The goal of this clinical trial is to evaluate the efficacy and safety of Ruxolitinib Phosphate Cream in treating non-segmental vitiligo in children aged 2 to 11 years under real-world conditions. The main question\[s\] it aims to answer are:
Primary Efficacy: What is the improvement rate (e.g., proportion of participants achieving F-VASI75) after 24 weeks of treatment with Ruxolitinib Phosphate Cream in this population? Safety Profile: What is the safety profile of the treatment over 24 weeks, specifically regarding the incidence of Application Site Acne, Application Site Pruritus, and other adverse events?
Participants will:
Apply Ruxolitinib Phosphate Cream topically to vitiligo lesions as prescribed by the investigator.
Attend scheduled clinic visits at Weeks 4, 8, 12, and 24 for efficacy and safety assessments.
Undergo standardized clinical photography and severity scoring of their vitiligo lesions at each visit.
Report any adverse events or skin reactions experienced during the study period to the research team.
Children aged 2 to 11 years, regardless of sex.
Clinical diagnosis of non-segmental vitiligo, with affected Body Surface Area (BSA) ≥0.1%, T-VASI score ≥0.1, and total depigmented area not exceeding 10% BSA.
Legal guardian voluntarily provides signed informed consent and agrees to scheduled follow-ups.
Diagnosis of other forms of vitiligo (e.g., segmental vitiligo).
Presence of other hypopigmentary or depigmentary disorders that could interfere with efficacy assessment (e.g., pityriasis alba, leprosy, post-inflammatory hypopigmentation, progressive macular hypomelanosis, nevus depigmentosus, and tinea versicolor).
Prior or current use of any treatment for depigmentation.
History of failure with any systemic or topical JAK inhibitor therapy for vitiligo or any other inflammatory condition.
Single group
Ruxolitinib 1.5% Cream BID
DrugIn this single-arm clinical trial, all eligible subjects will receive the same investigational intervention. The study drug is Ruxolitinib Phosphate Cream, 1.5% (w/w), supplied in 100 g tubes. The dosing regimen consists of applying a thin layer of the cream to all vitiligo lesions twice daily, with approximately 12 hours between applications. Throughout the treatment period, the total application area must not exceed 10% of the Body Surface Area, and the maximum usage is limited to two tubes (totaling 200 g) per month. The entire investigational intervention will last for 24 weeks, unless a subject meets early discontinuation criteria beforehand. It must be emphasized that this drug is for cutaneous use only and is strictly prohibited for application to mucous membranes (e.g., inside the mouth, vagina) or in or around the eyes.
Total-Vitiligo Area Scoring Index (T-VASI)
Improvement from baseline in the Total Vitiligo Area Scoring Index (T-VASI) at Week 24. The T-VASI ranges from 0 to 100, with higher scores indicating worse outcome (greater depigmentation).
Total-Vitiligo Area Scoring Index (T-VASI)
Improvement from baseline in the Total Vitiligo Area Scoring Index (T-VASI) at Week 4, 8, 12. The T-VASI ranges from 0 to 100, with higher scores indicating worse outcome (greater depigmentation).
Vitiligo Noticeability Scale (VNS)
Proportion of patients with Vitiligo Noticeability Scale (VNS) score of 4 or 5 at Weeks 4, 8, 12, and 24. The VNS is a patient-reported outcome measure ranging from 1 to 5, where 1 = more noticeable and 5 = no longer noticeable. Higher scores indicate better outcome. The proportion of patients achieving a score of 4 ("less noticeable") or 5 ("no longer noticeable") will be reported, including the breakdown of patients in each category.
Total Body Surface Area (T-BSA)
Change from baseline in Total Body Surface Area (T-BSA) affected at Weeks 4, 8, 12, and 24. T-BSA is measured as the percentage of body surface area affected by vitiligo, ranging from 0% to 100%. Higher percentage indicates worse outcome.
Children's Dermatology Life Quality Index (CDLQI)
Change from baseline in Children's Dermatology Life Quality Index (CDLQI) score at Weeks 4, 8, 12, and 24. The CDLQI is a validated pediatric dermatology quality of life questionnaire ranging from 0 to 30, where 0 = no impact on quality of life and 30 = maximum impact. Higher scores indicate worse outcome.
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