Topical treatment of dermatophytosis and cutaneous candidosis with flutrimazole 1% cream: double-blind, randomized comparative trial with ketoconazole 2% cream

In a double-blind, randomized study the efficacy and tolerance of flutrimaz ole 1% cream were compared with ketoconazole 2% cream, applied once daily f or 4 weeks, in 60 patients with culturally proven dermatophytosis (47 patie nts) or cutaneous candidosis (13 patients). Both groups of patients and dis tribution of target lesions were similar. The sum of clinical scores had an even distribution in both groups at the end of treatment. The proportion o f patients with negative microscopy and culture after 4 weeks of treatment was 70% in the flutrimazole group and 53% in the ketoconazole group; seven ketoconazole-treated patients (23%) compared with two flutrimazole-treated patients (6.6%) were asymptomatic carriers (clinically cured with positive cultures) at the end of treatment. At the assessment 6 weeks after the end of therapy the percentages of flutrimazole- and ketoconazole-treated patien ts with negative mycology were 57 and 70%, respectively. There were one rel apse (3.3%) in the ketoconazole group and four (13.3%) in the flutrimazole group. One patient treated with ketoconazole (3%) had a premature terminati on due to adverse events attributable to the medication. The results of thi s study show that flutrimazole 1% cream is as effective and safe as ketocon azole 2% cream for Candida and dermatophyte skin infections.