Phase 2
N=22
An Open-Label Study Investigating the Effects of Early Skin Barrier Protection on the Development of Atopic Dermatitis
Atopic Dermatitis
Bottom Line
View on ClinicalTrials.gov: NCT00806221 ↗Enrolled (actual)
22
Serious AEs
0.0%
Results posted
Jul 2017
Primary outcome: Primary: Incidence of Skin Irritation — 0 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- emollient (Cetaphil cream) (Drug)
- Age
- Pediatric
- Sex
- All
- Sponsor
- Oregon Health and Science University
- Primary completion
- Nov 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Incidence of Skin Irritation |
— | — |
| PRIMARY Incidence of Skin Infection |
— | — |
| PRIMARY Compliance With Protocol |
20 | — |
| SECONDARY Development of Eczema |
5 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT00806221). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.