Clinical trial NCT01291940: The Effects of Emollient Therapy on the Skin Barrier
Official title: The Effects of Emollient Therapy on the Skin Barrier Function
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Atopic Dermatitis
Eczema
Lead sponsor: Oregon Health and Science University
Sponsor class: OTHER
First posted: 2011-02-09
Enrollment: 25
Sex: ALL
Minimum age (years): 3
Maximum age (years): 99
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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


Eligibility 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.

Primary outcomes:
measure: Number of participants with improved skin barrier function as a result of emollient use
timeFrame: 3-4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Portland
country: United States
facility: Oregon Health & Science University Center for Health & Healing
state: Oregon
Study officials:
affiliation: Oregon Health & Science University, Department of Dermatology
name: Eric Simpson, MD, MCR
role: PRINCIPAL_INVESTIGATOR
References: