Feasibility Study of Barrier Enhancement for Eczema Prevention (BEEP)

Feasibility Study of Barrier Enhancement for Eczema Prevention (BEEP)

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.

Study Overview

• Status: Unknown
• Conditions: Eczema
• Intervention / Treatment: Drug: Sunflower oil; Drug: Aquaphor ointment; Drug: Cetaphil cream; Drug: Control group

• Study Type: Interventional
• Enrollment (Actual): 46
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Oregon
    • Portland, Oregon, United States, 97239
      • Oregon Health & Science University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 minute to 6 months (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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	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

Collaborators and Investigators

• Sponsor: Oregon Health and Science University
• Investigators: Principal Investigator: Eric L. Simpson, M.D., M.C.R., Oregon Health and Science University

Study record dates

Study Major Dates

• Study Start: May 1, 2010
• Primary Completion (Anticipated): August 1, 2011
• Study Completion (Anticipated): September 1, 2012

Study Registration Dates

• First Submitted: June 10, 2010
• First Submitted That Met QC Criteria: June 11, 2010
• First Posted (Estimate): June 14, 2010

Study Record Updates

• Last Update Posted (Estimate): August 5, 2011
• Last Update Submitted That Met QC Criteria: August 4, 2011
• Last Verified: June 1, 2010

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Dermatitis; Skin Diseases, Eczematous; Eczema
• Other Study ID Numbers: BEEP