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ACTIVE NOT RECRUITING
NCT03742414
PHASE2

Seal, Stopping Eczema and Allergy Study

Sponsor: Kari Nadeau, MD, PhD

View on ClinicalTrials.gov

Summary

This is a randomized, controlled trial designed for children who are have already developed atopic dermatitis (AD or eczema) by 12 weeks of age. The aim is to compare the effect of proactive sequential skin care, including the twice-daily use of a tri-lipid skin barrier cream (Epiceram) and proactive use of fluticasone propionate cream, against reactive AD therapy, to reduce the occurrence and severity of AD in early infancy and thereby prevent food allergy (FA).

Official title: SEAL (Stopping Eczema and ALlergy) Study: Prevent the Allergic March by Enhancing the Skin Barrier

Key Details

Gender

All

Age Range

1 Week - 12 Weeks

Study Type

INTERVENTIONAL

Enrollment

398

Start Date

2021-06-30

Completion Date

2028-06-30

Last Updated

2026-02-27

Healthy Volunteers

No

Interventions

COMBINATION_PRODUCT

Tri-lipid skin barrier cream (Epiceram)

The aim is to compare the effect of proactive sequential skin care, including the twice daily use of a tri-lipid skin barrier cream (Epiceram) and proactive use of fluticasone proprionate cream, against reactive AD therapy, to reduce the occurrence and severity of AD in early infancy and thereby prevent food allergy (FA).

COMBINATION_PRODUCT

Fluticasone propionate Cream 0.05%

Proactive use of fluticasone proprionate cream for inflammation of the skin, to reduce the occurrence and severity of AD in early infancy and thereby prevent food allergy (FA).

OTHER

Standard of Care

Participants' eczema will be managed by their primary physician, i.e. standard of care with routine reactive topical products for atopic dermatitis flares.

Locations (5)

Sean N. Parker Center for Allergy & Asthma Research at Stanford University

Palo Alto, California, United States

Division of Pediatric Allergy and Clinical Immunology, National Jewish Health

Denver, Colorado, United States

University of Chicago

Chicago, Illinois, United States

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, United States

• King's College London and Guy's and St. Thomas' NHS Foundation Trust, UK

London, London, United Kingdom