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

Launched by HOSPITAL AUTHORITY, HONG KONG · Dec 2, 2024

Keywords

ClinConnect Summary

This clinical trial is investigating the effectiveness of a cream called Ruxolitinib for treating vitiligo on the face and neck in adults who have not seen improvement with another treatment called tacrolimus. The study will compare Ruxolitinib cream applied twice a day to a regular cream (called aqueous cream) to see which works better for skin areas that have lost color. Participants must be between 18 and 85 years old, have stable vitiligo affecting at least 0.5% of their body surface area on the face and neck, and have previously used tacrolimus without success.

If you join the trial, you will apply the Ruxolitinib or the control cream to one side of your face and neck for the duration of the study. You will also be asked to share your thoughts on how your skin has changed at the end of the study. Participants must agree to stop using other treatments for vitiligo during the trial and use effective birth control if they are capable of becoming pregnant. This study is still looking for participants, so if you think you might be eligible, it could be a good opportunity to explore a new treatment option for vitiligo.

Gender

ALL

Eligibility criteria

• 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