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Feasibility Study of Barrier Enhancement for Eczema Prevention (BEEP)

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ClinicalTrials.gov Identifier: NCT01142999
Recruitment Status : Unknown
Verified June 2010 by Oregon Health and Science University.
Recruitment status was:  Active, not recruiting
First Posted : June 14, 2010
Last Update Posted : August 5, 2011
Sponsor:
Information provided by:
Oregon Health and Science University

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.

Condition or disease Intervention/treatment Phase
Eczema Drug: Sunflower oil Drug: Control group Drug: Aquaphor ointment Drug: Cetaphil cream Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 46 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Feasibility Study of Barrier Enhancement for Eczema Prevention (BEEP)
Study Start Date : May 2010
Estimated Primary Completion Date : August 2011
Estimated Study Completion Date : September 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eczema
U.S. FDA Resources

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 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.



Primary Outcome Measures :
  1. Proportion of families willing to be randomized. [ Time Frame: 6 months ]
    Determine proportion of families willing to be randomized in order to design larger study in the future.


Secondary Outcome Measures :
  1. Proportion of families eligible for the trial, willing to participate [ Time Frame: 6 months ]
  2. Proportion of families who found the interventions acceptable [ Time Frame: 6 months ]
  3. Reported adherence with intervention [ Time Frame: 6 months ]
  4. Proportion of families for whom the blinding of the assessor to the allocation ostatus was not compromised [ Time Frame: 6 months ]
  5. Amount of contamination as a result of increased awareness in the control group [ Time Frame: 6 months ]
  6. Percentage of missing data and early withdrawal rates [ Time Frame: 6 months ]
  7. Incidence of emollient-related adverse events [ Time Frame: 6 months ]
  8. Incidence of eczema at 6 and 12 months [ Time Frame: 12 months ]
  9. Age at onset of eczema [ Time Frame: 6 months ]
  10. Filaggrin mutation status [ Time Frame: 6 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   up to 6 Months   (Child)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Posted: June 14, 2010    Key Record Dates
Last Update Posted: August 5, 2011
Last Verified: June 2010

Additional relevant MeSH terms:
Eczema
Dermatitis
Skin Diseases
Skin Diseases, Eczematous