One hundred fifty seven men with candidal balanitis were entered in a randomised, open-label parallel-group multicentre study comparing efficacy and safety of a single oral 150-mg fluconazole-dose with clotrimazole applied topically twice daily for 7 days. Of 64 fluconazole and 68 clotrimazole treated patients who were evaluable at short term follow up, 92% and 91% respectively were clinically cured or improved. Candida albicans was eradicated in 78% and 83% of patients respectively. Median time to relief of erythema was 6 days for fluconazole and 7 days for clotrimazole. Twelve of 15 patients who had received previous topical therapy for balanitis said they preferred oral therapy. At the one month follow up visit, 24/36 and 29/33 patients in the two groups were clinically cured or improved. Nine in the fluconazole group experienced a relapse; 6 of these 9 patients reported previous episodes of this infection during the past year. Two patients in the clotrimazole group had a relapse; neither had a history of previous episodes. Mycological eradication was noted in 26/36 and 25/33 patients in the two groups. Both treatment regimens were well tolerated. Thus a single 150 mg dose of fluconazole was comparable in efficacy and safety to clotrimazole cream applied topically for 7 days when administered to patients with balanitis.
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