1%依柏康唑乳膏治疗皮肤浅部真菌病安全有效:与2%咪康唑乳膏比较的多中心、随机、双盲临床试验

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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. Background: Eberconazole is a topical, broad-spectrum imidazole derivative, effective in dermatophytoses, candidiasis, and pityriasis treatment. In a previous trial, 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 eberoconazole and in 75.0% of patients receiving mic onazole. 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.
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