Back to resultsAn Open-Label Study Investigating the Effects of Early Skin Barrier Protection on the Development of Atopic Dermatitis
Primary Purpose
Atopic Dermatitis
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
emollient (Cetaphil cream)
Sponsored by
About this trial
This is an interventional prevention trial for Atopic Dermatitis focused on measuring Atopic Dermatitis, Prevention, Skin Barrier
Eligibility Criteria
Inclusion Criteria:
- at least one parent diagnosed with Atopic Dermatitis
- one parent or sibling with hayfever or asthma
Exclusion Criteria:
- newborns with dermatitis at birth
- newborns born greater than four weeks prematurely
- newborns with medical problems necessitating prolonged hospitalization
- newborns diagnosed with any immune deficiency syndrome
Sites / Locations
- Oregon Health & Science University, Department of Dermatology
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Emollient
Arm Description
Skin barrier protection from birth
Outcomes
Primary Outcome Measures
Incidence of Skin Irritation
Incidence of Skin Infection
Compliance With Protocol
Secondary Outcome Measures
Development of Eczema
Full Information
NCT ID
NCT00806221
First Posted
December 8, 2008
Last Updated
June 9, 2017
Sponsor
Oregon Health and Science University
Collaborators
Galderma R&D
1. Study Identification
Unique Protocol Identification Number
NCT00806221
Brief Title
An Open-Label Study Investigating the Effects of Early Skin Barrier Protection on the Development of Atopic Dermatitis
Official Title
An Open-Label Study Investigating the Effects of Early Skin Barrier Protection on the Development of Atopic Dermatitis
Study Type
Interventional
2. Study Status
Record Verification Date
June 2017
Overall Recruitment Status
Completed
Study Start Date
November 2006 (undefined)
Primary Completion Date
November 2008 (Actual)
Study Completion Date
November 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Oregon Health and Science University
Collaborators
Galderma R&D
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to determine whether early use of a bland emollient in newborns, prior to the clinical signs of skin disease, will delay the onset or prevent the development of atopic dermatitis.
Detailed Description
All neonates will be treated with Cetaphil cream starting within 1 week of birth. All neonates enrolled will have an increased risk of developing atopic dermatitis because they have a family history of either asthma, hay fever, or atopic dermatitis. These neonates will then be followed for 2 years for the signs and symptoms of atopic dermatitis.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atopic Dermatitis
Keywords
Atopic Dermatitis, Prevention, Skin Barrier
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
22 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Emollient
Arm Type
Experimental
Arm Description
Skin barrier protection from birth
Intervention Type
Drug
Intervention Name(s)
emollient (Cetaphil cream)
Intervention Description
Cetaphil cream applied daily from birth
Primary Outcome Measure Information:
Title
Incidence of Skin Irritation
Time Frame
1 and 2 year time points
Title
Incidence of Skin Infection
Time Frame
1 and 2 year timepoints
Title
Compliance With Protocol
Time Frame
over two years
Secondary Outcome Measure Information:
Title
Development of Eczema
Time Frame
1 and 2 year time points
10. Eligibility
Sex
All
Maximum Age & Unit of Time
1 Month
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
at least one parent diagnosed with Atopic Dermatitis
one parent or sibling with hayfever or asthma
Exclusion Criteria:
newborns with dermatitis at birth
newborns born greater than four weeks prematurely
newborns with medical problems necessitating prolonged hospitalization
newborns diagnosed with any immune deficiency syndrome
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eric Simpson, MD
Organizational Affiliation
Oregon Health and Science University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Oregon Health & Science University, Department of Dermatology
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
12. IPD Sharing Statement
Learn more about this trial
An Open-Label Study Investigating the Effects of Early Skin Barrier Protection on the Development of Atopic Dermatitis
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