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NCT04052425 · ClinicalTrials.gov registry record · Phase 3
Topical Ruxolitinib Evaluation in Vitiligo Study 1 (TRuE-V1)
A Phase 3 study of Non-segmental Vitiligo, sponsored by Incyte Corporation.
- Completed
- Registry status
- Phase 3
- Development phase
- 330
- Enrollment target
- 20
- Study locations
NCT04052425: Completed Phase 3 study of Non-segmental Vitiligo, sponsored by Incyte Corporation.
NCT04052425 is a Phase 3 study of Non-segmental Vitiligo that has completed, run by Incyte Corporation. The registered enrollment target is 330 participants, above the 233-participant average among 9 other Non-segmental Vitiligo trials with a reported enrollment target (42% higher). The trial reports 20 study locations across 10 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04052425, a Phase 3 study of Non-segmental Vitiligo, has completed, sponsored by Incyte Corporation.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 330 participants
- Enrollment target
- 20
- Study locations
Study Summary
The purpose of this study is to evaluate the efficacy and safety of ruxolitinib cream in adolescent and adult participants with non-segmental vitiligo for whom total body involved vitiligo area (facial and nonfacial) does not exceed 10% body surface area (BSA).
Primary Outcome
An F-VASI75 responder achieved at least 75% improvement from Baseline in F-VASI, measured by the percentage of vitiligo involvement (percentage of body surface area \[BSA\]) and the degree of depigmentation: 0% (no depigmentation), 10% (only specks of depigmentation), 25% (pigmented area exceeded depigmented area), 50% (depigmented and pigmented area was equal), 75% (depigmented area exceeded pigmented area), 90% (specks of pigment), or 100% (no pigment). The percentage of BSA (hand unit) vitili
Conditions Studied
Interventions
- DRUG Vehicle
- DRUG Ruxolitinib cream
Study Locations (20)
Florida
- Harmony Medical Research Institute - Hialeah
- San Marcus Research Clinic Inc. - Miami Lakes
- ForCare Medical Center - Tampa
- Forcare Clinical Research Fcr Forward Clinical Trials, Inc - Tampa
- Metabolic Research Institute Inc - West Palm Beach
California
- First Oc Dermatology - Fountain Valley
- Marvel Clinical Research Llc - Huntington Beach
- Rady Children'S Hospital - San Diego - San Diego
- University of California San Francisco Sub Location - San Francisco
New York
- Suny Downstate Medical Center - Brooklyn
- Forest Hills Dermatology Group - Forest Hills
- The Dermatology Specialists Greenwich - New York
Michigan
- Great Lakes Research Group Inc - Bay City
- Dermatology Specialists of Brighton - Brighton
Alabama
- Cahaba Dermatology - Hoover
Arizona
- Cognitive Clinical Trials Scottsdale Btc Ppds - Scottsdale
Arkansas
- Burke Pharmaceutical Research - Hot Springs
Connecticut
- Clinical Research Center of Ct - Danbury
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 330 participants |
| Start Date | 2019-09-20 |
| Est. Completion | 2021-10-21 |
| Phase | Phase 3 |
What the finished NCT04052425 record still lists
NCT04052425 is an interventional study that assigns participants to a tested intervention. The registered 330 participants enrollment target is mid-sized for trials with a published cap, above the 233-participant average among 9 other Non-segmental Vitiligo trials with a reported enrollment target (42% higher).
The record links to 1 condition, with Non-segmental Vitiligo appearing as the primary indexed condition, and to 2 interventions - of which Vehicle is the first listed.
NCT04052425 names 20 study sites across 10 states, led by Florida, California, New York.
Frequently Asked Questions
What is clinical trial NCT04052425 about?
NCT04052425 is a clinical study titled "Topical Ruxolitinib Evaluation in Vitiligo Study 1 (TRuE-V1)". The purpose of this study is to evaluate the efficacy and safety of ruxolitinib cream in adolescent and adult participants with non-segmental vitiligo for whom total body involved vitiligo area (facial and nonfacial) does not exceed 10% body surface area (BSA).
What is the current status of trial NCT04052425?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 330 participants. The study started on 2019-09-20. Estimated completion is 2021-10-21.
What conditions does trial NCT04052425 study?
This clinical trial studies the following conditions: Non-segmental Vitiligo.
What interventions are being tested in trial NCT04052425?
The interventions under investigation include: Vehicle (DRUG), Ruxolitinib cream (DRUG).
Who is sponsoring clinical trial NCT04052425?
This trial is sponsored by Incyte Corporation, which has 239 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04052425 being conducted?
This trial has 20 study locations across Alabama, Arizona, Arkansas, California, Connecticut. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Non-segmental Vitiligo
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04052425's enrollment target sits among peer trials
330 3rd of 9 higher than 7 of 9 other Non-segmental Vitiligo trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Non-segmental Vitiligo 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
-
A Study to Evaluate the Safety and Efficacy of Ruxolitinib Cream in Pediatric Participants With Nonsegmental Vitiligo
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