Back to results

Seal, Stopping Eczema and Allergy Study

Primary Purpose

Eczema, Infantile, Eczema, Atopic Dermatitis Eczema

Status

Recruiting

Phase

Phase 2

Locations

International

Study Type

Interventional

Intervention

Tri-lipid skin barrier cream (Epiceram)

Fluticasone propionate Cream 0.05%

Moisturizer

Standard of Care

About this trial

This is an interventional prevention trial for Eczema, Infantile focused on measuring Dermatitis, Dry skin, Food allergy, Moisturizer

Eligibility Criteria

1 Week - 12 Weeks (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Sean N. Parker Center for Allergy & Asthma Research at Stanford UniversityRecruiting
Division of Pediatric Allergy and Clinical Immunology, National Jewish HealthRecruiting
University of ChicagoRecruiting
Nadeau Lab. Department of Environmental HealthRecruiting
Cincinnati Children's Hospital Medical Center
Paediatric Allergy Group, Department of Women and Childrens' Health, School of Life Course and Science

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Arm Label

Control arm (Standard of care)

Active Intervention arm (proactive treatment)- Epiceram

Active Intervention arm (proactive treatment)- Moisturizer

Arm Description

The study doctors will provide standard of care with routine reactive topical products for atopic dermatitis flares

Participants will receive proactive sequential skin care with the twice-daily use of a tri-lipid skin barrier cream (SBC). Clinically apparent eczema in this group will be managed with a short course of topical steroids (fluticasone propionate cream and/or hydrocortisone).

Participants will receive proactive sequential skin care with the twice-daily use of a moisturizer. Clinically apparent eczema in this group will be managed with a short course of topical steroids (fluticasone propionate cream and/or hydrocortisone).

Outcomes

Primary Outcome Measures

Cumulative number of challenge-proven food allergy

The per-participant cumulative number of challenge-proven food allergy

Secondary Outcome Measures

Scoring Atopic Dermatitis (SCORAD)

Atopic dermatitis assessment- the score ranges from 0 to 103 with higher scores a worse (more severe eczema) outcome

Full Information

NCT ID

NCT03742414

First Posted

October 30, 2018

Last Updated

October 23, 2023

Sponsor

Kari Nadeau

Collaborators

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

1. Study Identification

Unique Protocol Identification Number

NCT03742414

Brief Title

Seal, Stopping Eczema and Allergy Study

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2023

Overall Recruitment Status

Recruiting

Study Start Date

June 30, 2021 (Actual)

Primary Completion Date

July 2026 (Anticipated)

Study Completion Date

July 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Kari Nadeau

Collaborators

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief 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) or moisturizer 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).

Detailed Description

This is a randomized, controlled, parallel design, open-label phase 2 clinical study to compare the efficacy of the two proactive treatment arms versus the reactive arm, for the prevention of atopic dermatitis in children at high risk of food allergy. We will recruit 875 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) or moisturizer 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

Keywords

Dermatitis, Dry skin, Food allergy, Moisturizer

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Model Description

This is a randomized, controlled, parallel design trial designed for children (total n = 875) 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) or moisturizer 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).

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

875 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Control arm (Standard of care)

Arm Type

Active Comparator

Arm Description

The study doctors will provide standard of care with routine reactive topical products for atopic dermatitis flares

Arm Title

Active Intervention arm (proactive treatment)- Epiceram

Arm Type

Experimental

Arm Description

Arm Title

Active Intervention arm (proactive treatment)- Moisturizer

Arm Type

Experimental

Arm Description

Intervention Type

Combination Product

Intervention Name(s)

Tri-lipid skin barrier cream (Epiceram)

Intervention Description

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).

Intervention Type

Combination Product

Intervention Name(s)

Fluticasone propionate Cream 0.05%

Intervention Description

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).

Intervention Type

Combination Product

Intervention Name(s)

Moisturizer

Intervention Description

The aim is to compare the effect of proactive sequential skin care, including the twice daily use of a moisturizer 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).

Intervention Type

Other

Intervention Name(s)

Standard of Care

Intervention Description

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

Primary Outcome Measure Information:

Title

Cumulative number of challenge-proven food allergy

Description

The per-participant cumulative number of challenge-proven food allergy

Time Frame

Number of challenge-proven food allergy at 3 years

Secondary Outcome Measure Information:

Title

Scoring Atopic Dermatitis (SCORAD)

Description

Atopic dermatitis assessment- the score ranges from 0 to 103 with higher scores a worse (more severe eczema) outcome

Time Frame

Change from Baseline SCORAD at 1, 2 and 3 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

1 Week

Maximum Age & Unit of Time

12 Weeks

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Kari Nadeau, MD, PhD

Phone

650.867.4592

knadeau@hsph.harvard.edu

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Kari Nadeau, MD, PhD

Organizational Affiliation

Harvard

Official's Role

Principal Investigator

Facility Information:

Facility Name

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

City

Palo Alto

State/Province

California

ZIP/Postal Code

94304

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

SNP Center Inquiry

Phone

650-521-7237

snpcenterallergy_inquiry@stanford.edu

First Name & Middle Initial & Last Name & Degree

Sayantani Sindher, MD

Facility Name

Division of Pediatric Allergy and Clinical Immunology, National Jewish Health

City

Denver

State/Province

Colorado

ZIP/Postal Code

80206

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Jane Rice, RN

Phone

303-398-1317

ricej@njhealth.org

First Name & Middle Initial & Last Name & Degree

Donald Leung, MD, PhD

Facility Name

University of Chicago

City

Chicago

State/Province

Illinois

ZIP/Postal Code

60637

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Matthew Moy

Phone

773-702-9173

mattmoy@bsd.uchicago.edu

First Name & Middle Initial & Last Name & Degree

Christina Ciaccio, MD MSc

Facility Name

Nadeau Lab. Department of Environmental Health

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02115

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Kari Nadeau, MD, PhD

Phone

650-867-4592

knadeau@hsph.harvard.edu

First Name & Middle Initial & Last Name & Degree

Kari Nadeau, MD, PhD

Facility Name

Cincinnati Children's Hospital Medical Center

City

Cincinnati

State/Province

Ohio

ZIP/Postal Code

45229

Country

United States

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Shelley Randall

Phone

513-636-2362

Shelley.Randall@cchmc.org

First Name & Middle Initial & Last Name & Degree

Gurjit Hershey, MD, PhD

Facility Name

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

City

London

Country

United Kingdom

Individual Site Status

Not yet recruiting

12. IPD Sharing Statement

Plan to Share IPD

IPD Sharing Plan Description

No current plan to share data

Links:

URL

http://med.stanford.edu/allergyandasthma/about-us.html

Description

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

URL

https://sealstudy.sites.stanford.edu/

Description

SEAL study information

Learn more about this trial

Seal, Stopping Eczema and Allergy Study

We'll reach out to this number within 24 hrs