This draft guidance will represent the treatment of dermatophytosis and the mechanism of action.

In a double-blind, randomized study, the efficacy and tolerance of flutrimazole 1% cream were compared with ketoconazole 2% cream, applied once daily for 4 weeks, in 60 patients with culturally proven dermatophytosis.Both groups of patients and targets were the same.The distribution of clinical scores at the end of treatment was even.The proportion of patients with negative microscopy and culture after 4 weeks of treatment was 70% in the flutrimazole group.At the assessment 6 weeks after the end of therapy, the percentages of patients with negative mycology were 57 and 70%.There were two relapses in the flutrimazole group.One patient had a premature end because of adverse events associated with the medication.According to the results of the study, flutrimazole 1% cream is as effective and safe as ketoconazole 2% cream for skin infections.

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