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Topical Ruxolitinib Evaluation in Vitiligo Study 1 (TRuE-V1) | Clinical Trials | Clareo Health

COMPLETEDPHASE3

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

Topical Ruxolitinib Evaluation in Vitiligo Study 1 (TRuE-V1): A Phase 3, Double-Blind, Randomized, Vehicle-Controlled, Efficacy and Safety Study of Ruxolitinib Cream Followed by an Extension Period in Participants With Vitiligo

NCT04052425•Incyte Corporation

View on ClinicalTrials.gov

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).

Eligibility

Age

12 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Clinical diagnosis of non-segmental vitiligo with depigmented area including ≥ 0.5% BSA on the face, ≥ 0.5 F-VASI, ≥ 3% BSA on nonfacial areas, ≥ 3 T-VASI, and total body vitiligo area (facial and nonfacial) not exceeding 10% BSA.
•Agree to discontinue all agents used to treat vitiligo from screening through the final safety follow-up visit. Over-the-counter preparations deemed acceptable by the investigator and camouflage makeups are permitted.
•Must be willing to take appropriate contraceptive measures to avoid pregnancy or fathering a child for the duration of study participation.

Exclusion Criteria

•No pigmented hair within any of the vitiligo areas on the face.
•Other forms of vitiligo (eg, segmental) or other differential diagnosis of vitiligo or other skin depigmentation disorders (eg, piebaldism, pityriasis alba, leprosy, postinflammatory hypopigmentation, progressive macule hypomelanosis, nevus anemicus, chemical leukoderma, and tinea versicolor).
•Have used depigmentation treatments (eg, monobenzone) for past treatment of vitiligo or other pigmented areas.
•Use of protocol-defined treatments within the indicated washout period before baseline.

Locations (57)

Cahaba Dermatology

Hoover, Alabama, United States

Cognitive Clinical Trials Scottsdale Btc Ppds

Scottsdale, Arizona, United States

Burke Pharmaceutical Research

Hot Springs, Arkansas, United States

First Oc Dermatology

Fountain Valley, California, United States

Marvel Clinical Research Llc

Huntington Beach, California, United States

Rady Children'S Hospital - San Diego

San Diego, California, United States

University of California San Francisco Sub Location

San Francisco, California, United States

Clinical Research Center of Ct

Danbury, Connecticut, United States

Harmony Medical Research Institute

Hialeah, Florida, United States

San Marcus Research Clinic Inc.

Miami Lakes, Florida, United States

Key Dates

Start Date

September 20, 2019

Primary Completion Date

March 18, 2021

Completion Date

October 21, 2021

Last Updated

August 22, 2025

Enrollment

330

ACTUAL participants

Conditions

Non-segmental Vitiligo

Interventions

Ruxolitinib cream

DRUG

Vehicle

DRUG

A Phase IIb Dose-ranging Study to Assess the Efficacy and Safety of GIA632 in Participants With Non-segmental Vitiligo

NCT07431177

Non-segmental Vitiligo

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RECRUITINGPHASE4

Comparison of Needling and Microneedling Plus Phototherapy in Localized Vitiligo Patients

NCT06991972

VitiligoNon-segmental Vitiligo

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RECRUITING

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 22, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

A Phase IIb Dose-ranging Study to Assess the Efficacy and Safety of GIA632 in Participants With Non-segmental Vitiligo

Comparison of Needling and Microneedling Plus Phototherapy in Localized Vitiligo Patients

A Study to Evaluate the Efficacy and Safety of SYHX1901 Tablet in Non-segmental Vitiligo Patients

A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of VYN201 Gel in Subjects With Non-segmental Vitiligo.

Cross-sectional Study to Characterize Real World Burden of Disease in Patients With Vitiligo in China

Topical Ruxolitinib Evaluation in Vitiligo Study 2 (TRuE-V2)