A phase i study of daily treatment with a ceramide-dominant triple lipid mixture commencing in neonates

BMC Family Practice

John Su⁴  Katrina J Allen²  Michael J Abramson⁴  Colin F Robertson⁵  Lyle C Gurrin¹  Della Forster³  George Varigos⁵  Shyamali C Dharmage¹  Mimi LK Tang⁵  Adrian J Lowe¹ 

[1] The University of Melbourne, Melbourne, Australia;Murdoch Children's Research Institute, Royal Children's Hospital, Flemington Rd, Parkville 3052, Australia;La Trobe University, Melbourne, Australia;Monash University, Melbourne, Australia;Royal Children's Hospital, Melbourne, Australia

关键词: Atopy;    Asthma;    Skin barrier function;    Eczema;    Eczema prevention;   

Others  :  855277
DOI  :  10.1186/1471-5945-12-3

 received in 2011-12-19, accepted in 2012-04-04,  发布年份 2012

【 摘 要 】

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.

Trial registration

The study was listed at the Australian/New Zealand Clinical Trial Registry (ANZCTR): reg. no. ACTRN12609000727246.

【 授权许可】

   
2012 Lowe et al; licensee BioMed Central Ltd.

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