Longitudinal Endotyping Of Atopic Dermatitis Through Transcriptomic Skin Analysis
Phase 4
Completed
NCT05436535
| Condition | Atopic Dermatitis |
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| Phase | Phase 4 |
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| Sponsor | National Institute of Allergy and Infectious Diseases (NIAID) |
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| Status | Completed |
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| Enrollment | 433 participants |
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| Interventions | Dupilumab, Vanicream- Dupilumab-naïve, Triamcinolone Acetonide, Hydrocortisone, Vanicream- Active |
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| Start date | Nov 21, 2022 |
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| Completion date | Apr 7, 2025 |
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| Results posted | Jun 4, 2026 |
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Summary
This is a multi-center, longitudinal study which will characterize the gene expression profiles and transcriptomic endotypes that underlie mild and moderate-severe Atopic dermatitis (AD) and will determine changes in these expression patterns and endotypes in response to standard-of-care treatment. Participants will complete up to ten scheduled study visits with assessment of topical steroid response and dupilumab response (if uncontrolled with topical steroids). Skin samples will be collected at all study visits to determine the gene expression profiles and transcriptomic endotypes that underlie mild vs. moderate-severe AD disease. The investigators will also evaluate the lipidomic, metabolomic, proteomic, and microbiome profiles of AD skin endotypes associated with mild and moderate-severe AD disease. Non-AD participants will serve as a control population. The primary objective of this study is to determine if the type 2-high non-lesional skin (skin tape) endotype is associated with current mild versus moderate-severe AD disease.
Number of Dupilumab-naïve AD Participants With Mild (EASI ≤ 7) vs. Moderate-to-severe (EASI > 7) AD Severity Between Type 2-high vs. Type 2-low Endotype From Non-lesional Skin Transcriptome.
Day 7 · Participants
| Type 2-high Endotype | 20 Participants |
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| Type 2-low Endotype | 43 Participants |
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| Type 2-high Endotype | 34 Participants |
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| Type 2-low Endotype | 44 Participants |
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| Type 2-high Endotype | 16 Participants |
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| Type 2-low Endotype | 18 Participants |
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| p-value | 0.1488 |
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| Odds Ratio (OR) | 1.661 (95% CI 0.835–3.361) |
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Open in BENITIONS
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