Multicenter clinical evaluation of ketoconazole in the treatment of cutaneous fungal infections.

An open, multicenter study was conducted to evaluate the efficacy and adverse effects of ketoconazole in patients with cutaneous fungal infections seen in typical dermatology practices. One hundred twelve American investigators entered 954 patients into this trial. Responses based on clinical and mycologic assessments were available on 672 patients. Mycologic evaluations were conducted using pre- and post-therapy wet mounts in potassium hydroxide. Eighty percent of these patients were mycologically clear and clinically rated as either excellent (cured) or marked improvement. Adverse effects were mild to moderate in severity and only rarely caused therapy to be interrupted. Gastrointestinal effects were the most frequently reported complaints.