Atopic dermatitis (AD) is a common, chronic skin disorder often beginning in infancy. Skin barrier dysfunction early in life serves as a central event in the pathogenesis of AD. In infants at high risk of developing AD, preventative application of lipid-rich emollients may reduce the risk of developing AD. This study aims to measure the effectiveness of this intervention in a population not selected for risk via a pragmatic, randomized, physician-blinded trial in the primary care setting. Infant–parent dyads are recruited from a primary care practice participating through one of four practice-based research networks in Oregon, Colorado, Wisconsin, and North Carolina. Eligible dyads are randomized to the intervention (daily use of lipid-rich emollient) or the control (no emollient) group (n = 625 infants in each) and are followed for 24 months. The primary outcome is the cumulative incidence of physician-diagnosed AD and secondary outcomes include caregiver-reported measures of AD and development of other atopic diseases. Data collection occurs via chart review and surveys, with no study visits required. Data will be analyzed utilizing intention-to-treat principles. AD is a common skin condition in infants that affects quality of life and is associated with the development of other atopic diseases. If a safe intervention, such as application of lipid-rich emollients, in the general population effectively decreases AD prevalence, this could alter the guidance given by providers regarding routine skin care of infants. Because of the pragmatic design, we anticipate that this trial will yield generalizable results. ClinicalTrials.gov: NCT03409367. Registered on 11 February 2018.

中文翻译：

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基于社区的皮肤护理、过敏和湿疹评估 (CASCADE)：一项使用润肤剂的特应性皮炎一级预防研究 - 随机对照试验方案


特应性皮炎 (AD) 是一种常见的慢性皮肤病，通常始于婴儿期。生命早期的皮肤屏障功能障碍是 AD 发病机制的核心事件。对于患 AD 的高风险婴儿，预防性使用富含脂质的润肤剂可能会降低患 AD 的风险。本研究旨在通过初级保健机构中的务实、随机、医生盲法试验来衡量这种干预措施在未选择风险的人群中的有效性。婴儿-父母二人组是从初级保健实践中招募的，这些实践是通过俄勒冈州、科罗拉多州、威斯康星州和北卡罗来纳州的四个基于实践的研究网络之一参与的。符合条件的二人组被随机分为干预组（每天使用富含脂质的润肤剂）或对照组（无润肤剂）（每组 n = 625 名婴儿），并随访 24 个月。主要结局是医生诊断的 AD 的累积发生率，次要结局包括护理人员报告的 AD 测量值和其他特应性疾病的发展。数据收集通过图表审查和调查进行，无需进行研究访问。将利用意向治疗原则对数据进行分析。 AD 是婴儿常见的皮肤病，影响生活质量，并与其他特应性疾病的发生有关。如果在普通人群中采取安全干预措施，例如使用富含脂质的润肤剂，可以有效降低 AD 患病率，这可能会改变医疗服务提供者对婴儿日常皮肤护理的指导。由于务实的设计，我们预计该试验将产生可推广的结果。 ClinicalTrials.gov：NCT03409367。注册日期：2018 年 2 月 11 日。