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The Effects of Emollient Therapy on the Skin Barrier (EES)

2019年7月11日 更新者:Eric Simpson、Oregon Health and Science University

The Effects of Emollient Therapy on the Skin Barrier Function

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.
  2. 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

研究概览

研究类型

介入性

注册 (实际的)

25

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

    • Oregon
      • Portland、Oregon、美国、97239
        • Oregon Health & Science University Center for Health & Healing

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

3个月 至 99年 (孩子、成人、年长者)

接受健康志愿者

是的

有资格学习的性别

全部

描述

  1. Pediatric study

    • Inclusion Criteria

      • Enrollment in the BEEP emollient intervention study (IRB #6083)
      • Overall good health
    • Exclusion Criteria

      • Have a history of or are being evaluated for a skin barrier disease
      • Have an active skin infection
      • Are receiving phototherapy
      • Any immunodeficiency disorder or severe genetic skin disorder
      • Any other serious condition that would make the use of emollients inadvisable
      • Any other major medical problems that the investigator deems may increase the risk of adverse events with the intervention
  2. Adult Study

    • Inclusion Criteria

      • Have a history of atopic dermatitis
      • 12 years or older
      • 4 x 4 cm of non-lesional skin on both inner forearms
      • No other conditions that would make the use of the four emollients harmful to the subject, such as known allergy to an emollient or a component o the emollient
    • Exclusion Criteria

      • Use of topical steroids on the inner forearms or oral immunosuppressive medications for 4 weeks prior to participation in the study.
      • Receiving phototherapy or systemic immunosuppressive therapy three months prior to participation in the study.

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:预防
  • 分配:非随机化
  • 介入模型:单组作业
  • 屏蔽:单身的

武器和干预

参与者组/臂
干预/治疗
实验性的:Pediatric Moisturizer Intervention
Apply one of four moisturizers to one arm daily for four weeks.
Apply moisturizer for four weeks daily to only one arm. Do not apply moisturizer to the other arm.
其他名称:
  • Cetaphil Cream
  • Aveeno Eczema Therapy Moisturizing Cream
  • CeraVe Moisturizing Cream
  • Aveeno Skin Relief Moisture Repair Cream
实验性的:Adult Moisturizer Intervention
Apply moisturizer to one arm once a day for four weeks.
Apply moisturizer for four weeks daily to only one arm. Do not apply moisturizer to the other arm.
其他名称:
  • Cetaphil Cream
  • Aveeno Eczema Therapy Moisturizing Cream
  • CeraVe Moisturizing Cream
  • Vaseline 100% Petroleum Jelly
无干预:Adult Control
No intervention.

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Number of participants with improved skin barrier function as a result of emollient use
大体时间:3-4 weeks
Change in TEWL measurements of intervention arms compared to controls.
3-4 weeks

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:Eric Simpson, MD, MCR、Oregon Health & Science University, Department of Dermatology

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2011年1月1日

初级完成 (实际的)

2014年12月1日

研究完成 (实际的)

2014年12月1日

研究注册日期

首次提交

2011年2月8日

首先提交符合 QC 标准的

2011年2月8日

首次发布 (估计)

2011年2月9日

研究记录更新

最后更新发布 (实际的)

2019年7月15日

上次提交的符合 QC 标准的更新

2019年7月11日

最后验证

2019年7月1日

更多信息

与本研究相关的术语

其他相关的 MeSH 术语

其他研究编号

  • Emollient Evaluation Study

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

Pediatric Moisturizer的临床试验

3
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