Double-blind comparison of amorolfine and bifonazole in the treatment of dermatomycoses.

A total of 232 patients with mycoses of skin folds, body, or feet were entered into a double-blind, parallel group-study. Therapy with 0.125, 0.25, 0.5% amorolfine cream or 1% bifonazole cream was randomly allocated to patients. The cream was applied once daily for 4 weeks on average. At screening, in 208 patients evaluated for efficacy, a total of 225 fungi were isolated: T. rubrum (77), T. mentagrophytes (65), other dermatophytes (15), C. albicans (34), other yeasts (26) and moulds (8). One to three weeks after ending therapy, the percentage of patients with negative cultures were as follows: 87.3, 91.7, 90.7 and 92.2% in the amorolfine cream 0.125%, 0.25%, 0.5% and bifonazole cream 1% groups respectively. The differences were not statistically significant. Six out of 223 patients evaluated for safety had local adverse events: one (1.7%), two (3.6%) and three (5.4%) in the amorolfine cream 0.125%, 0.25% and bifonazole cream 1% groups respectively. The most common local adverse events were burning and increased itching, erythema or weeping. A once-daily application of amorolfine cream can be recommended for the treatment of dermatomycoses on the basis of the results from this study. However, a further and similar study with a larger number of patients was required to select the concentration of amorolfine cream for therapeutic use.

RCT Entities:   Population Interventions Outcomes