BACKGROUND: Treatment of tinea pedis with conventional oral antifungal agents produces poor response rates. Itraconazole is a broad-spectrum, orally active antifungal agent with pronounced antimycotic activity. However treatment cost of itraconazole is problematical in developing countries. OBJECTIVES: To study the efficacy of the 1-pulse dosing regimen of two generic products of itraconazole (Itracon and Itra) in comparison with the innovative product (Sporal) for the treatment of tinea pedis. MATERIAL AND METHOD: The study was a double-blind randomized controlled trial. One hundred and thirty-three patients with tinea pedis were treated with Itracon, Itra or Sporal 200 mg twice daily for 1 week. Clinical and mycological examinations were performed at baseline and at the follow-up visits (taking place at 1, 2, 4 and 12 weeks after the medication administration). RESULTS:Fifty-four, sixty-one and eighteen patients were randomized to Sporal, Itracon and Itra treatment group respectively. Mycological cure rate and clinical response rates were not significantly different among the three groups. Moreover there were also no statistically significant differences with regard to relapse rate. During treatment, no serious adverse events were recorded in any groups. CONCLUSION: The present study demonstrated that the efficacy of the original and generic itraconazole is not significantly different in the treatment of tinea pedis by the pulse regimen.
RCT Entities:
BACKGROUND: Treatment of tinea pedis with conventional oral antifungal agents produces poor response rates. Itraconazole is a broad-spectrum, orally active antifungal agent with pronounced antimycotic activity. However treatment cost of itraconazole is problematical in developing countries. OBJECTIVES: To study the efficacy of the 1-pulse dosing regimen of two generic products of itraconazole (Itracon and Itra) in comparison with the innovative product (Sporal) for the treatment of tinea pedis. MATERIAL AND METHOD: The study was a double-blind randomized controlled trial. One hundred and thirty-three patients with tinea pedis were treated with Itracon, Itra or Sporal 200 mg twice daily for 1 week. Clinical and mycological examinations were performed at baseline and at the follow-up visits (taking place at 1, 2, 4 and 12 weeks after the medication administration). RESULTS: Fifty-four, sixty-one and eighteen patients were randomized to Sporal, Itracon and Itra treatment group respectively. Mycological cure rate and clinical response rates were not significantly different among the three groups. Moreover there were also no statistically significant differences with regard to relapse rate. During treatment, no serious adverse events were recorded in any groups. CONCLUSION: The present study demonstrated that the efficacy of the original and generic itraconazole is not significantly different in the treatment of tinea pedis by the pulse regimen.