Firooz 2006.
Methods | Study type: individual RCT Randomisation method: computer‐generated randomisation list Blinding: investigator‐blind Intention‐to‐treat analysis used: yes |
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Participants |
Inclusion criteria of the trial
Exclusion criteria of the trial
Number of randomised participants: 40 in total (pimecrolimus N = 20, hydrocortisone N = 20) Number of dropouts: 3 (8%) Sex: 28 males, 12 females Age (mean): pimecrolimus arm = 28.65 years, hydrocortisone arm = 37.45 years Country: Iran |
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Interventions |
Treatment
Comparator/s
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Outcomes |
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Notes | ‐ | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Randomisation was computer‐generated |
Allocation concealment (selection bias) | Unclear risk | This was not reported |
Similarity of the study groups (selection bias) | Low risk | There were no statistically significant differences between groups |
Blinding of participants (performance bias) | High risk | Only investigators were blinded |
Blinding of care providers (performance bias) | Unclear risk | Quote: "investigator blind" This probably refers to outcome assessment |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | The investigator was blinded. We assume this refers to outcome assessment |
Incomplete outcome data (attrition bias) All outcomes | Low risk | The number of dropouts was acceptable |
Selective reporting (reporting bias) | Low risk | Predefined outcomes were reported |
Other bias | Unclear risk | The pharmaceutical industry provided ‐ free of charge ‐ the intervention creams |