Seal, Stopping Eczema and Allergy Study

PHASE2Active, not recruitingINTERVENTIONAL
Enrollment

398

Participants

Timeline

Start Date

June 30, 2021

Primary Completion Date

May 31, 2028

Study Completion Date

June 30, 2028

Conditions
Eczema, InfantileEczemaAtopic Dermatitis EczemaAtopic Dermatitis
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.

Trial Locations (5)

45229

Cincinnati Children's Hospital Medical Center, Cincinnati

60637

University of Chicago, Chicago

80206

Division of Pediatric Allergy and Clinical Immunology, National Jewish Health, Denver

94304

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

Unknown

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

All Listed Sponsors
collaborator

National Jewish Health

OTHER

collaborator

University of Chicago

OTHER

collaborator

Children's Hospital Medical Center, Cincinnati

OTHER

collaborator

Harvard School of Public Health (HSPH)

OTHER

collaborator

Stanford University

OTHER

collaborator

National Institute of Allergy and Infectious Diseases (NIAID)

NIH

collaborator

King's College London

OTHER

collaborator

Guy's and St Thomas' NHS Foundation Trust

OTHER

lead

Kari Nadeau, MD, PhD

OTHER