difference (IV, Random, 95% CI)

‐0.53 [‐1.74, 0.68]

5.2 Calcipotriol vs. coal tar polytherapy

2

209

Std. Mean Difference (IV, Random, 95% CI)

‐0.59 [‐0.87, ‐0.31]

5.3 Calcipotriol vs. nicotinamide 1.4%, twice daily

1

96

Std. Mean Difference (IV, Random, 95% CI)

‐0.09 [‐0.49, 0.31]

5.4 Calcipotriol vs. calcipotriol + nicotinamide (0.05%, 0.1%, 0.7%, or 1.4%), twice daily

1

192

Std. Mean Difference (IV, Random, 95% CI)

0.19 [‐0.14, 0.52]

5.5 Calcipotriol vs. corticosteroid + salicylic acid

2

360

Std. Mean Difference (IV, Random, 95% CI)

‐0.05 [‐0.26, 0.15]

5.6 Calcipotriol vs. propylthiouracil cream

1

27

Std. Mean Difference (IV, Random, 95% CI)

‐2.24 [‐3.23, ‐1.25]

5.7 Calcipotriol vs. tacrolimus ointment

2

171

Std. Mean Difference (IV, Random, 95% CI)

‐0.55 [‐1.28, 0.17]

5.8 Calcipotriol vs. tazarotene

2

237

Std. Mean Difference (IV, Random, 95% CI)

‐0.10 [‐0.35, 0.16]

5.9 Calcipotriol vs. tazarotene gel plus mometasone furoate cream

0

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

5.10 Calcipotriol vs. vitamin B12 cream

1

26

Std. Mean Difference (IV, Random, 95% CI)

‐0.55 [‐1.33, 0.24]

5.11 Head‐to‐head vitamin D alone or in combination: twice daily vs OD

3

988

Std. Mean Difference (IV, Random, 95% CI)

‐0.20 [‐0.32, ‐0.07]

5.12 Head‐to‐head vitamin D alone or in combination: no occlusion vs. occlusion

2

247

Std. Mean Difference (IV, Random, 95% CI)

‐0.18 [‐2.04, 1.68]

6 Total withdrawals Show forest plot

15

Risk Difference (M‐H, Random, 95% CI)

Subtotals only

6.1 Calcipotriol vs. coal tar

2

120

Risk Difference (M‐H, Random, 95% CI)

‐0.02 [‐0.12, 0.08]

6.2 Calcipotriol vs. coal tar polytherapy

2

220

Risk Difference (M‐H, Random, 95% CI)

‐0.03 [‐0.10, 0.04]

6.3 Calcipotriol vs. nicotinamide 1.4%, twice daily

1

96

Risk Difference (M‐H, Random, 95% CI)

0.02 [‐0.05, 0.09]

6.4 Calcipotriol vs. calcipotriol + nicotinamide (0.05%, 0.1%, 0.7%, or 1.4%), twice daily

1

192

Risk Difference (M‐H, Random, 95% CI)

0.01 [‐0.06, 0.07]

6.5 Calcipotriol vs. corticosteroid + salicylic acid

1

160

Risk Difference (M‐H, Random, 95% CI)

0.04 [‐0.09, 0.17]

6.6 Calcipotriol vs. propylthiouracil cream

1

28

Risk Difference (M‐H, Random, 95% CI)

0.07 [‐0.16, 0.30]

6.7 Calcipotriol vs. tacrolimus ointment

1

124

Risk Difference (M‐H, Random, 95% CI)

‐0.13 [‐0.25, ‐0.01]

6.8 Calcipotriol vs. tazarotene

2

254

Risk Difference (M‐H, Random, 95% CI)

‐0.04 [‐0.10, 0.01]

6.9 Calcipotriol vs. tazarotene gel plus mometasone furoate cream

1

120

Risk Difference (M‐H, Random, 95% CI)

‐0.03 [‐0.15, 0.08]

6.10 Calcipotriol vs. vitamin B12 cream

1

26

Risk Difference (M‐H, Random, 95% CI)

0.0 [‐0.14, 0.14]

6.11 Head‐to‐head vitamin D alone or in combination: twice daily vs OD

3

1001

Risk Difference (M‐H, Random, 95% CI)

0.01 [‐0.03, 0.05]

6.12 Head‐to‐head vitamin D alone or in combination: no occlusion vs. occlusion

0

0

Risk Difference (M‐H, Random, 95% CI)

0.0 [0.0, 0.0]

7 Withdrawals due to adverse events Show forest plot

15

Risk Difference (M‐H, Random, 95% CI)

Subtotals only

7.1 Calcipotriol vs. coal tar

2

120

Risk Difference (M‐H, Random, 95% CI)

0.01 [‐0.04, 0.06]

7.2 Calcipotriol vs. coal tar polytherapy

2

210

Risk Difference (M‐H, Random, 95% CI)

‐0.02 [‐0.07, 0.03]

7.3 Calcipotriol vs. nicotinamide 1.4%, twice daily

1

96

Risk Difference (M‐H, Random, 95% CI)

0.0 [‐0.04, 0.04]

7.4 Calcipotriol vs. calcipotriol + nicotinamide (0.05%, 0.1%, 0.7%, or 1.4%), twice daily

1

192

Risk Difference (M‐H, Random, 95% CI)

0.0 [‐0.03, 0.03]

7.5 Calcipotriol vs. corticosteroid + salicylic acid

1

160

Risk Difference (M‐H, Random, 95% CI)

0.05 [‐0.00, 0.10]

7.6 Calcipotriol vs. propylthiouracil cream

1

28

Risk Difference (M‐H, Random, 95% CI)

0.07 [‐0.16, 0.30]

7.7 Calcipotriol vs. tacrolimus ointment

1

124

Risk Difference (M‐H, Random, 95% CI)

0.02 [‐0.08, 0.11]

7.8 Calcipotriol vs. tazarotene

2

254

Risk Difference (M‐H, Random, 95% CI)

‐0.05 [‐0.16, 0.05]

7.9 Calcipotriol vs. tazarotene gel plus mometasone furoate cream

1

120

Risk Difference (M‐H, Random, 95% CI)

‐0.02 [‐0.10, 0.07]

7.10 Calcipotriol vs. vitamin B12 cream

1

26

Risk Difference (M‐H, Random, 95% CI)

0.0 [‐0.14, 0.14]

7.11 Head‐to‐head vitamin D alone or in combination: twice daily vs OD

3

998

Risk Difference (M‐H, Random, 95% CI)

0.01 [‐0.01, 0.02]

7.12 Head‐to‐head vitamin D alone or in combination: no occlusion vs. occlusion

0

0

Risk Difference (M‐H, Random, 95% CI)

0.0 [0.0, 0.0]

8 Withdrawals due to treatment failure Show forest plot

12

Risk Difference (M‐H, Random, 95% CI)

Subtotals only

8.1 Calcipotriol vs. coal tar

1

60

Risk Difference (M‐H, Random, 95% CI)

0.0 [‐0.06, 0.06]

8.2 Calcipotriol vs. coal tar polytherapy

1

88

Risk Difference (M‐H, Random, 95% CI)

0.00 [‐0.06, 0.07]

8.3 Calcipotriol vs. nicotinamide 1.4%, twice daily

1

96

Risk Difference (M‐H, Random, 95% CI)

0.0 [‐0.04, 0.04]

