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. 2019 Mar 4;2019(3):CD011380. doi: 10.1002/14651858.CD011380.pub2

Keipert 1976.

Methods Double‐blind, cross‐over randomised controlled trial, 3 weeks then cross‐over to other intervention.
Intention‐to‐treat analysis not reported
Participants 19 participants completed.
Inclusion criteria: infants with typical clinical changes of seborrhoeic dermatitis of infancy, rash in nappy area, and other typical sites
Exclusion criteria: not stated
Number of participants randomised: not stated; 19 completed trial; 7 completed 1 extra 3‐week course
Number of dropouts: not stated
Sex: not stated
Mean age: not stated; range: 6 weeks to 6 months
Location: Australia, probably secondary care
Interventions Treatment (n not reported, possibly 10)
Oral biotin powder 2mg twice daily for 3 weeks, and topical therapy of betamethasone 12‐valerate cream 0.02%
Comparator (n not reported, possibly 10)
Placebo powder twice daily for 3 weeks, and topical therapy of betamethasone 12‐valerate cream 0.02%
Outcomes Primary outcome measures
  • Quantitative change in area of skin involvement measured according to % increase or decrease.

  • Qualitative changes scored using 5 grades of 0–10 points, giving a score out of 50. Not reported what the qualitative criteria measured were.


Actual scores and percentages not reported
Assessment performed at end of each 3‐week period, with no reported washout time.
No reporting of adverse effects.
No reporting of quality of life outcomes.
Notes Note: 7 participants reported to have completed 3 courses of treatment, creating a total of 45 courses of treatment.
Study design flawed given that the condition was likely to improve rapidly over time especially given that both groups received a topical steroid that was likely to improve the rash.
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Quote: "independently allotted at random".
Comment: did not specify method of random sequence generation.
Allocation concealment (selection bias) Unclear risk Quote: "independently allotted at random".
Comment: no further details given.
Blinding of participants and personnel (performance bias) 
 All outcomes Unclear risk No description of presentation of the 2 interventions.
Blinding of outcome assessment (detection bias) 
 All outcomes Unclear risk Quote: "Changes were blindly assessed at the end of each three‐week period".
Comment: no further details given.
Incomplete outcome data (attrition bias) 
 All outcomes Unclear risk Not reported how many participants were recruited.
Selective reporting (reporting bias) Unclear risk No study protocol.
Other bias High risk No statistical methods reported. Pharmaceutical company provided the products and provided help with literature and statistical analysis.