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

In a multicentre, double-blind, randomized, parallel group clinical tr ial, the efficacy and tolerability of flutrimazole 1% dermal cream wer e compared with those of a reference compound, clotrimazole 1% dermal cream, applied topically twice daily for 4 weeks in patients with clin ically and mycologically diagnosed fungal infection of the skin. A tot al of 484 patients were included in the study (244 patients received f lutrimazole cream and 240 clotrimazole cream). According to an intenti on to treat analysis of the data, there was no difference between the treatments in terms of the rate of mycological cure after 4 weeks: 79% of patients in the clotrimazole group and 80% of patients in the flut rimazole group were mycologically cured (P = 0.83). From a safety poin t of view, flutrimazole and clotrimazole were well tolerated and the o verall incidence of adverse reactions (mainly mild local reactions suc h as irritation or burning sensation) was 7%. This study shows that, i n the treatment of fungal infections of the skin, topically applied fl utrimazole has good efficacy, similar to that of clotrimazole, and is well tolerated.