8.4 Calcipotriol vs. calcipotriol + nicotinamide (0.05%, 0.1%, 0.7%, or 1.4%), twice daily

1

192

Risk Difference (M‐H, Random, 95% CI)

0.0 [‐0.03, 0.03]

8.5 Calcipotriol vs. corticosteroid + salicylic acid

1

160

Risk Difference (M‐H, Random, 95% CI)

‐0.02 [‐0.07, 0.02]

8.6 Calcipotriol vs. propylthiouracil cream

1

28

Risk Difference (M‐H, Random, 95% CI)

‐0.07 [‐0.25, 0.11]

8.7 Calcipotriol vs. tacrolimus ointment

1

124

Risk Difference (M‐H, Random, 95% CI)

‐0.02 [‐0.07, 0.03]

8.8 Calcipotriol vs. tazarotene

1

208

Risk Difference (M‐H, Random, 95% CI)

0.0 [‐0.02, 0.02]

8.9 Calcipotriol vs. tazarotene gel plus mometasone furoate cream

1

120

Risk Difference (M‐H, Random, 95% CI)

0.0 [‐0.05, 0.05]

8.10 Calcipotriol vs. vitamin B12 cream

1

26

Risk Difference (M‐H, Random, 95% CI)

0.0 [‐0.14, 0.14]

8.11 Head‐to‐head vitamin D alone or in combination: twice daily vs OD

3

998

Risk Difference (M‐H, Random, 95% CI)

0.00 [‐0.01, 0.01]

8.12 Head‐to‐head vitamin D alone or in combination: no occlusion vs. occlusion

0

0

Risk Difference (M‐H, Random, 95% CI)

0.0 [0.0, 0.0]

9 Adverse events (local) Show forest plot

11

Risk Difference (M‐H, Random, 95% CI)

Subtotals only

9.1 Calcipotriol vs. coal tar

2

120

Risk Difference (M‐H, Random, 95% CI)

0.02 [‐0.06, 0.10]

9.2 Calcipotriol vs. coal tar polytherapy

1

122

Risk Difference (M‐H, Random, 95% CI)

0.06 [‐0.09, 0.20]

9.3 Calcipotriol vs. nicotinamide 1.4%, twice daily

1

96

Risk Difference (M‐H, Random, 95% CI)

‐0.15 [‐0.32, 0.03]

9.4 Calcipotriol vs. calcipotriol + nicotinamide (0.05%, 0.1%, 0.7%, or 1.4%), twice daily

1

192

Risk Difference (M‐H, Random, 95% CI)

‐0.17 [‐0.30, ‐0.03]

9.5 Calcipotriol vs. corticosteroid + salicylic acid

1

160

Risk Difference (M‐H, Random, 95% CI)

0.09 [0.02, 0.15]

9.6 Calcipotriol vs. propylthiouracil cream

1

28

Risk Difference (M‐H, Random, 95% CI)

‐0.07 [‐0.25, 0.11]

9.7 Calcipotriol vs. tacrolimus ointment

1

124

Risk Difference (M‐H, Random, 95% CI)

‐0.19 [‐0.37, ‐0.01]

9.8 Calcipotriol vs. tazarotene

1

204

Risk Difference (M‐H, Random, 95% CI)

‐0.03 [‐0.11, 0.06]

9.9 Calcipotriol vs. tazarotene gel plus mometasone furoate cream

0

0

Risk Difference (M‐H, Random, 95% CI)

0.0 [0.0, 0.0]

9.10 Calcipotriol vs. vitamin B12 cream

1

26

Risk Difference (M‐H, Random, 95% CI)

0.23 [‐0.06, 0.52]

9.11 Head‐to‐head vitamin D alone or in combination: twice daily vs OD

2

731

Risk Difference (M‐H, Random, 95% CI)

‐0.00 [‐0.06, 0.05]

9.12 Head‐to‐head vitamin D alone or in combination: no occlusion vs. occlusion

0

0

Risk Difference (M‐H, Random, 95% CI)

0.0 [0.0, 0.0]

10 Adverse events (systemic) Show forest plot

8

Risk Difference (M‐H, Random, 95% CI)

Subtotals only

10.1 Calcipotriol vs. coal tar

1

60

Risk Difference (M‐H, Random, 95% CI)

0.0 [‐0.09, 0.09]

10.2 Calcipotriol vs. coal tar polytherapy

1

88

Risk Difference (M‐H, Random, 95% CI)

0.0 [‐0.04, 0.04]

10.3 Calcipotriol vs. nicotinamide 1.4%, twice daily

0

0

Risk Difference (M‐H, Random, 95% CI)

0.0 [0.0, 0.0]

10.4 Calcipotriol vs. calcipotriol + nicotinamide 1.4%, twice daily

0

0

Risk Difference (M‐H, Random, 95% CI)

0.0 [0.0, 0.0]

10.5 Calcipotriol vs. corticosteroid + salicylic acid

1

160

Risk Difference (M‐H, Random, 95% CI)

0.0 [‐0.02, 0.02]

10.6 Calcipotriol vs. propylthiouracil cream

1

28

Risk Difference (M‐H, Random, 95% CI)

0.0 [‐0.13, 0.13]

10.7 Calcipotriol vs. tacrolimus ointment

1

124

Risk Difference (M‐H, Random, 95% CI)

0.0 [‐0.04, 0.04]

10.8 Calcipotriol vs. tazarotene

1

183

Risk Difference (M‐H, Random, 95% CI)

‐0.01 [‐0.05, 0.03]

10.9 Calcipotriol vs. tazarotene gel plus mometasone furoate cream

0

0

Risk Difference (M‐H, Random, 95% CI)

0.0 [0.0, 0.0]

10.10 Calcipotriol vs. vitamin B12 cream

0

0

Risk Difference (M‐H, Random, 95% CI)

0.0 [0.0, 0.0]

10.11 Head‐to‐head vitamin D alone or in combination: twice daily vs OD

1

264

Risk Difference (M‐H, Random, 95% CI)

0.0 [‐0.01, 0.01]

10.12 Head‐to‐head vitamin D alone or in combination: no occlusion vs. occlusion

1

38

Risk Difference (M‐H, Random, 95% CI)

0.0 [‐0.10, 0.10]

Figuras y tablas -
Comparison 15. Vitamin D analogues versus other treatment
Comparison 16. Flexural/facial psoriasis: placebo‐controlled trials

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 IAGI Show forest plot

1

Std. Mean Difference (IV, Random, 95% CI)

Totals not selected

1.1 Betamethasone valerate 0.1%, OD

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

1.2 Calcipotriol ointment, OD

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

1.3 Pimecrolimus cream, 1% OD/twice daily

1

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

1.4 Tacrolimus ointment 0.1%, twice daily

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

2 TSS Show forest plot

1

Std. Mean Difference (IV, Random, 95% CI)

Totals not selected

2.1 Betamethasone valerate 0.1%, OD

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

2.2 Calcipotriol ointment, OD

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

2.3 Pimecrolimus cream, 1% OD/twice daily

1

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

2.4 Tacrolimus ointment 0.1%, twice daily

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

3 PASI Show forest plot

1

Std. Mean Difference (IV, Random, 95% CI)

Totals not selected

3.1 Betamethasone valerate 0.1%, OD

1

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

3.2 Calcipotriol ointment, OD

1

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

3.3 Pimecrolimus cream, 1% OD/twice daily

1

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

3.4 Tacrolimus ointment 0.1%, twice daily

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

4 PAGI Show forest plot

1

Std. Mean Difference (IV, Random, 95% CI)

