ACTIVE_NOT_RECRUITING

Seal, Stopping Eczema and Allergy Study

Conditions

Eczema, Infantile Eczema Atopic Dermatitis Eczema Atopic Dermatitis Dermatitis Dry skin Food allergy Moisturizer

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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).

Official Title

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

Quick Facts

Study Start:2021-06-30

Study Completion:2028-06-30

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:ACTIVE_NOT_RECRUITING

Study ID

NCT03742414

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.

Ages Eligible for Study:1 Week to 12 Weeks

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:CHILD

Inclusion Criteria	Exclusion 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

Inclusion Criteria

Exclusion 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

Contacts and Locations

Principal Investigator

Kari Nadeau, MD, PhD

PRINCIPAL_INVESTIGATOR

Harvard

Study Locations (Sites)

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

Palo Alto, California, 94304

United States

Division of Pediatric Allergy and Clinical Immunology, National Jewish Health

Denver, Colorado, 80206

United States

University of Chicago

Chicago, Illinois, 60637

United States

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229

United States

Collaborators and Investigators

Sponsor: Kari Nadeau, MD, PhD

Kari Nadeau, MD, PhD, PRINCIPAL_INVESTIGATOR, Harvard

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-06-30

Study Completion Date2028-06-30

Study Record Updates

Study Start Date2021-06-30

Study Completion Date2028-06-30

Terms related to this study

Keywords Provided by Researchers

Dermatitis
Dry skin
Food allergy
Moisturizer

Additional Relevant MeSH Terms

Eczema, Infantile
Eczema
Atopic Dermatitis Eczema
Atopic Dermatitis