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

Author(s): Alomar A, Videla S, Delgadillo J, Gich I, Izquierdo I, Forn J

Affiliation(s): Hospital Santa Creu i Sant Pau, Barcelona, Spain.

Publication date & source: 1995, Dermatology., 190(4):295-300.

Publication type: Clinical Trial; Multicenter Study; Randomized Controlled Trial

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, randomized, 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.

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