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

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.

Study Overview

• Status: Recruiting
• Conditions: Vitiligo
• Intervention / Treatment: Drug: Ruxolitinib Cream 1.5%; Drug: Aqueous cream

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 Type: Interventional
• Enrollment (Estimated): 20
• Phase: Phase 2; Phase 3

Contacts and Locations

• Study Contact: Name: Research Assistant; Phone Number: +85222555885; Email: js83213@hku.hk

Study Locations

• Hong Kong
  • Hong Kong, Hong Kong
    • Recruiting
    • Queen Mary Hospital, Hospital Authority
    • Contact: YM Lau

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Ruxolitinib cream; a thin layer of the assigned topical to the selected lesions twice daily	Drug: 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
Placebo Comparator: Aqueous cream; a thin layer of the assigned topical to the selected lesions twice daily	Drug: Aqueous cream; a thin layer of the assigned topical to the selected lesions twice daily, maintaining at least an 8-hour interval between applications

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	week 24

Collaborators and Investigators

• Sponsor: Hospital Authority, Hong Kong
• Investigators: Principal Investigator: YM Lau, Queen Mary Hospital, Hospital Authority

Study record dates

Study Major Dates

• Study Start (Actual): November 29, 2024
• Primary Completion (Estimated): June 16, 2025
• Study Completion (Estimated): January 30, 2026

Study Registration Dates

• First Submitted: November 2, 2024
• First Submitted That Met QC Criteria: December 2, 2024
• First Posted (Estimated): December 5, 2024

Study Record Updates

• Last Update Posted (Estimated): December 5, 2024
• Last Update Submitted That Met QC Criteria: December 2, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Keywords: randomized controlled trial; Chinese; non-segmental vitiligo
• Additional Relevant MeSH Terms: Skin Diseases; Hypopigmentation; Pigmentation Disorders; Vitiligo
• Other Study ID Numbers: UW 24-613

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No