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

NCT07673640 | Not Yet Recruiting

• 1 other identifier: Opzelura-CHN-IIT-001
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 12

Brief 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. 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.

Conditions

Non-Segmental Vitiligo (NSV)

Keywords

Ruxolitinib phosphate cream; Corticosteroid therapy; Multicenter study; Real-world study; Active Vitiligo

Outcome Measures

Primary Outcomes (1)

• 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.

  Week 12

Secondary Outcomes (7)

• Proportion of Participants Achieving F-VASI 50 and F-VASI 90

  Weeks 4, 8, 12, and 24

• Proportion of Participants Achieving F-VASI 75 at Remaining Timepoints

  Weeks 4, 8, and 24

• Proportion of Participants Achieving T-VASI 50, T-VASI 75, and T-VASI 90

  Weeks 4, 8, 12, and 24

• Change From Baseline in Vitiligo Disease Activity (VIDA) Score

  Weeks 4, 8, 12, and 24

• Change From Baseline in Facial Body Surface Area (F-BSA) and Total Body Surface Area (T-BSA)

  Weeks 4, 8, 12, and 24

Other Outcomes (2)

• Incidence of Adverse Events (AEs), Serious Adverse Events (SAEs), and Adverse Drug Reactions (ADRs)

  Throughout the study period (Up to Week 24)

• Proportion of Participants Discontinuing Treatment or Withdrawing Due to Adverse Events

  Throughout the study period (Up to Week 24)

Interventions

Corticosteroid Therapy DRUG

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

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

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• ShanShan Li: lead

Study Sites (12)

The Second People's Hospital of Huai'an

Huai'an, Jiangsu, China

Location

The Fourth Affiliated Hospital of Soochow University

Suzhou, Jiangsu, China

Location

Affiliated Hospital of Xuzhou Medical University

Xuzhou, Jiangsu, China

Location

Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, China

Location

Changzhou First People's Hospital

Changzhou, China

Location

Dongying People's Hospital

Dongying, China

Location

The First People's Hospital of Lianyungang

Lianyungang, China

Location

Nanjing Drum Tower Hospital

Nanjing, China

Location

U-Family Clinic (Nanjing) Co., Ltd.

Nanjing, China

Location

Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine

Shanghai, China

Location

Shenzhen Hospital, Southern Medical University

Shenzhen, China

Location

The First Affiliated Hospital of Soochow University

Suzhou, China

Location

MeSH Terms

Interventions

ruxolitinib

Central Study Contacts

ShanShan Li

CONTACT

+86 18201346463; lishanshan@cms.net.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: PI

Study Record Dates

• First Submitted: June 23, 2026
• First Posted: June 29, 2026
• Study Start: June 20, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 31, 2028
• Last Updated: July 2, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (12)