Lebwohl 2004
Methods | Individual randomised controlled trial | |
Participants | Dx: SD of the scalp (physician diagnosis implied) Exclusion criteria: psoriasis, atopic dermatitis, previous use of systemic antimycotic medication and lots more (see Table 1, page 18) Sex: ciclo (male 46%), vehicle (male 49%) |
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Interventions | Intervention: ciclopirox (1%) shampoo applied twice weekly to scalp for 28 days (n = 250) Control: vehicle shampoo applied similarly (n = 249) |
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Outcomes | Complete clearance | |
Notes | Country: USA Conflict of interest: The second study author is employed by Medicis Pharmaceutical Corporation |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | "The present study was a randomized double blind, vehicle-controlled multicenter trial" |
Allocation concealment (selection bias) | Unclear risk | See above |
Baseline comparable? | Low risk | Baseline characteristics reported and similar |
Patient blinded? | Unclear risk | "This randomized, double blind, vehicle-controlled study was conducted ..." |
Provider blinded? | Unclear risk | "This randomized, double blind, vehicle-controlled study was conducted ..." |
Outcome assessor blinded? | Unclear risk | "This randomized, double blind, vehicle-controlled study was conducted ..." |
Co-interventions avoided? | Unclear risk | Not reported |
Compliance acceptable? | Unclear risk | Mean treatment duration was 27 days for both groups |
Drop-out acceptable? | Unclear risk | Not reported |
Selective outcome reporting acceptable? | Low risk | All outcomes reported |
ITT? | Unclear risk | Not reported |