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

Abstract

Purpose. The efficacies of flutrimazole versus clotrimazole for the treatment of acute vulvovaginal candidiasis were compared using a randomized double-blind study design. Both drugs were administered as a Single-dose vaginal tablet containing 500 mg of drug, and then as a topical cream twice- daily for 7 days. Materials and methods. All patients were aged more than 18 years, and were suffering from acute vulvovaginal or vaginal candidiasis as revealed by clinical 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 completed the treatment correctly (53 in the clotrimazole-treated group, 48 in the flutrimazole-treated group). At the first follow-up (day 9-10), the mycological 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), the 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 were not statistically significant. In most cases mycological cure was associated 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-dose vaginal tablets of clotrimazole and flutrimazole show similar high efficacy and tolerability in the treatment of acute vulvovaginal candidiasis.