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Topical Ruxolitinib Evaluation in Vitiligo Study 1 (TRuE-V1)

NCT04052425 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 330

Last updated 2025-08-22

Study results available
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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).

Conditions

  • Non-segmental Vitiligo

Interventions

DRUG

Ruxolitinib cream

Ruxolitinib cream is a topical formulation applied as a thin film to affected areas.

DRUG

Vehicle

Vehicle cream is a topical formulation applied as a thin film to affected areas.

Sponsors & Collaborators

Principal Investigators

  • Kathleen Butler, MD · Incyte Corporation

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-09-20
Primary Completion
2021-03-18
Completion
2021-10-21
FDA Drug
Yes

Countries

  • United States
  • Bulgaria
  • Canada
  • France
  • Germany
  • Italy
  • Poland
  • Spain

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04052425 on ClinicalTrials.gov