BENITIONSClinical Trial Intelligence

Longitudinal Endotyping Of Atopic Dermatitis Through Transcriptomic Skin Analysis

4期 已完成 NCT05436535

适应症Atopic Dermatitis
分期4期
申办方National Institute of Allergy and Infectious Diseases (NIAID)
状态已完成
受试者人数433 人
干预(药物)Dupilumab, Vanicream- Dupilumab-naïve, Triamcinolone Acetonide, Hydrocortisone, Vanicream- Active
开始日期2022年11月21日
完成日期2025年4月7日
结果公布日2026年6月4日

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 Endotype20 Participants
Type 2-low Endotype43 Participants
Type 2-high Endotype34 Participants
Type 2-low Endotype44 Participants
Type 2-high Endotype16 Participants
Type 2-low Endotype18 Participants
p-value0.1488
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。