An Open-Label Study Investigating the Effects of Early Skin Barrier Protection on the Development of Atopic Dermatitis
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 22
- 试验地点
- 1
- 主要终点
- Incidence of Skin Irritation
研究概览
简要总结
The purpose of this study is to determine whether early use of a bland emollient in newborns, prior to the clinical signs of skin disease, will delay the onset or prevent the development of atopic dermatitis.
详细描述
All neonates will be treated with Cetaphil cream starting within 1 week of birth. All neonates enrolled will have an increased risk of developing atopic dermatitis because they have a family history of either asthma, hay fever, or atopic dermatitis. These neonates will then be followed for 2 years for the signs and symptoms of atopic dermatitis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- — 至 1 Month（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •at least one parent diagnosed with Atopic Dermatitis
- •one parent or sibling with hayfever or asthma
排除标准
- •newborns with dermatitis at birth
- •newborns born greater than four weeks prematurely
- •newborns with medical problems necessitating prolonged hospitalization
- •newborns diagnosed with any immune deficiency syndrome
研究组 & 干预措施
Emollient
Skin barrier protection from birth
干预措施: emollient (Cetaphil cream) (Drug)
结局指标
主要结局
Incidence of Skin Irritation
时间窗: 1 and 2 year time points
Incidence of Skin Infection
时间窗: 1 and 2 year timepoints
Compliance With Protocol
时间窗: over two years
次要结局
- Development of Eczema(1 and 2 year time points)
研究者
Eric Simpson
Professor, Dermatology
Oregon Health and Science University