drugset / Trial / NCT07595939

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

NCT07595939

NaSingle-groupOpen-labelTreatment

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.

Timeline

Start
2026-06-01
Primary completion
2028-12-31
Completion
2028-12-31

Drugs

EvaluationDrugModalityDoseRoute
Subject Ruxolitinib Small molecule 1.5 % Topical

Indications