FLUTRIMAZOLE 1-PERCENT DERMAL CREAM IN THE TREATMENT OF DERMATOMYCOSES - A MULTICENTER, DOUBLE-BLIND, RANDOMIZED, COMPARATIVE CLINICAL-TRIAL WITH BIFONAZOLE 1-PERCENT CREAM - EFFICACY OF FLUTRIMAZOLE 1-PERCENTDERMAL CREAM IN DERMATOMYCOSES

Background: Flutrimazole is a new imidazole derivate. Its antifungal a ctivity has been demonstrated in in vivo and in vitro studies to be co mparable to that of clotrimazole and higher than bifonazole. Aim: To c ompare the efficacy and tolerability of flutrimazole cream 1% with a r eference drug, bifonazole, in the treatment of dermatomycoses, eligibl e for topical treatment exclusively. Methods: A multicentre, double-bl ind, ramdomized, parallel-group clinical trial was conducted. Patients with clinically and mycologically (KHO and/or culture) diagnosed fung al infection of the skin were included in this study and were randomiz ed into two treatment groups: 1% flutrimazole or 1% bifonazole, applie d to the affected area (target lesion) once a day. The principal crite rion of efficacy, 'cure', was based on clinical and mycological assess ment. Results: Four hundred and forty-nine patients were included in t he study (228 flutrimazole, 221 bifonazole). 'Intention-to-treat' anal ysis of the data showed a difference between the treatments in terms o f the rate of cure (clinical and mycological) after 4 weeks: 73% in th e 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 effec ts like irritation or burning sensation) was 5%. Conclusions: One perc ent flutrimazole applied topically once a day in the treatment of fung al infections of the skin presents a better efficacy than bifonazole a nd a good tolerability.