Double-blind comparison of 2% ketoconazole cream and placebo in the treatment of tinea versicolor.

Malassezia furfur (Pityrosporum orbiculare) was confirmed by microscopic potassium hydroxide (KOH) examination in 101 patients with recurring lesions of tinea versicolor. In a double-blind comparative study, patients were randomly assigned to once-daily ketoconazole 2% or placebo cream. At the end of treatment, 98% (p less than 0.0001) of the patients using ketoconazole and 28% of those using placebo responded clinically (healed or had mild residual disease). There was an overall 84% mycologic cure rate (negative KOH at treatment end) for patients using ketoconazole 2% cream and 10% for those using placebo cream (p less than 0.0001). Ketoconazole-treated patients who were cured at the end of treatment remained cured 8 weeks later. By contrast 75% of those responding to placebo had relapsed by the 8-week follow-up visit. Follow-up after 2 years revealed that 79% (38/48) of the patients treated with ketoconazole remained clear 12 or more months.

RCT Entities:   Population Interventions Outcomes