The Effects of Emollient Therapy on the Skin Barrier

NCT01291940 | Completed DMC

• 1 other identifier: Emollient Evaluation Study
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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.

• 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.
• 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

Outcome Measures

Primary Outcomes (1)

• Number of participants with improved skin barrier function as a result of emollient use

  Change in TEWL measurements of intervention arms compared to controls.

  3-4 weeks

Study Arms (3)

Pediatric Moisturizer Intervention

EXPERIMENTAL

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

Other: Pediatric Moisturizer

Adult Moisturizer Intervention

EXPERIMENTAL

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

Other: Adult Moisturizer

Adult Control

NO INTERVENTION

No intervention.

Interventions

Pediatric Moisturizer OTHER

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

Also known as: Cetaphil Cream, Aveeno Eczema Therapy Moisturizing Cream, CeraVe Moisturizing Cream, Aveeno Skin Relief Moisture Repair Cream

Pediatric Moisturizer Intervention

Adult Moisturizer OTHER

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

Also known as: Cetaphil Cream, Aveeno Eczema Therapy Moisturizing Cream, CeraVe Moisturizing Cream, Vaseline 100% Petroleum Jelly

Adult Moisturizer Intervention

Eligibility Criteria

• Age: 3 Months - 99 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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
• Have a history of atopic dermatitis
• years or older
• 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
• 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.

Sponsors & Collaborators

• Oregon Health and Science University: lead

Study Sites (1)

Oregon Health & Science University Center for Health & Healing

Portland, Oregon, 97239, United States

Location

MeSH Terms

Conditions

Dermatitis, Atopic; Eczema

Interventions

Petrolatum

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Hydrocarbons; Organic Chemicals

Study Officials

• Eric Simpson, MD, MCR

  Oregon Health & Science University, Department of Dermatology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, MCR

Study Record Dates

• First Submitted: February 8, 2011
• First Posted: February 9, 2011
• Study Start: January 1, 2011
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: July 15, 2019

Record last verified: 2019-07

Locations

US (1)