NCT03742414Active, not recruitingPhase 2
Seal, Stopping Eczema and Allergy Study
SEAL (Stopping Eczema and ALlergy) Study: Prevent the Allergic March by Enhancing the Skin Barrier
Source: ClinicalTrials.gov · Last updated 27 Feb 2026
Brief summary (registry, in English)
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).
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 398 (actual)
- First submitted
- 30 Oct 2018
- Start date
- 30 Jun 2021
- Primary completion date
- 31 May 2028
- Lead sponsor
- Kari Nadeau, MD, PhD
- Diseases
- Atopic dermatitis (eczema)
- NCT number
- NCT03742414
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 398
- From 30 Jun 2021 to the primary completion date, 31 May 2028
- 5 sites in 2 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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
- Any known food allergies
Other
- Infants \<3kg body weight
- Parents or guardians unwilling to sign consent
- Current participant or participation since birth in any interventional study
- Investigator or designee considers that the participant or parent/guardian would be unsuitable for inclusion in the study (for ex/ long stay in NICU)
- A course of antibiotics in infant within 7 days of enrollment
Who the study is looking for
- 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
Age in the registry: 1 week to 12 weeks · Sex: All · Does not accept healthy volunteers
Sites (5)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| • King's College London and Guy's and St. Thomas' NHS Foundation Trust, UK Coordinator of this site? Confirm its status | London | United Kingdom | Unknown status |
| University of Chicago Coordinator of this site? Confirm its status | Chicago | United States | Unknown status |
| Cincinnati Children's Hospital Medical Center Coordinator of this site? Confirm its status | Cincinnati | United States | Unknown status |
| Division of Pediatric Allergy and Clinical Immunology, National Jewish Health Coordinator of this site? Confirm its status | Denver | United States | Unknown status |
| Sean N. Parker Center for Allergy & Asthma Research at Stanford University Coordinator of this site? Confirm its status | Palo Alto | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.