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

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
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)
Outcomes Symptom severity score for erythema and scaling at 12 weeks
Notes Country: Turkey
Adverse effects: keto (1/24), hydrocortisone (2/26)
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