Longitudinal Endotyping Of Atopic Dermatitis Through Transcriptomic Skin Analysis
4상
완료
NCT05436535
| 대상 질환 | Atopic Dermatitis |
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| 임상 단계 | 4상 |
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| 스폰서 | National Institute of Allergy and Infectious Diseases (NIAID) |
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| 상태 | 완료 |
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| 참여자 수 | 433 명 |
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| 중재(약물) | Dupilumab, Vanicream- Dupilumab-naïve, Triamcinolone Acetonide, Hydrocortisone, Vanicream- Active |
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| 시작일 | 2022년 11월 21일 |
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| 완료일 | 2025년 4월 7일 |
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| 결과 공개일 | 2026년 6월 4일 |
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요약
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 |
| Odds Ratio (OR) | 1.661 (95% CI 0.835–3.361) |
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