Koc 2009
Methods | Individual randomised controlled trials | |
Participants | Diagnosis: SebDerm Exclusion criteria: patients with severe SebDerm, other skin conditions including psoriasis and acne; patients allergic to chemicals used in shampoos; patients who have used systemic treatments for SD within the past month Implied from context that this was SD of the face Sex: M (34/38); age: 21 to 42 years |
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Interventions | Intervention: pimecrolimus 1% cream applied twice daily for 42 days (n = 23) Control: ketoconazole 2% cream applied twice daily for 42 days (n = 25) |
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Outcomes | Symptom severity score for erythema and scaling at 12 weeks | |
Notes | Country: Turkey Adverse effects: keto (1/24), hydrocortisone (2/26) |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | "Patients were randomized into two treatment groups according to a random digits table" (page 5) |
Allocation concealment (selection bias) | High risk | "In this 6 week open label, randomized comparative study ..." |
Baseline comparable? | Low risk | "The treatment groups were not statistically significantly different at baseline with respect to age, sex, mean disease duration and with regards to the criteria (erythema, scaling and infiltration) (p = 0.05)" (page 5) |
Patient blinded? | High risk | "In this 6 week open label, randomized comparative study ..." |
Provider blinded? | High risk | "In this 6 week open label, randomized comparative study ..." |
Outcome assessor blinded? | High risk | "In this 6 week open label, randomized comparative study ..." |
Co-interventions avoided? | Low risk | "No other medications for SD were allowed during the trial, except for anti-dandruff shampoos started more than 1 month in advance and not used on the face" (page 5) |
Compliance acceptable? | Unclear risk | Not reported |
Drop-out acceptable? | Low risk | Pimecrolimus 5/21, ketoconazole 4/22 (page XX) |
Selective outcome reporting acceptable? | Low risk | All outcomes reported |
ITT? | High risk | Not reported |