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

A. Alomar, S. Videla, J. Delgadillo, I. Gich, I. Izquierdoh, J. Forn, A. Alomar Muntañola, A. Azon Masoliver, A. Ballestero Corominas, E. Barberá Montesinos, S. Bassas Bresca, J. M.Casanoves Seuma, A. Castells Rodellas, C. Ferràndiz Foraster, J. M.García Marqués, J. Gil Alava, C. Janes Sariola, E. Llistosella Llach, C. Marqués Cardell, X. Noguera TosquetsM. Planagumà Vila, N. Salvatella Danés, I. Vilaltella Domenjó, J. Vilaplana Vilaplana, P. Vives Vila, J. M.Vives Sendra, M. Algueró Musons, E. Boncompte Satorras

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Abstract

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 tol- erability of flutrimazole cream 1% with a reference drug, bifonazole, in the treat-ment 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: I % 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. © 1995 S. Karger AG, Basel.
Original languageEnglish
Pages (from-to)295-300
JournalDermatology
Volume190
Issue number4
DOIs
Publication statusPublished - 1 Jan 1995

Keywords

  • Antifungal therapy
  • Bifonazole
  • Dennatomycoses
  • Flutrimazole

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