Systemic Treatments for Alopecia Areata Registry
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 10,000
- 试验地点
- 1
- 主要终点
- Safety of systemic treatments
研究概览
简要总结
A multicenter prospective registry (STA2R) is conducted to assess systemic treatments for alopecia areata, focusing on effectiveness, safety, and long-term outcomes.
详细描述
Rationale:
Alopecia areata (AA) is a dermatological disorder characterized by non-scarring hair loss, significantly affecting the quality of life of patients. While some patients experience spontaneous hair regrowth or respond well to localized treatments, patients with moderate-to-severe AA represent a subgroup that requires more extensive systemic therapies for effective management. Currently, the clinical management of moderate-to-severe AA is primarily based on expert opinions. There is a lack of research on systemic treatments for moderate-to-severe AA, comprising only a small number of randomized controlled trials and observational studies. Furthermore, there is a clear absence of long-term, prospective, and comparative data on these therapies. Most conventional systemic treatments for AA are prescribed off-label, underlining the importance of gaining a more comprehensive understanding of their effectiveness and safety.
Therefore, a long-term prospective registry is conducted. This registry will evaluate the real-world utilization of systemic treatments in AA patients, aiming to provide valuable insights into the effectiveness, safety, and long-term outcomes of these therapies. By collecting and analyzing such data, this registry endeavors to contribute to evidence-based clinical management, ultimately improving care for AA patients.
Objective:
The aim is to establish a comprehensive cohort of AA patients receiving systemic treatments, with the primary objective of assessing the short- and long-term effectiveness and safety of various systemic treatments for AA.
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
- 16 Years 至 —(Child, Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed with alopecia areata;
- •Starting/using a systemic treatment for alopecia areata;
- •Informed consent for registry participation obtained from patient and/or caretaker.
排除标准
- •Not sufficiently capable of understanding the Dutch language;
- •Not willing to participate.
结局指标
主要结局
Safety of systemic treatments
时间窗: A minimum of 10 years from last patient enrolled (every 3-6 months)
The primary study parameters and endpoints include assessing the short- and long-term safety of various systemic treatments for alopecia areata. Measured by the number of participants with treatment-related adverse events.
Effectiveness of systemic treatments
时间窗: A minimum of 10 years from last patient enrolled (every 3-6 months)
The primary study parameters and endpoints include assessing the short- and long-term effectiveness of various systemic treatments for alopecia areata. Effectiveness ranging from strong improvement to strong deterioration (5 categories).
次要结局
- Physician Reported - Severity of Alopecia Tool (SALT Score)(A minimum of 10 years from last patient enrolled (every 3-6 months))
- Epidemiological data(Baseline)
- