Biotin compared to placebo for infantile seborrhoeic dermatitis (including cradle cap)

Patient or population: infantile seborrhoeic dermatitis (including cradle cap)
Setting: paediatric department in Israel (Erlichman 1981) and Australia (Keipert 1976)
Intervention: biotin
Comparison: placebo

Change in severity

—

39 (2 RCTs) randomised but only 35 included in analysis

⊕⊝⊝⊝

Very low^a

Change in severity assessed using different scales and metrics.

Erlichman 1981 reported duration of rash 1.3 (SD 0.9) months in the placebo group and 1.4 (SD 0.8) months in the biotin group, but the study did not report an explicit measure of change in severity.

Keipert 1976 did not report raw data for changes in severity but reported no statistical difference between biotin and placebo. There was "a strongly significant difference in the quantitative measure for whatever was used first" (likely due to effectiveness of the topical steroid).

Adverse events

—

39 (2 RCTs)

—

Not reported.

Quality of life

—

—

—

Not measured.

*The risk in the intervention group (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI).

CI: confidence interval; RCT: randomised controlled trial; SD: standard deviation.

GRADE Working Group grades of evidence
High certainty: we are very confident that the true effect lies close to that of the estimate of the effect.
Moderate certainty: we are moderately confident in the effect estimate: the true effect is likely to be close to the estimate of the effect, but there is a possibility that it is substantially different.
Low certainty: our confidence in the effect estimate is limited: the true effect may be substantially different from the estimate of the effect.
Very low certainty: we have very little confidence in the effect estimate: the true effect is likely to be substantially different from the estimate of effect.

Proprietary products compared to placebo for infantile seborrhoeic dermatitis (including cradle cap)

Patient or population: infantile seborrhoeic dermatitis (including cradle cap)
Setting: paediatric hospitals and practices
Intervention: proprietary products
Comparison: placebo

Change in severity

—

166 randomised (2 RCTs); 160 included in analysis

⊕⊝⊝⊝

Very low^a

Change in severity assessed using different scales and metrics.

David 2013: success on IGA (day 14): 96% (95% CI 80% to 99%) with Promiseb vs 92% (95% CI 65% to 99%) with placebo; absolute risk reduction 4% (95% CI ‐13% to 32%).

Ribet 2007: lesional score reduction (reduction of surface area covered) (day 21): 81.4% with lactamide MEA gel + shampoo vs 70.2% with shampoo alone.

Adverse events

—

166 (2 RCTs)

⊕⊝⊝⊝

Very low^a

David 2013: no adverse events reported.

Ribet 2007: tolerance of the intervention and comparator was described as very good or good in "almost all2 in both groups, but no numerical data reported or obtainable. Specific adverse events not described but signs of discomfort similar in both groups.

Quality of life

—

—

—

Not measured.

*The risk in the intervention group (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI).

CI: confidence interval; IGA: investigator global assessment; MEA gel: a moisturising agent; RCT: randomised controlled trial.

GRADE Working Group grades of evidence
High certainty: we are very confident that the true effect lies close to that of the estimate of the effect.
Moderate certainty: we are moderately confident in the effect estimate: the true effect is likely to be close to the estimate of the effect, but there is a possibility that it is substantially different.
Low certainty: our confidence in the effect estimate is limited: the true effect may be substantially different from the estimate of the effect.
Very low certainty: we have very little confidence in the effect estimate: the true effect is likely to be substantially different from the estimate of effect.

Topical steroids compared to comparator for infantile seborrhoeic dermatitis (including cradle cap)

Patient or population: infantile seborrhoeic dermatitis (including cradle cap)
Setting: paediatric departments in Thailand (Wananukul 2012) and Israel (Shohat 1987)
Intervention: topical steroids
Comparison: comparator (licochalcone 0.025% lotion; eosin 2% aqueous solution)

Change in severity

—

105 (2 RCTs) randomised; 102 included in analysis

⊕⊝⊝⊝

Very low^a

Change in severity assessed using different scales and metrics.

Wananukul 2012: cleared by day 14: 97% (95% CI 91% to 99%) with licochalcone 0.025% lotion vs 96% (95% CI 89% to 99%) with hydrocortisone 1% lotion; absolute risk reduction 1.3% (95% CI –6% to 9%) (no difference between groups on day 14).

Shohat 1987: < 10% of body surface in both groups on day 10 (flumethasone pivalate 0.02% ointment vs eosin 2% aqueous solution)

Adverse events

—

105 (2 RCTs)

⊕⊝⊝⊝

Very low^a

1 participant in the licochalcone group developed an adverse effect. No other adverse events observed.

Quality of life

—

—

—

Not measured.

*The risk in the intervention group (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI).

CI: confidence interval; RCT: randomised controlled trial.

GRADE Working Group grades of evidence
High quality/certainty: we are very confident that the true effect lies close to that of the estimate of the effect.
Moderate quality/certainty: we are moderately confident in the effect estimate: the true effect is likely to be close to the estimate of the effect, but there is a possibility that it is substantially different.
Low quality/certainty: our confidence in the effect estimate is limited: the true effect may be substantially different from the estimate of the effect.
Very low quality/certainty: we have very little confidence in the effect estimate: the true effect is likely to be substantially different from the estimate of effect.