Topical Ruxolitinib for Face and Neck Vitiligo of Adult Chinese Patients Refractory to Topical Tacrolimus

Sponsor
Hospital Authority, Hong Kong
Study ID
NCT06719024
Phase
PHASE2/PHASE3
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 85 Years
Healthy Volunteers
Not accepted

Interventions

  • 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 cream — DRUG
    a thin layer of the assigned topical to the selected lesions twice daily, maintaining at least an 8-hour interval between applications

Study Details

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.

Key Dates

Start date
Nov 29, 2024
Status verified
Dec 2024
Primary completion
Jun 16, 2025
Completion
Jan 30, 2026

Study Design

Enrollment
20 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Active Comparator: Ruxolitinib cream
    a thin layer of the assigned topical to the selected lesions twice daily
  • Placebo Comparator: Aqueous cream
    a thin layer of the assigned topical to the selected lesions twice daily

Primary Outcome Measure

Degree of repigmentation at week 24 comparing to baseline [ Time Frame: week 24 ]

Central Contacts

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