title: A phase I study of daily treatment with a ceramide-dominant triple lipid mixture commencing in neonates.
abstract: BACKGROUND
  Defects in skin barrier function are associated with an increase risk of eczema and atopic sensitisation. Ceramide-dominant triple lipid mixture may improve and maintain the infant skin barrier function, and if shown to be safe and feasible, may therefore offer an effective approach to reduce the incidence of eczema and subsequent atopic sensitisation. We sort to assess the safety and compliance with daily application of a ceramide-dominant triple lipid formula (EpiCeram™) commencing in the neonatal period for the prevention of eczema.
  
  
  METHODS
  Ten infants (0-4 weeks of age) with a family history of allergic disease were recruited into an open-label, phase one trial of daily application of EpiCeram™ for six weeks. The primary outcomes were rate of compliance and adverse events. Data on development of eczema, and physiological properties of the skin (transepidermal water loss, hydration, and surface pH) were also measured.
  
  
  RESULTS
  Eighty percent (8/10) of mothers applied the study cream on 80% or more of days during the six week intervention period. Though a number of adverse events unrelated to study product were reported, there were no adverse skin reactions to the study cream.
  
  
  CONCLUSIONS
  These preliminary results support the safety and parental compliance with daily applications of a ceramide-dominant formula for the prevention of eczema, providing the necessary ground work for a randomised clinical trial to evaluate EpiCeram™ for the prevention of eczema.
  
  
  BACKGROUND
  The study was listed at the Australian/New Zealand Clinical Trial Registry (ANZCTR): reg. no. ACTRN12609000727246.
authors.affiliation: Murdoch Children's Research Institute, Royal Children's Hospital, Flemington Rd, Parkville 3052, Australia. lowe.adrian@gmail.com
authors.forename: Adrian J
authors.initials: AJ
authors.lastname: Lowe
authors.forename: Mimi Lk
authors.initials: ML
authors.lastname: Tang
authors.forename: Shyamali C
authors.initials: SC
authors.lastname: Dharmage
authors.forename: George
authors.initials: G
authors.lastname: Varigos
authors.forename: Della
authors.initials: D
authors.lastname: Forster
authors.forename: Lyle C
authors.initials: LC
authors.lastname: Gurrin
authors.forename: Colin F
authors.initials: CF
authors.lastname: Robertson
authors.forename: Michael J
authors.initials: MJ
authors.lastname: Abramson
authors.forename: Katrina J
authors.initials: KJ
authors.lastname: Allen
authors.forename: John
authors.initials: J
authors.lastname: Su
mesh_terms: D000287:Administration, Topical; D001315:Australia; D002518:Ceramides / Q000009:adverse effects / Q000627:therapeutic use*; D002784:Cholesterol / Q000009:adverse effects / Q000627:therapeutic use*; D004338:Drug Combinations; D004485:Eczema / Q000517:prevention & control*; D004655:Emulsions / Q000627:therapeutic use; D005227:Fatty Acids / Q000009:adverse effects / Q000627:therapeutic use*; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007231:Infant, Newborn; D008297:Male; D055118:Medication Adherence
chemical_list: D002518:Ceramides; D004338:Drug Combinations; D004655:Emulsions; C539259:EpiCeram; D005227:Fatty Acids; D002784:Cholesterol