title: Long-term safety of ketoconazole foam, 2% in the treatment of seborrheic dermatitis: results of a phase IV, open-label study.
abstract: BACKGROUND
  Ketoconazole foam, 2%, is approved in the United States for seborrheic dermatitis therapy in immunocompetent patients aged ≥12 years. While short-term trials have demonstrated its safety and efficacy, seborrheic dermatitis often requires long-term treatment.
  
  
  OBJECTIVE
  To assess the long-term safety of ketoconazole foam, 2%, twice daily, as required.
  
  
  METHODS
  A 12-month, open-label, multicenter study. Subjects were evaluated at baseline and at weeks 4, 8, 16, 26, 39, and 52 (or early termination [ET]) for adverse events (AEs), serious AEs (SAEs), target lesion erythema, scaling, and pruritus, as well as Investigator's Static Global Assessment (ISGA) scores. Physical examinations were performed at baseline and at week 52/ET, and laboratory evaluations at baseline and at weeks 8, 26, and 52. A poststudy product-preference questionnaire was completed.
  
  
  RESULTS
  Of 500 subjects enrolled, 498 were included in the safety population, and 363 completed the study. Overall, 57% of subjects reported ≥1 AE. Treatment-related AEs occurred in 14% of subjects, including application-site irritation (8%), application-site pain (4%), application-site pruritus (1%), and increased alanine aminotransferase (1%). Seven subjects were withdrawn because of treatment-related AEs. No SAEs (21 in 17 subjects) were considered to be related to study drug. Mean target lesion erythema, scaling, and pruritus scores improved by 2 units from baseline at all study visits; mean ISGA score improved by 1 unit at week 4 and by 2 units at subsequent visits. The foam vehicle was preferred by 67% of subjects.
  
  
  CONCLUSIONS
  Evaluation of severity was limited to target lesion; no objective measure of adherence.
  
  
  CONCLUSIONS
  The long-term safety profile of ketoconazole foam, 2%, in subjects with seborrheic dermatitis was favorable and efficacy was maintained.
authors: Department of Dermatology, Duke University School of Medicine, Durham, NC, USA. zdraelos@northstrate.net
authors: Zoë D
authors: ZD
authors: Draelos
authors: Steven R
authors: SR
authors: Feldman
authors: Victoria
authors: V
authors: Butners
authors: Alessandra B
authors: AB
authors: Alió Saenz
mesh_terms: D000293:Adolescent; D000328:Adult; D000367:Age Factors; D000368:Aged; D000369:Aged, 80 and over; D000935:Antifungal Agents / Q000009:adverse effects* / Q000627:therapeutic use*; D002648:Child; D002908:Chronic Disease; D012628:Dermatitis, Seborrheic / Q000188:drug therapy* / Q000473:pathology; D023381:Endpoint Determination; D005006:Ethnicity; D005260:Female; D006801:Humans; D007654:Ketoconazole / Q000009:adverse effects* / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D010349:Patient Compliance; D057240:Patient Preference; D014677:Pharmaceutical Vehicles; D018401:Sample Size; D012737:Sex Factors; D055815:Young Adult
chemical_list: D000935:Antifungal Agents; D014677:Pharmaceutical Vehicles; D007654:Ketoconazole