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NCT05436535 · ClinicalTrials.gov registry record · Phase 4
Longitudinal Endotyping Of Atopic Dermatitis Through Transcriptomic Skin Analysis
A Phase 4 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Completed
- Registry status
- Phase 4
- Development phase
- 433
- Enrollment target
NCT05436535: Completed Phase 4 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
NCT05436535 is a Phase 4 study that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 433 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (16% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05436535, a Phase 4 study, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 433 participants
- Enrollment target
Study Summary
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.
Primary Outcome
Eczema Area and Severity Index (EASI) is a composite score (range: 0-72) measuring physical signs of atopic dermatitis (AD), including area of involvement and severity. Severity components include: erythema, papulation, excoriation and lichenification \[0=absent, 1=mild, 2=moderate, 3=severe\] for each body region (head/neck, trunk, arms, legs). Area of involvement (%) is assessed for each body region. Area and severity of each body region is weighted based on size of region, and region scores a
Interventions
- BIOLOGICAL Dupilumab
- DRUG Hydrocortisone
- DRUG Triamcinolone Acetonide
- DRUG Vanicream- Dupilumab-naïve
- DRUG Vanicream- Active
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 433 participants |
| Start Date | 2022-11-21 |
| Est. Completion | 2025-10-24 |
| Phase | Phase 4 |
What the finished NCT05436535 record still lists
NCT05436535 is an interventional study that assigns participants to a tested intervention. The registered 433 participants enrollment target is mid-sized for trials with a published cap, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (16% lower).
The record links to 0 conditions, and to 5 interventions - of which Dupilumab is the first listed.
NCT05436535 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05436535 about?
NCT05436535 is a clinical study titled "Longitudinal Endotyping Of Atopic Dermatitis Through Transcriptomic Skin Analysis". 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. ...
What is the current status of trial NCT05436535?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 433 participants. The study started on 2022-11-21. Estimated completion is 2025-10-24.
What interventions are being tested in trial NCT05436535?
The interventions under investigation include: Dupilumab (BIOLOGICAL), Hydrocortisone (DRUG), Triamcinolone Acetonide (DRUG), Vanicream- Dupilumab-naïve (DRUG), Vanicream- Active (DRUG).
Who is sponsoring clinical trial NCT05436535?
This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05436535's enrollment target sits among peer trials
433 193rd of 2000 higher than 1,808 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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