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.

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 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.

• Authors: A Alomar, S Videla, J Delgadillo, I Gich, I Izquierdo, J Forn
• Journal: Dermatology (Basel, Switzerland) (Dermatology) Vol. 190 Issue 4 Pg. 295-300 ( 1995) ISSN: 1018-8665 [Print] Switzerland
• PMID: 7655109 (Publication Type: Clinical Trial, Comparative Study, Journal Article, Multicenter Study, Randomized Controlled Trial)

Chemical References

• Antifungal Agents
• Dosage Forms
• Imidazoles
• flutrimazole
• Clotrimazole
• bifonazole

Topics

• Administration, Topical
• Adolescent
• Adult
• Aged
• Antifungal Agents (administration & dosage, therapeutic use)
• Candidiasis, Cutaneous (drug therapy)
• Chi-Square Distribution
• Child
• Clotrimazole (administration & dosage, analogs & derivatives, therapeutic use)
• Dermatomycoses (drug therapy)
• Dosage Forms
• Double-Blind Method
• Female
• Humans
• Imidazoles (administration & dosage, therapeutic use)
• Male
• Middle Aged
• Spain
• Tinea Versicolor (drug therapy)