BENITIONSClinical Trial Intelligence

Longitudinal Endotyping Of Atopic Dermatitis Through Transcriptomic Skin Analysis

4상 완료 NCT05436535

대상 질환Atopic Dermatitis
임상 단계4상
스폰서National Institute of Allergy and Infectious Diseases (NIAID)
상태완료
참여자 수433 명
중재(약물)Dupilumab, Vanicream- Dupilumab-naïve, Triamcinolone Acetonide, Hydrocortisone, Vanicream- Active
시작일2022년 11월 21일
완료일2025년 4월 7일
결과 공개일2026년 6월 4일

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 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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