Seal, Stopping Eczema and Allergy Study

Atopic Dermatitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03742414
• Other study ID #: 48199
• Secondary ID: 1U01AI147462-01A
• Status: Recruiting
• Phase: Phase 2
• Start date: June 30, 2021
• Est. completion date: June 30, 2027

Study information

• Verified date: October 2023
• Source: Harvard School of Public Health (HSPH)
• Contact: Kari Nadeau, MD, PhD
• Phone: 650.867.4592
• Email: knadeau[@]hsph.harvard.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 312
• Est. completion date: June 30, 2027
• Est. primary completion date: May 31, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Week to 12 Weeks

Eligibility

Inclusion 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

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 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

Related Conditions & MeSH terms

• Atopic Dermatitis
• Atopic Dermatitis Eczema
• Dermatitis
• Dermatitis, Atopic
• Eczema
• Eczema, Infantile
• Hypersensitivity

Intervention

Combination Product:
• Tri-lipid skin barrier cream (Epiceram)
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%
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).

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

Locations

Country	Name	City	State
United Kingdom	• King's College London and Guy's and St. Thomas' NHS Foundation Trust, UK	London
United States	University of Chicago	Chicago	Illinois
United States	Cincinnati Children's Hospital Medical Center	Cincinnati	Ohio
United States	Division of Pediatric Allergy and Clinical Immunology, National Jewish Health	Denver	Colorado
United States	Sean N. Parker Center for Allergy & Asthma Research at Stanford University	Palo Alto	California

Sponsors (7)

Lead Sponsor	Collaborator
Kari Nadeau, MD, PhD	Children's Hospital Medical Center, Cincinnati, Harvard School of Public Health (HSPH), King's College London and Guy's & St. Thomas Hospital, National Jewish Health, Stanford University, University of Chicago

Countries where clinical trial is conducted

United States,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	number of foods each participant is sensitized to	Sensitization is defined as food-specific IgE > 0.1 kU/L	2 years
Secondary	The per-subject cumulative number of proven Food Allergy	Double-blind placebo-controlled oral food challenges used	2 years
Secondary	Number of foods each participant is sensitized to	Sensitization is defined as food-specific skin prick test (SPT) = 1 mm	24 months of age
Secondary	Number of foods each participant is sensitized to	Sensitization is defined as food-specific skin prick test (SPT) = 3 mm.	24 months of age
Secondary	Presence, duration, and severity of dry skin and/or AD by clinical assessment	Patient-oriented SCORAD (PO-SCORAD) application used	Baseline, 12, and 24 months of age and as necessary

External Links

•   SEAL study information
•   The Sean N. Parker Center for Allergy and Asthma Research at Stanford University