Efficacy and Safety of a New Once-Daily Topical Ketoconazole 2% Gel in the Treatment of Seborrheic Dermatitis: A Phase III Trial
July 2006 | Volume 5 | Issue 7 | Original Article | 646 | Copyright © July 2006
Boni Elewski MD, Mark R. Ling MD PhD, Tania J. Phillips MD
Background: The first gel formulation of ketoconazole has been tested in 2-week treatment courses.
Objective: To evaluate the efficacy and safety of a new, once-daily, 2-week ketoconazole 2% gel treatment in moderate to
severe seborrheic dermatitis.
Methods: 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).
Results: 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.
Conclusion: Once-daily ketoconazole 2% gel is an effective, well-tolerated, convenient, and cosmetically acceptable treatment
for moderate to severe seborrheic dermatitis.