Topical Ruxolitinib for treating vitiligo in adults

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• crisaborole 2% versus tacrolimus 0.1% with light therapy for facial vitiligo

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• Testing WJ01024 Alone and with Ruxolitinib for Myelofibrosis with Splenomegaly

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.