VitiligoPhase 2/3RCTNCT06719024
Topical Ruxolitinib for Face and Neck Vitiligo of Adult Chinese Patients Refractory to Topical Tacrolimus
A Phase 2/3 study testing Ruxolitinib Cream 1.5% and Aqueous cream in people with Vitiligo, run by Hospital Authority, Hong Kong at 1 site in Hong Kong.
Trial summary
This trial is a prospective, open-label, single-center, split face randomized controlled study comparing 1.5% topical Ruxolitinib cream twice daily (BD) to aqueous cream in treating non-segmental vitiligo (NSV) of the face and neck in patient previous failed to respond to topical tacrolimus 0.1%. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Vitiligo
- What is being tested?
- Ruxolitinib Cream 1.5% and Aqueous cream
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteHong Kong
- Study dates
- 29 Nov 2024to 30 Jan 2026
- Phase
- Phase 2/3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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):
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Hong Kong1 site, 1 recruiting
- Recruiting
Queen Mary Hospital, Hospital Authority
Hong Kong
YM Lau
About this study
Official title: 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 trial is a prospective, open-label, single-center, split face randomized controlled study comparing 1.5% topical Ruxolitinib cream twice daily (BD) to aqueous cream in treating non-segmental vitiligo (NSV) of the face and neck in patient previous failed to respond to topical tacrolimus 0.1%. Aqueous cream twice daily application will be used as control group treatment. Patients with stable NSV at least 0.5% of their total body surface area (BSA) on the face and neck, as determined by the fingertip method, are screened. Recruited subjects will be asked to review their impression of change of their lesion by the end of the study using a 7-point scale.
Read the detailed description
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.
- Conditions
- Vitiligo
- Being tested
- Ruxolitinib Cream 1.5%, Aqueous cream
- Keywords
- non-segmental vitiligo, randomized controlled trial, Chinese
- Medical subject headings
- Vitiligo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ruxolitinib Cream 1.5%Drug
a thin layer of the assigned topical to the selected lesions twice daily, maintaining at least an 8-hour interval between applications
Aqueous creamDrug
a thin layer of the assigned topical to the selected lesions twice daily, maintaining at least an 8-hour interval between applications
| Study group | Role | What they receive |
|---|---|---|
| Ruxolitinib cream | Active comparator | a thin layer of the assigned topical to the selected lesions twice daily Receives: Drug: Ruxolitinib Cream 1.5% |
| Aqueous cream | Placebo comparator | a thin layer of the assigned topical to the selected lesions twice daily Receives: Drug: Aqueous cream |
What is being measured
The primary outcome is the main question the study is designed to answer.
Degree of repigmentation at week 24 comparing to baseline
Comparing the degree of repigmentation of lesion site between baseline and week 24 with Physician global assessment of the degrees of repigmentation of the vitiligo lesions
Measured: week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2024
- Study start29 Nov 2024
- Primary completion16 Jun 2025 (estimated)
- Study completion30 Jan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for VitiligoStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Authority, Hong Kong
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Yuk Ming Lau, Hospital Authority, Hong Kong
- Investigators
- YM Lau, Principal investigator, Queen Mary Hospital, Hospital Authority
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06719024
- Sponsor's protocol ID
- UW 24-613
- Acronym
- RCT
- Status last verified
- Dec 2024
- First submitted
- 2 Nov 2024
- Last updated
- 5 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06719024
- Acronym / sponsor ID
- RCT / UW 24-613
- Conditions
- Vitiligo
- Keywords
- non-segmental vitiligo, randomized controlled trial, Chinese
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Hospital Authority, Hong KongOther government
- Study start
- 29 Nov 2024 (actual)
- Primary completion
- 16 Jun 2025 (estimated)
- Study completion
- 30 Jan 2026 (estimated)
- First posted
- 5 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This trial is a prospective, open-label, single-center, split face randomized controlled study comparing 1.5% topical Ruxolitinib cream twice daily (BD) to aqueous cream in treating non-segmental vitiligo (NSV) of the face and neck in patient previous failed to respond to topical tacrolimus 0.1%. Aqueous cream twice daily application will be used as control group treatment. Patients with stable NSV at least 0.5% of their total body surface area (BSA) on the face and neck, as determined by the fingertip method, are screened. Recruited subjects will be asked to review their impression of change of their lesion by the end of the study using a 7-point scale.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ruxolitinib cream | Active comparator | Drug: Ruxolitinib Cream 1.5%a thin layer of the assigned topical to the selected lesions twice daily |
| Aqueous cream | Placebo comparator | Drug: Aqueous creama thin layer of the assigned topical to the selected lesions twice daily |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ruxolitinib Cream 1.5%a thin layer of the assigned topical to the selected lesions twice daily, maintaining at least an 8-hour interval between applications | Drug | Ruxolitinib cream |
| Aqueous creama thin layer of the assigned topical to the selected lesions twice daily, maintaining at least an 8-hour interval between applications | Drug | Aqueous cream |
Primary outcome
Degree of repigmentation at week 24 comparing to baseline
Time frame: week 24
Comparing the degree of repigmentation of lesion site between baseline and week 24 with Physician global assessment of the degrees of repigmentation of the vitiligo lesions
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
YM Lau principal investigator
Queen Mary Hospital, Hospital Authority
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Ruxolitinib Cream 1.5% and Aqueous cream in people with Vitiligo, run by Hospital Authority, Hong Kong at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Research Assistant (+85222555885, js83213@hku.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Degree of repigmentation at week 24 comparing to baseline (time frame: week 24). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Dec 2024.