An Open-Label Study Investigating the Effects of Early Skin Barrier Protection on the Development of Atopic Dermatitis
Phase 2
Completed
- Conditions
- Atopic Dermatitis
- Interventions
- Drug: emollient (Cetaphil cream)
- Registration Number
- NCT00806221
- Lead Sponsor
- Oregon Health and Science University
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 22
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Emollient emollient (Cetaphil cream) Skin barrier protection from birth
- Primary Outcome Measures
Name Time Method Incidence of Skin Irritation 1 and 2 year time points Incidence of Skin Infection 1 and 2 year timepoints Compliance With Protocol over two years
- Secondary Outcome Measures
Name Time Method Development of Eczema 1 and 2 year time points
Trial Locations
- Locations (1)
Oregon Health & Science University, Department of Dermatology
🇺🇸Portland, Oregon, United States