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

NCT07595939 · Status: NOT_YET_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2026-05-19

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Ruxolitinib 1.5% Cream BID

In 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.

Sponsors & Collaborators

  • The Children's Hospital of Zhejiang University School of Medicine

    lead OTHER

Principal Investigators

  • Yunqing Ren, PhD · The Children's Hospital of Zhejiang University School of Medicine

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
2 Years
Max Age
11 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-06-01
Primary Completion
2028-12-31
Completion
2028-12-31
FDA Drug
Yes

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07595939 on ClinicalTrials.gov