Seckin 2007
Methods | Individual randomised controlled trial; double-dummy technique | |
Participants | Diagnosis: SebDermExcluded: those with severe seborrhoeic dermatitis requiring systemic therapy or very mild disease with a baseline score less than 5; other skin conditions such as rosacea; use of topical treatments in the previous 2 weeks and systemic treatments in the previous 4 weeks; HIV positivity; allergy to imidazoles; acne vulgaris Sex: M (124/200); age: 16 to 81; duration: 6 years average; severity (?) |
|
Interventions | Int: both metronidazole 0.75% gel 1× per day and cream vehicle applied facially 1× daily for 28 days (n = 30) Control: both ketoconazole 2% cream 1× per day and gel vehicle 1× per day for 28 days (n = 30) |
|
Outcomes |
|
|
Notes | Country: Turkey | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | "Patients were randomized to two groups according to a random digits table" (page 346) |
Allocation concealment (selection bias) | Unclear risk | Not reported |
Baseline comparable? | High risk | Yes for mean disease duration, baseline clinical severity score and pruritus score; no for age and sex |
Patient blinded? | Low risk | "Vehicles of both agents were identical in appearance to their original forms?" (page 346) Double-dummy technique: Participants used active drug, and vehicle of the other drug was gel or cream |
Provider blinded? | High risk | Investigator gave instructions during treatment. We believe this was based on knowledge of the treatment |
Outcome assessor blinded? | Low risk | "All of the efficacy assessments were carried out by an investigator (DS) who was unaware of which group patients were allocated to" (page 346) |
Co-interventions avoided? | Low risk | "Patients who had used any topical and systemic treatments in the previous 2 and 4 weeks respectively were not enrolled in the study" |
Compliance acceptable? | Unclear risk | Not reported |
Drop-out acceptable? | Low risk | 10% overall |
Selective outcome reporting acceptable? | Low risk | Everything reported |
ITT? | Low risk | Number of participants evaluated corresponds with the number randomly assigned |