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Active, Not Recruiting

NCT Number: NCT03742414

Seal, Stopping Eczema and Allergy Study

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).

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Eczema, Infantile Atopic Dermatitis Atopic Dermatitis Eczema Congenital, Hereditary, and Neonatal Diseases and Abnormalities Dermatitis Dermatitis, Atopic Eczema Food Hypersensitivity Genetic Diseases, Inborn Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Skin Diseases Skin Diseases, Eczematous Skin Diseases, Genetic Skin and Connective Tissue Diseases

Age range

1 week–12 week

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

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

Loading trial locations.

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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
  • 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
  • Any known food allergies

Treatment and study plan

Tri-lipid skin barrier cream (Epiceram)

Combination Product

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).

Fluticasone propionate Cream 0.05%

Combination Product

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).

Standard of care

Other

Participants' eczema will be managed by their primary physician, i.e. standard of care with routine reactive topical products for atopic dermatitis flares.

Primary outcomes

  1. number of foods each participant is sensitized to

    Time frame: 2 years

    Sensitization is defined as food-specific IgE > 0.1 kU/L

Secondary outcomes

  1. The per-subject cumulative number of proven Food Allergy

    Time frame: 2 years

    Double-blind placebo-controlled oral food challenges used

  2. Number of foods each participant is sensitized to

    Time frame: 24 months of age

    Sensitization is defined as food-specific skin prick test (SPT) ≥ 1 mm

  3. Number of foods each participant is sensitized to

    Time frame: 24 months of age

    Sensitization is defined as food-specific skin prick test (SPT) ≥ 3 mm.

  4. Presence, duration, and severity of dry skin and/or AD by clinical assessment

    Time frame: Baseline, 12, and 24 months of age and as necessary

    Patient-oriented SCORAD (PO-SCORAD) application used

Sponsors and collaborators

Lead sponsor

Kari Nadeau, MD, PhD

Other

Collaborators

  • Children's Hospital Medical Center, Cincinnati
  • Guy's and St Thomas' NHS Foundation Trust
  • Harvard School of Public Health (HSPH)
  • King's College London
  • National Institute of Allergy and Infectious Diseases (NIAID)
  • National Jewish Health
  • Stanford University
  • University of Chicago

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2028
Study completion
2028
First posted
Nov 15, 2018
Registry last updated
Feb 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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