A double‐blind comparison of itraconazole and fluconazole in tinea pedis and tinea manuum

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AbstractBackground It has been reported that azole derivatives are useful in the treatment of dermatophytoses, also in tinea pedis and tinea manuum.Aim The aim of the present multicentre, randomized, double‐blind study was to compare the efficacy and safety of oral itraconazole with fluconazole in the treatment of tinea pedis and tinea manuum.Patients and methods In this multicenter, double‐blind, comparative study, 37 patients with tinea pedis or tinea manus were randomized to receive treatment with itraconazole (100 mg/day) or fluconazole (50 mg/day) for 30 days.Results Two patients were not evaluable for efficacy. Both treatments reduced the number of patients with positive mycological findings, so that at the end of treatment. 64.7% of patients receiving itraconazole and 61.1% of those treated with fluconazole had negative results. Both drugs also resulted in a marked improvement in, or elimination of all clinical symptoms; however the improvement appeared to occur more rapidly with itraconazole. The overall assessment at the end of the 6 week follow‐up showed that 88.2% of patients treated with itraconazole and 72.2% of those treated with fluconazole were cured with negative mycological tests. Adverse events were reported by one patient treated with itraconazole and 5 subjects receiving fluconazole. The only changes in laboratory parameters were elevated SGOT and SGPT values in one patient in the fluconazole group, who dropped out from the study.Discussion The results suggest that itraconazole is at least as effective as fluconazole in the treatment of tinea pedis and tinea manus, the onset of improvement in clinical symptoms is more rapid an prolonged after cessation of therapy with itraconazole, and that itraconazole appears to be better tolerated.