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
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.
• 18 - 85 year old
• Have a clinical diagnosis of stable non-segmental vitiligo
• Depigmentation including at least 0.5% of the BSA on the face and neck
• Previously treated with topical tacrolimus 0.1% BD for at least 3 months without significant response
• Agree to stop using any topical treatments on face and neck and systemic treatment for vitiligo during the washout period until the trial concludes. Use of over-the-counter products approved by the investigator and camouflage makeup is allowed
• Both male and female patients must commit to using effective birth control to prevent pregnancy or fathering a child throughout the study
• Subjects or their legally authorized representative, if applicable, must be able to understand and willing to provide informed consent at Screening visit