The Effects of Emollient Therapy on the Skin Barrier (EES)

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2013 by Oregon Health and Science University
Sponsor:
Information provided by (Responsible Party):
Eric Simpson, Oregon Health and Science University
ClinicalTrials.gov Identifier:
NCT01291940
First received: February 8, 2011
Last updated: June 19, 2013
Last verified: June 2013
  Purpose

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

Condition Intervention
Atopic Dermatitis
Eczema
Other: Pediatric Moisturizer
Other: Adult Moisturizer

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Prevention
Official Title: The Effects of Emollient Therapy on the Skin Barrier Function

Resource links provided by NLM:


Further study details as provided by Oregon Health and Science University:

Primary Outcome Measures:
  • Number of participants with improved skin barrier function as a result of emollient use [ Time Frame: 3-4 weeks ] [ Designated as safety issue: No ]
    Change in TEWL measurements of intervention arms compared to controls.


Estimated Enrollment: 190
Study Start Date: January 2011
Estimated Study Completion Date: January 2014
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Pediatric Moisturizer Intervention
Apply one of four moisturizers to one arm daily for four weeks.
Other: Pediatric Moisturizer
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
Experimental: Adult Moisturizer Intervention
Apply moisturizer to one arm once a day for four weeks.
Other: Adult Moisturizer
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
No Intervention: Adult Control
No intervention.

  Eligibility

Ages Eligible for Study:   3 Months and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
    • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01291940

Locations
United States, Oregon
Oregon Health & Science University Center for Health & Healing Recruiting
Portland, Oregon, United States, 97239
Contact: Maureen Keene    503-228-7350      
Sponsors and Collaborators
Oregon Health and Science University
Investigators
Principal Investigator: Eric Simpson, MD, MCR Oregon Health & Science University, Department of Dermatology
  More Information

No publications provided

Responsible Party: Eric Simpson, Eric Simpson, M.D., M.C.R., Oregon Health and Science University
ClinicalTrials.gov Identifier: NCT01291940     History of Changes
Other Study ID Numbers: Emollient Evaluation Study
Study First Received: February 8, 2011
Last Updated: June 19, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Eczema
Dermatitis
Dermatitis, Atopic
Skin Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Emollients
Petrolatum
Pramoxine
Dermatologic Agents
Therapeutic Uses
Pharmacologic Actions
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on August 21, 2014