Subtotals only

4.1 Betamethasone valerate 0.1%, OD

0

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

4.2 Calcipotriol ointment, OD

0

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

4.3 Pimecrolimus cream, 1% OD/twice daily

1

47

Std. Mean Difference (IV, Random, 95% CI)

‐0.65 [‐1.24, ‐0.06]

4.4 Tacrolimus ointment 0.1%, twice daily

0

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

5 Combined end point (IAGI/TSS/PASI/PAGI) Show forest plot

2

Std. Mean Difference (IV, Random, 95% CI)

Subtotals only

5.1 Betamethasone valerate 0.1%, OD

1

36

Std. Mean Difference (IV, Random, 95% CI)

‐2.83 [‐3.79, ‐1.88]

5.2 Calcipotriol ointment, OD

1

38

Std. Mean Difference (IV, Random, 95% CI)

‐1.08 [‐1.77, ‐0.40]

5.3 Pimecrolimus cream, 1% OD/twice daily

2

86

Std. Mean Difference (IV, Random, 95% CI)

‐0.86 [‐1.30, ‐0.41]

5.4 Tacrolimus ointment 0.1%, twice daily

0

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

6 Total withdrawals Show forest plot

3

Risk Difference (M‐H, Random, 95% CI)

Subtotals only

6.1 Betamethasone valerate 0.1%, OD

1

40

Risk Difference (M‐H, Random, 95% CI)

0.10 [‐0.08, 0.28]

6.2 Calcipotriol ointment, OD

1

40

Risk Difference (M‐H, Random, 95% CI)

0.0 [‐0.14, 0.14]

6.3 Pimecrolimus cream, 1% OD/twice daily

2

97

Risk Difference (M‐H, Random, 95% CI)

‐0.06 [‐0.16, 0.04]

6.4 Tacrolimus ointment 0.1%, twice daily

1

167

Risk Difference (M‐H, Random, 95% CI)

‐0.17 [‐0.30, ‐0.03]

7 Withdrawals due to adverse events Show forest plot

3

Risk Difference (M‐H, Random, 95% CI)

Subtotals only

7.1 Betamethasone valerate 0.1%, OD

1

40

Risk Difference (M‐H, Random, 95% CI)

0.0 [‐0.09, 0.09]

7.2 Calcipotriol ointment, OD

1

40

Risk Difference (M‐H, Random, 95% CI)

0.0 [‐0.09, 0.09]

7.3 Pimecrolimus cream, 1% OD/twice daily

2

97

Risk Difference (M‐H, Random, 95% CI)

0.0 [‐0.05, 0.05]

7.4 Tacrolimus ointment 0.1%, twice daily

1

167

Risk Difference (M‐H, Random, 95% CI)

‐0.02 [‐0.06, 0.03]

8 Withdrawals due to treatment failure Show forest plot

3

Risk Difference (M‐H, Random, 95% CI)

Subtotals only

8.1 Betamethasone valerate 0.1%, OD

1

40

Risk Difference (M‐H, Random, 95% CI)

‐0.05 [‐0.18, 0.08]

8.2 Calcipotriol ointment, OD

1

40

Risk Difference (M‐H, Random, 95% CI)

‐0.05 [‐0.18, 0.08]

8.3 Pimecrolimus cream, 1% OD/twice daily

2

97

Risk Difference (M‐H, Random, 95% CI)

‐0.04 [‐0.13, 0.04]

8.4 Tacrolimus ointment 0.1%, twice daily

1

167

Risk Difference (M‐H, Random, 95% CI)

‐0.11 [‐0.19, ‐0.02]

9 Adverse events (local) Show forest plot

3

Risk Difference (M‐H, Random, 95% CI)

Subtotals only

9.1 Betamethasone valerate 0.1%, OD

1

40

Risk Difference (M‐H, Random, 95% CI)

‐0.05 [‐0.18, 0.08]

9.2 Calcipotriol ointment, OD

1

40

Risk Difference (M‐H, Random, 95% CI)

0.05 [‐0.11, 0.21]

9.3 Pimecrolimus cream 1%, OD/twice daily

2

97

Risk Difference (M‐H, Random, 95% CI)

0.08 [‐0.15, 0.31]

9.4 Tacrolimus ointment 0.1%, twice daily

1

167

Risk Difference (M‐H, Random, 95% CI)

‐0.17 [‐0.30, ‐0.03]

10 Adverse events (systemic) Show forest plot

1

Risk Difference (M‐H, Random, 95% CI)

Totals not selected

10.1 Betamethasone valerate 0.1%, OD

0

Risk Difference (M‐H, Random, 95% CI)

0.0 [0.0, 0.0]

10.2 Calcipotriol ointment, OD

0

Risk Difference (M‐H, Random, 95% CI)

0.0 [0.0, 0.0]

10.3 Pimecrolimus cream 1%, OD/twice daily

0

Risk Difference (M‐H, Random, 95% CI)

0.0 [0.0, 0.0]

10.4 Tacrolimus ointment 0.1%, twice daily

1

Risk Difference (M‐H, Random, 95% CI)

0.0 [0.0, 0.0]

Figuras y tablas -
Comparison 16. Flexural/facial psoriasis: placebo‐controlled trials
Comparison 17. Flexural/facial psoriasis: vitamin D alone or in combination versus other treatment

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 IAGI Show forest plot

2

Std. Mean Difference (IV, Random, 95% CI)

Subtotals only

1.1 Calcipotriol vs. BMV

0

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

1.2 Calcipotriol vs. calcipotriol + hydrocortisone

1

408

Std. Mean Difference (IV, Random, 95% CI)

0.30 [0.11, 0.50]

1.3 Calcipotriol vs. calcitriol

0

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

1.4 Calcipotriol vs. pimecrolimus

0

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

1.5 Calcitriol vs. tacrolimus

1

49

Std. Mean Difference (IV, Random, 95% CI)

0.42 [‐0.15, 0.98]

2 TSS Show forest plot

2

Std. Mean Difference (IV, Random, 95% CI)

Subtotals only

2.1 Calcipotriol vs. BMV

0

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

2.2 Calcipotriol vs. calcipotriol + hydrocortisone

0

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

2.3 Calcipotriol vs. calcitriol

1

150

Std. Mean Difference (IV, Random, 95% CI)

0.61 [0.28, 0.94]

2.4 Calcipotriol vs. pimecrolimus

0

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

2.5 Calcitriol vs. tacrolimus

1

49

Std. Mean Difference (IV, Random, 95% CI)

0.29 [‐0.27, 0.85]

3 PASI Show forest plot

2

Std. Mean Difference (IV, Random, 95% CI)

Subtotals only

3.1 Calcipotriol vs. BMV

1

36

Std. Mean Difference (IV, Random, 95% CI)

2.02 [1.20, 2.84]

3.2 Calcipotriol vs. calcipotriol + hydrocortisone

1

408

Std. Mean Difference (IV, Random, 95% CI)

0.32 [0.12, 0.51]

3.3 Calcipotriol vs. calcitriol

0

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

3.4 Calcipotriol vs. pimecrolimus

1

39

Std. Mean Difference (IV, Random, 95% CI)

‐0.53 [‐1.17, 0.11]

3.5 Calcitriol vs. tacrolimus

0

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

4 PAGI

0

Std. Mean Difference (IV, Random, 95% CI)

