Completed

NCT Number: NCT01291940

The Effects of Emollient Therapy on the Skin Barrier

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

Completed

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Key information

Conditions

Atopic Dermatitis Congenital, Hereditary, and Neonatal Diseases and Abnormalities Dermatitis Dermatitis, Atopic Eczema Genetic Diseases, Inborn Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Skin Diseases Skin Diseases, Eczematous Skin Diseases, Genetic Skin and Connective Tissue Diseases

Age range

3 month–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Oregon Health & Science University Center for Health & Healing

Portland, Oregon, 97239, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Pediatric Moisturizer

Other

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

Other names: Cetaphil Cream, Aveeno Eczema Therapy Moisturizing Cream, CeraVe Moisturizing Cream, Aveeno Skin Relief Moisture Repair Cream

Adult Moisturizer

Other

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

Other names: Cetaphil Cream, Aveeno Eczema Therapy Moisturizing Cream, CeraVe Moisturizing Cream, Vaseline 100% Petroleum Jelly

Primary outcomes

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.

Sponsors and collaborators

Lead sponsor

Oregon Health and Science University

Other

Registry information

Official study title

The Effects of Emollient Therapy on the Skin Barrier Function

Acronym: EES

Important dates

Study start: 2011
Primary completion: 2014
Study completion: 2014
First posted: Feb 9, 2011
Registry last updated: Jul 15, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed