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Seal, Stopping Eczema and Allergy Study

Atopic Dermatitis Clinical Trial

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

Clinical Trial 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) or moisturizer 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).

Clinical Trial Description

This is a randomized, controlled, parallel design, open-label phase 3 clinical study to compare the efficacy of the two proactive treatment arms versus the reactive arm, for the prevention of atopic dermatitis in children at high risk of food allergy. We will recruit 750 infants who have signs of dry skin or atopic dermatitis between 0-12 weeks of life. 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) or moisturizer 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). ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03742414
Study type Interventional
Source Harvard School of Public Health (HSPH)
Contact Kari Nadeau, MD, PhD
Phone 650.867.4592
Email knadeau@hsph.harvard.edu
Status Recruiting
Phase Phase 3
Start date June 30, 2021
Completion date June 30, 2027
View Details
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