Feasibility Study of Barrier Enhancement for Eczema Prevention

Eczema Clinical Trial

— BEEP  

Official title:

Feasibility Study of Barrier Enhancement for Eczema Prevention (BEEP)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01142999
• Other study ID #: BEEP
• Status: Active, not recruiting
• Phase: N/A
• First received: June 10, 2010
• Last updated: August 4, 2011
• Start date: May 2010
• Est. completion date: September 2012

Study information

• Verified date: June 2010
• Source: Oregon Health and Science University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 46
• Est. completion date: September 2012
• Est. primary completion date: August 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 6 Months

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Dermatitis
• Eczema

Intervention

Drug:
• Sunflower oil
One group will be instructed to use FDA-approved moisturizers and soap substitutes on their newborn infants.
• Control group
This group will be asked NOT to use any skin moisturizers and use only soap substitutes on their infants.
• Aquaphor ointment
One group will be instructed to use FDA-approved moisturizers and soap substitutes on their newborn infants.
• Cetaphil cream
One group will be instructed to use FDA-approved moisturizers and soap substitutes on their newborn infants.

Locations

Country	Name	City	State
United States	Oregon Health & Science University	Portland	Oregon

Sponsors (1)

Lead Sponsor	Collaborator
Oregon Health and Science University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Proportion of families eligible for the trial, willing to participate		6 months	No
Secondary	Proportion of families who found the interventions acceptable		6 months	No
Secondary	Reported adherence with intervention		6 months	No
Secondary	Proportion of families for whom the blinding of the assessor to the allocation ostatus was not compromised		6 months	No
Secondary	Amount of contamination as a result of increased awareness in the control group		6 months	No
Secondary	Percentage of missing data and early withdrawal rates		6 months	No
Secondary	Incidence of emollient-related adverse events		6 months	No
Secondary	Incidence of eczema at 6 and 12 months		12 months	No
Secondary	Age at onset of eczema		6 months	No
Secondary	Filaggrin mutation status		6 months	No