The Effects of Emollient Therapy on the Skin Barrier

NCT ID: NCT01291940

Last Updated: 2019-07-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-01-31
• Study Completion Date: 2014-12-31

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

Conditions

Atopic Dermatitis; Eczema

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Pediatric Moisturizer Intervention

Apply one of four moisturizers to one arm daily for four weeks.

Group Type: EXPERIMENTAL

Pediatric Moisturizer

Intervention Type: OTHER

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

Adult Moisturizer Intervention

Apply moisturizer to one arm once a day for four weeks.

Group Type: EXPERIMENTAL

Adult Moisturizer

Intervention Type: OTHER

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

Adult Control

No intervention.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Pediatric Moisturizer

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

Intervention Type: OTHER

Adult Moisturizer

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

Intervention Type: OTHER

Other Intervention Names

Cetaphil Cream; Aveeno Eczema Therapy Moisturizing Cream; CeraVe Moisturizing Cream; Aveeno Skin Relief Moisture Repair Cream; Cetaphil Cream; Aveeno Eczema Therapy Moisturizing Cream; CeraVe Moisturizing Cream; Vaseline 100% Petroleum Jelly

Eligibility Criteria

Inclusion Criteria

• Enrollment in the BEEP emollient intervention study (IRB #6083)
• Overall good health

• 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

• 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

• 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.

• Minimum Eligible Age: 3 Months
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Oregon Health and Science University

OTHER

Sponsor Role: lead

Responsible Party

Eric Simpson

MD, MCR

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Eric Simpson, MD, MCR

Role: PRINCIPAL_INVESTIGATOR

Oregon Health & Science University, Department of Dermatology

Locations

Oregon Health & Science University Center for Health & Healing

Portland, Oregon, United States

Countries

United States

Other Identifiers

Emollient Evaluation Study

Identifier Type: -

Identifier Source: org_study_id