Feasibility Study of Barrier Enhancement for Eczema Prevention

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

46 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-05-31

Study Completion Date

2012-09-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Eczema

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Intervention (moisturizer group)

One group will be instructed to use a choice of 3 FDA-approved moisturizers and soap substitutes on their newborn infants.

Group Type ACTIVE_COMPARATOR

Sunflower oil

Intervention Type DRUG

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

Aquaphor ointment

Intervention Type DRUG

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

Cetaphil cream

Intervention Type DRUG

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

Control group (no moisturizers)

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

Group Type ACTIVE_COMPARATOR

Control group

Intervention Type DRUG

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

Interventions

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Sunflower oil

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

Intervention Type DRUG

Control group

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

Intervention Type DRUG

Aquaphor ointment

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

Intervention Type DRUG

Cetaphil cream

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

Intervention Type DRUG

Other Intervention Names

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Moisturizers

Eligibility Criteria

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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

Minimum Eligible Age

1 Minute

Maximum Eligible Age

6 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No