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

• Agree to stop using any topical treatments on face and neck and systemic treatmentfor vitiligo during the washout period until the trial concludes. Use ofover-the-counter products approved by the investigator and camouflage makeup isallowed

• Both male and female patients must commit to using effective birth control toprevent pregnancy or fathering a child throughout the study

• Subjects or their legally authorized representative, if applicable, must be able tounderstand 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 likepiebaldism or leprosy, etc.

• History of using depigmentation treatments other than hydroquinone for vitiligo orpigmentation issues

• Any skin condition affecting study participation, active skin infections one weekbefore the study starts, issues impacting vitiligo evaluation, or serious healthproblems 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 exceptadequately treated non metastatic cancer, evidence of clinically significant oruncontrolled cardiovascular disease, thrombosis including DVT and PE, bloodabnormality including significant thrombocytopenia, anaemia (Hb <10g/dL) andsignificant 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 orphototherapy 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 HIVinfection 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, orthose planning pregnancy during the study

• Those unlikely or unable to comply with the requirements of this study protocol