A novel foam formulation of ketoconazole 2% for the treatment of seborrheic dermatitis on multiple body regions.
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).


CONCLUSIONS
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.
Elewski
Boni E
BE
University of Alabama at Birmingham, Birmingham, AL 35294, USA. beelewski@aol.com
Abramovits
William
W
Kempers
Steven
S
Schlessinger
Joel
J
Rosen
Theodore
T
Gupta
Aditya K
AK
Abraham
Sabra
S
Rowell
Richard
R
D000287:Administration, Topical; D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000935:Antifungal Agents / Q000008:administration & dosage* / Q000009:adverse effects; D002648:Child; D012628:Dermatitis, Seborrheic / Q000188:drug therapy* / Q000473:pathology; D004304:Dosage Forms; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D007654:Ketoconazole / Q000008:administration & dosage* / Q000009:adverse effects; D008297:Male; D008875:Middle Aged; D012720:Severity of Illness Index; D016896:Treatment Outcome
D000935:Antifungal Agents; D004304:Dosage Forms; D007654:Ketoconazole