Feasibility Study of Barrier Enhancement for Eczema Prevention

Study Overview
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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.

Official Title
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Feasibility Study of Barrier Enhancement for Eczema Prevention (BEEP)

Conditions
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Eczema

Intervention / Treatment
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* Drug: Sunflower oil
* Drug: Control group
* Drug: Aquaphor ointment
* Drug: Cetaphil cream


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Participant must have a parent or sibling with a history of at least one of the following: eczema, allergic rhinitis or asthma Infant in overall good health Mother between the ages of 16 and 45 years of age at delivery; infant from birth thru 6 months of age Capable of giving informed consent Exclusion Criteria: Preterm birth defined as birth prior to 37 weeks gestation Major congenital anomaly Hydrops fetalis Significant dermatitis at birth not including seborrheic dermatitis (cradle cap) Any immunodeficiency disorder or severe genetic skin disorder Any other serious condition that would make the use of emollients inadvisable Any other major medical problems that the investigator deems may increase the risk of adverse events with the intervention

Ages Eligible for Study
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Minimum Age: 1 Minute
Maximum Age: 6 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Intervention (moisturizer group)<br>One group will be instructed to use a choice of 3 FDA-approved moisturizers and soap substitutes on their newborn infants. | Drug: Sunflower oil<br>* One group will be instructed to use FDA-approved moisturizers and soap substitutes on their newborn infants.<br>* Other names: Moisturizers;Drug: Aquaphor ointment<br>* One group will be instructed to use FDA-approved moisturizers and soap substitutes on their newborn infants.<br>Drug: Cetaphil cream<br>* One group will be instructed to use FDA-approved moisturizers and soap substitutes on their newborn infants.<br>|
| Active Comparator: Control group (no moisturizers)<br>This group will be asked NOT to use any skin moisturizers and use only soap substitutes on their infants. | Drug: Control group<br>* This group will be asked NOT to use any skin moisturizers and use only soap substitutes on their infants.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of families willing to be randomized. | Determine proportion of families willing to be randomized in order to design larger study in the future. | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |