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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 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.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05436535
The ClinicalTrials.gov registry entry for NCT05436535 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 433 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which Dupilumab is the first listed.
NCT05436535 reports 0 study locations.
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.
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