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Open Access Research article

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

Adrian J Lowe12*, Mimi LK Tang123, Shyamali C Dharmage12, George Varigos3, Della Forster45, Lyle C Gurrin12, Colin F Robertson123, Michael J Abramson6, Katrina J Allen1 and John Su236

Author affiliations

1 Murdoch Children's Research Institute, Royal Children's Hospital, Flemington Rd, Parkville 3052, Australia

2 The University of Melbourne, Melbourne, Australia

3 Royal Children's Hospital, Melbourne, Australia

4 Royal Women's Hospital, Melbourne, Australia

5 La Trobe University, Melbourne, Australia

6 Monash University, Melbourne, Australia

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Citation and License

BMC Dermatology 2012, 12:3  doi:10.1186/1471-5945-12-3

Published: 4 April 2012

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 (EpiCeramâ„¢) 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 EpiCeramâ„¢ 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 EpiCeramâ„¢ for the prevention of eczema.

Trial registration

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

Keywords:
Eczema prevention; Eczema; Skin barrier function; Asthma; Atopy