Longitudinal Endotyping Of Atopic Dermatitis Through Transcriptomic Skin Analysis
4期
已完成
NCT05436535
| 适应症 | Atopic Dermatitis |
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| 分期 | 4期 |
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| 申办方 | National Institute of Allergy and Infectious Diseases (NIAID) |
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| 状态 | 已完成 |
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| 受试者人数 | 433 人 |
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| 干预(药物) | Dupilumab, Vanicream- Dupilumab-naïve, Triamcinolone Acetonide, Hydrocortisone, Vanicream- Active |
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| 开始日期 | 2022年11月21日 |
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| 完成日期 | 2025年4月7日 |
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| 结果公布日 | 2026年6月4日 |
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摘要
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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本页整理自 ClinicalTrials.gov 的公开数据,不构成医疗建议,也不构成投资建议。请务必咨询专业医师。