BENITIONSClinical Trial Intelligence

Longitudinal Endotyping Of Atopic Dermatitis Through Transcriptomic Skin Analysis

Фаза 4 Завершено NCT05436535

ЗаболеваниеAtopic Dermatitis
ФазаФаза 4
СпонсорNational Institute of Allergy and Infectious Diseases (NIAID)
СтатусЗавершено
Участники433 участн.
ВмешательствоDupilumab, Vanicream- Dupilumab-naïve, Triamcinolone Acetonide, Hydrocortisone, Vanicream- Active
Дата начала21.11.2022
Дата завершения7.04.2025
Публикация результатов4.06.2026

Кратко

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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