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Feasibility Study of Barrier Enhancement for Eczema Prevention (BEEP)

Primary Purpose

Eczema

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Sunflower oil
Control group
Aquaphor ointment
Cetaphil cream
Sponsored by
Oregon Health and Science University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Eczema

Eligibility Criteria

1 Minute - 6 Months (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Oregon Health & Science University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Intervention (moisturizer group)

Control group (no moisturizers)

Arm Description

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

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

Outcomes

Primary Outcome Measures

Proportion of families willing to be randomized.
Determine proportion of families willing to be randomized in order to design larger study in the future.

Secondary Outcome Measures

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

Full Information

First Posted
June 10, 2010
Last Updated
August 4, 2011
Sponsor
Oregon Health and Science University
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1. Study Identification

Unique Protocol Identification Number
NCT01142999
Brief Title
Feasibility Study of Barrier Enhancement for Eczema Prevention
Acronym
BEEP
Official Title
Feasibility Study of Barrier Enhancement for Eczema Prevention (BEEP)
Study Type
Interventional

2. Study Status

Record Verification Date
June 2010
Overall Recruitment Status
Unknown status
Study Start Date
May 2010 (undefined)
Primary Completion Date
August 2011 (Anticipated)
Study Completion Date
September 2012 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Oregon Health and Science University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Eczema

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
46 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention (moisturizer group)
Arm Type
Active Comparator
Arm Description
One group will be instructed to use a choice of 3 FDA-approved moisturizers and soap substitutes on their newborn infants.
Arm Title
Control group (no moisturizers)
Arm Type
Active Comparator
Arm Description
This group will be asked NOT to use any skin moisturizers and use only soap substitutes on their infants.
Intervention Type
Drug
Intervention Name(s)
Sunflower oil
Other Intervention Name(s)
Moisturizers
Intervention Description
One group will be instructed to use FDA-approved moisturizers and soap substitutes on their newborn infants.
Intervention Type
Drug
Intervention Name(s)
Control group
Intervention Description
This group will be asked NOT to use any skin moisturizers and use only soap substitutes on their infants.
Intervention Type
Drug
Intervention Name(s)
Aquaphor ointment
Intervention Description
One group will be instructed to use FDA-approved moisturizers and soap substitutes on their newborn infants.
Intervention Type
Drug
Intervention Name(s)
Cetaphil cream
Intervention Description
One group will be instructed to use FDA-approved moisturizers and soap substitutes on their newborn infants.
Primary Outcome Measure Information:
Title
Proportion of families willing to be randomized.
Description
Determine proportion of families willing to be randomized in order to design larger study in the future.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Proportion of families eligible for the trial, willing to participate
Time Frame
6 months
Title
Proportion of families who found the interventions acceptable
Time Frame
6 months
Title
Reported adherence with intervention
Time Frame
6 months
Title
Proportion of families for whom the blinding of the assessor to the allocation ostatus was not compromised
Time Frame
6 months
Title
Amount of contamination as a result of increased awareness in the control group
Time Frame
6 months
Title
Percentage of missing data and early withdrawal rates
Time Frame
6 months
Title
Incidence of emollient-related adverse events
Time Frame
6 months
Title
Incidence of eczema at 6 and 12 months
Time Frame
12 months
Title
Age at onset of eczema
Time Frame
6 months
Title
Filaggrin mutation status
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Minute
Maximum Age & Unit of Time
6 Months
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eric L. Simpson, M.D., M.C.R.
Organizational Affiliation
Oregon Health and Science University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Oregon Health & Science University
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States

12. IPD Sharing Statement

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Feasibility Study of Barrier Enhancement for Eczema Prevention

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