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. 2014 May 19;2014(5):CD009446. doi: 10.1002/14651858.CD009446.pub2

Koc 2009.

Methods Study type: individual RCT
Randomisation method: participants were randomised according to a random digit table
Blinding: no (open‐label)
Intention‐to‐treat analysis used: no
Participants Inclusion criteria of the trial
  • Seborrhoeic dermatitis


Exclusion criteria of the trial
  • Coexistent other dermatoses involving the face or other affected area (e.g. psoriasis, rosacea, and acne vulgaris)

  • Allergy to medications

  • Use of any topical or systematic treatments in the previous month

  • Participants who had severe SeD requiring systemic treatment


Number of randomised participants: 48 in total (pimecrolimus N = 23, ketoconazole N = 25)
Number of dropouts: 10 (21%)
Sex: 34 males, 4 females
Mean age (range): pimecrolimus arm = 32.3 (21 to 50), ketoconazole arm = 29.8 (20 to 47)
Country: Turkey
Interventions Treatment
  • Pimecrolimus 1% cream, applied twice daily for 6 weeks


Comparator/s
  • Ketoconazole 2% cream, applied twice daily for 6 weeks


The total follow‐up time was 12 weeks
Outcomes
  1. Total clinical severity scores (including erythema, scaling, and infiltration with scale 0 to 3)

  2. Adverse events

Notes We received additional data from the first author
The affected area or site of SeD lesions as inclusion criteria were not reported. However, coexistent dermatoses involving the face or other affected areas were mentioned as exclusion criteria, suggesting that facial SeD was an inclusion criterion
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Quote: "random digits table"
Allocation concealment (selection bias) Unclear risk Quote: "random digits table"
Similarity of the study groups (selection bias) Low risk Quote: "The treatment groups were not statistically significantly different at baseline"
Blinding of participants (performance bias) High risk This was an open‐label study
Blinding of care providers (performance bias) High risk This was an open‐label study
Blinding of outcome assessment (detection bias) 
 All outcomes High risk This was an open‐label study
Incomplete outcome data (attrition bias) 
 All outcomes Unclear risk The dropout rate over was 20%; reasons were not given in detail. There was discrepancy between text and figure 1 with regard to distribution of dropouts
Selective reporting (reporting bias) Low risk Predefined outcomes as stated in the article were reported
Other bias Low risk Note: The affected area was not reported