Elewski 2006
Methods | Individual randomised controlled trials | |
Participants | Dx: seborrhoeic dermatitis (physician diagnosis implied from text) Exclude if patient has other skin conditions, is allergic to agents used, is pregnant, has used systemic or topical antiseborrhoeic treatment within 30 to 14 days of trial, respectively Sex: keto - male (59.4%), vehicle - male (59.1%); age: keto (52 ± 17.8), vehicle (50 ± 17.2); duration: keto (12.2 ± 13.4), vehicle (11.1 ± 12.2); previous treatment: keto (64.6%), vehicle (68.7%) |
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Interventions | Intervention: ketoconazole 2% gel applied once daily to face for 14 days (n = 229) Control: vehicle gel applied similarly (n = 230) |
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Outcomes | Symptom severity scores for erythema, pruritus and scaling | |
Notes | Country: United Kingdom; COI: sponsorship by Barrier Therapeutics; side effects: application site burning and erythema - keto (35), vehicle (44) This study reported symptom scores but did not provide standard deviations. For this reason, we omitted the study from the data tables and reported data in text in appropriate sections |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Not reported |
Allocation concealment (selection bias) | Unclear risk | Not reported |
Baseline comparable? | Low risk | Refer to Table 1 |
Patient blinded? | Unclear risk | "... double-blind ..." |
Provider blinded? | Unclear risk | "... double-blind ..." |
Outcome assessor blinded? | Unclear risk | "... double-blind ..." |
Co-interventions avoided? | Low risk | "No other topical medications or moisturizers were to be applied to affected area(s) during the study, and medicated shampoos were prohibited" |
Compliance acceptable? | Unclear risk | Not reported |
Drop-out acceptable? | Low risk | "... 442 (96.3%) completed the study... 222 (96.9%) in the ketoconazole group and 220 (95.7%) in the vehicle group" |
Selective outcome reporting acceptable? | Unclear risk | Not reported |
ITT? | Unclear risk | Not reported |