A randomized, double-blind clinical trial was undertaken in 41 patients with dermatomycosis to compare topical 2% fenticonazole cream (group A: 21 patients) with topical 1% bifonazole cream (group B: 20 patients). Treatment was performed as a once daily application. Mycological and clinical parameters were assessed before treatment and after 7, 14, 21 and 28 days. At the control visits the clinical investigator also expressed an overall judgement on the patient’s state of disease. This parameter was based on a combined clinical and mycological assessment by the physician; laboratory screening investigations were undertaken before and at the end of treatments. All patients were checked for their state of disease 3–4 weeks after the end of treatment. All assessment criteria showed fenticonazole to be at least as efficacious as bifonazole. Several trends in favor of fenticonazole were also found: fenticonazole achieved superior results in the overall clinical evaluation, and after 3 weeks of treatment 15 patients out of 21 on fenticonazole were cured in mycological and clinical terms, whereas treatment with bifonazole resulted in complete healing of only 7 patients out of 20. This difference is statistically significant (p = 0.021) and indicates a more rapid therapeutic activity of fenticonazole. At the posttreatment rechecks no recurrent disease was registered, irrespective of whether patients had received fenticonazole or bifonazole. Laboratory screening investigations revealed no evidence of significant treatment-related changes or abnormalities in both treatments. No adverse events were noted for either treatment.

Fenticonazole is an imidazole derivative with a broad spectrum of antimycotic activity. The therapeutic activity and tolerability of 600 mg fenticonazole versus 500 mg clotrimazole were evaluated in an investigator-blind trial in 80 patients with mycologically confirmed vaginal candidiasis. Fenticonazole was administered as an ovule and clotrimazole as a vaginal pessary, both in a single administration. Therapeutic efficacy was assessed by microbiological and clinical criteria 7 days after the start of treatment. Patients cured at the end of the trial were rechecked 4-5 weeks after the start of therapy in order to identify and evaluate possible relapse. Both treatments resulted in a statistically significant reduction in vaginal symptoms (erythema, itching, discharge and oedema) and in elimination of Candida albicans in about 90% of patients. 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 was indicated.