Evaluation of the efficacy of ciclopirox 0.77% gel in the treatment of tinea pedis interdigitalis (dermatophytosis complex) in a randomized, double-blind, placebo-controlled trial.

摘要

Abstract Background Ciclopirox is an antifungal agent and is effective against both Gram-positive and Gram-negative bacteria. These properties may give ciclopirox an advantage over other antifungal agents in the treatment of interdigital tinea pedis with secondary bacterial infection (dermatophytosis complex). Objective To evaluate the efficacy of ciclopirox 0.77% gel in the treatment of tinea pedis interdigitalis with secondary bacterial infection in a prospective, randomized, double-blind, placebo-controlled clinical study. Subjects and methods One hundred subjects were enrolled in this 8-week study (twice-daily ciclopirox, 40 subjects; once-daily ciclopirox, 40 subjects; twice-daily vehicle, 20 subjects). Mycologic sampling, bacterial swabs, and evaluations for symptoms and signs of tinea pedis were performed on a target webspace at baseline and at weeks 2, 4, and 8. Global evaluations were made by both investigator and subject at each visit. Results Ciclopirox gel applied once or twice daily significantly reduced the signs and symptoms at week 8, compared with vehicle (P < 0.0036). The mycologic cure and complete cure rates were much higher for the ciclopirox regimens than for the vehicle regimen. Early reduction of bacterial counts was noted with the ciclopirox regimens. There was no significant difference in the adverse event rate between the ciclopirox groups and the placebo group. Conclusion Ciclopirox 0.77% gel, applied once or twice daily, is effective and safe in the treatment of tinea pedis interdigitalis with concomitant bacterial infection (dermatophytosis complex).