COMPARISON OF THE EFFICACY AND SAFETY OF ORAL FLUCONAZOLE AND TOPICALCLOTRIMAZOLE IN PATIENTS WITH CANDIDA-BALANITIS

One hundred fifty seven men with candidal balanitis were entered in a randomised, open-label parallel-group multicentre study comparing effi cacy and safety of a single oral 150-mg fluconazole-dose with clotrima zole applied topically twice daily for 7 days. Of 64 fluconazole and 6 8 clotrimazole treated patients who were evaluable at short term follo w up, 92% and 91% respectively were clinically cured or improved. Cand ida albicans was eradicated in 78% and 83% of patients respectively. M edian time to relief of erythema was 6 days for fluconazole and 7 days for clotrimazole. Twelve of 15 patients who had received previous top ical therapy for balanitis said they preferred oral therapy. At the on e month follow up visit, 24/36 and 29/33 patients in the two groups we re clinically cured or improved. Nine in the fluconazole group experie nced a relapse; 6 of these 9 patients reported previous episodes of th is infection during the past year. Two patients in the clotrimazole gr oup had a relapse; neither had a history of previous episodes. Mycolog ical eradication was noted in 26/36 and 25/33 patients in the two grou ps. Both treatment regimens were well tolerated. Thus a single 150 mg dose of fluconazole was comparable in efficacy and safety to clotrimaz ole cream applied topically for 7 days when administered to patients w ith balanitis.