Seal, Stopping Eczema and Allergy Study
SEAL (Stopping Eczema and ALlergy) Study: Prevent the Allergic March by Enhancing the Skin Barrier
2 other identifiers
interventional
398
2 countries
5
Brief 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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Jun 2021
Longer than P75 for phase_2
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 30, 2018
CompletedFirst Posted
Study publicly available on registry
November 15, 2018
CompletedStudy Start
First participant enrolled
June 30, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 31, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 30, 2028
February 27, 2026
February 1, 2026
6.9 years
October 30, 2018
February 25, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
number of foods each participant is sensitized to
Sensitization is defined as food-specific IgE \> 0.1 kU/L
2 years
Secondary Outcomes (4)
The per-subject cumulative number of proven Food Allergy
2 years
Number of foods each participant is sensitized to
24 months of age
Number of foods each participant is sensitized to
24 months of age
Presence, duration, and severity of dry skin and/or AD by clinical assessment
Baseline, 12, and 24 months of age and as necessary
Study Arms (2)
Control arm (Standard of care)
ACTIVE COMPARATORThe study doctors will provide standard of care with routine reactive topical products for atopic dermatitis flares
Active Intervention arm (proactive treatment)- Epiceram
EXPERIMENTALParticipants will receive proactive sequential skin care with the twice-daily use of a tri-lipid skin barrier cream (SBC). Clinically apparent eczema in this group will be managed with a short course of topical steroids (fluticasone propionate cream and/or hydrocortisone).
Interventions
Participants' eczema will be managed by their primary physician, i.e. standard of care with routine reactive topical products for atopic dermatitis flares.
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).
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).
Eligibility Criteria
You may qualify if:
- Participants who develop early onset visible dry skin or atopic dermatitis up to and equal to 12 weeks of age.
- Stated willingness to comply with all study procedures and availability for the duration of the study
- In good general health as evidenced by medical history
- No known adverse reaction to any of the study medications, their components or excipients
You may not qualify if:
- Infants \<3kg body weight
- Infants with a chronic disease requiring therapy (e.g. heart disease, diabetes, serious neurological defects, immunodeficiency)
- Known moderate to severe cutaneous skin disorder other than AD, including but not limited to cutaneous mastocytosis, bullous skin disease, pustular skin disease, neonatal HSV, aplasia, and albinism
- Parents or guardians unwilling to sign consent
- Current participant or participation since birth in any interventional study
- A course of antibiotics in infant within 7 days of enrollment
- Any known food allergies
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Kari Nadeau, MD, PhDlead
- National Jewish Healthcollaborator
- University of Chicagocollaborator
- Children's Hospital Medical Center, Cincinnaticollaborator
- Harvard School of Public Health (HSPH)collaborator
- Stanford Universitycollaborator
- National Institute of Allergy and Infectious Diseases (NIAID)collaborator
- King's College Londoncollaborator
- Guy's and St Thomas' NHS Foundation Trustcollaborator
Study Sites (5)
Sean N. Parker Center for Allergy & Asthma Research at Stanford University
Palo Alto, California, 94304, United States
Division of Pediatric Allergy and Clinical Immunology, National Jewish Health
Denver, Colorado, 80206, United States
University of Chicago
Chicago, Illinois, 60637, United States
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229, United States
• King's College London and Guy's and St. Thomas' NHS Foundation Trust, UK
London, London, United Kingdom
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Kari Nadeau, MD, PhD
Harvard
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Chair, Department of Environmental Health
Study Record Dates
First Submitted
October 30, 2018
First Posted
November 15, 2018
Study Start
June 30, 2021
Primary Completion (Estimated)
May 31, 2028
Study Completion (Estimated)
June 30, 2028
Last Updated
February 27, 2026
Record last verified: 2026-02
Data Sharing
- IPD Sharing
- Will not share
No current plan to share data