The Effect of Isosorbide Diesters Based Moisturizer on Skin Health
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 34
- 试验地点
- 1
- 主要终点
- EASI75
研究概览
简要总结
The overall objective of this study is to assess how a natural ingredient, isosorbide diesters (IDEAS), works in association with colloidal oatmeal for eczema.
详细描述
The topical therapy of eczema largely focuses on the use of topical medications but there is demand for topical moisturizers and ingredients that can reduce the need for topical steroids. The goal of this study is to assess the use of a natural ingredient, isosorbide diesters (IDEAS), for eczema and if it can reduce the need for the use of topical steroids.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men and women aged 18 or over
- •Subjects with a diagnosis of mild to moderate eczema with a SCORAD between 1-50.
排除标准
- •Individuals who have a known allergy to isosorbide diesters.
- •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
研究组 & 干预措施
Moisturizer Containing Isosorbide Diesters and Colloidal Oatmeal
Topical lotion containing isosorbide diesters and colloidal oatmeal to be applied to the entire body once daily.
干预措施: Moisturizer Containing Isosorbide Diesters and Colloidal Oatmeal (Other)
Moisturizer containing colloidal oatmeal
Topical moisturizer with colloidal oatmeal to be applied to the entire body once daily
干预措施: Moisturizer containing Colloidal Oatmeal only (Other)
结局指标
主要结局
EASI75
时间窗: Week 4
75% improvement in Eczema severity is assessed using the Eczema Area and Severity Index
Change in IVAS
时间窗: 4 weeks
Itch severity is assessed using the Itch Visual Analog Scale.
次要结局
- Change in DLQI survey responses(Week 5)
- Change in relative abundance of S. aureus(4 weeks)
- Change in EASI score(Week 5)
- Change in IVAS(Week 5)
- Change in skin hydration level(Week 5)
- Change in TEWL(Week 5)
- Change in TEWL(Week 1)
- Change in TEWL(Week 4)
- Change in EASI score(Week 1)
- Change in IVAS(Week 1)
- Change in skin hydration level(Week 1)
- Change in skin hydration level(Week 4)
- Change in DLQI survey responses(Week 1)
- Change in DLQI survey responses(Week 4)
研究者
Raja Sivamani, MD MS AP
Principal Investigator
Integrative Skin Science and Research