Seal, Stopping Eczema and Allergy Study

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

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).

Study Overview

• Status: Active, not recruiting
• Conditions: Eczema; Atopic Dermatitis; Atopic Dermatitis Eczema; Eczema, Infantile
• Intervention / Treatment: Other: Standard of Care; Combination product: Tri-lipid skin barrier cream (Epiceram); Combination product: Fluticasone propionate Cream 0.05%

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).

• Study Type: Interventional
• Enrollment (Actual): 398
• Phase: Phase 2

Contacts and Locations

Study Locations

• United Kingdom
  • London
    • London, London, United Kingdom
      • • King's College London and Guy's and St. Thomas' NHS Foundation Trust, UK
• United States
  • California
    • Palo Alto, California, United States, 94304
      • Sean N. Parker Center for Allergy & Asthma Research at Stanford University
  • Colorado
    • Denver, Colorado, United States, 80206
      • Division of Pediatric Allergy and Clinical Immunology, National Jewish Health
  • Illinois
    • Chicago, Illinois, United States, 60637
      • University of Chicago
  • Ohio
    • Cincinnati, Ohio, United States, 45229
      • Cincinnati Children's Hospital Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 week to 2 months (Child)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Participants who develop early onset visible dry skin or atopic dermatitis up to and equal to 12 weeks of age.
2. Stated willingness to comply with all study procedures and availability for the duration of the study
3. In good general health as evidenced by medical history
4. No known adverse reaction to any of the study medications, their components or excipients

Exclusion Criteria:

1. Infants <3kg body weight
2. Infants with a chronic disease requiring therapy (e.g. heart disease, diabetes, serious neurological defects, immunodeficiency)
3. 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
4. Parents or guardians unwilling to sign consent
5. Current participant or participation since birth in any interventional study
6. Investigator or designee considers that the participant or parent/guardian would be unsuitable for inclusion in the study (for ex/ long stay in NICU)
7. A course of antibiotics in infant within 7 days of enrollment
8. Any known food allergies

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Control arm (Standard of care); The study doctors will provide standard of care with routine reactive topical products for atopic dermatitis flares	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.
Experimental: Active Intervention arm (proactive treatment)- Epiceram; Participants 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).	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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
number of foods each participant is sensitized to	Sensitization is defined as food-specific IgE > 0.1 kU/L	2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The per-subject cumulative number of proven Food Allergy	Double-blind placebo-controlled oral food challenges used	2 years
Number of foods each participant is sensitized to	Sensitization is defined as food-specific skin prick test (SPT) ≥ 1 mm	24 months of age
Number of foods each participant is sensitized to	Sensitization is defined as food-specific skin prick test (SPT) ≥ 3 mm.	24 months of age
Presence, duration, and severity of dry skin and/or AD by clinical assessment	Patient-oriented SCORAD (PO-SCORAD) application used	Baseline, 12, and 24 months of age and as necessary

Collaborators and Investigators

• Sponsor: Kari Nadeau, MD, PhD
• Collaborators: King's College London; National Institute of Allergy and Infectious Diseases (NIAID); University of Chicago; Stanford University; Guy's and St Thomas' NHS Foundation Trust; Children's Hospital Medical Center, Cincinnati; Harvard School of Public Health (HSPH); National Jewish Health
• Investigators: Principal Investigator: Kari Nadeau, MD, PhD, Harvard

Publications and helpful links

Helpful Links

• The Sean N. Parker Center for Allergy and Asthma Research at Stanford University
• SEAL study information

Study record dates

Study Major Dates

• Study Start (Actual): June 30, 2021
• Primary Completion (Estimated): May 31, 2028
• Study Completion (Estimated): June 30, 2028

Study Registration Dates

• First Submitted: October 30, 2018
• First Submitted That Met QC Criteria: November 13, 2018
• First Posted (Actual): November 15, 2018

Study Record Updates

• Last Update Posted (Actual): February 27, 2026
• Last Update Submitted That Met QC Criteria: February 25, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: Dermatitis; Food allergy; Dry skin; Moisturizer
• Additional Relevant MeSH Terms: Genetic Diseases, Inborn; Immune System Diseases; Hypersensitivity, Immediate; Hypersensitivity; Skin Diseases; Skin Diseases, Genetic; Skin Diseases, Eczematous; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Skin and Connective Tissue Diseases; Food Hypersensitivity; Dermatitis, Atopic; Dermatitis; Eczema; Health Services Administration; Health Care Quality, Access, and Evaluation; Quality of Health Care; Quality Indicators, Health Care; Standard of Care; EpiCeram
• Other Study ID Numbers: 48199; 1U01AI147462-01A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: No current plan to share data

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No