Patients were fully compliant with the trial preparations and none discontinued treatment; therefore, all 60 patients were available for efficacy analysis. Demographic data (table I) showed that the patients in the three treatment groups were comparable with regard to age, race, severity of tinea pedis history, experience of previous therapy, duration of disease and causative dermatophyte species. The mean duration of tinea pedis disease in the participants was 28.4 weeks.
At the end of the treatment, 60% of patients were cured. Butenafine 1% cream produced a significantly higher mycological cure rate than terbinafine 1%cream or placebo. Butenafine cured 90% of patients in 7 days, terbinafine cured 80% of patients in 14 days, and placebo cured 10% of patients in 14 days.
T. rubrum (24), T. mentagrophytes (20), T. violaceum (8) and T. tonsurans (5) were the most common isolated causative dermatophytes in the patients.
The most common signs and symptoms (0 to 3 scale) recorded at entry were erythema (100%), pustules (100%), incrustation (98%) and pruritus (95%). Such signs and symptoms were reduced to none in 60% of patients after 2 weeks of treatment. The overall effectiveness of the trial preparation based on the combined clinical and mycological assessments performed at the cessation of the therapy and at the subsequent follow-up visits at weeks 4, 8 and 12 (as judged from the investigator's global assessment of 100% remission of all signs and symptoms) showed that butenafine 1% in cream was significantly more effective than terbinafine 1% cream and placebo.
All the relevant standard laboratory test results were within the normal range before and after the treatment. No adverse events were experienced by any participant in the three treatment groups.
No further improvements or beneficial effects after 2 weeks were observed in the remaining uncured 6 patients in the active treatment groups [butenafine (n = 2) and terbinafine (n = 4)]. 18 placebo recipients showed no change at follow-up monitoring. Two participants, one in the terbinafine group and one in the placebo group, relapsed after 11 months. Patients used 102 tubes of 25g within 2 weeks. Pre- and post study patient demographics are summarised in table I.
Clin Drug Invest. 2000;19(6) © 2000 Adis Data Information BV
Cite this: Butenafine 1% Versus Terbinafine 1% in Cream for the Treatment of Tinea Pedis: A Placebo Controlled, Double-Blind, Comparative Study - Medscape - Jun 01, 2000.