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Evaluating Skin Barrier Dysfunction in Infants at High Risk of Atopy

Sponsor
National Jewish Health (Other)
Overall Status
Withdrawn
CT.gov ID
NCT03089476
Collaborator
(none)
0
Enrollment
1
Location
2
Arms
10
Anticipated Duration (Months)
0
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

It is hypothesized that food allergy is preceded by atopic dermatitis (AD), due to a disruption of skin barrier which can predispose one to food sensitization through the skin. The central hypothesis is that increased transepidermal water loss (TEWL) assessment and skin tape strip analysis (STS) of lipid and filaggrin breakdown products will be predictive markers for the development of AD. Additionally, the associated changes in TEWL and STS will further improve the identification of infants at risk of early food sensitization, compared to family history alone.

Condition or Disease Intervention/Treatment Phase
  • Other: Evaluating atopy in infants
  • Other: Evaluating TEWL and STS in adults
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
0 participants
Allocation:
Randomized
Intervention Model:
Single Group Assignment
Intervention Model Description:
Children at high risk of atopy will be followed up to 6 months of age. The investigator will obtain TEWL measurements, skin tape stripping, and questionnaire data each subsequent visit. During the latter 2 visits, skin prick allergy testing will be obtained for milk, egg, and peanut to determine risk of food allergy. Biologic parents will also undergo STS and TEWL measurements on the first visit.Children at high risk of atopy will be followed up to 6 months of age. The investigator will obtain TEWL measurements, skin tape stripping, and questionnaire data each subsequent visit. During the latter 2 visits, skin prick allergy testing will be obtained for milk, egg, and peanut to determine risk of food allergy. Biologic parents will also undergo STS and TEWL measurements on the first visit.
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
Hypothesis: Skin Barrier Dysfunction With Altered Expression of Skin Barrier Proteins and Lipids Predicts Early Food Sensitizations in Infants at High Risk of Atopy
Anticipated Study Start Date :
Sep 30, 2017
Anticipated Primary Completion Date :
Jul 30, 2018
Anticipated Study Completion Date :
Jul 30, 2018

Arms and Interventions

Arm Intervention/Treatment
Other: High Risk Atopic Infants

Infants, who are at high risk of atopy, which will be determined by a validated questionnaire, will be enrolled. Infants will undergo skin tape stripping (STS), transepidermal water loss assessment (TEWL), bacterial swabs, and parental questionnaires at each visit (3 visits total). At the latter 2 visits, infants will also undergo skin prick testing to evaluate for food sensitization.

Other: Evaluating atopy in infants
This study does not have an intervention. There is the evaluation of the predictive value of TEWL and STS in atopic infants at risk of developing eczema and TEWL and STS in parents of infants.
Other Names:
  • Atopy
  • Allergies

    		•
    Other: Atopic Adults

    Parents of infants enrolled in the study will undergo skin tape stripping (STS), transepidermal water loss assessment (TEWL), and complete questionnaires at the first visit.

    Other: Evaluating TEWL and STS in adults
    This study does not have an intervention. There is the evaluation of the predictive value of TEWL and STS in atopic infants at risk of developing eczema and TEWL and STS in parents of infants.
    Other Names:
  • Atopy
  • Transepidermal water loss
  • Skin tape stripping

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Serial Transepidermal Water Loss (TEWL) [12 months]

      Skin Barrier Assessment measured through serial transepidermal water loss (TEWL) in grams of water/meters-squared/hour

    Secondary Outcome Measures

    1. Skin Tape Stripping (STS) and Filaggrin(FLG) breakdown products [Up to 12 months]

      Risk of atopic dermatitis as evaluated through FLG breakdown products, lipid composition in the skin, and skin ape strip samples

    2. Skin prick testing to milk, egg, and peanut [12 months]

      Food Allergen Sensitization measured by positive skin prick testing to milk, egg, and peanut measured as positive or negative

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    34 Weeks to 50 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    • Women with physician confirmed pregnancy at a gestational age of ≥ 34 weeks. Infants at high risk for atopy will have one or both parents affected by an allergic disease. Infants at low risk for atopy will have no parent or sibling affected by allergic disease. Biologic parent(s) of infants at high risk of atopy will also be enrolled in the study.
    Exclusion Criteria:
    • Pregnancy loss or delivery prior to a gestational age of ≥ 34 weeks, a history of substance or alcohol abuse, psychiatric and developmental co-morbidities that would render a subject unable to provide informed consent or perform study-related procedures, AIDS and HIV infection, or a fetus with chromosomal or congenital abnormalities.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 National Jewish Health Denver Colorado United States 80206

    Sponsors and Collaborators

    • National Jewish Health

    Investigators

    • Principal Investigator: Pia Hauk, MD, National Jewish Health

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Melissa Robinson, Allergy Fellow, National Jewish Health
    ClinicalTrials.gov Identifier:
    NCT03089476
    Other Study ID Numbers:
    • 3083
    First Posted:
    Mar 24, 2017
    Last Update Posted:
    Jun 12, 2018
    Last Verified:
    Jun 1, 2018
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    Yes
    Keywords provided by Melissa Robinson, Allergy Fellow, National Jewish Health
    Prevention
    Predictors
    Additional relevant MeSH terms:
    Dermatitis, Atopic
    Dermatitis
    Food Hypersensitivity

    Study Results

    No Results Posted as of Jun 12, 2018