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Evaluating Skin Barrier Dysfunction in Infants at High Risk of Atopy

Primary Purpose

Atopic Dermatitis, Eczema, Food Allergy

Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Evaluating atopy in infants
Evaluating TEWL and STS in adults
Sponsored by
National Jewish Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Atopic Dermatitis focused on measuring Prevention, Predictors

Eligibility Criteria

34 Weeks - 50 Years (Child, Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • National Jewish Health

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

High Risk Atopic Infants

Atopic Adults

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Skin Tape Stripping (STS) and Filaggrin(FLG) breakdown products
Risk of atopic dermatitis as evaluated through FLG breakdown products, lipid composition in the skin, and skin ape strip samples
Skin prick testing to milk, egg, and peanut
Food Allergen Sensitization measured by positive skin prick testing to milk, egg, and peanut measured as positive or negative

Full Information

First Posted
March 20, 2017
Last Updated
June 11, 2018
Sponsor
National Jewish Health
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1. Study Identification

Unique Protocol Identification Number
NCT03089476
Brief Title
Evaluating Skin Barrier Dysfunction in Infants at High Risk of Atopy
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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2018
Overall Recruitment Status
Withdrawn
Why Stopped
Study will not go forward
Study Start Date
September 30, 2017 (Anticipated)
Primary Completion Date
July 30, 2018 (Anticipated)
Study Completion Date
July 30, 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National Jewish Health

4. Oversight

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
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atopic Dermatitis, Eczema, Food Allergy
Keywords
Prevention, Predictors

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
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)
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
High Risk Atopic Infants
Arm Type
Other
Arm Description
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.
Arm Title
Atopic Adults
Arm Type
Other
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Evaluating atopy in infants
Other Intervention Name(s)
Atopy, Allergies
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Evaluating TEWL and STS in adults
Other Intervention Name(s)
Atopy, Transepidermal water loss, Skin tape stripping
Intervention Description
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.
Primary Outcome Measure Information:
Title
Serial Transepidermal Water Loss (TEWL)
Description
Skin Barrier Assessment measured through serial transepidermal water loss (TEWL) in grams of water/meters-squared/hour
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Skin Tape Stripping (STS) and Filaggrin(FLG) breakdown products
Description
Risk of atopic dermatitis as evaluated through FLG breakdown products, lipid composition in the skin, and skin ape strip samples
Time Frame
Up to 12 months
Title
Skin prick testing to milk, egg, and peanut
Description
Food Allergen Sensitization measured by positive skin prick testing to milk, egg, and peanut measured as positive or negative
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
34 Weeks
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pia Hauk, MD
Organizational Affiliation
National Jewish Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Jewish Health
City
Denver
State/Province
Colorado
ZIP/Postal Code
80206
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
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Evaluating Skin Barrier Dysfunction in Infants at High Risk of Atopy

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