Efficacy and Safety of Ruxolitinib Cream in Chinese Children Aged 2-11 Years With Non-segmental Vitiligo

ConditionVitiligo
Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age2-11
SponsorThe Children's Hospital of Zhejiang University School of Medicine

About this trial

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.

Eligibility criteria

Qualifiers

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.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • Ruxolitinib 1.5% Cream BID

Treatment groups

20 Participants
are divided into 1 treatment group