Ruxolitinib Cream Combined With Corticosteroids for Progressive Non-Segmental Vitiligo: A Multicenter Real-World Study

September 2, 2026 updated by: ShanShan Li

Efficacy and Safety of Ruxolitinib Phosphate Cream Combined With Corticosteroids in Patients With Progressive Non-Segmental Vitiligo: A Multicenter Real-World Study

This study is a prospective, multicenter, real-world observational study to assess the clinical efficacy and safety of topical 1.5% Ruxolitinib phosphate cream used in combination with systemic corticosteroids in a real-world clinical setting. The study plans to observe patients aged 12 years and older with active, progressive non-segmental vitiligo involving the face. All treatments are prescribed based on standard routine clinical care and medical practice guidelines. Participants will apply Ruxolitinib cream twice daily to affected skin areas for up to 24 weeks alongside a standard corticosteroid regimen. The primary goal of the study is to evaluate how many patients achieve a 75% or greater improvement in their facial vitiligo patches after 12 weeks of combined treatment. Safety and side effects will also be closely monitored throughout the 24-week period.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This prospective, multicenter, real-world cohort study plans to enroll 300 patients with active, progressive non-segmental vitiligo. Following routine medical diagnosis and standard-of-care clinical decisions, patients will receive treatment combining topical 1.5% Ruxolitinib phosphate cream applied twice daily (maximum 2 tubes/200g per month) for up to 24 weeks with concurrent corticosteroid therapy. Corticosteroid regimens consist of either intramuscular Compound Betamethasone injection (1ml once monthly) or Dexamethasone oral low-dose pulse therapy (2.25mg single dose once daily on Saturdays and Sundays) for a maximum duration of 24 weeks.The sample size of 300 patients is mathematically powered to test a superiority hypothesis. While historical single-center real-world data for ruxolitinib cream monotherapy demonstrated a 12-week response rate of 24.7%, this study establishes a conservative historical target control threshold baseline (P0) of 24%. Assuming the real-world addition of corticosteroid pulse therapy achieves an improved true response rate (P1) of 32%, a sample size of 237 evaluable participants provides 80% statistical power (beta = 0.20) to reject the null hypothesis using a two-sided exact binomial test at a significance level of alpha = 0.05. Accounting for an expected 20% drop-out or loss-to-follow-up rate, the final enrollment target was set to 300 participants. Efficacy analyses for the primary endpoint at Week 12 will utilize Multiple Imputation methods to account for missing data under Missing at Random (MAR) assumptions.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • China
      • Changzhou, China
        • Not yet recruiting
        • Changzhou First People's Hospital
        • Contact:
      • Dongying, China
        • Not yet recruiting
        • Dongying People's Hospital
        • Contact:
      • Jiaozuo, China
        • Not yet recruiting
        • Central Hospital of Jiaozuo Coal Industry (Group) Co., Ltd.
        • Contact:
      • Lanzhou, China
        • Recruiting
        • The Second Hospital of Lanzhou University
        • Contact:
      • Lianyungang, China
        • Not yet recruiting
        • The First People's Hospital of Lianyungang
        • Contact:
      • Nanjing, China
        • Not yet recruiting
        • Nanjing Drum Tower Hospital
        • Contact:
      • Nanjing, China
        • Not yet recruiting
        • U-Family Clinic (Nanjing) Co., Ltd.
        • Contact:
      • Ningxiang, China
        • Recruiting
        • People's Hospital of Ningxia Hui Autonomous Region
        • Contact:
      • Shanghai, China
        • Recruiting
        • Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine
        • Contact:
      • Shangxi, China
        • Not yet recruiting
        • Changzhi Second People's Hospital
        • Contact:
      • Shenzhen, China
        • Not yet recruiting
        • Shenzhen Hospital, Southern Medical University
        • Contact:
      • Shiyan, China
        • Not yet recruiting
        • Shiyan People's Hospital (Hubei University of Medicine Affiliated People's Hospital)
        • Contact:
      • Suzhou, China
        • Not yet recruiting
        • The First Affiliated Hospital of Soochow University
        • Contact:
      • Xi'an, China
        • Recruiting
        • The First Affiliated Hospital of Xi'an Jiaotong University
        • Contact:
    • Guangdong
      • Shenzhen, Guangdong, China
        • Recruiting
        • Shenzhen Hospital of Southern Medical University
        • Contact:
    • Jiangsu
      • Huai'an, Jiangsu, China
        • Not yet recruiting
        • The Second People's Hospital of Huai'an
        • Contact:
      • Suzhou, Jiangsu, China
        • Not yet recruiting
        • The Fourth Affiliated Hospital of Soochow University
        • Contact:
      • Xuzhou, Jiangsu, China
        • Not yet recruiting
        • Affiliated Hospital of Xuzhou Medical University
        • Contact:
    • Shandong
      • Dongying, Shandong, China
        • Recruiting
        • Dongying People's Hospital
        • Contact:
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, China
        • Not yet recruiting
        • Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Males and females aged 12 and older presenting with active, progressive non-segmental vitiligo with facial involvement and a total body surface area (BSA) depigmentation under 10%. Subjects are selected via a non-probability clinical recruitment strategy.

