BACKGROUND:Eberconazole is a topical, broad-spectrum imidazole derivative, effective in dermatophytoses, candidiasis, and pityriasis treatment. In previous trials, it showed a higher efficacy than clotrimazole in the treatment of dermatophytoses. The purpose of this trial was to evaluate the efficacy of eberconazole 1% cream compared with miconazole 2% cream in the treatment of dermatophytoses. METHODS: A multicenter, double-blind, randomized trial was performed in 653 patients with dermatophytoses, randomized to eberconazole 1% cream every 12 h or miconazole 2% cream every 12 h for 4 weeks. Treatment efficacy was assessed on the basis of the percentage of effective response after 4 weeks through mycologic and clinical assessment. RESULTS: Of the 653 patients included in the trial, 360 produced positive baseline mycologic cultures and were included in the efficacy assessment. Clinical efficacy was shown in 76.1% of patients receiving eberconazole and in 75.0% of patients receiving miconazole. The incidence of adverse events related to treatment was 0.91% for eberconazole and 0.92% for miconazole, none being serious, and all being local and transient. CONCLUSIONS:Eberconazole 1% cream is an effective treatment for fungal infections produced by dermatophytes, with a good safety and tolerability profile, and can be considered a good alternative for the treatment of dermatophytoses.
RCT Entities:
BACKGROUND:Eberconazole is a topical, broad-spectrum imidazole derivative, effective in dermatophytoses, candidiasis, and pityriasis treatment. In previous trials, it showed a higher efficacy than clotrimazole in the treatment of dermatophytoses. The purpose of this trial was to evaluate the efficacy of eberconazole 1% cream compared with miconazole 2% cream in the treatment of dermatophytoses. METHODS: A multicenter, double-blind, randomized trial was performed in 653 patients with dermatophytoses, randomized to eberconazole 1% cream every 12 h or miconazole 2% cream every 12 h for 4 weeks. Treatment efficacy was assessed on the basis of the percentage of effective response after 4 weeks through mycologic and clinical assessment. RESULTS: Of the 653 patients included in the trial, 360 produced positive baseline mycologic cultures and were included in the efficacy assessment. Clinical efficacy was shown in 76.1% of patients receiving eberconazole and in 75.0% of patients receiving miconazole. The incidence of adverse events related to treatment was 0.91% for eberconazole and 0.92% for miconazole, none being serious, and all being local and transient. CONCLUSIONS:Eberconazole 1% cream is an effective treatment for fungal infections produced by dermatophytes, with a good safety and tolerability profile, and can be considered a good alternative for the treatment of dermatophytoses.
Authors: Maria Fernanda Reis Gavazzoni Dias; Fred Bernardes-Filho; Maria Victória Pinto Quaresma-Santos; Adriana Gutstein da Fonseca Amorim; Regina Casz Schechtman; David Rubem Azulay Journal: An Bras Dermatol Date: 2013 Nov-Dec Impact factor: 1.896