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 |
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Participants |
Inclusion criteria of the trial
Exclusion criteria of the trial
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 |
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Interventions |
Treatment
Comparator/s
The total follow‐up time was 12 weeks |
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Outcomes |
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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 |
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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 |