A Comparison of the Efficacy between Two Itraconazole Generic Products and the Innovative Itraconazole in the Treatment of Tinea Pedis
Saowanee Hoharitanon, MD*, Janejira Chaichalotornkul, MD*, Wannasri Sindhupak, MD*
Affiliation : * Department of Pathology, Faculty of Medicine, Chulalongkorn University
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.
Materials and Methods : 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.
Keywords : Itraconazole, T. pedis, Dermatophytes, Hendersonula
