Comparison of oral fluconazole and topical clotrimazole in the treatment of fungal infections of the skin: European and American experience

An open, comparative, multicenter study conducted in Europe and the United States evaluated the efficacy and safety of oral fluconazole and topical clotrimazole in fungal infections of the skin. Patients were randomized to receive fluconazole, 50 mg per day, or clotrimazole 1% topical cream, twice daily, for up to 6 weeks. Clinical response at the end of therapy was similar in both treatment groups. In the European trial, 96% and 95% of evaluable sites were cured or improved following treatment with fluconazole or clotrimazole, respectively. Results of the US trial revealed response rates of 94% and 89%, respectively. Improvement was maintained at follow-up 2 to 4 weeks after the end of treatment. Mycologic cure at the end of treatment in the European trial, which was observed in 85% and 86% of fluconazole-treated and clotrimazole-treated sites, respectively, was maintained at follow-up. A similar trend was seen in the US trial with cure rates of 66% and 72%, respectively. Both drugs were well tolerated. Whereas side effects in the fluconazole group consisted mainly of headaches and gastrointestinal disorders, the clotrimazole group exhibited local hypersensitivity reactions. Laboratory test abnormalities occurred with equal frequency within both treatment groups, with no evidence of clinically significant adverse changes. The results of these studies confirm that fluconazole is as efficacious as the established agent clotrimazole in the treatment of patients with fungal infections of the skin.