Effect of emollients on the prevention of infantile eczema and atopic dermatitis - Effect of emollients on the prevention of atopic dermatitis
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 216
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- ot applicable 至 1weeks-old(—)
- 性别
- All
入选标准
- 未提供
排除标准
- •(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
