Feasibility Study of Barrier Enhancement for Eczema Prevention

NCT01142999 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 46

Last updated 2011-08-05

No results posted yet for this study

Summary

The purpose of this protocol is to determine the feasibility of doing larger follow-up studies examining whether emollients used from birth can prevent eczema in high-risk babies and to help investigators find out if emollients (moisturizing skin creams) used from birth can prevent eczema in high-risk babies. Hypothesis: Enhancing the skin barrier from birth using emollients will prevent or delay the onset of eczema, especially in predisposed infants.

Conditions

Interventions

DRUG

Sunflower oil

One group will be instructed to use FDA-approved moisturizers and soap substitutes on their newborn infants.

DRUG

Control group

This group will be asked NOT to use any skin moisturizers and use only soap substitutes on their infants.

DRUG

Aquaphor ointment

One group will be instructed to use FDA-approved moisturizers and soap substitutes on their newborn infants.

DRUG

Cetaphil cream

One group will be instructed to use FDA-approved moisturizers and soap substitutes on their newborn infants.

Sponsors & Collaborators

  • Oregon Health and Science University

    lead OTHER

Principal Investigators

  • Eric L. Simpson, M.D., M.C.R. · Oregon Health and Science University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
1 Minute
Max Age
6 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-05-31
Primary Completion
2011-08-31
Completion
2012-09-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01142999 on ClinicalTrials.gov