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Ketoconazole 2% Foam as Effective as Ketoconazole 2% Cream for Seborrhoeic Dermatitis: Presented at AAD

By Bruce Sylvester

WASHINGTON, DC -- February 13, 2004 -- The investigative foam formulation of ketoconazole 2% is as effective for seborrhoeic dermatitis as ketoconazole 2% cream, researchers reported on February 9^th here at the American Academy of Dermatology 62^nd Annual Meeting.

"The efficacy data from this study demonstrate that ketoconazole foam is non-inferior (similar or better than) to ketoconazole cream," the investigators noted. "The data also demonstrate that ketoconazole foam was safe and well tolerated," they added.

The researchers enrolled 619 subjects (12 years or older and diagnosed with seborrhoeic dermatitis) in this 4-week multicentre, randomised, double-blind, double-dummy, placebo-controlled study.

The subjects were randomised to 1 of 4 study cohorts: active foam (n = 233), active cream (n = 233) or their vehicles (foam, n = 77 and cream, n = 76). Subjects self-administered twice each day.

The primary endpoint was the proportion of subjects with an Investigator's Static Global Assessment (ISGA) score of 0-1 at endpoint, defined as "treatment success."

The secondary endpoint was percent change from baseline to 4 weeks in sum of scores of the signs of seborrhoeic dermatitis (erythaema, scaling and induration) at target area.

The investigators also noted the proportion of subjects achieving a 0 ISGA, or "clear," for all groups.

The difference in "treatment success" rate between foam and cream was 5.58%. There was a "trend in favor of ketoconazole foam versus foam vehicle," the investigators reported. "Treatment success was achieved by 50% of patients treated with ketoconazole foam, and 44% of patients treated with ketoconazole cream," they said.

For improvement in sum of scores from baseline to endpoint (intent-to-treat population), the difference between ketoconazole foam and cream formulations was 4.48 %. "The median percent change from baseline in the sum of scores of signs of seborrhoeic dermatitis at the target area was 80% for ketoconazole foam and 67% for ketoconazole cream," the investigators noted.

For a "clear" score of 0 on ISGA at Week 4 (intent-to-treat population), the reported difference between ketoconazole foam and ketoconazole cream formulations was 6.44%.
"Additionally, an ISGA score of 'clear' was achieved by 39% of patients treated with ketoconazole foam, and 33% of patients treated with ketoconazole cream," the authors wrote.

The researchers added that the most frequent adverse ketoconazole-foam reactions were mild and transient application-site reactions, resulting in no early subject withdrawals from the study.


[A Randomized, Double-Blind, Double-Dummy, Placebo-Controlled Study of the Safety and Efficacy of Ketoconazole Foam, 2%, Versus Ketoconazole 2% Cream in the Treatment of Seborrheic Dermatitis. Abstract 397]

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