a phase i study of daily treatment with a ceramide-dominant triple lipid mixture commencing in neonates一个阶段我学习的日常治疗新生儿ceramide-dominant三脂质混合物开始.pdfVIP
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a phase i study of daily treatment with a ceramide-dominant triple lipid mixture commencing in neonates一个阶段我学习的日常治疗新生儿ceramide-dominant三脂质混合物开始
Lowe et al. BMC Dermatology 2012, 12:3
/1471-5945/12/3
RESEARCH ARTICLE Open Access
A phase I study of daily treatment with a
ceramide-dominant triple lipid mixture
commencing in neonates
1,2* 1,2,3 1,2 3 4,5 1,2
Adrian J Lowe , Mimi LK Tang , Shyamali C Dharmage , George Varigos , Della Forster , Lyle C Gurrin ,
1,2,3 6 1 2,3,6
Colin F Robertson , Michael J Abramson , Katrina J Allen and John Su
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
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