A Novel Foam Formulation of Ketoconazole 2% for the Treatment of Seborrheic Dermatitis on Multiple Body Regions
October 2007 | Volume 6 | Issue 10 | Original Article | 1001 | Copyright © October 2007
Boni E. Elewski MD, William Abramovits MD, Steven Kempers MD, Joel Schlessinger MD, Theodore Rosen MD, Aditya K. Gupta MD PhD, Sabra Abraham MS, Richard Rowell
Background: A novel topical foam formulation of ketoconazole has been developed for use on the scalp, body, and face.
Objective: To evaluate the efficacy and safety of twice-daily treatment with ketoconazole 2%foam for seborrheic dermatitis
on the scalp, body, and face.
Methods: One thousand one hundred sixty-two subjects, aged 12 years or older, with mild to severe seborrheic dermatitis
were randomized to receive ketoconazole foam (n=427), vehicle foam (n=420), ketoconazole cream (n=210), or vehicle
cream(n=105) twice daily for 4 weeks. The primary endpoint was the proportion of subjects achieving an Investigator’s Static
Global Assessment score of 0 or 1 at week 4 (treatment success).
Results: A significantly greater percentage of subjects achieved treatment success using ketoconazole foam than vehicle
foam (56% and 42%, respectively; P<.0001); ketoconazole foam was shown to be equivalent to ketoconazole cream.
Ketoconazole foam was well-tolerated with a low incidence of treatment-related adverse events (14%; 59/427).
Conclusion: Ketoconazole foam 2% is a safe, effective, and versatile formulation for use on the scalp, body, and face for
the treatment of seborrheic dermatitis in patients aged 12 years or older.