A Randomized Pilot Trial Comparing Cetaphil® Restoraderm® System and Standard Skin Care in Infants at Risk for Atopic Dermatitis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Percentage of Participants With Cumulative Atopic Dermatitis Diagnosed by Investigator at 12 Months
研究概览
简要总结
The goal of this study is to determine what effect Cetaphil® Restoraderm® system has on babies' skin versus Johnson & Johnson baby lotion and skin cleanser.
详细描述
Subjects will randomly be divided into a group using Cetaphil® Restoraderm® system or a group using Johnson & Johnson baby lotion and skin cleanser . At 3, 6, and 12 months non-invasive measurements of barrier function will be used to test the babies' skin. The procedures are as follows:
- Transepidermal loss (TEWL - measures the water loss from the skin)
- Skin electrical capacitance (measures how much water stays in the top layer of skin)
- Skin pH (measures level of pH)
- Skin microbiome analysis (skin swabs to check genetic code of skin bacteria)
- Lipidomic and natural moisturizing factor analysis (measures lipids (oils) in the top layer of skin)
Both groups will be reminded to follow the instructions about general good skin care of infants. Subjects will be asked if they agree to provide a saliva sample. If yes, a saliva sample will be collected from the inside of the infant's cheek at the 6 month visit and will be shipped to the laboratory of Dr. Irwin McLean at the University of Dundee, where it will be tested for gene defects in the skin barrier that might trigger the development of eczema. Defects in the gene called filaggrin have been shown to increase the risk of developing eczema. The samples will be identified by a code to protect your infant's identity. The saliva samples will be stored only for this study, and then the sample will be destroyed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 1 Day 至 3 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Infants up to three weeks of age born to mothers aged 18-45 years will be recruited for this study.
- •Infants must have a family history of asthma, eczema, or hayfever in at least one first-degree relative and be in otherwise good overall health.
排除标准
- •Preterm birth defined as birth prior to 37 weeks gestation
- •Major congenital anomaly
- •Hydrops fetalis
- •Significant dermatitis at birth not including seborrheic dermatitis on the scalp ("cradle cap")
- •Any immunodeficiency disorder
- •Any severe genetic skin disorder
- •Any other serious condition that would make the use of emollients inadvisable
- •Any other major medical problems that the investigator deems may increase the risk of adverse events with the intervention or in whom assessing the outcomes may be masked by the underlying problem or practically very difficult to assess
结局指标
主要结局
Percentage of Participants With Cumulative Atopic Dermatitis Diagnosed by Investigator at 12 Months
时间窗: 12 months
Percentage of cumulative Atopic Dermatitis diagnosed by a blinded investigator at 12 months
次要结局
- Skin pH(2 month, 6 month, and 12 month visits)
- Filaggrin Mutation Status(6 month visit)
- Skin Hydration (Skin Electrical Capacitance)(2 month, 6 month, and 12 month visits)
- Percentage of High Emollient Use(2, 6, 12, 18, and 24 months)
- Transepidermal Water Loss (TEWL)(2 month, 6 month, and 12 month visits)
- Age at Onset of Eczema(Baseline through Month 24 Follow-up)
研究者
Eric Simpson
M.D., M.C.R.
Oregon Health and Science University