Open comparative study of efficacy and safety of ketoconazole soap and oral ketoconazole in tinea versicolor

Objective: To compare the efficacy and safety of 2% ketoconazole soap in treatment of tinea versicolor (TV) and to compare it with stat 400mg dose of ketoconazole. Methods: Patients of TV confirmed by potassium hydroxide (KOH) mount were divided by block randomization into 2 groups. Group 1 received 400mg of oral ketoconazole single dose and a nonmedicated soap for daily bath. Group 2 received 2% ketoconazole soap for daily bath. The lather from the soap while bathing was to be left on the skin for 3 minutes. Patients were assessed at the end one month and KOH repeated from index lesion. Results: Twelve patients out of 25 completed the study, 6 in each group. Four patients (66%) were mycologically cured in group 1 while two patients (34%) were mycologically cured in group 2. All these patients were compliant with the usage of soap. Conclusion: Ketoconazole soap is at best an adjunct in the treatment of TV. It might however be useful in the prophylactic management of patients with chronic TV as bathing is almost a daily routine in most patients especially in tropics. Further studies are required in this aspect.