An Open-Label Study Investigating the Effects of Early Skin Barrier Protection on the Development of Atopic Dermatitis
Overview
- Phase
- Phase 2
- Intervention
- emollient (Cetaphil cream)
- Conditions
- Atopic Dermatitis
- Sponsor
- Oregon Health and Science University
- Enrollment
- 22
- Locations
- 1
- Primary Endpoint
- Incidence of Skin Irritation
- Status
- Completed
- Last Updated
- 8 years ago
Overview
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.
Investigators
Eric Simpson
Professor, Dermatology
Oregon Health and Science University
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
Arms & Interventions
Emollient
Skin barrier protection from birth
Intervention: emollient (Cetaphil cream)
Outcomes
Primary Outcomes
Incidence of Skin Irritation
Time Frame: 1 and 2 year time points
Incidence of Skin Infection
Time Frame: 1 and 2 year timepoints
Compliance With Protocol
Time Frame: over two years
Secondary Outcomes
- Development of Eczema(1 and 2 year time points)