NCT01291940: EES

The Effects of Emollient Therapy on the Skin Barrier Function

Completed NA Last updated 11 July 2019

What this trial tests

NA trial testing Pediatric Moisturizer in Atopic Dermatitis in 25 participants. Completed in 1 December 2014.

Timeline

1 January 2011

Primary endpoint
1 December 2014

1 December 2014

Quick facts

Lead sponsor	Oregon Health and Science University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	single group
Masking	single
Primary purpose	prevention
Enrollment	25
Start date	1 January 2011
Primary completion	1 December 2014
Estimated completion	1 December 2014
Sites	1 location across United States

Drugs / interventions tested

• Pediatric Moisturizer
• Adult Moisturizer

Conditions studied

• Atopic Dermatitis — all drugs for Atopic Dermatitis →
• Eczema — all drugs for Eczema →

Sponsor

Oregon Health and Science University

Who can join

Adults 3 Months to 99, any sex, with Atopic Dermatitis or Eczema. Healthy volunteers can join.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

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

Sponsor's own description

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

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Clinical Measurement of Transepidermal Water Loss.
   Kundu D, Jayaraman A, Sen CK. · · 2026 · cited 4× · PMID 40476522 · DOI 10.1089/wound.2024.0148