Seal, Stopping Eczema and Allergy Study

Phase 2

Recruiting

• Conditions: Eczema; Atopic Dermatitis Eczema; Atopic Dermatitis; Eczema, Infantile
• Interventions: Other: Standard of Care; Combination Product: Tri-lipid skin barrier cream (Epiceram); Combination Product: Fluticasone propionate Cream 0.05%

• Registration Number: NCT03742414
• Lead Sponsor: Kari Nadeau, MD, PhD

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).

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 312 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 Timeline

• Study First Submitted: 2018-10-30
• Study First Submitted QC: 2018-11-13
• Study First Posted: 2018-11-15
• Study Start: 2021-06-30
• Status Verified: 2024-10
• Last Update Submitted: 2025-04-17
• Last Update Posted: 2025-04-22
• Primary Completion: 2028-05-31
• Study Completion: 2028-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 312

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control arm (Standard of care)	Standard of Care	The study doctors will provide standard of care with routine reactive topical products for atopic dermatitis flares
Active Intervention arm (proactive treatment)- Epiceram	Tri-lipid skin barrier cream (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).
Active Intervention arm (proactive treatment)- Epiceram	Fluticasone propionate Cream 0.05%	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).

Primary Outcome Measures

Name	Time	Method
number of foods each participant is sensitized to	2 years	Sensitization is defined as food-specific IgE \> 0.1 kU/L

Secondary Outcome Measures

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

Trial Locations

Locations (5)

Division of Pediatric Allergy and Clinical Immunology, National Jewish Health; 🇺🇸 Denver, Colorado, United States

Sean N. Parker Center for Allergy & Asthma Research at Stanford University; 🇺🇸 Palo Alto, California, United States

• King's College London and Guy's and St. Thomas' NHS Foundation Trust, UK; 🇬🇧 London, United Kingdom

Cincinnati Children's Hospital Medical Center; 🇺🇸 Cincinnati, Ohio, United States

University of Chicago; 🇺🇸 Chicago, Illinois, United States