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The Effects of Emollient Therapy on the Skin Barrier

The Effects of Emollient Therapy on the Skin Barrier Function

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01291940
Acronym
EES
Enrollment
25
Registered
2011-02-09
Start date
2011-01-31
Completion date
2014-12-31
Last updated
2019-07-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atopic Dermatitis, Eczema

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

Interventions

OTHERPediatric Moisturizer

Apply moisturizer for four weeks daily to only one arm. Do not apply moisturizer to the other arm.

OTHERAdult Moisturizer

Apply moisturizer for four weeks daily to only one arm. Do not apply moisturizer to the other arm.

Sponsors

Oregon Health and Science University
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
SINGLE (Investigator)

Eligibility

Sex/Gender
ALL
Age
3 Months to 99 Years
Healthy volunteers
Yes

Inclusion criteria

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 *

Design outcomes

Primary

MeasureTime frameDescription
Number of participants with improved skin barrier function as a result of emollient use3-4 weeksChange in TEWL measurements of intervention arms compared to controls.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026