NCT05750823

A Study to Assess the Safety and Efficacy of Ruxolitinib Cream in Participants With Genital Vitiligo

An Open-Label, Phase 2, Safety, and Efficacy Study of Ruxolitinib Cream in Participants With Genital Vitiligo

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 49 (actual)
• Sponsor: Incyte Corporation · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

An open-label study in which participants with non-segmental vitiligo with genital involvement will apply ruxolitinib 1.5% cream twice a day (BID) to all depigmented areas (up to 10% BSA) for up to 48 weeks. Participants should continue to treat depigmented areas identified for treatment at baseline regardless of whether the area begins to improve or fully repigment.

Conditions

• Nonsegmental Vitiligo With Genital Involvement

Interventions

Type	Name	Description
DRUG	Ruxolitinib Cream	Ruxolitinib cream will be applied twice daily for upto 48 weeks

Timeline

• Start date: 2023-04-11
• Primary completion: 2025-03-06
• Completion: 2025-03-06
• First posted: 2023-03-02
• Last updated: 2026-03-20
• Results posted: 2026-03-20

Locations

13 sites across 3 countries: United States, Canada, France

Regulatory

• FDA-regulated drug study