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| ID | Type | Description | Link |
|---|---|---|---|
| 1U01AI147462-01A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Jewish Health | OTHER |
| University of Chicago | OTHER |
| Children's Hospital Medical Center, Cincinnati | OTHER |
| Harvard School of Public Health (HSPH) |
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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).
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control arm (Standard of care) | Active Comparator | The study doctors will provide standard of care with routine reactive topical products for atopic dermatitis flares |
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| Active Intervention arm (proactive treatment)- Epiceram | Experimental | 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). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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). |
| Measure | Description | Time Frame |
|---|---|---|
| number of foods each participant is sensitized to | Sensitization is defined as food-specific IgE > 0.1 kU/L | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| The per-subject cumulative number of proven Food Allergy | Double-blind placebo-controlled oral food challenges used | 2 years |
| Number of foods each participant is sensitized to | Sensitization is defined as food-specific skin prick test (SPT) ≥ 1 mm |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kari Nadeau, MD, PhD | Harvard | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sean N. Parker Center for Allergy & Asthma Research at Stanford University | Palo Alto | California | 94304 | United States | ||
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| Label | URL |
|---|---|
| The Sean N. Parker Center for Allergy and Asthma Research at Stanford University | View source |
| SEAL study information | View source |
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No current plan to share data
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| ID | Term |
|---|---|
| D003876 | Dermatitis, Atopic |
| D004485 | Eczema |
| D003872 | Dermatitis |
| D005512 | Food Hypersensitivity |
| ID | Term |
|---|---|
| D012873 | Skin Diseases, Genetic |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| C539259 | EpiCeram |
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
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| OTHER |
| Stanford University | OTHER |
| National Institute of Allergy and Infectious Diseases (NIAID) | NIH |
| King's College London | OTHER |
| Guy's and St Thomas' NHS Foundation Trust | OTHER |
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).
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| 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). |
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| Standard of Care | Other | Participants' eczema will be managed by their primary physician, i.e. standard of care with routine reactive topical products for atopic dermatitis flares. |
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| 24 months of age |
| Number of foods each participant is sensitized to | Sensitization is defined as food-specific skin prick test (SPT) ≥ 3 mm. | 24 months of age |
| 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 |
| Division of Pediatric Allergy and Clinical Immunology, National Jewish Health |
| Denver |
| Colorado |
| 80206 |
| United States |
| University of Chicago | Chicago | Illinois | 60637 | United States |
| Cincinnati Children's Hospital Medical Center | Cincinnati | Ohio | 45229 | United States |
| • King's College London and Guy's and St. Thomas' NHS Foundation Trust, UK | London | London | United Kingdom |
| D017437 | Skin and Connective Tissue Diseases |
| D017443 | Skin Diseases, Eczematous |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |