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Evaluating Skin Barrier Dysfunction in Infants at High Risk of Atopy

Hypothesis: Skin Barrier Dysfunction With Altered Expression of Skin Barrier Proteins and Lipids Predicts Early Food Sensitizations in Infants at High Risk of Atopy

NCT03089476•National Jewish Health

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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.

Eligibility

Age

0 - 50 years

Sex

ALL

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.

Locations (1)

National Jewish Health

Denver, Colorado, United States

Key Dates

Start Date

September 30, 2017

Primary Completion Date

July 30, 2018

Completion Date

July 30, 2018

Last Updated

June 12, 2018

Conditions

Atopic DermatitisEczemaFood Allergy

Interventions

Evaluating atopy in infants

OTHER

Evaluating TEWL and STS in adults

OTHER

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: June 12, 2018Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Evaluating Skin Barrier Dysfunction in Infants at High Risk of Atopy

Inclusion Criteria

Exclusion Criteria

Evaluating the Safety and Tolerability of Baricitinib in Patients With Job Syndrome With Lupus-Like Disease and/or Atopic Dermatitis

A Study of Upadacitinib in Adult Participants With Moderate-to-Severe Atopic Dermatitis and Inadequate Response to Dupilumab

A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single- and Multiple-Ascending Doses and Food Effect of BGB-45035 in Healthy Participants and in Adults With Autoimmune Dermatological Diseases

A Long Term Extension Study to Evaluate the Safety and Efficacy of Afimkibart (RO7790121) in Participants With Atopic Dermatitis

This Study is a Non-interventional Disease Registry of Adolescent and Adult Patients With Atopic Dermatitis Who Initiate or Switch Any Systemic Treatment

A Study to Investigate Safety and Efficacy of Tapinarof Cream, 1% in Participants Ages 3 Months to < 24 Months With Atopic Dermatitis