NCT06719024

Topical Ruxolitinib for Face and Neck Vitiligo of Adult Chinese Patients Refractory to Topical Tacrolimus

A Randomized Controlled Trial to Assess the Efficacy and Safety of Topical Ruxolitinib for Face and Neck Vitiligo of Adult Chinese Patients Refractory to Topical Tacrolimus

• Status: Recruiting
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Hospital Authority, Hong Kong · Other Government
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

This trial is a prospective, open-label, single-center, split face randomized controlled study comparing 1.5% topical Ruxolitinib cream twice daily (BD) to aqueous cream in treating non-segmental vitiligo (NSV) of the face and neck in patient previous failed to respond to topical tacrolimus 0.1%. Aqueous cream twice daily application will be used as control group treatment. Patients with stable NSV at least 0.5% of their total body surface area (BSA) on the face and neck, as determined by the fingertip method, are screened. Recruited subjects will be asked to review their impression of change of their lesion by the end of the study using a 7-point scale.

Detailed description

Vitiligo is a chronic autoimmune skin disorder marked by the loss of melanocytes, leading to the development of depigmented patches on the skin. In this study, the investigators hypothesis that there is a noticeable difference in responses between using 1.5% ruxolitinib cream applied twice daily (BD) and aqueous cream BD at the end of the trial period. The investigators aim to investigate the efficacy and safety of topical 1.5% topical ruxolitinib cream on non-segmental vitiligo of the face and neck in Chinese patients who previously failed to improve with topical tacrolimus.

Conditions

• Vitiligo

Interventions

Type	Name	Description
DRUG	Ruxolitinib Cream 1.5%	a thin layer of the assigned topical to the selected lesions twice daily, maintaining at least an 8-hour interval between applications
DRUG	Aqueous cream	a thin layer of the assigned topical to the selected lesions twice daily, maintaining at least an 8-hour interval between applications

Timeline

• Start date: 2024-11-29
• Primary completion: 2025-06-16
• Completion: 2026-01-30
• First posted: 2024-12-05
• Last updated: 2024-12-05

Locations

1 site across 1 country: Hong Kong