Subtotals only

4.1 Calcipotriol vs. BMV

0

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

4.2 Calcipotriol vs. calcipotriol + hydrocortisone

0

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

4.3 Calcipotriol vs. calcitriol

0

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

4.4 Calcipotriol vs. pimecrolimus

0

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

4.5 Calcitriol vs. tacrolimus

0

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

5 Combined end point (IAGI/TSS/PASI/PAGI) Show forest plot

4

Std. Mean Difference (IV, Random, 95% CI)

Subtotals only

5.1 Calcipotriol vs. BMV

1

36

Std. Mean Difference (IV, Random, 95% CI)

2.02 [1.20, 2.84]

5.2 Calcipotriol vs. calcipotriol + hydrocortisone

1

408

Std. Mean Difference (IV, Random, 95% CI)

0.30 [0.11, 0.50]

5.3 Calcipotriol vs. calcitriol

1

150

Std. Mean Difference (IV, Random, 95% CI)

0.61 [0.28, 0.94]

5.4 Calcipotriol vs. pimecrolimus

1

39

Std. Mean Difference (IV, Random, 95% CI)

‐0.53 [‐1.17, 0.11]

5.5 Calcitriol vs. tacrolimus

1

49

Std. Mean Difference (IV, Random, 95% CI)

0.42 [‐0.15, 0.98]

6 Total withdrawals Show forest plot

4

Risk Difference (M‐H, Random, 95% CI)

Subtotals only

6.1 Calcipotriol vs. BMV

1

40

Risk Difference (M‐H, Random, 95% CI)

‐0.10 [‐0.28, 0.08]

6.2 Calcipotriol vs. calcipotriol + hydrocortisone

1

408

Risk Difference (M‐H, Random, 95% CI)

0.04 [‐0.03, 0.11]

6.3 Calcipotriol vs. calcitriol

1

150

Risk Difference (M‐H, Random, 95% CI)

0.0 [‐0.11, 0.11]

6.4 Calcipotriol vs. pimecrolimus

1

40

Risk Difference (M‐H, Random, 95% CI)

0.05 [‐0.08, 0.18]

6.5 Calcitriol vs. tacrolimus

1

50

Risk Difference (M‐H, Random, 95% CI)

0.12 [‐0.02, 0.26]

7 Withdrawals due to adverse events Show forest plot

4

Risk Difference (M‐H, Random, 95% CI)

Subtotals only

7.1 Calcipotriol vs. BMV

1

40

Risk Difference (M‐H, Random, 95% CI)

0.0 [‐0.09, 0.09]

7.2 Calcipotriol vs. calcipotriol + hydrocortisone

1

408

Risk Difference (M‐H, Random, 95% CI)

0.06 [0.02, 0.11]

7.3 Calcipotriol vs. calcitriol

1

150

Risk Difference (M‐H, Random, 95% CI)

0.09 [0.01, 0.18]

7.4 Calcipotriol vs. pimecrolimus

1

40

Risk Difference (M‐H, Random, 95% CI)

0.0 [‐0.09, 0.09]

7.5 Calcitriol vs. tacrolimus

1

50

Risk Difference (M‐H, Random, 95% CI)

0.0 [‐0.07, 0.07]

8 Withdrawals due to treatment failure Show forest plot

4

Risk Difference (M‐H, Random, 95% CI)

Subtotals only

8.1 Calcipotriol vs. BMV

1

40

Risk Difference (M‐H, Random, 95% CI)

0.0 [‐0.09, 0.09]

8.2 Calcipotriol vs. calcipotriol + hydrocortisone

1

408

Risk Difference (M‐H, Random, 95% CI)

0.02 [‐0.01, 0.05]

8.3 Calcipotriol vs. calcitriol

1

150

Risk Difference (M‐H, Random, 95% CI)

0.0 [‐0.03, 0.03]

8.4 Calcipotriol vs. pimecrolimus

1

40

Risk Difference (M‐H, Random, 95% CI)

0.0 [‐0.09, 0.09]

8.5 Calcitriol vs. tacrolimus

1

50

Risk Difference (M‐H, Random, 95% CI)

0.0 [‐0.07, 0.07]

9 Adverse events (local) Show forest plot

3

Risk Difference (M‐H, Random, 95% CI)

Subtotals only

9.1 calcipotriol vs. BMV

1

40

Risk Difference (M‐H, Random, 95% CI)

0.10 [‐0.05, 0.25]

9.2 Calcipotriol vs. calcipotriol + hydrocortisone

1

404

Risk Difference (M‐H, Random, 95% CI)

0.15 [0.08, 0.23]

9.3 Calcipotriol vs. calcitriol

1

150

Risk Difference (M‐H, Random, 95% CI)

0.09 [0.02, 0.17]

9.4 Calcipotriol vs. pimecrolimus

1

40

Risk Difference (M‐H, Random, 95% CI)

‐0.15 [‐0.38, 0.08]

9.5 Calcitriol vs. tacrolimus

0

0

Risk Difference (M‐H, Random, 95% CI)

0.0 [0.0, 0.0]

10 Adverse events (systemic)

0

Risk Difference (M‐H, Random, 95% CI)

Subtotals only

10.1 Calcipotriol vs. BMV

0

0

Risk Difference (M‐H, Random, 95% CI)

0.0 [0.0, 0.0]

10.2 Calcipotriol vs. calcipotriol + hydrocortisone

0

0

Risk Difference (M‐H, Random, 95% CI)

0.0 [0.0, 0.0]

10.3 Calcipotriol vs. calcitriol

0

0

Risk Difference (M‐H, Random, 95% CI)

0.0 [0.0, 0.0]

10.4 Calcipotriol vs. pimecrolimus

0

0

Risk Difference (M‐H, Random, 95% CI)

0.0 [0.0, 0.0]

10.5 Calcitriol vs. tacrolimus

0

0

Risk Difference (M‐H, Random, 95% CI)

0.0 [0.0, 0.0]

Figuras y tablas -
Comparison 17. Flexural/facial psoriasis: vitamin D alone or in combination versus other treatment
Comparison 18. Scalp psoriasis: placebo‐controlled trials

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 IAGI Show forest plot

9

Std. Mean Difference (IV, Random, 95% CI)

Subtotals only

1.1 Vitamin D: calcipotriol

2

457

Std. Mean Difference (IV, Random, 95% CI)

‐0.72 [‐1.28, ‐0.16]

1.2 Potent steroid: betamethasone dipropionate

2

712

Std. Mean Difference (IV, Random, 95% CI)

‐1.09 [‐1.29, ‐0.90]

1.3 Potent steroid: betamethasone valerate

0

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

1.4 Very potent steroid: amcinonide

1

132

Std. Mean Difference (IV, Random, 95% CI)

‐1.42 [‐1.80, ‐1.04]

1.5 Very potent steroid: clobetasol propionate

2

458

Std. Mean Difference (IV, Random, 95% CI)

‐1.73 [‐1.99, ‐1.48]

1.6 Very potent steroid: halcinonide

1

54

Std. Mean Difference (IV, Random, 95% CI)

‐1.11 [‐1.69, ‐0.53]

1.7 Vitamin D in combination: calcipotriol + BMD

2

854

Std. Mean Difference (IV, Random, 95% CI)

‐0.97 [‐1.61, ‐0.32]

