DOSE-FINDING STUDY OF AMOROLFINE CREAM (0.125-PERCENT, 0.25-PERCENT AND 0.5-PERCENT) IN THE TREATMENT OF DERMATOMYCOSES

A total of 725 patients with mycosis of the skin folds, large areas of the body or feet were entered into this double-blind, dose-finding study. Treatment with 0.125, 0.25 or 0.5% amorolfine cream was randomly allocated to patients. The cream was applied once daily for 4 weeks on average. At screening, in 527 patients evaluated for efficacy, a total of 533 pathogens were isolated: T. rubrum (322), T. mentagrophytes (84), E. floccosum (45), M. canis (42), other dermatophytes (14), C. albicans (24) and other yeasts (2). One week after the end of treatment, the culture was negative in 80.5, 81.3 and 84.8% of patients treated with 0.125, 0.25 or 0.5% amorolfine cream, respectively. The differences were not statistically significant. Forty-four out of 714 patients evaluated for safety had local adverse events: 14 (5.8%), 13 (5.5%) and 17 (7.1%) in the amorolfine cream 0.125, 0.25 and 0.5% groups, respectively. Due to local adverse events, six patients (2.5%) in the 0.125% group, six patients (2.6%) in the 0.25% group and seven patients (2.9%) in the 0.5% group discontinued the trial treatment. The most common adverse events were burning, itching, erythema and scaling. No systemic adverse events were reported.