ONE-WEEK THERAPY WITH TWICE-DAILY BUTENAFINE 1-PERCENT CREAM VERSUS VEHICLE IN THE TREATMENT OF TINEA-PEDIS - A MULTICENTER, DOUBLE-BLIND TRIAL

Background: Butenafine hydrochloride, a benzylamine derivative with po tent antifungal activity, has been used in Japan to treat superficial fungal diseases.Objective: We evaluated the safety and efficacy of twi ce-daily butenafine versus its vehicle in the treatment of interdigita l tinea pedis in a multicenter, randomized, double-blind, parallel-gro up trial. Methods: A total of 402 patients with interdigital tinea ped is and a positive potassium hydroxide examination were enrolled. Of th e 271 patients who had culture-confirmed tinea pedis and were assessed for efficacy, 132 applied butenafine and 139 applied vehicle twice da ily for 1 week. Patients were assessed for mycologic cure, effective t reatment, overall cure, and mycologic/clinical cure. Results: The rate s of all four end points were significantly higher with butenafine tha n with vehicle 5 weeks after treatment ended Rates of mycologic cure a nd effective treatment with butenafine were significantly higher than with vehicle at cessation of treatment. Adverse events to treatment oc curred in less than 1% of patients treated with butenafine and 2% of p atients who applied vehicle. Conclusion: Butenafine applied twice dail y for 1 week is highly effective in treating interdigital tinea pedis.