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Trial record 13 of 232 for:    eczema
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Feasibility Study of Barrier Enhancement for Eczema Prevention (BEEP)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2010 by Oregon Health and Science University.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Oregon Health and Science University
ClinicalTrials.gov Identifier:
NCT01142999
First received: June 10, 2010
Last updated: August 4, 2011
Last verified: June 2010
History of Changes
  Purpose

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.


Condition Intervention
Eczema
 Drug: Sunflower oil
Drug: Control group
Drug: Aquaphor ointment
Drug: Cetaphil cream

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Feasibility Study of Barrier Enhancement for Eczema Prevention (BEEP)

Resource links provided by NLM:

MedlinePlus related topics: Eczema
Drug Information available for: Cetaphil
U.S. FDA Resources

Further study details as provided by Oregon Health and Science University:

Primary Outcome Measures:
  • Proportion of families willing to be randomized. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    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 [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Proportion of families who found the interventions acceptable [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Reported adherence with intervention [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Proportion of families for whom the blinding of the assessor to the allocation ostatus was not compromised [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Amount of contamination as a result of increased awareness in the control group [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Percentage of missing data and early withdrawal rates [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Incidence of emollient-related adverse events [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Incidence of eczema at 6 and 12 months [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Age at onset of eczema [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Filaggrin mutation status [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Enrollment: 46
Study Start Date: May 2010
Estimated Study Completion Date: September 2012
Estimated Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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.

  Eligibility

Ages Eligible for Study:   up to 6 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01142999

Locations
United States, Oregon
Oregon Health & Science University
Portland, Oregon, United States, 97239
Sponsors and Collaborators
Oregon Health and Science University
Investigators
Principal Investigator: Eric L. Simpson, M.D., M.C.R. Oregon Health and Science University
  More Information

No publications provided

Responsible Party: Eric L. Simpson, M.D., M.C.R., Oregon Health & Science University
ClinicalTrials.gov Identifier: NCT01142999     History of Changes
Other Study ID Numbers: BEEP
Study First Received: June 10, 2010
Last Updated: August 4, 2011
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Eczema
Dermatitis
Skin Diseases
Skin Diseases, Eczematous
 Emollients
Dermatologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on June 18, 2013