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. 2012 Oct 17;2012(10):CD003584. doi: 10.1002/14651858.CD003584.pub2

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
  • No systemic antifungals taken 1 month before the study

Interventions
  • Group 1: itraconazole 100 mg ‐ 1 capsule taken daily for 30 days

  • Group 2: fluconazole 50 mg ‐ 1 capsule taken orally daily for 30 days

Outcomes Primary outcomes of the trial
  1. Cure, demonstrated by negative results on microscopy and no growth of dermatophyte in culture


Secondary outcomes of the trial
  1. Clinical signs and symptoms: exudation, erythema, vesicles, desquamation, maceration, fissuring

  2. Adverse events

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.