Seal, Stopping Eczema and Allergy Study

Study Overview
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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) 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
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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).

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

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

Intervention / Treatment
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* Combination Product: Tri-lipid skin barrier cream (Epiceram)
* Combination Product: Fluticasone propionate Cream 0.05%
* Combination Product: Moisturizer
* Other: Standard of Care


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 1 Week
Maximum Age: 12 Weeks

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Control arm (Standard of care)<br>The study doctors will provide standard of care with routine reactive topical products for atopic dermatitis flares | Other: Standard of Care<br>* Participants' eczema will be managed by their primary physician, i.e. standard of care with routine reactive topical products for atopic dermatitis flares.<br>|
| Experimental: Active Intervention arm (proactive treatment)- Epiceram<br>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). | Combination Product: Tri-lipid skin barrier cream (Epiceram)<br>* 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).<br>Combination Product: Fluticasone propionate Cream 0.05%<br>* 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).<br>|
| Experimental: Active Intervention arm (proactive treatment)- Moisturizer<br>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). | Combination Product: Fluticasone propionate Cream 0.05%<br>* 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).<br>Combination Product: Moisturizer<br>* 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).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cumulative number of challenge-proven food allergy | The per-participant cumulative number of challenge-proven food allergy | Number of challenge-proven food allergy at 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Scoring Atopic Dermatitis (SCORAD) | Atopic dermatitis assessment- the score ranges from 0 to 103 with higher scores a worse (more severe eczema) outcome | Change from Baseline SCORAD at 1, 2 and 3 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Dermatitis, Dry skin, Food allergy, Moisturizer