Seal, Stopping Eczema and Allergy Study

Phase 2Active Not RecruitingNCT03742414

Kari Nadeau, MD, PhD398 enrolled

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).

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 398 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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Enrollment

398

Conditions

Eczema, Infantile Eczema Atopic Dermatitis Eczema Atopic Dermatitis

Interventions

Tri-lipid skin barrier cream (Epiceram)COMBINATION_PRODUCT

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%COMBINATION_PRODUCT

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).

Standard of CareOTHER

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

Eligibility

Sex: ALLMin age: 1 WeekMax age: 12 Weeks

Medical Language ↔ Plain English

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

Locations (5)

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

Palo Alto, California, United States

Division of Pediatric Allergy and Clinical Immunology, National Jewish Health

Denver, Colorado, United States

University of Chicago

Chicago, Illinois, United States

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, United States

Outcomes

Primary Outcomes

number of foods each participant is sensitized to

Sensitization is defined as food-specific IgE \> 0.1 kU/L

Time frame: 2 years

Secondary Outcomes

The per-subject cumulative number of proven Food Allergy

Double-blind placebo-controlled oral food challenges used

Time frame: 2 years

Number of foods each participant is sensitized to

Sensitization is defined as food-specific skin prick test (SPT) ≥ 1 mm

Time frame: 24 months of age

Number of foods each participant is sensitized to

Sensitization is defined as food-specific skin prick test (SPT) ≥ 3 mm.

Time frame: 24 months of age

Presence, duration, and severity of dry skin and/or AD by clinical assessment

Patient-oriented SCORAD (PO-SCORAD) application used

Time frame: Baseline, 12, and 24 months of age and as necessary

Data from ClinicalTrials.gov

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