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

PMID 10680442


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 (47 patients) or cutaneous candidosis (13 patients). Both groups of patients and distribution of target lesions were similar. The sum of clinical scores had an even distribution in both groups at the end of treatment. The proportion of 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 patients with negative mycology were 57 and 70%, respectively. There were one relapse (3.3%) in the ketoconazole group and four (13.3%) in the flutrimazole group. One patient treated with ketoconazole (3%) had a premature termination due to adverse events attributable to the medication. The results of this study show that flutrimazole 1% cream is as effective and safe as ketoconazole 2% cream for Candida and dermatophyte skin infections.

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F0290000 Flutrimazole, European Pharmacopoeia (EP) Reference Standard