Efficacy and safety of a new once-daily topical ketoconazole 2% gel in the treatment of seborrheic dermatitis: a phase III trial.

The first gel formulation of ketoconazole has been tested in 2-week treatment courses.To evaluate the efficacy and safety of a new, once-daily, 2-week ketoconazole 2% gel treatment in moderate to severe seborrheic dermatitis.Four hundred fifty-nine subjects with moderate to severe seborrheic dermatitis were randomized to receive ketoconazole 2% gel or vehicle gel once daily for 14 days. The primary efficacy was the proportion of successfully treated subjects at day 28 (cleared and almost cleared).A significantly greater percentage of subjects were successfully treated with ketoconazole 2% gel compared with vehicle (25.3% vs. 13.9%, P = .0014). Ketoconazole 2% gel improved erythema, scaling (P = .0022 vs. vehicle), and pruritus. Mean overall symptom severity was reduced by 53% and 39% with ketoconazole gel and vehicle, respectively. Adverse events were few, generally mild or moderate, and similar between treatment groups.Once-daily ketoconazole 2% gel is an effective,well-tolerated, convenient, and cosmetically acceptable treatment for moderate to severe seborrheic dermatitis.