NCT05688735招募中不适用
Prospective Randomized Vehicle-Controlled, Double-Blind Assessment of the Effect of Coconut and Sunflower Seed Oil Derived Isosorbide Diseters and Colloidial Oatmeal
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Eczema Area and Severity Index (EASI)
研究概览
简要总结
The goal of this study is to compare coconut oil and sunflower seed oil derived isosorbide disesters and colloidal oatmeal, and observe their effect on pediatric atopic dermatitis among males and females aged 2-17.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
盲法说明
Double-blind, randomized
入排标准
- 年龄范围
- 2 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Males and females ages 2-17 years old at the time of consent.
- •Clinical diagnosis of active atopic dermatitis
- •vIGA-AD (validated Investigator Global Assessment-Atopic Dermatitis) score of "mild" (2) or "moderate" (3) at Baseline
- •EASI (Eczema Area and Severity Index) score of >/= 5 at Baseline
排除标准
- •Individuals who have a known allergy to isosorbide diesters, coconut oil, or sunflower seed oil
- •Individuals who have solely hand and/or foot eczema without evidence of eczema anywhere else on their body.
- •Individuals who have been on topical calcineurin inhibitors or crisaborole to the predetermined areas within two weeks of initiation of participation or unwilling to undergo a washout period.
- •Subjects with an ongoing secondary infection of the skin.
- •Subjects who are on systemic therapy or who need systemic therapy at the discretion of the investigator. Systemic therapies include cyclosporine, systemic steroids, methotrexate, and dupilumab. Subjects who have been on cyclosporine, systemic steroids, or methotrexate in the month prior to initiation of study intervention or are unwilling to undergo a washout period. Subjects who have been on dupilumab in two months prior to initiation of study intervention or are unwilling to undergo a washout period.
- •Subjects with a diagnosis of Scabies.
- •Pregnant women
- •Prisoners
结局指标
主要结局
Eczema Area and Severity Index (EASI)
时间窗: 8 Weeks
Percent Achieving EASI 75
Itch
时间窗: 8 Weeks
Change in the Itch Visual Analog Scale from Baseline
次要结局
- Skin Hydration(8 weeks)
- Eczema Area and Severity Index (EASI)(8 Weeks)
- Itch(4 Weeks)
- Topical steroid use(8 Weeks)
- Skin Transepidermal Water Loss (TEWL)(8 Weeks)
- Shift in the Skin Microbiome(8 weeks)
研究者
研究点 (2)
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