A phase-III comparative study of the efficacies of flutrimazole versus clotrimazole for the treatment of vulvovaginal candidiasis

Purpose. The efficacies of flutrimazole versus clotrimazole for the treatme nt of acute vulvovaginal candidiasis were compared using a randomized doubl e-blind study design. Both drugs were administered as a single-dose vaginal tablet containing 500 mg of drug, and then as a topical cream tu ice-daily for 7 days. Materials and methods. All patients were aged more than IX years, and were suffering from acute vulvovaginal or vaginal candidiasis as revealed by cli nical examination and confirmed by Sabouraud culture and direct microscopic examination. Other pathologies were ruled out by Gram and Giemsa staining of smears. All patients were examined before treatment and 9-10 days and 25 -31 days after the start of treatment. Results and conclusions. Of the 107 patients included at the outset, 101 co mpleted the treatment correctly (53 in the clotrimazole-treated group, 48 i n the flutrimazole-treated group). At the first follow-up (day 9-10), the m ycological cure rate was 78.9 % in the clotrimazole-treated group and 87.5 % in the flutrimazole-treated group. At the second follow-up (day 25-31), t he cure rate was 86.8 % in the clotrimazole-treated group and 95.8 % in the flutrimazole-treated group. The between-group differences in cure rate wer e not statistically significant. In most cases mycological cure was associa ted with disappearance of symptoms. Adverse effects were observed in a very small percentage of patients, and were in all cases minor. Both treatments were well tolerated. In conclusion, single-doss vaginal tablets of clotrim azole and flutrimazole show similar high efficacy and tolerability in the t reatment of acute vulvovaginal candidiasis.