title: A novel foam formulation of ketoconazole 2% for the treatment of seborrheic dermatitis on multiple body regions.
abstract: 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.
authors.affiliation: University of Alabama at Birmingham, Birmingham, AL 35294, USA. beelewski@aol.com
authors.forename: Boni E
authors.initials: BE
authors.lastname: Elewski
authors.forename: William
authors.initials: W
authors.lastname: Abramovits
authors.forename: Steven
authors.initials: S
authors.lastname: Kempers
authors.forename: Joel
authors.initials: J
authors.lastname: Schlessinger
authors.forename: Theodore
authors.initials: T
authors.lastname: Rosen
authors.forename: Aditya K
authors.initials: AK
authors.lastname: Gupta
authors.forename: Sabra
authors.initials: S
authors.lastname: Abraham
authors.forename: Richard
authors.initials: R
authors.lastname: Rowell
mesh_terms: 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
chemical_list: D000935:Antifungal Agents; D004304:Dosage Forms; D007654:Ketoconazole