SEAL (Stopping Eczema and ALlergy) Study: Prevent the Allergic March by Enhancing the Skin Barrier
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 398
- 试验地点
- 9
- 主要终点
- number of foods each participant is sensitized to
研究概览
简要总结
This is a randomized, controlled trial designed for children who are have already developed atopic dermatitis (AD or eczema) by 12 weeks of age. The aim is to compare the effect of proactive sequential skin care, including the twice-daily use of a tri-lipid skin barrier cream (Epiceram) and proactive use of fluticasone propionate cream, against reactive AD therapy, to reduce the occurrence and severity of AD in early infancy and thereby prevent food allergy (FA).
详细描述
This is a randomized, controlled, parallel design, open-label phase 2 clinical study to compare the efficacy of a proactive treatment arm versus the reactive arm, for the prevention of atopic dermatitis in children at high risk of food allergy. We will recruit 398 infants who have signs of dry skin or atopic dermatitis between 0-12 weeks of life.
The aim is to compare the effect of proactive sequential skin care, including the twice-daily use of a tri-lipid skin barrier cream (Epiceram) and proactive use of fluticasone propionate cream, against reactive AD therapy, to reduce the occurrence and severity of AD in early infancy and thereby prevent food allergy (FA).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 1 Week 至 12 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants who develop early onset visible dry skin or atopic dermatitis up to and equal to 12 weeks of age.
- •Stated willingness to comply with all study procedures and availability for the duration of the study
- •In good general health as evidenced by medical history
- •No known adverse reaction to any of the study medications, their components or excipients
排除标准
- •Infants <3kg body weight
- •Infants with a chronic disease requiring therapy (e.g. heart disease, diabetes, serious neurological defects, immunodeficiency)
- •Known moderate to severe cutaneous skin disorder other than AD, including but not limited to cutaneous mastocytosis, bullous skin disease, pustular skin disease, neonatal HSV, aplasia, and albinism
- •Parents or guardians unwilling to sign consent
- •Current participant or participation since birth in any interventional study
- •Investigator or designee considers that the participant or parent/guardian would be unsuitable for inclusion in the study (for ex/ long stay in NICU)
- •A course of antibiotics in infant within 7 days of enrollment
- •Any known food allergies
结局指标
主要结局
number of foods each participant is sensitized to
时间窗: 2 years
Sensitization is defined as food-specific IgE \> 0.1 kU/L
次要结局
- The per-subject cumulative number of proven Food Allergy(2 years)
- Presence, duration, and severity of dry skin and/or AD by clinical assessment(Baseline, 12, and 24 months of age and as necessary)
- Number of foods each participant is sensitized to(24 months of age)
研究者
Kari Nadeau, MD, PhD
Chair, Department of Environmental Health
Harvard School of Public Health (HSPH)