Cross-sectional Study to Characterize Real World Burden of Disease in Patients With Vitiligo in China
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 4
- 主要终点
- Total Vitiligo Area Scoring Index (T-VASI)
研究概览
简要总结
The purpose of this study is to evaluate the patterns of treatment, healthcare resources utilized and the burdens associated with non-segmental vitiligo (NSV) amongst participants in China
This study is a cross-sectional, multicenter, observational study of vitiligo patients in China. The cross-sectional design is sufficient to characterize the overall current burden of NSV.
详细描述
Cross-Sectional
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 12 Years 至 99 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female patients, age ≥
- •Chinese patients meet the diagnosis of Non-Segmental Vitiligo (NSV) and 5≤ Total Vitiligo Area Scoring Index (T-VASI<50) with or without facial involvement.
- •Medical history available within the last 6 months.
- •Ability to understand the questionnaires, with parental support as required for adolescents (between ≥ 12 and < 18 years of age at inclusion visit).
- •Willing to provide a patient authorization form to use and disclose personal health information (or informed consent, where applicable) to participate in the study; for adolescent subjects, authorization and/or consent will be provided by a parent or legal guardian, where applicable.
排除标准
- •Unable or unwilling to comply with study requirements and electronic Patient-Reported Outcome (ePRO) collection.
- •Segmental or localized vitiligo.
- •Greater than 33% leukotrichia in areas of vitiligo on the face or on the body.
- •History of active skin disease other than vitiligo that could interfere with the assessment of vitiligo.
- •Patients who are participating in interventional clinical trial(s) at time of study visit.
- •Patients who are currently receiving treatment with any investigational drug/device/intervention or have received any investigational product within 1 month or 5 half-lives of the investigational agent (whichever is longer) prior to enrollment.
结局指标
主要结局
Total Vitiligo Area Scoring Index (T-VASI)
时间窗: At Inclusion Visit (Day 1)
The T-VASI is calculated using a formula that includes contributions from all body regions, with a possible range from 0 to 100, with higher scores indicating more severe disease.
Vitiligo Quality of Life Scale (VitiQoL)
时间窗: At Inclusion Visit (Day 1)
The VitiQoL is an 16-item instrument assessing impact of vitiligo on quality of life. 15 items are scored on a 7-point Likert scale, ranging from "not at all" to "all the time". An additional item (not contributing to total score) assesses current severity of condition on a 7-point scale ranging from "no skin involvement" to "most severe case"
次要结局
未报告次要终点