Butenafine 1% versus terbinafine 1% in cream for the treatment of tinea pedis - A placebo-controlled, double-blind, comparative study

Objective: To compare the clinical efficacy and tolerability of butenafine 1% in cream with terbinafine 1% in cream in the treatment of plantar or moc casin-type tinea pedis (athlete's foot). Design and Setting: This was a placebo-controlled, double-blind study. Patients and Participants: 60 men aged between 18 and 60 years (mean 35.4 y ears) with a mean duration of disease of 28.4 weeks, positive mycology and culture-confirmed tinea pedis participated in the study. Methods: The participants were sequentially randomised into three parallel groups (butenafine cream, terbinafine cream and placebo). Each patient was given a preceded 25g tube and instructed to apply the trial medication to a ll tinea pedis lesions once daily at bedtime for 5 consecutive days per wee k (maximum of 2 weeks' active treatment). Patients were examined on a weekl y basis. Cure was defined as negative potassium hydroxide test results and negative fungal culture (mycological cure). Participants cured during the t reatment were allowed to discontinue the treatment. Results: By the end of the treatment 60% of all patients were cured. Butena fine cured 18 (90%) patients at 1 week and no further patients at 2 weeks. Terbinafine cured no patients at 1 week and 16 (80%) patients at 2 weeks. P lacebo cured no patients at 1 week and 2 (10%) patients at 2 weeks (p < 0.0 001, butenafine and terbinafine vs placebo at 2 weeks). None of the patient s reported any drug-related adverse events and no patients discontinued tre atment. Conclusion: Butenafine 1% in cream is well tolerated and comparatively bett er than terbinafine 1% in cream or placebo to cure plantar or moccasin-type tinea pedis in men. Further clinical studies appear warranted.