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This is a prospective, multicenter, sample collection study using DermTech's non-invasive skin collection kits to evaluate genomic biomarkers and microbiome information from pediatric and adult subjects with atopic dermatitis(AD). Samples collected will be analyzed to detect gene signatures and microbiome populations associated with AD and sub-populations of AD.
This is a prospective, multicenter, sample collection study using DermTech's non-invasive skin collection kits to evaluate genomic biomarkers and microbiome information from pediatric and adult subjects with atopic dermatitis. Samples collected will be analyzed to detect gene signatures and microbiome populations associated with atopic dermatitis and sub-populations of AD.
Approximately 500 pediatric and adult subjects with moderate to severe AD will be enrolled in this study. Non-invasive skin samples will be collected at baseline, before drug administration 16 weeks (+/- 2 weeks) after treatment with biological therapy and a final visit at 26 weeks ((+/- 4 weeks).
Subjects will enter the Screening Period once the informed consent and/or assent process has been completed.
Once patient eligibility is confirmed, non-invasive skin samples will be collected using DermTech's non-invasive sample collection kit.
Samples will be collected from the following areas:
Data to be collected includes eczema area and severity index (EASI), patient oriented eczema measure (POEM), investigator global assessment (IGA), peak pruritus numerical rating scale (PPNRS), and transepidermal water loss (TEWL).
Photographic documentation of the site(s) sampled should be obtained to confirm consistent sampling of the lesional and non-lesional sites. Each non-invasive sample collection will consist of sequential application of 4 individual patches to a site. If during active treatment the skin lesion disappears during active treatment, skin samples will still be obtained from the same location.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Biologic Treatment | Subjects prescribed a biologic agent per standard of care |
| |
| Other Treatments | Subjects prescribed other treatment modalities exclusive of biologic therapy per standard of care |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Biologic therapy versus no biologic therapy | Other | Biologic therapy administered per standard of care |
|
| Measure | Description | Time Frame |
|---|---|---|
| Gene expression with primary disease assessment EASI | Expression of genes with disease activity measures including the EASI score | Week 16 |
| Measure | Description | Time Frame |
|---|---|---|
| Gene expression correlated with POEM assessment | Expression of genes in the DermTech assay with POEM disease activity | Week 16 |
| Gene expression correlated with IGA assessment | Expression of genes in the DermTech assay with IGA disease activity |
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Inclusion Criteria:
Exclusion Criteria:
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Approximately 500 pediatric and adult subjects with moderate to severe atopic dermatitis will be enrolled in this study
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| James Rock | Contact | 18582052736 | jrock@dermtech.com | |
| Susan Huynh | Contact | 8584504222 | susan.huynh@dermtech.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Orit Markowitz | Recruiting | New York | New York | 10128 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29036251 | Background | Yao Z, Moy R, Allen T, Jansen B. An Adhesive Patch-Based Skin Biopsy Device for Molecular Diagnostics and Skin Microbiome Studies. J Drugs Dermatol. 2017 Oct 1;16(10):979-986. |
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Individual data will not be shared with other researchers and patient data will be de-identified.
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| ID | Term |
|---|---|
| D003876 | Dermatitis, Atopic |
| ID | Term |
|---|---|
| D012873 | Skin Diseases, Genetic |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D003872 | Dermatitis |
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samples collected non-invasively will be assess for nucleic acids and microbiome
| Week 16 |
| Gene expression correlated with TEWL assessment | Expression of genes in the DermTech assay with TEWL | Week 16 |
| Gene expression correlated with PRNS assessment | Expression of genes in the DermTech asssay with PPRNS | Week 16 |
| Lisa A. Beck | Recruiting | Rochester | New York | 14620 | United States |
|
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D017443 | Skin Diseases, Eczematous |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |