Effect of Fenticonazole in Vaginal Candidiasis: A Double-Blind Clinical Trial versus Clotrimazole

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Abstract
Fenticonazole is an imidazole derivative which possesses a broad spectrum antimycotic activity, including activity against Candida albicans. Its therapeutic activity and tolerability have been evaluated, in a double-blind clinical trial versus clotrimazole, in 54 patients affected by mycologically confirmed symptomatic vaginal candidiasis. Both drugs were administered intravaginally as a cream once a day for 7 days. Assessment was by laboratory mycological investigations and symptomatic evaluation. Patients ‘cured’ at the end of the trial were re-evaluated after 4–6 weeks for possible relapses. Both treatments resulted in a progressive, statistically significant reduction in vaginal symptoms (itching and discharge) and in elimination of Candida in more than 95% of patients. When ‘cured’ patients were reassessed 4–6 weeks after therapy, relapses occurred in four patients after fenticonazole treatment, but in none following clotrimazole treatment. This apparent difference between treatments is far from being statistically significant and, therefore, may have been a chance occurrence. It should also be noted that patients from the fenticonazole group had a previous history of significantly more frequent episodes of candidiasis suggesting that they may have been at greater risk of re-infection than patients from the control group. The tolerance of both treatments was excellent since no local or systemic signs or symptoms of toxicity were reported. An equally high efficacy and safety for both drugs in the elimination of symptoms and objective evidence of vaginal candidiasis is indicated.