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

Svejgaard 1998.

Methods This was an open‐label trial.
Participants The treatment setting was multicentre.
 There were 72 participants in the initial sample (moccasin type tinea pedis).
 The total evaluable sample was 69 participants (group 1 = 34 participants; group 2 = 35 participants).
Exclusion criteria of the trial
  • No systemic agent 6 months before the start of the study

Interventions
  • Group 1: itraconazole 200 mg taken twice daily for 1 week

  • Group 2: placebo taken twice daily for 1 week

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, scaling, vesicular, pustules, crusting, pruritus, itching, burning

  2. Clinical global evaluation was reported

  3. Adverse events (number of events)

Notes Funding was supplied by a pharmaceutical company. Additionally, co‐authors of the paper were affiliated to the company.
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: There was no mention of allocation concealment.
Blinding of participants and personnel (performance bias) 
 All outcomes Unclear risk Quote: "Double blind..." 72 participants "were treated with itraconazole (200mg twice daily) or placebo for 1 week with an 8 week treatment free follow up period".
Comment: Participants received active treatment or a placebo. It was not specifically stated that the participants were blinded nor was it clear which placebo regimen or appearance of treatment the placebo group received. Whilst the authors reported the trial to be 'double‐blind', it was not reported who was blinded. Therefore, this domain was judged to be at unclear risk.
Blinding (performance bias and detection bias) 
 All outcomes Unclear risk Comment: There was no report regarding whether the treatment provider was blinded.
Blinding of outcome assessment (detection bias) 
 All outcomes Unclear risk Comment: The authors did not report if the outcome assessor was blinded.
Incomplete outcome data (attrition bias) 
 All outcomes High risk Comment: 1 participant was recruited and then not randomised; 22 participants withdrew (adverse event and insufficient response); and 1 participant was lost to follow up. The attrition rate was 32%, which was judged to be high risk of bias.
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 Unclear risk Quote: "No significant inter group differences were seen, although the placebo group had fewer men (22 versus 30)." 
Comment: Baselines characteristics were not comparable with regard to gender.