Non-Segmental Vitiligo (NSV)NCT07673640
Ruxolitinib Cream Combined With Corticosteroids for Progressive Non-Segmental Vitiligo: A Multicenter Real-World Study
An observational study of Non-Segmental Vitiligo (NSV), run by ShanShan Li at 20 sites in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Non-Segmental Vitiligo (NSV)
- What is being tested?
- 1.5% Ruxolitinib Phosphate Cream (Opzelura) and Corticosteroid Therapy
- Type of treatment
- Pill or oral medicine, Injection or infusion
- How many people
- 300 participants
- Where
- 20 sitesChina
- Study dates
- 2 Jul 2026to 31 Dec 2028
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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
Trial locations and contacts
20 sites in 1 country. Contact the study team or a site near you to ask about taking part.
20 sites in 1 country
China20 sites, 20 recruiting
- Not yet recruiting
Changzhou First People's Hospital
Changzhou
Yu Hua Yang, +86 15995044892, manyinyan@163.com
- Recruiting
Dongying People's Hospital
Dongying, Shandong
Dr.Wang Haiying, +86-15505462533, whydf001@163.com
- Not yet recruiting
Dongying People's Hospital
Dongying
Hai Ying Wang, +86 15504562533, whydf001@163.com
- Not yet recruiting
The Second People's Hospital of Huai'an
Huai'an, Jiangsu
Chunsheng Yang, +86 18752409168, 8yung@sina.com
- Not yet recruiting
Central Hospital of Jiaozuo Coal Industry (Group) Co., Ltd.
Jiaozuo
Dr. Pei Guangde, +86-13839107659, peiguangde0308@126.com
- Recruiting
The Second Hospital of Lanzhou University
Lanzhou
Dr.Wu Jin, +86-13909400191, wujin0501@163.com
- Not yet recruiting
The First People's Hospital of Lianyungang
Lianyungang
Wen Long Hu, +86 18961325126, lyghuwl@163.com
- Not yet recruiting
Nanjing Drum Tower Hospital
Nanjing
Jun Bao, +86 13327809366, baojun@sina.com
- Not yet recruiting
U-Family Clinic (Nanjing) Co., Ltd.
Nanjing
Hong Jia, +86 13512516585, jhff2015@163.com
- Recruiting
People's Hospital of Ningxia Hui Autonomous Region
Ningxiang
Dr.Yang Rui, +86-13519209959, 40244208@qq.com
- Not yet recruiting
Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality
Pan Meng, +86 13601698537, pm_ClinicalTrial@126.com
- Recruiting
Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine
Shanghai
Xin Li, +86 13661956326, 13661956326@163.com
- Not yet recruiting
Changzhi Second People's Hospital
Shangxi
Dr. Li Yufei, +86-15635580696, 119023217@qq.com
- Recruiting
Shenzhen Hospital of Southern Medical University
Shenzhen, Guangdong
Dr. Liang Yanhua, +86-18665086898, liangdoctor@163.com
- Not yet recruiting
Shenzhen Hospital, Southern Medical University
Shenzhen
Yanhua Liang, +86 18665086898, liangdoctor@163.com
- Not yet recruiting
Shiyan People's Hospital (Hubei University of Medicine Affiliated People's Hospital)
Shiyan
Dr. Meng Zudong, +86-13997837543, 1970547910@qq.com
- Not yet recruiting
The Fourth Affiliated Hospital of Soochow University
Suzhou, Jiangsu
Xuejun Zhang, +86 13722781112, ayzxj@vip.sina.com
- Not yet recruiting
The First Affiliated Hospital of Soochow University
Suzhou
Yu Qian Zhu, +86 18136088888, zhuyueqian0711@126.com
- Recruiting
The First Affiliated Hospital of Xi'an Jiaotong University
Xi'an
Dr. Mou Kuanhou, +86-18991232459, mkhn001@163.com
- Not yet recruiting
Affiliated Hospital of Xuzhou Medical University
Xuzhou, Jiangsu
Guan Jiang, +86 13013941798, dr.guanjiang@gmail.com
About this study
Official title: 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.
Read the 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.
- Conditions
- Non-Segmental Vitiligo (NSV)
- Being tested
- 1.5% Ruxolitinib Phosphate Cream (Opzelura), Corticosteroid Therapy
- Keywords
- Ruxolitinib phosphate cream, Corticosteroid therapy, Multicenter study, Real-world study, Active Vitiligo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
1.5% Ruxolitinib Phosphate Cream (Opzelura)Drug
Applied topically twice daily (BID), maximum 2 tubes per month (100g/tube) for a total duration of 24 weeks
Corticosteroid TherapyDrug
Either Compound Betamethasone injection (1ml, intramuscularly once a month) OR Dexamethasone oral low-dose pulse therapy (2.25mg, single dose once daily on Saturdays and Sundays) . Maximum hormone duration is 24 weeks
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of Participants Achieving Facial Vitiligo Area Scoring Index 75 (F-VASI 75)
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.
Measured: Week 12
Secondary outcomes (7)
Proportion of Participants Achieving F-VASI 50 and F-VASI 90
Percentage of participants achieving a ≥50% or ≥90% improvement from baseline in the Facial Vitiligo Area Scoring Index (F-VASI).
Measured: Weeks 4, 8, 12, and 24
Proportion of Participants Achieving F-VASI 75 at Remaining Timepoints
Percentage of participants achieving a ≥75% improvement from baseline in the Facial Vitiligo Area Scoring Index (F-VASI).
Measured: Weeks 4, 8, and 24
Proportion of Participants Achieving T-VASI 50, T-VASI 75, and T-VASI 90
Percentage of participants achieving a ≥50%, ≥75%, or ≥90% improvement from baseline in the Total Vitiligo Area Scoring Index (T-VASI).
Measured: Weeks 4, 8, 12, and 24
Change From Baseline in Vitiligo Disease Activity (VIDA) Score
Evaluation of the mean change in disease progression activity using the VIDA score ranking scale.
Measured: Weeks 4, 8, 12, and 24
Change From Baseline in Facial Body Surface Area (F-BSA) and Total Body Surface Area (T-BSA)
Evaluation of the mean changes in percentage values for facial and total body surface area affected by vitiligo.
Measured: Weeks 4, 8, 12, and 24
Change From Baseline in F-VASI and T-VASI Scores
Continuous absolute scoring changes from baseline evaluation across both indices.
Measured: Weeks 4, 8, 12, and 24
Proportion of Participants Achieving a Vitiligo Noticeability Scale (VNS) Score of 4 or 5
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.
Measured: Weeks 4, 8, 12, and 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2026
- Study start2 Jul 2026
- Primary completionDec 2026 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-Segmental Vitiligo (NSV)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ShanShan Li
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor-investigator, ShanShan Li, Dermavon Holdings Limited
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07673640
- Sponsor's protocol ID
- Opzelura-CHN-IIT-001
- Status last verified
- Sep 2026
- First submitted
- 23 Jun 2026
- Last updated
- 8 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No