Seal, Stopping Eczema and Allergy Study

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).

Conditions

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

Sponsors & Collaborators

• National Jewish Health

  collaborator OTHER

• University of Chicago

  collaborator OTHER

• Children's Hospital Medical Center, Cincinnati

  collaborator OTHER

• Harvard School of Public Health (HSPH)

  collaborator OTHER

• Stanford University

  collaborator OTHER

• National Institute of Allergy and Infectious Diseases (NIAID)

  collaborator NIH

• King's College London

  collaborator OTHER

• Guy's and St Thomas' NHS Foundation Trust

  collaborator OTHER

• Kari Nadeau, MD, PhD

  lead OTHER

Principal Investigators

• Kari Nadeau, MD, PhD · Harvard

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

1 Week

Max Age

12 Weeks

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2021-06-30

Primary Completion

2028-05-31

Completion

2028-06-30

FDA Drug

Yes

Countries

• United States
• United Kingdom

Study Locations