Background: Defects in skin barrier function are associated with an increase risk of eczema and atopic\r\nsensitisation. Ceramide-dominant triple lipid mixture may improve and maintain the infant skin barrier function,\r\nand if shown to be safe and feasible, may therefore offer an effective approach to reduce the incidence of eczema\r\nand subsequent atopic sensitisation. We sort to assess the safety and compliance with daily application of a\r\nceramide-dominant triple lipid formula (EpiCeramââ??¢) commencing in the neonatal period for the prevention of\r\neczema.\r\nMethods: Ten infants (0-4 weeks of age) with a family history of allergic disease were recruited into an open-label,\r\nphase one trial of daily application of EpiCeramââ??¢ for six weeks. The primary outcomes were rate of compliance\r\nand adverse events. Data on development of eczema, and physiological properties of the skin (transepidermal\r\nwater loss, hydration, and surface pH) were also measured.\r\nResults: Eighty percent (8/10) of mothers applied the study cream on 80% or more of days during the six week\r\nintervention period. Though a number of adverse events unrelated to study product were reported, there were no\r\nadverse skin reactions to the study cream.\r\nConclusions: These preliminary results support the safety and parental compliance with daily applications of a\r\nceramide-dominant formula for the prevention of eczema, providing the necessary ground work for a randomised\r\nclinical trial to evaluate EpiCeramââ??¢ for the prevention of eczema.\r\nTrial registration: The study was listed at the Australian/New Zealand Clinical Trial Registry (ANZCTR): reg. no.\r\nACTRN12609000727246.
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