一项针对具有神经酰胺和丝聚合蛋白相关氨基酸的保湿剂用于高危婴儿特应性皮炎一级预防的随机对照试验。

A randomized controlled trial of an emollient with ceramide and filaggrin-associated amino acids for the primary prevention of atopic dermatitis in high-risk infants.

机构信息

Oregon Health & Science University, Portland, OR, USA.

Amsterdam UMC, Coronel Institute of Occupational Health, Amsterdam Public Health Research Institute, University of Amsterdam, Amsterdam, The Netherlands.

出版信息

J Eur Acad Dermatol Venereol. 2019 Nov;33(11):2087-2094. doi: 10.1111/jdv.15786. Epub 2019 Jul 30.

DOI:10.1111/jdv.15786

PMID:31287580

Abstract

BACKGROUND

Skin barrier dysfunction may precede infantile development of clinical atopic dermatitis (AD). Early-life emollient therapy to enhance barrier function may prevent or modify AD development in high-risk infants.

OBJECTIVES

(a) To determine whether daily full-body application of an emollient with ceramide and amino acids (study emollient) can reduce the cumulative AD incidence compared to standard skin care at 1 year of age. (b) To evaluate the study emollient's effect on skin barrier function, natural moisturizing factor and the microbiome using non-invasive biophysical and biochemical techniques.

METHODS

We performed a single-centre, investigator-blinded, randomized controlled trial enrolling infants at high risk for AD development determined by family history. The intervention was full-body once-daily application of the study emollient. The control arm was asked to not apply full-body emollient regularly and only use an emollient of their choice for dry skin. The primary outcome was the cumulative incidence of AD diagnosed at 12 months by a blinded investigator.

RESULTS

Less than half the target sample size was enrolled (n = 100, goal sample was 208) with 28% lost to follow-up. Across all clinical end points, a numerical trend was observed in favour of the intervention, although not statistically significant likely due to lack of power from under-enrolment. AD was diagnosed in 13.2% vs. 25.0% at 12 months (P = 0.204) and 19.4% vs. 31.0% at 2 years (P = 0.296) in intervention vs. control groups, respectively. There were no significant differences between groups in skin barrier or microbiome assessments. While there were no serious adverse events, there were more cases of reported contact dermatitis in the intervention vs. control arms, 9.3% vs. 4.3%, respectively; however, these events were not related to the study emollient and most mild in severity.

CONCLUSION

The observed trends suggest a protective effect of daily study emollient therapy compared to control.

摘要

背景

皮肤屏障功能障碍可能先于临床特应性皮炎（AD）的婴儿期发展。通过早期生活中使用保湿剂来增强屏障功能，可能会预防或改变高危婴儿的 AD 发展。

目的

（a）确定与标准皮肤护理相比，每天全身使用含有神经酰胺和氨基酸的保湿剂（研究保湿剂）是否可以降低 1 岁时累积 AD 的发病率。（b）使用非侵入性的生物物理和生化技术评估研究保湿剂对皮肤屏障功能、天然保湿因子和微生物组的影响。

方法

我们进行了一项单中心、研究者盲法、随机对照试验，招募了具有家族史的 AD 高危婴儿。干预措施是全身每天一次使用研究保湿剂。对照组被要求不要定期全身使用保湿剂，仅在皮肤干燥时使用他们选择的保湿剂。主要结局是由盲法研究者在 12 个月时诊断的累积 AD 发病率。

结果

目标样本量的不到一半（n=100，目标样本为 208）被招募，28%的婴儿失访。在所有临床终点中，尽管由于招募不足导致缺乏统计学意义，但干预组观察到有利于干预的数值趋势。在 12 个月时，AD 的诊断率为 13.2%对 25.0%（P=0.204），在 2 岁时为 19.4%对 31.0%（P=0.296），分别为干预组和对照组。在皮肤屏障或微生物组评估方面，两组之间没有显著差异。虽然没有严重不良事件，但干预组比对照组报告的接触性皮炎病例更多，分别为 9.3%对 4.3%；然而，这些事件与研究保湿剂无关，且大多数为轻度。