1.8 Other treatment: betamethasone‐17,21‐dipropionate plus salicylic acid

1

20

Std. Mean Difference (IV, Random, 95% CI)

‐1.48 [‐2.50, ‐0.47]

1.9 Other treatment: ciclopirox olamine shampoo

0

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

1.10 Other treatment: fluocinolone acetonide, plus occlusion

1

84

Std. Mean Difference (IV, Random, 95% CI)

‐1.22 [‐1.69, ‐0.76]

1.11 Other treatment: salicylic acid

1

20

Std. Mean Difference (IV, Random, 95% CI)

‐0.86 [‐1.79, 0.06]

2 TSS Show forest plot

11

Std. Mean Difference (IV, Random, 95% CI)

Subtotals only

2.1 Vitamin D: calcipotriol

2

457

Std. Mean Difference (IV, Random, 95% CI)

‐0.44 [‐0.64, ‐0.25]

2.2 Potent steroid: betamethasone dipropionate

2

712

Std. Mean Difference (IV, Random, 95% CI)

‐1.00 [‐1.19, ‐0.81]

2.3 Potent steroid: betamethasone valerate

1

172

Std. Mean Difference (IV, Random, 95% CI)

‐1.40 [‐1.75, ‐1.05]

2.4 Very potent steroid: amcinonide

1

126

Std. Mean Difference (IV, Random, 95% CI)

‐1.58 [‐1.98, ‐1.18]

2.5 Very potent steroid: clobetasol propionate

3

707

Std. Mean Difference (IV, Random, 95% CI)

‐1.53 [‐1.77, ‐1.28]

2.6 Very potent steroid: halcinonide

0

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

2.7 Vitamin D in combination: calcipotriol + BMD

2

854

Std. Mean Difference (IV, Random, 95% CI)

‐0.92 [‐1.42, ‐0.43]

2.8 Other treatment: betamethasone‐17,21‐dipropionate plus salicylic acid

1

20

Std. Mean Difference (IV, Random, 95% CI)

‐1.15 [‐2.11, ‐0.19]

2.9 Other treatment: ciclopirox olamine shampoo

1

37

Std. Mean Difference (IV, Random, 95% CI)

‐0.07 [‐0.82, 0.68]

2.10 Other treatment: fluocinolone acetonide, plus occlusion

1

84

Std. Mean Difference (IV, Random, 95% CI)

‐0.89 [‐1.34, ‐0.44]

2.11 Other treatment: salicylic acid

1

20

Std. Mean Difference (IV, Random, 95% CI)

‐0.57 [‐1.47, 0.32]

3 PASI

0

Std. Mean Difference (IV, Random, 95% CI)

Subtotals only

3.1 Vitamin D: calcipotriol

0

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

3.2 Potent steroid: betamethasone dipropionate

0

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

3.3 Potent steroid: betamethasone valerate

0

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

3.4 Very potent steroid: amcinonide

0

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

3.5 Very potent steroid: clobetasol propionate

0

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

3.6 Very potent steroid: halcinonide

0

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

3.7 Vitamin D in combination: calcipotriol + BMD

0

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

3.8 Other treatment: betamethasone‐17,21‐dipropionate plus salicylic acid

0

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

3.9 Other treatment: ciclopirox olamine shampoo

0

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

3.10 Other treatment: fluocinolone acetonide, plus occlusion

0

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

3.11 Other treatment: salicylic acid

0

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

4 PAGI Show forest plot

5

Std. Mean Difference (IV, Random, 95% CI)

Subtotals only

4.1 Vitamin D: calcipotriol

2

450

Std. Mean Difference (IV, Random, 95% CI)

‐0.66 [‐1.28, ‐0.05]

4.2 Potent steroid: betamethasone dipropionate

1

685

Std. Mean Difference (IV, Random, 95% CI)

‐1.23 [‐1.43, ‐1.03]

4.3 Potent steroid: betamethasone valerate

0

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

4.4 Very potent steroid: amcinonide

1

132

Std. Mean Difference (IV, Random, 95% CI)

‐0.97 [‐1.33, ‐0.61]

4.5 Very potent steroid: clobetasol propionate

0

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

4.6 Very potent steroid: halcinonide

0

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

4.7 Vitamin D in combination: calcipotriol + BMD

2

841

Std. Mean Difference (IV, Random, 95% CI)

‐1.00 [‐1.79, ‐0.22]

4.8 Other treatment: betamethasone‐17,21‐dipropionate plus salicylic acid

0

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

4.9 Other treatment: ciclopirox olamine shampoo

1

37

Std. Mean Difference (IV, Random, 95% CI)

‐0.11 [‐0.86, 0.64]

4.10 Other treatment: fluocinolone acetonide, plus occlusion

0

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

4.11 Other treatment: salicylic acid

0

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

5 Combined end point (IAGI/TSS/PASI/PAGI) Show forest plot

13

Std. Mean Difference (IV, Random, 95% CI)

Subtotals only

5.1 Vitamin D: calcipotriol

2

457

Std. Mean Difference (IV, Random, 95% CI)

‐0.72 [‐1.28, ‐0.16]

5.2 Potent steroid: betamethasone dipropionate

2

712

Std. Mean Difference (IV, Random, 95% CI)

‐1.09 [‐1.29, ‐0.90]

5.3 Potent steroid: betamethasone valerate

1

172

Std. Mean Difference (IV, Random, 95% CI)

‐1.40 [‐1.75, ‐1.05]

5.4 Very potent steroid: amcinonide

1

132

Std. Mean Difference (IV, Random, 95% CI)

‐1.42 [‐1.80, ‐1.04]

5.5 Very potent steroid: clobetasol propionate

4

788

Std. Mean Difference (IV, Random, 95% CI)

‐1.57 [‐1.81, ‐1.34]

5.6 Very potent steroid: halcinonide

1

54

Std. Mean Difference (IV, Random, 95% CI)

‐1.11 [‐1.69, ‐0.53]

5.7 Vitamin D in combination: calcipotriol + BMD

2

854

Std. Mean Difference (IV, Random, 95% CI)

‐0.97 [‐1.61, ‐0.32]

5.8 Other treatment: betamethasone‐17,21‐dipropionate plus salicylic acid

1

20

Std. Mean Difference (IV, Random, 95% CI)

‐1.48 [‐2.50, ‐0.47]

5.9 Other treatment: ciclopirox olamine shampoo

1

37

Std. Mean Difference (IV, Random, 95% CI)

‐0.07 [‐0.82, 0.68]

5.10 Other treatment: fluocinolone acetonide, plus occlusion

1

84

Std. Mean Difference (IV, Random, 95% CI)

‐1.22 [‐1.69, ‐0.76]

5.11 Other treatment: salicylic acid

1

20

Std. Mean Difference (IV, Random, 95% CI)

‐0.86 [‐1.79, 0.06]

6 Total withdrawals Show forest plot

13

Risk Difference (M‐H, Random, 95% CI)

Subtotals only

6.1 Vitamin D: calcipotriol

3

517

Risk Difference (M‐H, Random, 95% CI)

‐0.02 [‐0.08, 0.05]

6.2 Potent steroid: betamethasone dipropionate

1

692

Risk Difference (M‐H, Random, 95% CI)

‐0.14 [‐0.21, ‐0.06]

6.3 Potent steroid: betamethasone valerate

0

0

Risk Difference (M‐H, Random, 95% CI)

0.0 [0.0, 0.0]

