Evaluating Skin Barrier Dysfunction in Infants at High Risk of Atopy

Not Applicable

Withdrawn

• Conditions: Eczema; Food Allergy; Atopic Dermatitis
• Interventions: Other: Evaluating atopy in infants; Other: Evaluating TEWL and STS in adults

• Registration Number: NCT03089476
• Lead Sponsor: National Jewish Health

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-03-20
• Study First Submitted QC: 2017-03-20
• Study First Posted: 2017-03-24
• Study Start: 2017-09-30
• Status Verified: 2018-06
• Last Update Submitted: 2018-06-11
• Last Update Posted: 2018-06-12
• Primary Completion: 2018-07-30
• Study Completion: 2018-07-30

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
High Risk Atopic Infants	Evaluating atopy in 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.
Atopic Adults	Evaluating TEWL and STS in 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.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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
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

Trial Locations

Locations (1)

National Jewish Health; 🇺🇸 Denver, Colorado, United States