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Assess the Long Term Efficacy and Safety of Ruxolitinib Cream in Participants With Vitiligo

NCT04530344 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 458

Last updated 2025-08-14

Study results available
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Summary

The purpose of this study is to evaluate the duration of response following withdrawal of ruxolitinib cream (Cohort A vehicle group), safety and maintenance of response with continued use of ruxolitinib cream in participants who have completed either Study NCT04052425 or NCT04057573 (parent studies) in which the participants will have been using ruxolitinib cream BID for the previous 28 to 52 weeks depending on their initial randomization in the parent study.

Conditions

  • Vitiligo

Interventions

DRUG

ruxolitinib

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

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
DOUBLE
Model
PARALLEL

Eligibility

Min Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-09-24
Primary Completion
2022-11-14
Completion
2022-11-14
FDA Drug
Yes

Countries

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

Study Locations

More Related Trials

Entities

Drugs
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 NCT04530344 on ClinicalTrials.gov