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

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ClinicalTrials.gov Identifier: NCT01291940
Recruitment Status : Completed
First Posted : February 9, 2011
Last Update Posted : July 15, 2019
Sponsor:
Information provided by (Responsible Party):
Eric Simpson, Oregon Health and Science University

Tracking Information
First Submitted Date  ICMJE February 8, 2011
First Posted Date  ICMJE February 9, 2011
Last Update Posted Date July 15, 2019
Study Start Date  ICMJE January 2011
Actual Primary Completion Date December 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 19, 2013)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: February 8, 2011)
Number of participants with improved skin barrier function as a result of emollient use [ Time Frame: 3 weeks ]
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Effects of Emollient Therapy on the Skin Barrier
Official Title  ICMJE The Effects of Emollient Therapy on the Skin Barrier Function
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
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Single (Investigator)
Primary Purpose: Prevention
Condition  ICMJE
  • Atopic Dermatitis
  • Eczema
Intervention  ICMJE
  • 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
  • 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
Study Arms  ICMJE
  • Experimental: Pediatric Moisturizer Intervention
    Apply one of four moisturizers to one arm daily for four weeks.
    Intervention: Other: Pediatric Moisturizer
  • Experimental: Adult Moisturizer Intervention
    Apply moisturizer to one arm once a day for four weeks.
    Intervention: Other: Adult Moisturizer
  • No Intervention: Adult Control
    No intervention.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 11, 2019)
25
Original Estimated Enrollment  ICMJE
 (submitted: February 8, 2011)
60
Actual Study Completion Date  ICMJE December 2014
Actual Primary Completion Date December 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE
  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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 3 Months to 99 Years   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01291940
Other Study ID Numbers  ICMJE Emollient Evaluation Study
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Eric Simpson, Oregon Health and Science University
Study Sponsor  ICMJE Oregon Health and Science University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Eric Simpson, MD, MCR Oregon Health & Science University, Department of Dermatology
PRS Account Oregon Health and Science University
Verification Date July 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP