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Seal, Stopping Eczema and Allergy Study
Sponsor: Kari Nadeau, MD, PhD
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
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).
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).
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