Comparison of Two Different Skin Creams and Their Effect on Transepidermal Water Loss (TEWL) in Pediatric and Adult Patients With Atopic Dermatitis: A Pilot Study
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 17
- 试验地点
- 1
- 主要终点
- Skin barrier function
研究概览
简要总结
Prospective, single center, clinical pilot study to test the hypothesis that lipid rich EpiCeram® is superior in improving skin barrier function compared to Aveeno Daily Moisturising Sheer Hydration Lotion®.
详细描述
Prospective, single center, clinical pilot study to test the hypothesis that lipid rich EpiCeram® is superior in improving skin barrier function compared to Aveeno Daily Moisturising Sheer Hydration Lotion®.
Primary Objective: To compare skin barrier function, assessed by TEWL AUC, between non-lesional areas of the skin treated with EpiCeram®, Aveeno Daily Moisturising Sheer Hydration Lotion® or no emollient use for one week.
Secondary Objectives: To assess lipid and protein profiles of skin tape strips from non-lesional skin, after a week of either EpiCeram®, Aveeno Daily Moisturising Sheer Hydration Lotion® or no treatment.
Exploratory Objectives :
- To study whether the effects on TEWL on lesional and non-lesional skin persist 24 hours after cessation of therapy.
- To evaluate whether baseline food and environmental allergy sensitization (assessed via skin prick testing during screening) affects the outcomes. See protocol section 3.1 for allergen details.
- A central repository of blood samples will be stored for future use to assess plasma biomarkers to help characterize clinical outcome data.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 1 Day 至 40 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Parent guardian must be able to understand and provide informed consent per Institutional Review Board (IRB) guidelines and regulations.
- •Male or female participants, between the ages of 0 to 40 years will be included
- •Diagnosis of moderate to severe active AD (Scoring Atopic Dermatitis (SCORAD) score > 26) without a history or current manifestations of eczema herpeticum (EH)
- •AD affecting at least 3 different skin areas (contralateral arms and one lower extremity)
排除标准
- •Inability or unwillingness of a parent guardian to give written informed consent, or to comply with study protocol.
- •Participants with skin disease other than AD that might compromise the stratum corneum barriers (e.g., bullous diseases, psoriasis, cutaneous T-cell lymphoma (also called Mycosis Fungoides or Sezary syndrome], dermatitis herpetiformis, Hailey-Hailey, or Darier's disease).
- •Known or suspected immunosuppression
- •Severe concomitant illness(es)
- •History of serious life-threatening reaction to latex, tape, or adhesives
- •Has received total body phototherapy (e.g., ultraviolet light B [UVB], psoralen ultraviolet light A [PUVA], tanning beds [>1 visit per week]) within 30 days of the Enrollment Visit
- •Use of topical corticosteroids, topical immunomodulatory agents (such as calcineural inhibitors and crisaborole), or topical antibiotics on the upper or lower extremities within 7 days of the Enrollment Visit
- •Has taken a bleach bath within 7 days of the Enrollment Visit
- •Use of systemic antibiotics, antiparasitics, antivirals, or antifungals within 7 days of the Enrollment Visit.
研究组 & 干预措施
Clinical pilot study
To compare skin barrier function, assessed by TEWL AUC, between non-lesional areas of the skin treated with EpiCeram®, Aveeno Daily Moisturising Sheer Hydration Lotion®, and no emollient use over a period of one week.
干预措施: EpiCeram (Drug)
Clinical pilot study
To compare skin barrier function, assessed by TEWL AUC, between non-lesional areas of the skin treated with EpiCeram®, Aveeno Daily Moisturising Sheer Hydration Lotion®, and no emollient use over a period of one week.
干预措施: Aveeno Daily Moisturising Sheer Hydration Lotion® (Drug)
结局指标
主要结局
Skin barrier function
时间窗: 2 weeks
Skin barrier function, assessed by TEWL
次要结局
- Baseline food and environmental allergy sensitization(2 weeks)
研究者
Sayantani B. Sindher
Clinical Assistant Professor
Stanford University