Overview

This trial is active, not recruiting.

Condition eczema
Treatments sunflower oil, control group, aquaphor ointment, cetaphil cream
Sponsor Oregon Health and Science University
Start date May 2010
End date August 2011
Trial size 46 participants
Trial identifier NCT01142999, BEEP

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking single blind (outcomes assessor)
Primary purpose prevention
Arm
(Active Comparator)
One group will be instructed to use a choice of 3 FDA-approved moisturizers and soap substitutes on their newborn infants.
sunflower oil Moisturizers
One group will be instructed to use FDA-approved moisturizers and soap substitutes on their newborn 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.
(Active Comparator)
This group will be asked NOT to use any skin moisturizers and use only soap substitutes on their infants.
control group
This group will be asked NOT to use any skin moisturizers and use only soap substitutes on their infants.

Primary Outcomes

Measure
Proportion of families willing to be randomized.
time frame: 6 months

Secondary Outcomes

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

Eligibility Criteria

Male or female participants up to 6 months old.

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

Additional Information

Official title Feasibility Study of Barrier Enhancement for Eczema Prevention (BEEP)
Principal investigator Eric L. Simpson, M.D., M.C.R.
Trial information was received from ClinicalTrials.gov and was last updated in August 2011.
Information provided to ClinicalTrials.gov by Oregon Health and Science University.