Topical Ruxolitinib for treating vitiligo in adults
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 study is testing if a new cream called Ruxolitinib can help adults with vitiligo on their face and neck feel better when other treatments haven't worked.
Quick facts
| Phase | Phase2; Phase3 |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years to 85 Years |
| Sex | All |
| Sponsor | Hospital Authority, Hong Kong Government |
| Drugs / interventions | Ruxolitinib |
| Locations | 1 site (Hong Kong) |
| Trial ID | NCT06719024 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the efficacy and safety of 1.5% topical Ruxolitinib cream applied twice daily compared to aqueous cream in treating non-segmental vitiligo on the face and neck in adult Chinese patients who have not responded to topical tacrolimus. The study is a prospective, open-label, single-center, split face randomized controlled trial. Participants will be assessed for changes in their vitiligo lesions using a 7-point scale at the end of the trial period. The goal is to determine if Ruxolitinib provides a significant improvement over the control treatment.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 85 with stable non-segmental vitiligo affecting at least 0.5% of their body surface area on the face and neck.
Not a fit: Patients with other types of vitiligo or skin depigmentation conditions will not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could offer a new effective option for patients with vitiligo who have not responded to existing therapies.
How similar studies have performed: While this approach is novel in the context of Ruxolitinib for vitiligo, other studies have shown promising results with similar topical treatments for skin conditions.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Hong Kong
- Queen Mary Hospital, Hospital Authority — Hong Kong, Hong Kong (Recruiting)
Study contacts
- Principal investigator: YM Lau — Queen Mary Hospital, Hospital Authority
- Study coordinator: Research Assistant
- Email: js83213@hku.hk
- Phone: +85222555885
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.