A Real-world Study on the Influencing Factors of the Efficacy of Ruxolitinib Cream in the Treatment of Vitiligo
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 170
- 试验地点
- 1
- 主要终点
- the proportion of achieving T-VASI50 (50% improvement of total vitiligo area scoring index T-VASI)
研究概览
简要总结
Vitiligo is a common chronic autoimmune skin disease that can occur on any part of the body and severely impacts patients' quality of life. Current treatment for vitiligo primarily include topical medications, phototherapy, systemic therapy and surgical interventions, but their efficacy is limited, often failing to achieve ideal therapeutic outcomes, and are associated with a high recurrence rate. This study is an investigator-initiated real-world research on the application of ruxolitinib cream for vitiligo treatment, with the primary objective of exploring the factors influencing the efficacy of ruxolitinib cream in treating vitiligo.
详细描述
Vitiligo is a common chronic autoimmune skin disease characterized by skin depigmentation, resulting in white patches that can occur on any part of the body and significantly impact patients' quality of life. Currently, treatment options for vitiligo primarily include topical medications, phototherapy, systemic therapy and surgery; however, their efficacy is limited, making it difficult to achieve optimal therapeutic outcomes,with a high recurrence rate. Studies have demonstrated that the JAK-STAT signaling pathway plays a critical role in autoimmune diseases and is involved in the pathogenesis of vitiligo. The JAK inhibitor ruxolitinib cream can improve skin lesions in patients with vitiligo. This study is an investigator-initiated real-world study on the use of ruxolitinib cream for the treatment of vitiligo, with the primary objective of investigating the factors influencing the efficacy of ruxolitinib cream in vitiligo treatment. Primary outcome measure: At Week 24, the clinical characteristic differences between the groups achieving and not achieving T-VASI50 [50% improvement of total vitiligo area scoring index (T-VASI)]. Secondary outcome measures:
(1) At Week 12 and Week 24, the proportion of patients scoring 4(slightly noticeable) or 5(no longer noticeable) on the Vitiligo Noticeability Scale (VNS), as well as the distribution of patients within each category; (2) Change from baseline in vitiligo-specific quality-of-life score (vitiligo-specific quality-of-life, VitiQoL) at Week 12 and Week 24; (3) Proportion achieving T-VASI 50/75/90 at Week 12 and Week 24; (4) Proportion achieving F-VASI 50/75/90[facial vitiligo area scoring index(F-VASI)] at Week 12 and Week24.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age12 years or older, any gender;
- •Signed"Informed Consent Form";
- •Clinically diagnosed with non-segmental vitiligo;
- •Vitiligo area less than 10% of body surface area;
- •Agreed to discontinue all other vitiligo-related treatments from the screening visit until the final follow-up visit;
- •Female subjects must not plan for pregnancy or oocyte donation from screening until 4 weeks after the last dose and must voluntarily adopt highly effective physical contraception; male subjects must not plan for fertility or sperm donation during the same period and must voluntarily adopt highly effective physical contraception. Methods include:
- •Barrier methods: Condom or barrier cap (diaphragm or cervical cap);
- •Intrauterine device (IUD) or intrauterine system (IUS);
- •Surgical sterilization (bilateral oophorectomy with/without hysterectomy, total hysterectomy, bilateral tubal ligation, or vasectomy) performed ≥6 months prior to the first dose in the subject or their partner;
- •Other investigator-confirmed highly effective physical contraception.
排除标准
- •Allergy to ruxolitinib cream;
- •Pregnant or lactating women;
- •Any condition deemed inappropriate for study participation by the investigator.
研究组 & 干预措施
ruxolitinib
ruxolitinib twice per day
干预措施: Ruxolitinib 1.5% Cream BID (Drug)
结局指标
主要结局
the proportion of achieving T-VASI50 (50% improvement of total vitiligo area scoring index T-VASI)
时间窗: Week 24
First, determine the body parts to be evaluated, including the face and neck, palms, upper limbs, trunk, lower limbs and feet, five regions in total. Using the patient's palm as 1% of body surface area to estimate the area of depigmented patches in each body part, measuring the area of depigmented patches within each region. The T-VASI score categorizes the degree of depigmentation into seven levels: 0%, 10%,25%,50%,75%,90%, or 100%. Based on the area of depigmented patches and the degree of depigmentation in each region, the score for each region is calculated according to the T-VASI scoring formula. The specific calculation formula is:T-VASI=∑(number of handprint units occupied by each body part)× the percentage of pigment loss in that region. The score ranges from 0 to 100. The T-VASI50 score represents the proportion of subjects who achieve a≥50% improvement in the Vitiligo Area Scoring Index compared to baseline.
次要结局
- the proportion of patients scoring 4(slightly noticeable) or 5(no longer noticeable) on the Vitiligo Noticeability Scale (VNS)(Week 12 and Week 24)
- Change from baseline in VitiQoL(vitiligo-specific quality-of-life）(Week 12 and Week 24)
- Proportion achieving T-VASI 75/90 (75/90% improvement of total vitiligo area scoring index T-VASI)(Week 12 and Week 24)
- Proportion achieving F-VASI 50/75/90(50/75/90% improvement in facial vitiligo area scoring index)(Week 12 and Week24)
研究者
Guo Jin-Zhu
Deputy director of Dermatology Department
Peking University Third Hospital