Effect of emollients on the prevention of infantile eczema and atopic dermatitis
- Conditions
- atopic dermatitis, allergic sensitization
- Registration Number
- JPRN-UMIN000004544
- Lead Sponsor
- ational Center for Child Health & Development
- Brief Summary
Background: Recent studies have suggested that epidermal barrier dysfunction contributes to the development of atopic dermatitis (AD) and other allergic diseases. Objective: We performed a prospective, randomized controlled trial to investigate whether protecting the skin barrier with a moisturizer during the neonatal period prevents development of AD and allergic sensitization. Methods: An emulsion-type moisturizer was applied daily during the first 32 weeks of life to 59 out of 118 neonates at high risk for AD (based on having a parent or sibling with AD) who were enrolled in this study. The onset of AD (eczematous symptoms lasting more than 4 weeks) and eczema (lasting more than 2 weeks) were assessed by a dermatology specialist, based on the modified Hanifin and Rajka criteria. The primary outcome was the cumulative incidence of AD plus eczema (AD/eczema) at week 32 of life. A secondary outcome, allergic sensitization, was evaluated based on serum levels of allergen-specific IgE, determined using a novel allergen microarray of diamond-like carbon-coated chip. Results: Approximately 32% fewer neonates who received the moisturizer developed AD/eczema by week 32 than controls (P=.012 in log-rank test). Although similar proportions of infants in each group developed allergies, the rate of allergic sensitization was significantly higher in infants who developed AD/eczema than in those who did not (based on level of antibody against egg white, 0.34 kUA/L CAP-FEIA equivalents; odds ratio, 2.86; 95% confidence interval, 1.22-6.73). Conclusion: Daily application of moisturizer during the first 32 weeks of life reduces the risk of AD/eczema in infants. Allergic sensitization during this time period is associated with the presence of eczematous skin, but not with moisturizer use.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 216
Not provided
(1) Infants treated with corticosteroid ointment (except genital and anal area) (2) Infants with skin lesions such as dyskeratosis or bullosis diagnosed by specialists in dermatology (3) Small-for-gestational-age (<37 weeks) (4) Infants with hepatic disease, convulsion, cardiac disease, hemophilias, diabetes and auto immune diseases (5) Inappropriate cases evaluated by doctors
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method