The Effects of Emollient Therapy on the Skin Barrier

Not Applicable

Completed

• Conditions: Atopic Dermatitis; Eczema
• Interventions: Other: Adult Moisturizer; Other: Pediatric Moisturizer

• Registration Number: NCT01291940
• Lead Sponsor: Oregon Health and Science University

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.

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

Detailed Description

Not available

Study Timeline

• Study Start: 2011-01
• Study First Submitted: 2011-02-08
• Study First Submitted QC: 2011-02-08
• Study First Posted: 2011-02-09
• Primary Completion: 2014-12
• Study Completion: 2014-12
• Status Verified: 2019-07
• Last Update Submitted: 2019-07-11
• Last Update Posted: 2019-07-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Adult Moisturizer Intervention	Adult Moisturizer	Apply moisturizer to one arm once a day for four weeks.
Pediatric Moisturizer Intervention	Pediatric Moisturizer	Apply one of four moisturizers to one arm daily for four weeks.

Primary Outcome Measures

Name	Time	Method
Number of participants with improved skin barrier function as a result of emollient use	3-4 weeks	Change in TEWL measurements of intervention arms compared to controls.

Trial Locations

Locations (1)

Oregon Health & Science University Center for Health & Healing; 🇺🇸 Portland, Oregon, United States