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

NCT ID: NCT06719024

Last Updated: 2024-12-05

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-11-29
• Study Completion Date: 2026-01-30

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.

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.

Conditions

Vitiligo

Keywords

non-segmental vitiligo; randomized controlled trial; Chinese

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Ruxolitinib cream

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

Group Type: ACTIVE_COMPARATOR

Ruxolitinib Cream 1.5%

Intervention Type: 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

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

Group Type: PLACEBO_COMPARATOR

Aqueous cream

Intervention Type: DRUG

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

Interventions

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

Intervention Type: 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

Intervention Type: DRUG

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 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hospital Authority, Hong Kong

OTHER_GOV

Sponsor Role: lead

Responsible Party

Yuk Ming Lau

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

YM Lau

Role: PRINCIPAL_INVESTIGATOR

Queen Mary Hospital, Hospital Authority

Locations

Queen Mary Hospital, Hospital Authority

Hong Kong, , Hong Kong

Site Status: RECRUITING

Countries

Hong Kong

Central Contacts

Research Assistant

Role: CONTACT

Phone: +85222555885

Email: js83213@hku.hk

Facility Contacts

YM Lau

Role: primary

Other Identifiers

UW 24-613

Identifier Type: -

Identifier Source: org_study_id