Ortonne 2011.
Methods | Study type: individual RCT Randomisation method: "central computed randomization list, block‐size of 4" Blinding: "blinded investigators" 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: 326 in the whole study; we used only the results of the clobetasol group (N = 82) and the ketoconazole group (N = 80) Number of dropouts: 12 (7%) at "end of study" Sex: 88 males, 74 females Age (mean): clobetasol arm = 44.9 years, ketoconazole arm = 44.7 years Country: Belgium, France, Germany, Mexico, South Korea |
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Interventions |
Treatment
Comparator/s
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Outcomes |
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Notes | Only the results for the clobetasol propionate only, and the ketoconazole only, and for the treatment phase are used in the analyses The results for the outcomes were expressed in a way not relevant for the review; therefore, we could use only information for adverse events |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote: "randomized in a 1:1:1:1 ratio by a designated statistician (using a central computed randomization list that generated treatment numbers in a block‐size of 4)" |
Allocation concealment (selection bias) | Unclear risk | This was not reported clearly |
Similarity of the study groups (selection bias) | Low risk | Quote: "The demographic and baseline disease characteristics were similar among the four groups" |
Blinding of participants (performance bias) | High risk | The participants were not blinded |
Blinding of care providers (performance bias) | High risk | The care providers were not blinded |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | The investigator was blinded |
Incomplete outcome data (attrition bias) All outcomes | Low risk | The dropout rate was acceptable |
Selective reporting (reporting bias) | Low risk | Predefined outcomes were reported |
Other bias | Unclear risk | 4 out of 8 authors were affiliated to the pharmaceutical industry |