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

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.

Inclusion criteria

• 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

Exclusion criteria

• Patients who refuse to give consent
• Presence of different vitiligo types or other skin depigmentation conditions like piebaldism or leprosy, etc.
• History of using depigmentation treatments other than hydroquinone for vitiligo or pigmentation issues
• Any skin condition affecting study participation, active skin infections one week before the study starts, issues impacting vitiligo evaluation, or serious health problems limiting involvement or increasing risk
• Significant medical disease that may hinder use of topical JAK inhibitor, e.g. serious infection, untreated chronic hepatitis, malignancy within 5 years except adequately treated non metastatic cancer, evidence of clinically significant or uncontrolled cardiovascular disease, thrombosis including DVT and PE, blood abnormality including significant thrombocytopenia, anaemia (Hb <10g/dL) and significant neutropenia, substance misuse
• Specific treatment use within certain periods before starting (Baseline visit):

1 week for topical vitiligo treatments 4 weeks for immunomodulators, photosensitizers, oral retinoids, methoxsalen, or live vaccines 8 weeks for laser or phototherapy on face and neck 12 weeks for biologics

• Any prior application of topical or oral JAK inhibitors
• Hemoglobin under 10 g/dL, significant liver dysfunction, and/or evidence of HIV infection or positive for HIV antibodies at initial screening or current acquired, common variable or inherited, primary or secondary immunodeficiency
• Females of childbearing potential who are pregnant, during breastfeeding period, or those planning pregnancy during the study
• Those unlikely or unable to comply with the requirements of this study protocol