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Ruxolitinib cream for face and neck vitiligo after tacrolimus did not work

Tests ruxolitinib cream for face and neck vitiligo after tacrolimus failed.

Key facts

Who runs it
Hospital Authority, Hong Kong
Where
Hong Kong1 site in 1 countryChoose a country to see its sites
Trial code
Registry title
Topical Ruxolitinib for Face and Neck Vitiligo of Adult Chinese Patients Refractory to Topical Tacrolimus
Status
Recruiting
Phase
Phase 2/3
People taking part
20 people, planned
Started
29 Nov 2024
Planned end
30 Jan 2026
Type of study
Interventional, 2 groupsOne group gets an existing treatment, for comparison.
Treatments tested
  • Ruxolitinib Cream 1.5%
  • Aqueous cream
Record updated
5 December 2024

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with stable non-segmental vitiligo on the face and neck that did not respond to tacrolimus 0.1% ointment. Each person gets ruxolitinib cream on one side of the face and a plain cream on the other.

Age
18 to 85 years
Sex
All sexes can join
Disease stage
Stable non-segmental vitiligo. White patches must cover at least 0.5% of the body surface on the face and neck.
Earlier treatment
Must have used topical tacrolimus 0.1% twice daily for at least 3 months without a clear response. Must not have used topical or oral JAK inhibitors before. Must stop other vitiligo treatments for set times before the start: 1 week for skin treatments, 4 weeks for immunomodulators, photosensitizers, oral retinoids, methoxsalen or live vaccines, 8 weeks for laser or light therapy on face and neck, 12 weeks for biologics.

Main reasons for not taking part

  • Other types of vitiligo or other skin conditions that cause white patches, such as piebaldism or leprosy
  • Past use of skin-lightening treatments other than hydroquinone
  • Serious illness, such as serious infection, untreated chronic hepatitis, cancer within 5 years, uncontrolled heart disease, blood clots, or haemoglobin under 10 g/dL
  • HIV infection or other weakened immune system
  • Pregnant, breastfeeding, or planning a pregnancy during the study

The registry criteria, word for word

Show all 17 criteriaShow less

Who can take part

  • 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 take part

  • 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
  • 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
  • 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
  • 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
  • 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
  • Patients who refuse to give consent
  • 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

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you between 18 and 85 years old?

This trial has no sites in United States.

It has sites in one country. Choose a country to see its sites.

About the trial

What the trial wants to find out

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.

The 2 groups in the trial

  • Ruxolitinib creamExisting treatment, for comparison

    a thin layer of the assigned topical to the selected lesions twice daily

    Treatment: Ruxolitinib Cream 1.5%

  • Aqueous creamPlacebo, for comparison

    a thin layer of the assigned topical to the selected lesions twice daily

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
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
Plain-language title
Ruxolitinib cream for face and neck vitiligo after tacrolimus did not workGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 14 November 2026.
Fit questions
Built from NCT06719024, who can take part
Record updated
5 December 2024