Flutrimazole 1 % dermal cream in the treatment of dermatoycoses : a multicentre, double-blind, randomized, comparative clinical trial with bifonazole 1 % cream : efficacy of flutrimazole 1 % dermal cream in dermatomycoses

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 tolerability of flutrimazole cream 1% with a reference drug, bifonazole, in the treatment 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: 1% 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