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

NCT06719024 | Recruiting Phase 2

• 1 other identifier: UW 24-613
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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%. 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.

Conditions

Vitiligo

Keywords

non-segmental vitiligo; randomized controlled trial; Chinese

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Ruxolitinib cream

ACTIVE COMPARATOR

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

Drug: Ruxolitinib Cream 1.5%

Aqueous cream

PLACEBO COMPARATOR

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

Drug: Aqueous cream

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

Ruxolitinib cream

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

Aqueous cream

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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):
• 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

Sponsors & Collaborators

• Hospital Authority, Hong Kong: lead

Study Sites (1)

Queen Mary Hospital, Hospital Authority

Hong Kong, Hong Kong

RECRUITING

MeSH Terms

Conditions

Vitiligo

Condition Hierarchy (Ancestors)

Hypopigmentation; Pigmentation Disorders; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• YM Lau

  Queen Mary Hospital, Hospital Authority

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Research Assistant

CONTACT

+85222555885; js83213@hku.hk

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 2, 2024
• First Posted: December 5, 2024
• Study Start: November 29, 2024
• Primary Completion: June 16, 2025
• Study Completion: January 30, 2026
• Last Updated: December 5, 2024

Record last verified: 2024-12

Locations

HK (1)