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
About this trial
This is an interventional prevention trial for Atopic Dermatitis
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.
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
NCT ID
NCT01291940
First Posted
February 8, 2011
Last Updated
July 11, 2019
Sponsor
Oregon Health and Science University
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
Learn more about this trial
The Effects of Emollient Therapy on the Skin Barrier
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