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.
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.
Agrees to have no pregnancy plans and uses effective contraception during the study and up to 4 weeks after the last dose.
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.
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.
Cohort
Prospective
1.5% Ruxolitinib Phosphate Cream (Opzelura)
DrugApplied topically twice daily (BID), maximum 2 tubes per month (100g/tube) for a total duration of 24 weeks
Corticosteroid Therapy
DrugEither 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
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.
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).
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).
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).
Change From Baseline in Vitiligo Disease Activity (VIDA) Score
Evaluation of the mean change in disease progression activity using the VIDA score ranking scale.
Incidence of Adverse Events (AEs), Serious Adverse Events (SAEs), and Adverse Drug Reactions (ADRs)
Assessment of total safety events, with a specific focus on application-site reactions such as acne and pruritus.
Proportion of Participants Discontinuing Treatment or Withdrawing Due to Adverse Events
Evaluation of tolerability based on safety discontinuation metrics.
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ShanShan Li
Lead sponsor
Dermavon Holdings Limited
Sponsor institution
