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. 2015 Apr 29;(4):CD008138. doi: 10.1002/14651858.CD008138.pub2

Abeck 2004

Methods Individual randomised controlled trials
Participants Diagnosis: patients with seborrhoeic dermatitis of the scalp (physician's diagnosis implied) with scores of 2 to 4 for scaling and inflammation at baseline
Exclusion: persons with psoriasis, atopic dermatitis, long hair; those treated with systemic antibiotics or antifungals 2 weeks or less before commencement of study; pregnancy/breast feeding; child-bearing potential without adequate contraception or irregular menstrual cycles; history of drug or alcohol use; and many others (see Table 1, page 14)
Sex: male (109), female (74)
Interventions Intervention: ciclopirox 1% shampoo applied 3 times weekly for 28 days (n = 45)
Controls:
  • Vehicle shampoo applied 3 times weekly for 28 days (n = 46)


  • Ciclopirox 1% shampoo applied 2 times weekly for 28 days (n = 46)


  • Ciclopirox 1% shampoo applied once weekly for 28 days (n = 46)

Outcomes Complete clearance
Notes Country: Germany; conflict of interest: none; side effects: 27 participants overall had side effects, which included skin and appendage disorders, pruritus, mild hair loss, severe parietal erythema and moistness of scalp
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk "Subjects were randomized into four parallel groups ..."
Allocation concealment (selection bias) Unclear risk Not reported
Baseline comparable? Low risk "The differences in baseline characteristics among groups were minor and unlikely to affect results"
Patient blinded? Unclear risk "... randomized, double-blind, vehicle controlled four arm trial ..."
Provider blinded? Unclear risk "... randomized, double-blind, vehicle controlled four arm trial ..."
Outcome assessor blinded? Unclear risk "... randomized, double-blind, vehicle controlled four arm trial ..."
Co-interventions avoided? Low risk "No other cosmetic nor non-cosmetic treatment of the scalp or hair was permitted"
Compliance acceptable? Unclear risk Not reported
Drop-out acceptable? Unclear risk Not reported
Selective outcome reporting acceptable? Low risk All outcomes were reported
ITT? Low risk "All analyses were performed for the ITT population ..." Results confirm this