Seal, Stopping Eczema and Allergy Study

Description

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).

Conditions

Eczema, Infantile, Eczema, Atopic Dermatitis Eczema, Atopic Dermatitis

Talk to us

Study Overview

On this page

Study Details

Study overview

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).

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

Seal, Stopping Eczema and Allergy Study

Condition
Eczema, Infantile
Intervention / Treatment

-

Contacts and Locations

Palo Alto

Sean N. Parker Center for Allergy & Asthma Research at Stanford University, Palo Alto, California, United States, 94304

Denver

Division of Pediatric Allergy and Clinical Immunology, National Jewish Health, Denver, Colorado, United States, 80206

Chicago

University of Chicago, Chicago, Illinois, United States, 60637

Cincinnati

Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio, United States, 45229

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • 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

Ages Eligible for Study

1 Week to 12 Weeks

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Kari Nadeau, MD, PhD,

Kari Nadeau, MD, PhD, PRINCIPAL_INVESTIGATOR, Harvard

Study Record Dates

2027-06-30