About this trial
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- 1.5% Ruxolitinib Phosphate Cream (Opzelura)
- Corticosteroid Therapy
Treatment groups
Sponsors and collaborators
ShanShan Li
Lead sponsor
Dermavon Holdings Limited
Sponsor institution