6.4 Very potent steroid: amcinonide

1

165

Risk Difference (M‐H, Random, 95% CI)

‐0.00 [‐0.11, 0.11]

6.5 Very potent steroid: clobetasol propionate

5

1006

Risk Difference (M‐H, Random, 95% CI)

‐0.03 [‐0.10, 0.04]

6.6 Very potent steroid: halcinonide

1

58

Risk Difference (M‐H, Random, 95% CI)

0.0 [‐0.13, 0.13]

6.7 Vitamin D in combination: calcipotriol + BMD

2

854

Risk Difference (M‐H, Random, 95% CI)

‐0.09 [‐0.16, ‐0.03]

6.8 Other treatment: betamethasone‐17,21‐dipropionate plus salicylic acid

0

0

Risk Difference (M‐H, Random, 95% CI)

0.0 [0.0, 0.0]

6.9 Other treatment: ciclopirox olamine shampoo

1

40

Risk Difference (M‐H, Random, 95% CI)

‐0.15 [‐0.38, 0.09]

6.10 Other treatment: fluocinolone acetonide, plus occlusion

1

89

Risk Difference (M‐H, Random, 95% CI)

‐0.04 [‐0.13, 0.04]

6.11 Other treatment: salicylic acid

0

0

Risk Difference (M‐H, Random, 95% CI)

0.0 [0.0, 0.0]

7 Withdrawals due to adverse events Show forest plot

13

Risk Difference (M‐H, Random, 95% CI)

Subtotals only

7.1 Vitamin D: calcipotriol

3

517

Risk Difference (M‐H, Random, 95% CI)

0.02 [‐0.02, 0.05]

7.2 Potent steroid: betamethasone dipropionate

2

712

Risk Difference (M‐H, Random, 95% CI)

‐0.04 [‐0.08, ‐0.00]

7.3 Potent steroid: betamethasone valerate

1

172

Risk Difference (M‐H, Random, 95% CI)

0.0 [‐0.03, 0.03]

7.4 Very potent steroid: amcinonide

1

165

Risk Difference (M‐H, Random, 95% CI)

0.01 [‐0.02, 0.04]

7.5 Very potent steroid: clobetasol propionate

5

1006

Risk Difference (M‐H, Random, 95% CI)

‐0.00 [‐0.02, 0.01]

7.6 Very potent steroid: halcinonide

1

58

Risk Difference (M‐H, Random, 95% CI)

0.0 [‐0.06, 0.06]

7.7 Vitamin D in combination: calcipotriol + BMD

1

677

Risk Difference (M‐H, Random, 95% CI)

‐0.04 [‐0.08, 0.00]

7.8 Other treatment: betamethasone‐17,21‐dipropionate plus salicylic acid

1

20

Risk Difference (M‐H, Random, 95% CI)

0.0 [‐0.17, 0.17]

7.9 Other treatment: ciclopirox olamine shampoo

1

40

Risk Difference (M‐H, Random, 95% CI)

‐0.18 [‐0.42, 0.05]

7.10 Other treatment: fluocinolone acetonide, plus occlusion

0

0

Risk Difference (M‐H, Random, 95% CI)

0.0 [0.0, 0.0]

7.11 Other treatment: salicylic acid

1

20

Risk Difference (M‐H, Random, 95% CI)

0.0 [‐0.17, 0.17]

8 Withdrawals due to treatment failure Show forest plot

9

Risk Difference (M‐H, Random, 95% CI)

Subtotals only

8.1 Vitamin D: calcipotriol

2

457

Risk Difference (M‐H, Random, 95% CI)

‐0.05 [‐0.11, 0.00]

8.2 Potent steroid: betamethasone dipropionate

1

692

Risk Difference (M‐H, Random, 95% CI)

‐0.10 [‐0.16, ‐0.05]

8.3 Potent steroid: betamethasone valerate

0

0

Risk Difference (M‐H, Random, 95% CI)

0.0 [0.0, 0.0]

8.4 Very potent steroid: amcinonide

1

165

Risk Difference (M‐H, Random, 95% CI)

‐0.01 [‐0.05, 0.02]

8.5 Very potent steroid: clobetasol propionate

5

1006

Risk Difference (M‐H, Random, 95% CI)

‐0.01 [‐0.05, 0.02]

8.6 Very potent steroid: halcinonide

0

0

Risk Difference (M‐H, Random, 95% CI)

0.0 [0.0, 0.0]

8.7 Vitamin D in combination: calcipotriol + BMD

1

677

Risk Difference (M‐H, Random, 95% CI)

‐0.11 [‐0.17, ‐0.06]

8.8 Other treatment: betamethasone‐17,21‐dipropionate plus salicylic acid

0

0

Risk Difference (M‐H, Random, 95% CI)

0.0 [0.0, 0.0]

8.9 Other treatment: ciclopirox olamine shampoo

1

40

Risk Difference (M‐H, Random, 95% CI)

‐0.09 [‐0.28, 0.10]

8.10 Other treatment: fluocinolone acetonide, plus occlusion

0

0

Risk Difference (M‐H, Random, 95% CI)

0.0 [0.0, 0.0]

8.11 Other treatment: salicylic acid

0

0

Risk Difference (M‐H, Random, 95% CI)

0.0 [0.0, 0.0]

9 Adverse events (local) Show forest plot

12

Risk Difference (M‐H, Random, 95% CI)

Subtotals only

9.1 Vitamin D: calcipotriol

3

510

Risk Difference (M‐H, Random, 95% CI)

‐0.00 [‐0.05, 0.04]

9.2 Potent steroid: betamethasone dipropionate

2

703

Risk Difference (M‐H, Random, 95% CI)

‐0.07 [‐0.13, ‐0.01]

9.3 Potent steroid: betamethasone valerate

0

0

Risk Difference (M‐H, Random, 95% CI)

0.0 [0.0, 0.0]

9.4 Very potent steroid: amcinonide

0

0

Risk Difference (M‐H, Random, 95% CI)

0.0 [0.0, 0.0]

9.5 Very potent steroid: clobetasol propionate

4

817

Risk Difference (M‐H, Random, 95% CI)

0.00 [‐0.03, 0.04]

9.6 Very potent steroid: halcinonide

1

58

Risk Difference (M‐H, Random, 95% CI)

‐0.03 [‐0.12, 0.06]

9.7 Vitamin D in combination: calcipotriol + BMD

2

831

Risk Difference (M‐H, Random, 95% CI)

‐0.06 [‐0.13, 0.02]

9.8 Other treatment: betamethasone‐17,21‐dipropionate plus salicylic acid

1

20

Risk Difference (M‐H, Random, 95% CI)

0.0 [‐0.17, 0.17]

9.9 Other treatment: ciclopirox olamine shampoo

1

40

Risk Difference (M‐H, Random, 95% CI)

‐0.06 [‐0.24, 0.13]

9.10 Other treatment: fluocinolone acetonide, plus occlusion

1

89

Risk Difference (M‐H, Random, 95% CI)

0.02 [‐0.04, 0.08]

9.11 Other treatment: salicylic acid

1

20

Risk Difference (M‐H, Random, 95% CI)

0.0 [‐0.17, 0.17]

10 Adverse events (systemic) Show forest plot

4

Risk Difference (M‐H, Random, 95% CI)

Subtotals only

10.1 Vitamin D: calcipotriol

1

408

Risk Difference (M‐H, Random, 95% CI)

