Butenafine 1% cream in the treatment of tinea cruris: a multicenter, vehicle-controlled, double-blind trial.

BACKGROUND

Butenafine hydrochloride, a potent antifungal agent related to the allylamines, has been used in Japan for treating various cutaneous mycoses including tinea cruris.

OBJECTIVE

We compared the safety and efficacy of butenafine hydrochloride and its vehicle when used once daily for 2 weeks to treat tinea cruris.

METHODS

Patients (n = 93) with tinea cruris and a positive potassium hydroxide examination and mycologic culture were enrolled. Of the 76 patients assessed for efficacy, 37 applied butenafine and 39 applied vehicle once daily for 2 weeks. Assessments were made at the end of the 2-week treatment period and 4 weeks after the end of treatment.

RESULTS

Patients in the butenafine group had a higher mycologic cure rate by day 7 (66% vs 13%, p < 0.0001), with marked improvement 4 weeks after the end of treatment (81% vs 13%, p < 0.0001). They also had a higher rate of effective treatment at day 7 (29% vs 5%, p < 0.01) and at 4 weeks after treatment (73% vs 5%, p < 0.0001). Adverse events definitely related to butenafine treatment were limited to one case of burning sensation after application.

CONCLUSION

Butenafine applied once daily for 2 weeks is effective in treating tinea cruris. The proportion of patients cured increased between the end of treatment and 4 weeks after treatment.