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A phase I study of daily treatment with a ceramide-dominant triple lipid mixture commencing in neonates
Adrian J Lowe1, Mimi Lk Tang, Shyamali C Dharmage
1Murdoch Children's Research Institute, Royal Children's Hospital, Flemington Rd, Parkville 3052, Australia. lowe.adrian@gmail.com
Insights
A ceramide-dominant formula showed safety and good parental compliance for preventing eczema in newborns. This supports further trials to evaluate its effectiveness in reducing eczema incidence.
Area of Science:
- Dermatology
- Neonatal Care
- Allergy Research
Background:
- Skin barrier defects increase eczema and atopic sensitization risk.
- Ceramide-dominant lipids may improve infant skin barrier function.
- A ceramide-dominant formula (EpiCeram™) was investigated for eczema prevention.
Purpose of the Study:
- To assess the safety of daily EpiCeram™ application in newborns.
- To evaluate parental compliance with the study product.
- To explore EpiCeram™'s potential in preventing infant eczema.
Main Methods:
- Open-label, phase one trial with 10 infants (0-4 weeks old).
- Daily application of EpiCeram™ for six weeks.
- Primary outcomes: compliance rate and adverse events; secondary: eczema development, skin properties (TEWL, hydration, pH).
Main Results:
- 80% of mothers applied the cream on 80% or more of days.
- No adverse skin reactions to EpiCeram™ were reported.
- Unrelated adverse events were noted, but the study product was safe.
Conclusions:
- Preliminary data support the safety of daily ceramide-dominant formula application.
- Parental compliance was adequate for eczema prevention.
- Results provide a basis for a randomized clinical trial on EpiCeram™ for eczema prevention.
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.
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