NCT06804811

A Study to Evaluate the Efficacy and Safety of Ruxolitinib Cream in Children (6 to < 12 Years Old) With Nonsegmental Vitiligo

A Phase 3, Randomized, Double-Blind, Efficacy, and Safety Study of Ruxolitinib Cream in Children (6 to < 12 Years Old) With Nonsegmental Vitiligo

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 250 (estimated)
• Sponsor: Incyte Corporation · Industry
• Sex: All
• Age: 6 Years – 11 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the efficacy and safety of ruxolitinib cream in children (6 to \< 12 years old) with nonsegmental vitiligo.

Conditions

• NonSegmental Vitiligo

Interventions

Type	Name	Description
DRUG	Ruxolitinib Cream	Ruxolitinib cream applied topically to the affected area as a thin film twice daily.
DRUG	Vehicle Cream	Matching vehicle cream applied topically to the affected area as a thin film twice daily.

Timeline

• Start date: 2025-11-13
• Primary completion: 2027-04-30
• Completion: 2027-12-01
• First posted: 2025-02-03
• Last updated: 2025-12-17

Locations

86 sites across 14 countries: Argentina, Austria, Belgium, Bulgaria, Denmark, France, Germany, Hungary, Italy, Netherlands, Poland, Portugal, Spain, United Kingdom

Regulatory

• FDA-regulated drug study