Efficacy and Safety of Ruxolitinib Cream in Chinese Children Aged 2-11 Years With Non-segmental Vitiligo
Starting soon · Phase 3
Conditions studied: Vitiligo
In brief
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.
Key facts
- Study ID
- NCT07595939
- Run by
- The Children's Hospital of Zhejiang University School of Medicine
- People needed
- 20
- Starts
- 2026-06-01
- Expected to finish
- 2028-12-31
- Last updated by the study team
- 2026-05-19
Who can join
Age: 2 and older, up to 11. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- Children's Hospital, Zhejiang University School of Medicine — Hangzhou, Zhejiang, China
Full record on ClinicalTrials.gov
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