Efficacy and tolerability of topical terbinafine in the treatment of tinea cruris.

Abstract

Thirty men with clinical and mycologic evidence of tinea cruris were enrolled in a controlled, randomized, double-blind trial comparing terbinafine 1% cream and its cream vehicle as placebo. Patients applied the test medications to the affected area twice daily for 2 weeks. Therapeutic response was evaluable in 18 patients after each week of treatment and at a follow-up visit 2 weeks after therapy ended. At each visit, terbinafine was found to be more effective than the cream vehicle in the reduction of the signs and symptoms of infection and in the conversion of culture and microscopy findings to negative or normal. At the end of treatment, therapy was effective in 67% of the nine terbinafine-treated patients compared with only 11% of the nine placebo-treated patients. At the follow-up examination, efficacy rates were 78% in the terbinafine treatment group and 33% in the placebo group--a difference of borderline statistical significance (p = 0.077). Possible reasons for this result may include the higher incidence of chronic disease in the terbinafine group and the large number of patients who were classified as delayed exclusions because of negative initial culture for dermatophytes. No side effects or significant alterations in laboratory or hematologic tests were observed in either treatment group.