0.0 [‐0.01, 0.01]

10.2 Potent steroid: betamethasone dipropionate

1

692

Risk Difference (M‐H, Random, 95% CI)

0.0 [‐0.01, 0.01]

10.3 Potent steroid: betamethasone valerate

0

0

Risk Difference (M‐H, Random, 95% CI)

0.0 [0.0, 0.0]

10.4 Very potent steroid: amcinonide

0

0

Risk Difference (M‐H, Random, 95% CI)

0.0 [0.0, 0.0]

10.5 Very potent steroid: clobetasol propionate

2

385

Risk Difference (M‐H, Random, 95% CI)

‐0.01 [‐0.03, 0.02]

10.6 Very potent steroid: halcinonide

0

0

Risk Difference (M‐H, Random, 95% CI)

0.0 [0.0, 0.0]

10.7 Vitamin D in combination: calcipotriol + BMD

2

843

Risk Difference (M‐H, Random, 95% CI)

0.0 [‐0.01, 0.01]

10.8 Other treatment: betamethasone‐17,21‐dipropionate plus salicylic acid

0

0

Risk Difference (M‐H, Random, 95% CI)

0.0 [0.0, 0.0]

10.9 Other treatment: ciclopirox olamine shampoo

0

0

Risk Difference (M‐H, Random, 95% CI)

0.0 [0.0, 0.0]

10.10 Other treatment: fluocinolone acetonide, plus occlusion

0

0

Risk Difference (M‐H, Random, 95% CI)

0.0 [0.0, 0.0]

10.11 Other treatment: salicylic acid

0

0

Risk Difference (M‐H, Random, 95% CI)

0.0 [0.0, 0.0]

Figuras y tablas -
Comparison 18. Scalp psoriasis: placebo‐controlled trials
Comparison 19. Scalp psoriasis: vitamin D alone or in combination versus other treatments

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 IAGI Show forest plot

9

Std. Mean Difference (IV, Random, 95% CI)

Subtotals only

1.1 Vitamin D vs. corticosteroid (potent): calcipotriol vs. BMD

2

1676

Std. Mean Difference (IV, Random, 95% CI)

0.48 [0.32, 0.64]

1.2 Vitamin D vs. corticosteroid (potent): calcipotriol vs. BMV

2

510

Std. Mean Difference (IV, Random, 95% CI)

0.37 [0.20, 0.55]

1.3 Vitamin D vs. corticosteroid (very potent): calcipotriol vs. clobetasol propionate

0

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

1.4 Vitamin D + corticosteroid vs. corticosteroid: calcipotriol + BMD vs. BMD

3

2444

Std. Mean Difference (IV, Random, 95% CI)

‐0.18 [‐0.26, ‐0.10]

1.5 Vitamin D vs. vitamin D + corticosteroid: calcipotriol vs. calcipotriol + BMD

4

2581

Std. Mean Difference (IV, Random, 95% CI)

0.64 [0.44, 0.84]

1.6 Vitamin D vs. other treatments: calcipotriol vs. coal tar polytherapy

2

748

Std. Mean Difference (IV, Random, 95% CI)

‐0.24 [‐0.73, 0.25]

2 TSS Show forest plot

10

Std. Mean Difference (IV, Random, 95% CI)

Subtotals only

2.1 Vitamin D vs. corticosteroid (potent): calcipotriol vs. BMD

2

1676

Std. Mean Difference (IV, Random, 95% CI)

0.45 [0.28, 0.63]

2.2 Vitamin D vs. corticosteroid (potent): calcipotriol vs. BMV

2

487

Std. Mean Difference (IV, Random, 95% CI)

0.09 [‐0.09, 0.27]

2.3 Vitamin D vs. corticosteroid (very potent): calcipotriol vs. clobetasol propionate

1

151

Std. Mean Difference (IV, Random, 95% CI)

0.37 [0.05, 0.69]

2.4 Vitamin D + corticosteroid vs. corticosteroid: calcipotriol + BMD vs. BMD

3

2444

Std. Mean Difference (IV, Random, 95% CI)

‐0.19 [‐0.27, ‐0.11]

2.5 Vitamin D vs. vitamin D + corticosteroid: calcipotriol vs. calcipotriol + BMD

3

1978

Std. Mean Difference (IV, Random, 95% CI)

0.70 [0.56, 0.84]

2.6 Vitamin D vs. other treatments: calcipotriol vs. coal tar polytherapy

3

925

Std. Mean Difference (IV, Random, 95% CI)

‐0.30 [‐0.84, 0.24]

3 PASI

0

Std. Mean Difference (IV, Random, 95% CI)

Subtotals only

3.1 Vitamin D vs. corticosteroid (potent): calcipotriol vs. BMD

0

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

3.2 Vitamin D vs. corticosteroid (potent): calcipotriol vs. BMV

0

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

3.3 Vitamin D vs. corticosteroid (very potent): calcipotriol vs. clobetasol propionate

0

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

3.4 Vitamin D + corticosteroid vs. corticosteroid: calcipotriol + BMD vs. BMD

0

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

3.5 Vitamin D vs. vitamin D + corticosteroid: calcipotriol vs. calcipotriol + BMD

0

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

3.6 Vitamin D vs. other treatments: calcipotriol vs. coal tar polytherapy

0

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

4 PAGI Show forest plot

5

Std. Mean Difference (IV, Random, 95% CI)

Subtotals only

4.1 Vitamin D vs. corticosteroid (potent): calcipotriol vs. BMD

2

1654

Std. Mean Difference (IV, Random, 95% CI)

0.56 [0.31, 0.81]

4.2 Vitamin D vs. corticosteroid (potent): calcipotriol vs. BMV

1

468

Std. Mean Difference (IV, Random, 95% CI)

0.41 [0.22, 0.59]

4.3 Vitamin D vs. corticosteroid (very potent): calcipotriol vs. clobetasol propionate

0

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

4.4 Vitamin D + corticosteroid vs. corticosteroid: calcipotriol + BMD vs. BMD

3

2414

Std. Mean Difference (IV, Random, 95% CI)

‐0.17 [‐0.25, ‐0.09]

4.5 Vitamin D vs. vitamin D + corticosteroid: calcipotriol vs. calcipotriol + BMD

3

1952

Std. Mean Difference (IV, Random, 95% CI)

0.84 [0.61, 1.08]

4.6 Vitamin D vs. other treatments: calcipotriol vs. coal tar polytherapy

0

0

Std. Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

5 Combined end point (IAGI/TSS/PASI/PAGI) Show forest plot

11

Std. Mean Difference (IV, Random, 95% CI)

Subtotals only

5.1 Vitamin D vs. corticosteroid (potent): calcipotriol vs. BMD

2

1676

Std. Mean Difference (IV, Random, 95% CI)

0.48 [0.32, 0.64]

5.2 Vitamin D vs. corticosteroid (potent): calcipotriol vs. BMV

2

510

Std. Mean Difference (IV, Random, 95% CI)

0.37 [0.20, 0.55]

5.3 Vitamin D vs. corticosteroid (very potent): calcipotriol vs. clobetasol propionate

1

151

Std. Mean Difference (IV, Random, 95% CI)

0.37 [0.05, 0.69]

5.4 Vitamin D + corticosteroid vs. corticosteroid: calcipotriol + BMD vs. BMD

3

2444

Std. Mean Difference (IV, Random, 95% CI)

‐0.18 [‐0.26, ‐0.10]

