Difonzo 1995.
Methods | This was a RCT. | |
Participants | The treatment setting was multicentre.
There were 37 participants in the original sample.
The total evaluable sample was 35 participants (group 1 = 17 participants; group 2 = 18). Exclusion criteria of the trial
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Interventions |
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Outcomes |
Primary outcomes of the trial
Secondary outcomes of the trial
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Notes | One of the co‐authors was affiliated to Janssen Farmaceutici, Italy; however, the source of funding was not declared. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Comment: The method of randomisation was not reported. |
Allocation concealment (selection bias) | Unclear risk | Comment: It was not reported if allocation was concealed. |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Quote: "...double‐blind." "Itraconazole (100 mg) or fluconazole (50 mg, posology usually administered in dermatophyte infections) was administered orally, in a capsule formulation, once‐daily with a meal for 30 days." Comment: Participants received the same capsule regimen and number of capsules. Whilst it was not specifically stated that the participants were blinded, it was judged to be sufficient that the study was reported to be 'double‐blind'; therefore, this domain was judged to be low risk. |
Blinding (performance bias and detection bias) All outcomes | Unclear risk | Comment: There was no report regarding who allocated treatment or provided medication. It was not clear from the report whether the treatment provider was blinded in this 'double‐blind' study; therefore, this was judged to be unclear risk. |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Quote: "Mycology testing, assessment of clinical and subjective symptoms of infection (erythema, desquamation, vesicles, exudation, maceration, fissuring) and a physicians overall assessment… Symptoms were scored using a 3 point scale." Comment: Participants were assessed in the same manner; however, it was unclear if blinding was ensured. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Quote: "Two of the 37 participants enrolled in the study were not included in the efficacy analysis: one, treated with itraconazole, was lost to follow up and the other treated with fluconazole, withdrew from the study due to elevated SGOT and SGPT levels." Comment: The authors reported the number of participants lost to follow up. The attrition rate was 5%. |
Selective reporting (reporting bias) | Low risk | Comment: The study protocol was not available. However, the outcomes stated in the methods of the report were all described in the results and discussion. |
Other bias | Low risk | Comment: This trial appeared to be free from other potential sources of bias. |