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Evaluating Skin Barrier Dysfunction in Infants at High Risk of Atopy

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ClinicalTrials.gov Identifier: NCT03089476
Recruitment Status : Withdrawn (Study will not go forward)
First Posted : March 24, 2017
Last Update Posted : June 12, 2018
Sponsor:
Information provided by (Responsible Party):
Melissa Robinson, National Jewish Health

Study Description
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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
Atopic Dermatitis Eczema Food Allergy Other: Evaluating atopy in infants Other: Evaluating TEWL and STS in adults Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
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.
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
Estimated Study Start Date : September 30, 2017
Estimated Primary Completion Date : July 30, 2018
Estimated Study Completion Date : July 30, 2018

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Arms and Interventions
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Arm Intervention/treatment
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
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
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Primary Outcome Measures :
  1. Serial Transepidermal Water Loss (TEWL) [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 12 months ]
    Food Allergen Sensitization measured by positive skin prick testing to milk, egg, and peanut measured as positive or negative


Eligibility Criteria
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Ages Eligible for Study:   34 Weeks to 50 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
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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): NCT03089476


Locations
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United States, Colorado
National Jewish Health
Denver, Colorado, United States, 80206
Sponsors and Collaborators
National Jewish Health
Investigators
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Principal Investigator: Pia Hauk, MD National Jewish Health
More Information
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Publications:

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Responsible Party: Melissa Robinson, Allergy Fellow, National Jewish Health
ClinicalTrials.gov Identifier: NCT03089476    
Other Study ID Numbers: 3083
First Posted: March 24, 2017    Key Record Dates
Last Update Posted: June 12, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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, National Jewish Health:
Prevention
Predictors
Additional relevant MeSH terms:
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Dermatitis
Food Hypersensitivity
Skin Diseases
 Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases