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.