NCT03742414

Seal, Stopping Eczema and Allergy Study

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

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 398 (actual)
• Sponsor: Kari Nadeau, MD, PhD · Academic / Other
• Sex: All
• Age: 1 Week – 12 Weeks
• Healthy volunteers: Not accepted

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).

Detailed description

This is a randomized, controlled, parallel design, open-label phase 2 clinical study to compare the efficacy of a proactive treatment arm versus the reactive arm, for the prevention of atopic dermatitis in children at high risk of food allergy. We will recruit 398 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) 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).

Conditions

• Eczema, Infantile
• Eczema
• Atopic Dermatitis Eczema
• Atopic Dermatitis

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2021-06-30
• Primary completion: 2028-05-31
• Completion: 2028-06-30
• First posted: 2018-11-15
• Last updated: 2026-02-27

Locations

5 sites across 2 countries: United States, United Kingdom

Regulatory

• FDA-regulated drug study