Topical Ruxolitinib for Face and Neck Vitiligo of Adult Chinese Patients Refractory to Topical Tacrolimus
Recruiting
Phase 2Phase 3Interventional Study
Vitiligo
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 – 85
Sex
Any
Trial phase
Phase 2/3
Study type
Interventional
Purpose
Treatment
Participants needed
20 (estimated)
Sponsor
Hospital Authority, Hong Kong · Government
Who this trial is looking for
This trial is looking for adults with stable vitiligo on their face and neck who have not improved with another treatment. Participants will use a cream to see if it helps their skin condition better than a standard cream.
Are You a Good Fit for This Trial?
You may be able to join if
I am between 18 and 85 years old.
I have stable non-segmental vitiligo.
I have spots of vitiligo covering at least 0.5% of my face and neck.
I have used topical tacrolimus 0.1% for at least 3 months without improvement.
I can stop using other treatments for vitiligo during the trial.
I will use effective birth control to prevent pregnancy.
I can understand and give consent for my participation.
You may not be able to join if
I refuse to give consent.
I have a different type of vitiligo or other skin conditions.
I have used depigmentation treatments other than hydroquinone.
I have an active skin infection or issues affecting my skin.
I have significant health problems that may increase risks.
I have serious untreated medical conditions.
I have had any prior use of JAK inhibitors.
I am pregnant, breastfeeding, or planning to get pregnant.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
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 NS…
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.
Trial Locations
Loading…
Loading trial locations…
Facility
City
State
Country
Status
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 …
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
Picking one helps us show the most relevant trials first.
Your results are loading in the background — you can
change this any time from the results page.
Set your location to continue
Find My Trials uses your location to surface clinical trials near you.
Add your city or zip code to your profile and try again.