Efficacy and Safety of Ruxolitinib Cream in Children Aged 2-11 Years With Non-segmental Vitiligo: A Single-Center, Real-World Study
Trial Snapshot
- Phase
- Phase 3
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 20
- Locations
- 1
Study Overview
Brief Summary
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.
Detailed Description
This is a single-center, prospective, interventional, real-world study conducted in China. The study aims to evaluate the efficacy and safety of Ruxolitinib Phosphate Cream in the treatment of non-segmental vitiligo in children aged 2 to 11 years.
A total of eligible participants will receive topical Ruxolitinib Cream applied to vitiligo lesions as prescribed by the investigator. The treatment regimen and dosage follow the product labeling (if applicable) or standard clinical practice, with no additional randomization or blinding procedures.
The study duration is approximately 3 years, including enrollment, a 24-week treatment observation period, and follow-up. Clinical assessments are scheduled at baseline (Week 0) and at Weeks 4, 8, 12, and 24 post-treatment initiation.
Primary Outcome Measures:
- Proportion of participants achieving ≥75% improvement from baseline in the Facial Vitiligo Area Scoring Index (F-VASI75) at Week 24.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 2 Years to 11 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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.
Exclusion Criteria
- •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.
- •Known hypersensitivity to the study drug or its excipients.
- •Concurrent participation in another clinical trial.
- •Considered by the investigator to be unsuitable for the study for any other reason.