Seal, Stopping Eczema and Allergy Study

Last updated: February 6, 2025
Sponsor: Kari Nadeau, MD, PhD
Overall Status: Active - Recruiting

Phase

2

Condition

Atopic Dermatitis

Skin Infections/disorders

Rash

Treatment

Fluticasone propionate Cream 0.05%

Moisturizer

Tri-lipid skin barrier cream (Epiceram)

Clinical Study ID

NCT03742414
48199
1U01AI147462-01A1
  • Ages 1-12
  • All Genders

Study 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).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Participants who develop early onset visible dry skin or atopic dermatitis up to andequal to 12 weeks of age.

  2. Stated willingness to comply with all study procedures and availability for theduration 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 orexcipients

Exclusion

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 notlimited 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 beunsuitable 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

Total Participants: 312
Treatment Group(s): 4
Primary Treatment: Fluticasone propionate Cream 0.05%
Phase: 2
Study Start date:
June 30, 2021
Estimated Completion Date:
June 30, 2027

Study 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).

Connect with a study center

  • Paediatric Allergy Group, Department of Women and Childrens' Health, School of Life Course and Science

    London,
    United Kingdom

    Site Not Available

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

    London,
    United Kingdom

    Active - Recruiting

  • Sean N Parker Center for Allergy and Asthma Research, Department of Medicine, Division of Pulmonary & Critical Care Medicine Stanford University School of Medicine

    Mountain View, California 94040
    United States

    Site Not Available

  • Sean N Parker Center for Allergy and Asthma Research, Department of Medicine, Division of Pulmonary & Critical Care Medicine Stanford University School of Medicine

    Palo Alto, California 94304
    United States

    Site Not Available

  • Sean N. Parker Center for Allergy & Asthma Research at Stanford University

    Palo Alto, California 94304
    United States

    Active - Recruiting

  • Sean N Parker Center Clinical Research Unit For Allergy and Asthma Research Department of Medicine, Division of Pulmonary & Critical Care Medicine Stanford University School of Medicine

    Sunnyvale, California 94040
    United States

    Site Not Available

  • Division of Pediatric Allergy and Clinical Immunology, National Jewish Health

    Denver, Colorado 80206
    United States

    Active - Recruiting

  • University of Chicago

    Chicago, Illinois 60637
    United States

    Active - Recruiting

  • Nadeau Lab. Department of Environmental Health

    Boston, Massachusetts 02115
    United States

    Site Not Available

  • Cincinnati Children's Hospital Medical Center

    Cincinnati, Ohio 45229
    United States

    Active - Recruiting

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