Description

Inclusion Criteria:

  • Age ≥ 12 years at the time of signing informed consent.
  • Clinical diagnosis of non-segmental vitiligo with facial involvement, and total body surface area (BSA) depigmentation ≤ 10%.
  • Diagnosed with progressive/active vitiligo meeting at least one of the following: Vitiligo Disease Activity (VIDA) score ≥ 3.

Clinical signs including trichrome vitiligo, confetti-like depigmentation, or Koebner phenomenon.

The extent of lesions under Wood's lamp is larger than that visible to the naked eye.

  • Agrees to have no pregnancy plans and uses effective contraception during the study and up to 4 weeks after the last dose.
  • Voluntarily signs the informed consent form and agrees to regular follow-up visits.

Exclusion Criteria:

  • Diagnosis of other clinical forms of vitiligo (e.g., segmental vitiligo).
  • Clinically diagnosed with stable vitiligo.
  • Co-existing skin depigmentation disorders affecting efficacy evaluation (e.g., pityriasis alba, leprosy, post-inflammatory hypopigmentation, progressive macular hypomelanosis, nevus anemicus, chemical leukoderma, tinea versicolor).
  • Leukoderma lesions with more than 1/3 white hair, or lesions accompanied by white hair where the investigator assesses the probability of benefit from participating is low based on clinical experience.
  • Contraindications to systemic corticosteroid use.
  • Known hypersensitivity or allergy to the study medications or excipients.
  • Known end-stage renal disease (ESRD) or currently undergoing renal replacement therapy (e.g., dialysis).
  • Concurrent participation in other clinical studies.
  • Any other condition which, in the investigator's judgment, makes the patient unsuitable for the study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Proportion of Participants Achieving Facial Vitiligo Area Scoring Index 75 (F-VASI 75)
Time Frame: Week 12
The percentage of patients achieving a ≥ 75% improvement from baseline in the Facial Vitiligo Area Scoring Index (F-VASI) score. F-VASI measures facial depigmentation using the Palmar method (1% Body Surface Area (BSA) corresponds to one hand surface area of the participant) across facial anatomical regions with a total score range of 0 to 3. Higher scores represent greater depigmentation. Missing primary endpoint data will be handled via Multiple Imputation based on Missing at Random (MAR) assumptions.
Week 12

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Proportion of Participants Achieving F-VASI 50 and F-VASI 90
Time Frame: Weeks 4, 8, 12, and 24
Percentage of participants achieving a ≥50% or ≥90% improvement from baseline in the Facial Vitiligo Area Scoring Index (F-VASI).
Weeks 4, 8, 12, and 24
Proportion of Participants Achieving F-VASI 75 at Remaining Timepoints
Time Frame: Weeks 4, 8, and 24
Percentage of participants achieving a ≥75% improvement from baseline in the Facial Vitiligo Area Scoring Index (F-VASI).
Weeks 4, 8, and 24
Proportion of Participants Achieving T-VASI 50, T-VASI 75, and T-VASI 90
Time Frame: Weeks 4, 8, 12, and 24
Percentage of participants achieving a ≥50%, ≥75%, or ≥90% improvement from baseline in the Total Vitiligo Area Scoring Index (T-VASI).
Weeks 4, 8, 12, and 24
Change From Baseline in Vitiligo Disease Activity (VIDA) Score
Time Frame: Weeks 4, 8, 12, and 24
Evaluation of the mean change in disease progression activity using the VIDA score ranking scale.
Weeks 4, 8, 12, and 24
Change From Baseline in Facial Body Surface Area (F-BSA) and Total Body Surface Area (T-BSA)
Time Frame: Weeks 4, 8, 12, and 24
Evaluation of the mean changes in percentage values for facial and total body surface area affected by vitiligo.
Weeks 4, 8, 12, and 24
Change From Baseline in F-VASI and T-VASI Scores
Time Frame: Weeks 4, 8, 12, and 24
Continuous absolute scoring changes from baseline evaluation across both indices.
Weeks 4, 8, 12, and 24
Proportion of Participants Achieving a Vitiligo Noticeability Scale (VNS) Score of 4 or 5
Time Frame: Weeks 4, 8, 12, and 24
Percentage of participants rating their lesions as 4 ("a lot less noticeable") or 5 ("no longer noticeable") on the patient-reported VNS scale, alongside individual category breakdowns.
Weeks 4, 8, 12, and 24

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Incidence of Adverse Events (AEs), Serious Adverse Events (SAEs), and Adverse Drug Reactions (ADRs)
Time Frame: Throughout the study period (Up to Week 24)
Assessment of total safety events, with a specific focus on application-site reactions such as acne and pruritus.
Throughout the study period (Up to Week 24)
Proportion of Participants Discontinuing Treatment or Withdrawing Due to Adverse Events
Time Frame: Throughout the study period (Up to Week 24)
Evaluation of tolerability based on safety discontinuation metrics.
Throughout the study period (Up to Week 24)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
ShanShan Li

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 2, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 23, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 23, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 29, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 8, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 2, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Opzelura-CHN-IIT-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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