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

Primary Purpose

Atopic Dermatitis, Eczema

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Pediatric Moisturizer
Adult Moisturizer
Sponsored by
Oregon Health and Science University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Atopic Dermatitis

Eligibility Criteria

3 Months - 99 Years (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers
  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.

Sites / Locations

  • Oregon Health & Science University Center for Health & Healing

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

No Intervention

Arm Label

Pediatric Moisturizer Intervention

Adult Moisturizer Intervention

Adult Control

Arm Description

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

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

No intervention.

Outcomes

Primary Outcome Measures

Number of participants with improved skin barrier function as a result of emollient use
Change in TEWL measurements of intervention arms compared to controls.

Secondary Outcome Measures

Full Information

First Posted
February 8, 2011
Last Updated
July 11, 2019
Sponsor
Oregon Health and Science University
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1. Study Identification

Unique Protocol Identification Number
NCT01291940
Brief Title
The Effects of Emollient Therapy on the Skin Barrier
Acronym
EES
Official Title
The Effects of Emollient Therapy on the Skin Barrier Function
Study Type
Interventional

2. Study Status

Record Verification Date
July 2019
Overall Recruitment Status
Completed
Study Start Date
January 2011 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
December 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Oregon Health and Science University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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. 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. 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atopic Dermatitis, Eczema

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Investigator
Allocation
Non-Randomized
Enrollment
25 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Pediatric Moisturizer Intervention
Arm Type
Experimental
Arm Description
Apply one of four moisturizers to one arm daily for four weeks.
Arm Title
Adult Moisturizer Intervention
Arm Type
Experimental
Arm Description
Apply moisturizer to one arm once a day for four weeks.
Arm Title
Adult Control
Arm Type
No Intervention
Arm Description
No intervention.
Intervention Type
Other
Intervention Name(s)
Pediatric Moisturizer
Other Intervention Name(s)
Cetaphil Cream, Aveeno Eczema Therapy Moisturizing Cream, CeraVe Moisturizing Cream, Aveeno Skin Relief Moisture Repair Cream
Intervention Description
Apply moisturizer for four weeks daily to only one arm. Do not apply moisturizer to the other arm.
Intervention Type
Other
Intervention Name(s)
Adult Moisturizer
Other Intervention Name(s)
Cetaphil Cream, Aveeno Eczema Therapy Moisturizing Cream, CeraVe Moisturizing Cream, Vaseline 100% Petroleum Jelly
Intervention Description
Apply moisturizer for four weeks daily to only one arm. Do not apply moisturizer to the other arm.
Primary Outcome Measure Information:
Title
Number of participants with improved skin barrier function as a result of emollient use
Description
Change in TEWL measurements of intervention arms compared to controls.
Time Frame
3-4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
3 Months
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eric Simpson, MD, MCR
Organizational Affiliation
Oregon Health & Science University, Department of Dermatology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Oregon Health & Science University Center for Health & Healing
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States

12. IPD Sharing Statement

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The Effects of Emollient Therapy on the Skin Barrier

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