Feasibility Study of Barrier Enhancement for Eczema Prevention

Not Applicable

• Conditions: Eczema
• Interventions: Drug: Control group; Drug: Sunflower oil; Drug: Aquaphor ointment; Drug: Cetaphil cream

• Registration Number: NCT01142999
• Lead Sponsor: Oregon Health and Science University

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-05
• Status Verified: 2010-06
• Study First Submitted: 2010-06-10
• Study First Submitted QC: 2010-06-11
• Study First Posted: 2010-06-14
• Primary Completion: 2011-08
• Last Update Submitted: 2011-08-04
• Last Update Posted: 2011-08-05
• Study Completion: 2012-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 46

Inclusion Criteria

1. Participant must have a parent or sibling with a history of at least one of the following: eczema, allergic rhinitis or asthma
2. Infant in overall good health
3. Mother between the ages of 16 and 45 years of age at delivery; infant from birth thru 6 months of age
4. Capable of giving informed consent

Exclusion Criteria

1. Preterm birth defined as birth prior to 37 weeks gestation
2. Major congenital anomaly
3. Hydrops fetalis
4. Significant dermatitis at birth not including seborrheic dermatitis ("cradle cap")
5. Any immunodeficiency disorder or severe genetic skin disorder
6. Any other serious condition that would make the use of emollients inadvisable
7. Any other major medical problems that the investigator deems may increase the risk of adverse events with the intervention

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention (moisturizer group)	Aquaphor ointment	One group will be instructed to use a choice of 3 FDA-approved moisturizers and soap substitutes on their newborn infants.
Intervention (moisturizer group)	Cetaphil cream	One group will be instructed to use a choice of 3 FDA-approved moisturizers and soap substitutes on their newborn infants.
Control group (no moisturizers)	Control group	This group will be asked NOT to use any skin moisturizers and use only soap substitutes on their infants.
Intervention (moisturizer group)	Sunflower oil	One group will be instructed to use a choice of 3 FDA-approved moisturizers and soap substitutes on their newborn infants.

Primary Outcome Measures

Name	Time	Method
Proportion of families willing to be randomized.	6 months	Determine proportion of families willing to be randomized in order to design larger study in the future.

Secondary Outcome Measures

Name	Time	Method
Proportion of families eligible for the trial, willing to participate	6 months
Proportion of families who found the interventions acceptable	6 months
Reported adherence with intervention	6 months
Proportion of families for whom the blinding of the assessor to the allocation ostatus was not compromised	6 months
Amount of contamination as a result of increased awareness in the control group	6 months
Percentage of missing data and early withdrawal rates	6 months
Incidence of emollient-related adverse events	6 months
Incidence of eczema at 6 and 12 months	12 months
Age at onset of eczema	6 months
Filaggrin mutation status	6 months

Trial Locations

Locations (1)

Oregon Health & Science University; 🇺🇸 Portland, Oregon, United States