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) or moisturizer 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: 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%; Combination product: Moisturizer

Detailed Description

This is a randomized, controlled, parallel design, open-label phase 2 clinical study to compare the efficacy of the two proactive treatment arms versus the reactive arm, for the prevention of atopic dermatitis in children at high risk of food allergy. We will recruit 875 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) or moisturizer 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 (Estimated): 875
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Kari Nadeau, MD, PhD; Phone Number: 650.867.4592; Email: knadeau@hsph.harvard.edu

Study Locations

• United Kingdom
  • London, United Kingdom
    • Not yet recruiting
    • Paediatric Allergy Group, Department of Women and Childrens' Health, School of Life Course and Science
• United States
  • California
    • Palo Alto, California, United States, 94304
      • Recruiting
      • Sean N. Parker Center for Allergy & Asthma Research at Stanford University
      • Contact: SNP Center Inquiry; Phone Number: 650-521-7237; Email: snpcenterallergy_inquiry@stanford.edu
      • Principal Investigator: Sayantani Sindher, MD
  • Colorado
    • Denver, Colorado, United States, 80206
      • Recruiting
      • Division of Pediatric Allergy and Clinical Immunology, National Jewish Health
      • Contact: Jane Rice, RN; Phone Number: 303-398-1317; Email: ricej@njhealth.org
      • Principal Investigator: Donald Leung, MD, PhD
  • Illinois
    • Chicago, Illinois, United States, 60637
      • Recruiting
      • University of Chicago
      • Contact: Matthew Moy; Phone Number: 773-702-9173; Email: mattmoy@bsd.uchicago.edu
      • Principal Investigator: Christina Ciaccio, MD MSc
  • Ohio
    • Cincinnati, Ohio, United States, 45229
      • Not yet recruiting
      • Cincinnati Children's Hospital Medical Center
      • Contact: Shelley Randall; Phone Number: 513-636-2362; Email: Shelley.Randall@cchmc.org
      • Principal Investigator: Gurjit Hershey, MD, PhD

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

3

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).
Experimental: Active Intervention arm (proactive treatment)- Moisturizer; Participants will receive proactive sequential skin care with the twice-daily use of a moisturizer. Clinically apparent eczema in this group will be managed with a short course of topical steroids (fluticasone propionate cream and/or hydrocortisone).	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).; Combination product: Moisturizer; The aim is to compare the effect of proactive sequential skin care, including the twice daily use of a moisturizer 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cumulative number of challenge-proven food allergy	The per-participant cumulative number of challenge-proven food allergy	Number of challenge-proven food allergy at 3 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Scoring Atopic Dermatitis (SCORAD)	Atopic dermatitis assessment- the score ranges from 0 to 103 with higher scores a worse (more severe eczema) outcome	Change from Baseline SCORAD at 1, 2 and 3 years

Collaborators and Investigators

• Sponsor: Kari Nadeau
• Collaborators: King's College London; National Institute of Allergy and Infectious Diseases (NIAID); University of Chicago; Stanford University; 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): July 1, 2026
• Study Completion (Estimated): July 1, 2027

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): October 26, 2023
• Last Update Submitted That Met QC Criteria: October 24, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: Dermatitis; Food allergy; Dry skin; Moisturizer
• Additional Relevant MeSH Terms: Skin Diseases; Immune System Diseases; Hypersensitivity, Immediate; Genetic Diseases, Inborn; Skin Diseases, Genetic; Skin Diseases, Eczematous; Hypersensitivity; Dermatitis; Eczema; Dermatitis, Atopic; Physiological Effects of Drugs; Autonomic Agents; Peripheral Nervous System Agents; Anti-Inflammatory Agents; Dermatologic Agents; Bronchodilator Agents; Anti-Asthmatic Agents; Respiratory System Agents; Anti-Allergic Agents; Fluticasone; Xhance
• 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