Background: Flutrimazole is a new imidazole derivate. Its antifungal activity has been demonstrated in in vivo and in vitro studies to be comparable to that of clotrimazole and higher than bifonazole. Aim: To compare the efficacy and tol- erability of flutrimazole cream 1% with a reference drug, bifonazole, in the treat-ment of dermatomycoses, eligible for topical treatment exclusively. Methods: A multicentre, double-blind, ramdomized, parallel-group clinical trial was conducted. Patients with clinically and mycologically (KHO and/or culture) diagnosed fungal infection of the skin were included in this study and were randomized into two treatment groups: I % flutrimazole or 1 % bifonazole, applied to the affected area (target lesion) once a day. The principal criterion of efficacy, ‘cure’, was based on clinical and mycological assessment. Results: Four hundred and forty-nine patients were included in the study (228 flutrimazole, 221 bifonazole). intention-to-treat’ analysis of the data showed a difference between the treatments in terms of the rate of cure (clinical and mycological) after 4 weeks: 73% in the flutrimazole group and 65% in the bifonazole group (p = 0.05). From a safety point of view, flutrimazole and bifonazole were well tolerated, and the overall incidence of adverse effects (mainly mild local effects like irritation or burning sensation) was 5%. Conclusions: One percent flutrimazole applied topically once a day in the treatment of fungal infections of the skin presents a better efficacy than bifonazole and a good tolerability. © 1995 S. Karger AG, Basel.
- Antifungal therapy