Non-segmental Vitiligo
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Age >=12 years at the time of signing informed consent, regardless of gender; 2. Clinically diagnosed with non-segmental vitiligo, meeting: Facial BSA >=0.3% ,F-VASI >=0.3, total body depigmentation area <=10% BSA; 3. Agreement to practice highly effective contraception during the study and for 6 months after the last dose, with no pregnancy plans; 4. Voluntary provision of written informed consent and commitment to regular follow-up visits.
Exclusion criteria
Exclusion criteria: 1. Presence of other hypopigmentary disorders that may interfere with efficacy assessment (e.g., pityriasis alba, leprosy, post-inflammatory hypopigmentation, idiopathic guttate hypomelanosis, nevus depigmentosus, chemical leukoderma, tinea versicolor); 2. a) Hypersensitivity to the investigational drug or its excipients; b) Concurrent participation in other clinical trials; 3. Deemed ineligible by the investigator based on clinical judgment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of Patients Achieving >=75% Improvement in Facial Vitiligo Area Scoring Index (F-VASI);safety; | — |
Secondary
| Measure | Time frame |
|---|---|
| Changes from baseline in F-BSA (Face Body Surface Area), T-BSA (Total Body Surface Area), F-VASI (Face Vitiligo Area Scoring Index), and T-VASI (Total Vitiligo Area Scoring Index) scores;1.The proportion of patients achieving F-VASI(Face Vitiligo Area Scoring Index) 50/75/90 ; 2.The proportion of patients achieving T-VASI(Total Vitiligo Area Scoring Index) 50/75/90 .;Proportion of patients achieving a Vitiligo Noticeability Scale (VNS) score of 4 ("less noticeable") or 5 ("no longer noticeable") ,along with the percentage distribution w;Changes from baseline in DLQI (Dermatology Life Quality Index) and CDLQI (Children's Dermatology Life Quality Index) scores; | — |
Countries
China
Contacts
Sun Yat-sen Memorial Hospital, Sun Yat-sen University