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
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Degree of repigmentation at week 24 comparing to baseline
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Ruxolitinib cream
a thin layer of the assigned topical to the selected lesions twice daily
干预措施: Ruxolitinib Cream 1.5% (Drug)
Aqueous cream
a thin layer of the assigned topical to the selected lesions twice daily
干预措施: Aqueous cream (Drug)
结局指标
主要结局
Degree of repigmentation at week 24 comparing to baseline
时间窗: week 24
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
次要结局
未报告次要终点
研究者
Yuk Ming Lau
Principal Investigator
Hospital Authority, Hong Kong