5.5 Vitamin D vs. vitamin D + corticosteroid: calcipotriol vs. calcipotriol + BMD

4

2581

Std. Mean Difference (IV, Random, 95% CI)

0.64 [0.44, 0.84]

5.6 Vitamin D vs. other treatments: calcipotriol vs. coal tar polytherapy

3

835

Std. Mean Difference (IV, Random, 95% CI)

‐0.45 [‐0.92, 0.02]

6 Total withdrawals Show forest plot

10

Risk Difference (M‐H, Random, 95% CI)

Subtotals only

6.1 Vitamin D vs. corticosteroid (potent): calcipotriol vs. BMD

2

1676

Risk Difference (M‐H, Random, 95% CI)

0.07 [‐0.04, 0.18]

6.2 Vitamin D vs. corticosteroid (potent): calcipotriol vs. BMV

2

516

Risk Difference (M‐H, Random, 95% CI)

0.04 [‐0.00, 0.08]

6.3 Vitamin D vs. corticosteroid (very potent): calcipotriol vs. clobetasol propionate

2

194

Risk Difference (M‐H, Random, 95% CI)

0.05 [‐0.07, 0.18]

6.4 Vitamin D + corticosteroid vs. corticosteroid: calcipotriol + BMD vs. BMD

3

2444

Risk Difference (M‐H, Random, 95% CI)

0.01 [‐0.04, 0.06]

6.5 Vitamin D vs. vitamin D + corticosteroid: calcipotriol vs. calcipotriol + BMD

4

2847

Risk Difference (M‐H, Random, 95% CI)

0.11 [0.05, 0.18]

6.6 Vitamin D vs. other treatments: calcipotriol vs. coal tar polytherapy

1

475

Risk Difference (M‐H, Random, 95% CI)

0.01 [‐0.07, 0.09]

7 Withdrawals due to adverse events Show forest plot

10

Risk Difference (M‐H, Random, 95% CI)

Subtotals only

7.1 Vitamin D vs. corticosteroid (potent): calcipotriol vs. BMD

2

1676

Risk Difference (M‐H, Random, 95% CI)

0.04 [‐0.01, 0.09]

7.2 Vitamin D vs. corticosteroid (potent): calcipotriol vs. BMV

2

516

Risk Difference (M‐H, Random, 95% CI)

0.03 [0.01, 0.06]

7.3 Vitamin D vs. corticosteroid (very potent): calcipotriol vs. clobetasol propionate

2

194

Risk Difference (M‐H, Random, 95% CI)

0.05 [‐0.05, 0.15]

7.4 Vitamin D + corticosteroid vs. corticosteroid: calcipotriol + BMD vs. BMD

3

2444

Risk Difference (M‐H, Random, 95% CI)

‐0.00 [‐0.01, 0.01]

7.5 Vitamin D vs. vitamin D + corticosteroid: calcipotriol vs. calcipotriol + BMD

4

2847

Risk Difference (M‐H, Random, 95% CI)

0.06 [0.02, 0.09]

7.6 Vitamin D vs. other treatments: calcipotriol vs. coal tar polytherapy

1

445

Risk Difference (M‐H, Random, 95% CI)

0.08 [0.02, 0.14]

8 Withdrawals due to treatment failure Show forest plot

8

Risk Difference (M‐H, Random, 95% CI)

Subtotals only

8.1 Vitamin D vs. corticosteroid (potent): calcipotriol vs. BMD

2

1676

Risk Difference (M‐H, Random, 95% CI)

0.03 [‐0.01, 0.07]

8.2 Vitamin D vs. corticosteroid (potent): calcipotriol vs. BMV

2

516

Risk Difference (M‐H, Random, 95% CI)

0.01 [‐0.01, 0.03]

8.3 Vitamin D vs. corticosteroid (very potent): calcipotriol vs. clobetasol propionate

2

194

Risk Difference (M‐H, Random, 95% CI)

0.01 [‐0.02, 0.04]

8.4 Vitamin D + corticosteroid vs. corticosteroid: calcipotriol + BMD vs. BMD

3

2444

Risk Difference (M‐H, Random, 95% CI)

‐0.01 [‐0.02, ‐0.00]

8.5 Vitamin D vs. vitamin D + corticosteroid: calcipotriol vs. calcipotriol + BMD

3

2535

Risk Difference (M‐H, Random, 95% CI)

0.05 [0.01, 0.10]

8.6 Vitamin D vs. other treatments: calcipotriol vs. coal tar polytherapy

0

0

Risk Difference (M‐H, Random, 95% CI)

0.0 [0.0, 0.0]

9 Adverse events (local) Show forest plot

10

Risk Difference (M‐H, Random, 95% CI)

Subtotals only

9.1 Vitamin D vs. corticosteroid (potent): calcipotriol vs. BMD

2

1652

Risk Difference (M‐H, Random, 95% CI)

0.07 [0.04, 0.11]

9.2 Vitamin D vs. corticosteroid (potent): calcipotriol vs. BMV

2

516

Risk Difference (M‐H, Random, 95% CI)

0.17 [0.01, 0.33]

9.3 Vitamin D vs. corticosteroid (very potent): calcipotriol vs. clobetasol propionate

2

194

Risk Difference (M‐H, Random, 95% CI)

0.19 [0.10, 0.28]

9.4 Vitamin D + corticosteroid vs. corticosteroid: calcipotriol + BMD vs. BMD

3

2415

Risk Difference (M‐H, Random, 95% CI)

‐0.00 [‐0.02, 0.01]

9.5 Vitamin D vs. vitamin D + corticosteroid: calcipotriol vs. calcipotriol + BMD

4

2801

Risk Difference (M‐H, Random, 95% CI)

0.09 [0.06, 0.12]

9.6 Vitamin D vs. other treatments: calcipotriol vs. coal tar polytherapy

1

445

Risk Difference (M‐H, Random, 95% CI)

0.24 [0.15, 0.33]

10 Adverse events (systemic) Show forest plot

6

Risk Difference (M‐H, Random, 95% CI)

Subtotals only

10.1 Vitamin D vs. corticosteroid (potent): calcipotriol vs. BMD

2

1666

Risk Difference (M‐H, Random, 95% CI)

0.0 [‐0.00, 0.00]

10.2 Vitamin D vs. corticosteroid (potent): calcipotriol vs. BMV

1

474

Risk Difference (M‐H, Random, 95% CI)

0.0 [‐0.01, 0.01]

10.3 Vitamin D vs. corticosteroid (very potent): calcipotriol vs. clobetasol propionate

1

151

Risk Difference (M‐H, Random, 95% CI)

0.0 [‐0.03, 0.03]

10.4 Vitamin D + corticosteroid vs. corticosteroid: calcipotriol + BMD vs. BMD

2

2216

Risk Difference (M‐H, Random, 95% CI)

0.0 [‐0.00, 0.00]

10.5 Vitamin D vs. vitamin D + corticosteroid: calcipotriol vs. calcipotriol + BMD

3

1970

Risk Difference (M‐H, Random, 95% CI)

0.0 [‐0.00, 0.00]

10.6 Vitamin D vs. other treatments: calcipotriol vs. coal tar polytherapy

1

445

Risk Difference (M‐H, Random, 95% CI)

0.0 [‐0.01, 0.01]

Figuras y tablas -
Comparison 19. Scalp psoriasis: vitamin D alone or in combination versus other treatments