Flutrimazole 1% dermal cream in the treatment of dermatomycoses: a randomized, multicentre, double-blind, comparative clinical trial with 1% clotrimazole cream. Flutrimazole Study Group

Abstract

In a multicentre, double-blind, randomized, parallel group clinical trial, the efficacy and tolerability of flutrimazole 1% dermal cream were compared with those of a reference compound, clotrimazole 1% dermal cream, applied topically twice daily for 4 weeks in patients with clinically and mycologically diagnosed fungal infection of the skin. A total of 484 patients were included in the study (244 patients received flutrimazole cream and 240 clotrimazole cream). According to an intention 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 flutrimazole group were mycologically cured (P = 0.83). From a safety point of view, flutrimazole and clotrimazole were well tolerated and the overall incidence of adverse reactions (mainly mild local reactions such as irritation or burning sensation) was 7%. This study shows that, in the treatment of fungal infections of the skin, topically applied flutrimazole has good efficacy, similar to that of clotrimazole, and is well tolerated.