Comparative Effectiveness of Ruxolitinib Monotherapy Versus Its Combination With Tacrolimus and Corticosteroids in the Management of Vitiligo: A Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- change in VASI score
研究概览
简要总结
this randomized controlled trial aims to compare the effectiveness and safety of ruxolitinib monotherapy versus its combination with topical tacrolimus or topical corticosteroids in patients with non-segmental vitiligo involving less than 10% body surface area. A total of 120 adult patients will be randomized into three treatment groups and followed for 24 weeks. Treatment response will be evaluated using validated scoring systems including the Vitiligo Area Severity Index (VASI), Vitiligo European Task Force (VETF) staging, and Physician Global Assessment. The findings may help optimize topical treatment strategies for vitiligo.
详细描述
Vitiligo is an acquired autoimmune skin disorder characterized by selective destruction of melanocytes, resulting in depigmented macules and patches affecting the skin, hair, and mucosa. The condition affects approximately 0.5-2% of the global population and can occur in both genders equally. Beyond its cutaneous manifestations, vitiligo has a profound psychosocial impact, often leading to reduced self-esteem and impaired quality of life.
The pathogenesis of vitiligo is multifactorial, involving genetic susceptibility, oxidative stress, immune dysregulation, and melanocyte apoptosis. Increased reactive oxygen species play a pivotal role in triggering melanocyte damage, particularly in genetically predisposed individuals. Conventional therapies, including topical corticosteroids, calcineurin inhibitors, and phototherapy, often yield variable results with frequent relapse.
Ruxolitinib, a topical Janus kinase (JAK) inhibitor, represents a novel targeted therapy that modulates the JAK-STAT signaling pathway involved in inflammatory cytokine signaling. It has demonstrated promising efficacy and an acceptable safety profile in non-segmental vitiligo. While ruxolitinib monotherapy is effective, the potential synergistic benefits of combining it with other topical immunomodulators such as tacrolimus or topical corticosteroids remain insufficiently studied.
This randomized controlled trial is designed to compare the clinical effectiveness of ruxolitinib monotherapy with its combination therapy using tacrolimus or topical corticosteroids. The study will be conducted in the outpatient dermatology department at Dow University of Health Sciences, Karachi, over a period of six months.
A total of 120 adult patients aged 18-65 years with non-segmental vitiligo involving less than 10% body surface area will be enrolled. Participants will be randomly assigned into three groups:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
盲法说明
this is an open label study in which participants and investigators are aware of treatment allocation
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •adult aged 18 to 65 years male or female patients non-segmental vitiligo vitiligo involving less then 10% body surface area willingness to provide written informed consent
排除标准
- •pregnant or lactating females known hypersentivity to ruxolitinib, tacrolimus or topical corticosteriods current use of systemic immunosuppressive therapy use of biologic therapy or phototherapy within the previous 12 weeks
研究组 & 干预措施
group c
ruxolitinib with corticosteriods
干预措施: ruxolitinib cream (Drug)
group a
ruxolitinib monotherapy
干预措施: ruxolitinib cream (Drug)
group b
ruxolitinib with tacrolimus
干预措施: ruxolitinib cream (Drug)
结局指标
主要结局
change in VASI score
时间窗: baseline to week 24
the VASI will be used to assess the extent and degree of depigmentation. change in total VASI score from base line will be calculated to evaluate treatment efficacy
次要结局
未报告次要终点
研究者
Tayyaba Iqbal
DR tAYYABA iQBAL
Dow University of Health Sciences