Non-segmental vitiligo
Conditions
Interventions
Observation group:None
Sponsors
Tianjin Children's Hospital
Eligibility
Sex/Gender
All
Age
6 Years to 12 Years
Inclusion criteria
Inclusion criteria: 1.When signing the informed consent form, the age shall be 6 to 12 years old, with no gender restriction. 2.Study participants with a clinical diagnosis of non-segmental vitiligo, accompanied by facial involvement, with a total body depigmented area not exceeding 10% BSA. 3.For children under 8 years of age: the legal guardian voluntarily signs the informed consent form, and the child provides assent. For children aged 8 years and above: both the legal guardian and the child voluntarily sign the informed consent form together and agree to regular follow-up.
Exclusion criteria
Exclusion criteria: 1.Diagnosis of other forms of vitiligo (e.g., segmental vitiligo). 2.Suffering from other cutaneous depigmenting disorders that may affect the assessment of efficacy (e.g., pityriasis alba, leprosy, post-inflammatory hypopigmentation, progressive macular hypomelanosis, nevus anemicus, chemical leukoderma, tinea versicolor, etc.). 3.Participants with more than 1/3 of white hair in the vitiligo area, or those with white hair in the vitiligo area and a low likelihood of study benefit as assessed by clinical experience. 4.Previous or current use of depigmenting treatments. 5.History of failure with any systemic or topical JAK inhibitor for the treatment of vitiligo or any other inflammatory disease. 6.Patients with a known diagnosis of end-stage renal disease (ESRD) or undergoing renal replacement therapy (e.g., dialysis). 7.Hypersensitivity to the study drug and its excipients. 8.Currently participating in another clinical study. 9.Participants judged by the investigator to be ineligible for this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Week 24, the proportion of study participants whose Facial Vitiligo Area Scoring Index (F-VASI) improved by >=75% compared to baseline; | — |
Secondary
| Measure | Time frame |
|---|---|
| Proportion of study participants achieving F-VASI 75 at weeks 12, 36, and 52;Rate of change from baseline in F-BSA, T-BSA, and F-VASI scores at 12, 24, 36, and 52 weeks;Rate of change in CDLQI scores at 12 weeks, 24 weeks, 36 weeks, and 52 weeks compared to baseline;Rate of change in T-VASI scores from baseline at weeks 12, 24, 36, and 52;The proportion of study participants with vitiligo who scored 4 (relatively not obvious) or 5 (no longer obvious) on the 12-week, 24-week, 36-week, and 52-week Visualized Vitiligo Scale (VNS), and the proportion of study participants in each category;Proportion of study participants achieving F-VASI 50/90 at weeks 12, 24, 36, and 52;Proportion of study participants achieving T-VASI 50/75/90 at 12 weeks, 24 weeks, 36 weeks, and 52 weeks; | — |
Countries
China
Contacts
Public ContactQinfeng Li
Tianjin Children's Hospital
Outcome results
None listed