Patients with non-segmental vitiligo involving facial lesions, whose total body depigmented area is no more than 10% BSA.
Conditions
Interventions
Control Group: Monotherapy Group(Treated with 1.5% ruxolitinib phosphate cream as monotherapy):None
Observation Group: Combination Therapy Group(1.5% ruxolitinib phosphate cream combined with phototherapy):None
Sponsors
Shanghai General Hospital
Eligibility
Sex/Gender
All
Age
12 Years to No maximum
Inclusion criteria
Inclusion criteria: 1.Aged 12 years or older at the time of signing the informed consent form, with no restriction on gender; 2.Patients clinically diagnosed with non-segmental vitiligo with facial involvement, whose total body surface area (BSA) of depigmented lesions does not exceed 10%; 3.Based on routine clinical practice principles and shared decision-making between physicians and patients, subjects are assessed by investigators to be suitable for treatment with 1.5% ruxolitinib cream (as monotherapy or combined with phototherapy); the subject and/or their legal guardian have received full information and voluntarily agree to receive either treatment regimen above; 4.Subjects agree to have no childbearing plans during the study period and for at least 4 weeks after the last study drug administration, and are willing to adopt effective contraceptive measures; 5.Study participants shall voluntarily sign and date the informed consent form, and agree to and be capable of complying with scheduled visits, treatment regimens, laboratory tests and other study procedures;
Exclusion criteria
Exclusion criteria: 1.Combined with other skin diseases that may affect the assessment of non-segmental vitiligo treatment efficacy; 2.Used other JAK inhibitors, biologics, or systemic steroids within 12 weeks; participated in another investigational drug study within the past 8 weeks; 3.Combined with other photosensitive diseases, or within the past week or currently taking photosensitizing medications; 4.Severe infectious disease, or conditions deemed by the investigator to pose a high risk for participation in the study or to interfere with assessment of study-related endpoints, such as: (1) Active skin diseases or skin infections (bacterial, fungal, or viral) requiring systemic treatment within the past 4 weeks, or conditions that may interfere with accurate assessment of vitiligo; (2) Concurrent active tuberculosis, HBV, HCV, HIV, syphilis, or other systemic infections; 5.Severe diseases of the cardiovascular, hepatic, renal, or endocrine systems, or history of immunodeficiency disorders or malignant tumors; 6.Research participants who are allergic or sensitive to the treatment drug and/or other similar products or excipients; 7.Pregnant female research participants, lactating female research participants; 8.The researcher considers the research participant unsuitable for participation in this study for any reason;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage Change from Baseline (%CFB) in T-VASI at Week 16; | — |
Secondary
| Measure | Time frame |
|---|---|
| Proportion of subjects achieving T-VASI 50/75/90 at Week 8 and Week 16;Proportion of subjects with Vitiligo Noticeability Scale (VNS) score of 4 (hardly noticeable) or 5 (no longer noticeable) at Week 8 and Week 16, as well as the proportion of subjects in each category;Change from baseline in F-BSA and T-BSA scores at Week 8 and Week 16 (the percentage of repigmented area calculated via Image J);Percentage change from baseline (%CFB) in Facial Vitiligo Area Severity Index (F-VASI) at Week 16;Proportion of subjects achieving F-VASI 50/75/90 at Week 8 and Week 16;Change from baseline in DLQI/CDLQI scores at Week 8 and Week 16; | — |
Countries
China
Contacts
Public ContactZhouwei Wu
Shanghai General Hospital
Outcome results
None listed