# SEAL (Stopping Atopic dermatitis and ALlergy) Study: Prevent allergy by enhancing the skin barrier

> **NIH NIH U01** · STANFORD UNIVERSITY · 2020 · $1,750,000

## Abstract

Project Summary and Abstract for the SEAL (Stopping Eczema and ALlergy) Study
 Food allergy (FA) is an epidemic among children in the U.S., U.K., and other countries. There is increasing
evidence that epicutaneous allergen sensitization through a dysfunctional skin barrier results in allergic
responses whereas early consumption of food allergens induces oral tolerance, as described by the dual
allergen exposure hypothesis. In the Learning Early About Peanut LEAP and Enquiring About Tolerance (EAT)
studies, dry skin and the severity and the duration of eczema or atopic dermatitis (AD) in the 1st year of life
were predictors of peanut allergy (PA) and sensitization. In the SEAL study, we aim to intervene very early in a
high-risk infant group, as soon they have the earliest onset of dry skin or eczema in the 1st 10 weeks of life,
but before they have developed allergies. By reducing the duration and severity of eczema and preventing
eczema exacerbations, we aim to prevent epicutaneous allergen sensitization and significantly reduce the
incidence of FA. Our primary objective is to test if the combination of trilipid skin emollient use early in life with
proactive topical steroids decreases the prevalence of FA compared to controls.
 We propose a randomized (1:1), controlled trial design for infants with dry skin or eczema (n=750 total) to
compare the effect of proactive treatment against a reactive treatment group for the prevention of FA, by
reducing dry skin, and the severity and duration of eczema in early infancy. We will test our hypothesis with the
following specific aims using world-class clinical research units known for excellent recruitment and retention of
patient cohorts, mechanistic testing, and state of the art research. Specific Aim 1: To determine if proactive
versus reactive treatment will reduce the occurrence of FA in a prospective, randomized, and controlled
intervention trial of infants with eczema. Specific Aim 2: To test whether the skin of children in the proactive
treatment will show improved epithelial barrier markers with increased commensal bacteria colonization.
Specific Aim 3: To determine whether proactive treatment will be associated with protective immune
responses. If the aims are achieved, our proposal will make a clinical impact by providing a new, clinical
strategy to prevent the occurrence of FA in young infants that present with the earliest signs of dry skin or
eczema.

## Key facts

- **NIH application ID:** 10068167
- **Project number:** 1U01AI147462-01A1
- **Recipient organization:** STANFORD UNIVERSITY
- **Principal Investigator:** HELEN A BROUGH
- **Activity code:** U01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $1,750,000
- **Award type:** 1
- **Project period:** 2020-08-14 → 2027-05-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10068167

## Citation

> US National Institutes of Health, RePORTER application 10068167, SEAL (Stopping Atopic dermatitis and ALlergy) Study: Prevent allergy by enhancing the skin barrier (1U01AI147462-01A1). Retrieved via AI Analytics 2026-05-21 from https://api.ai-analytics.org/grant/nih/10068167. Licensed CC0.

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