Seal, Stopping Eczema and Allergy Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE2

Total Enrollment

398 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-06-30

Study Completion Date

2028-06-30

Brief Summary

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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).

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Detailed Description

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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).

Conditions

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Eczema, Infantile Eczema Atopic Dermatitis Eczema Atopic Dermatitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

This is a randomized, controlled, parallel design trial designed for children (total n = 398) who 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).

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Control arm (Standard of care)

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

Group Type ACTIVE_COMPARATOR

Standard of Care

Intervention Type OTHER

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

Active Intervention arm (proactive treatment)- Epiceram

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).

Group Type EXPERIMENTAL

Tri-lipid skin barrier cream (Epiceram)

Intervention Type 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%

Intervention Type 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).

Interventions

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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).

Intervention Type COMBINATION_PRODUCT

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).

Intervention Type COMBINATION_PRODUCT

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.

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

1 Week

Maximum Eligible Age

12 Weeks

Eligible Sex

ALL

Accepts Healthy Volunteers

No