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临床试验/NCT01291940
NCT01291940已完成不适用

The Effects of Emollient Therapy on the Skin Barrier Function

Oregon Health and Science University2 个研究点 分布在 1 个国家目标入组 25 人开始时间: 2011年1月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
25
试验地点
2
主要终点
Number of participants with improved skin barrier function as a result of emollient use

研究概览

简要总结

The goal of this study is to better understand what effect emollients (moisturizers) have on the skin in young children and adults.

Subjects will be recruited from PI and Sub-I clinics and Oregon Health & Science University (OHSU) research opportunities website.

  1. Adult and Adolescent Study:

Moisturizer Intervention - There will be 2-3 visits for this study: a screening visit, a baseline visit, and a final visit. Adults with a history of eczema will be asked to apply one of four possible moisturizers to one arm and nothing to the other arm for four weeks. The moisturizers, which will be assigned to the subjects, include either Cetaphil Cream, Aveeno Eczema Therapy Moisturizing Cream, CeraVe Moisturizing Cream, or Vaseline 100% Petroleum Jelly. Subjects can use other skin treatments as needed for their skin condition, but may not treat the arms during the study. Non-invasive tests of the skin will be made at Visit 1 and after four weeks (Visit 2). The skin measurements that will be performed are:

  • Transepidermal loss (TEWL)- measures how much water is lost across the skin barrier
  • Skin Cohesion and TEWL - TEWL after 5, 10, 15, and 20 tape strips will measure skin barrier function after tape-stripping
  • Skin electrical capacitance - measures the moisture in the top layer of skin
  • Skin pH - measures the acidity of the skin
  • Stratum corneum cohesion assay - tape-stripping to measure the protein removed from the top layer of skin
  • Lipidomic analysis - measures the lipids, or oils, in the top layer of skin Control - There will be 1-2 visits for this group: a screening visit and baseline visit, which can be combined. Non-invasive tests of the skin will be taken and include the skin measurements that will be performed are the same as the Moisturizer Intervention group.
  1. Pediatric Study: There will be 2-3 visits for this study: a screening visit, a baseline visit, and a final visit. Infants and toddlers between 3 months and 3 years of age without a history of skin barrier diseases will be assigned to a moisturizer, which include either Cetaphil Cream, Aveeno Eczema Therapy Moisturizing Cream, CeraVe Moisturizing Cream, or Aveeno Skin Relief Moisture Repair Cream. Non-invasive tests of the skin will be made at Visit 1 and after four weeks (Visit 2).
  • TEWL- measures how much water is lost across the skin barrier
  • Skin electrical capacitance - measures the moisture in the top layer of skin
  • Skin pH - measures the acidity of the skin

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Single Group
主要目的
Prevention
盲法
Single (Investigator)

入排标准

年龄范围
3 Months 至 99 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

研究组 & 干预措施

Pediatric Moisturizer Intervention

Experimental

Apply one of four moisturizers to one arm daily for four weeks.

干预措施: Pediatric Moisturizer (Other)

Adult Moisturizer Intervention

Experimental

Apply moisturizer to one arm once a day for four weeks.

干预措施: Adult Moisturizer (Other)

Adult Control

No Intervention

No intervention.

结局指标

主要结局

Number of participants with improved skin barrier function as a result of emollient use

时间窗: 3-4 weeks

Change in TEWL measurements of intervention arms compared to controls.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Eric Simpson

MD, MCR

Oregon Health and Science University

研究点 (2)

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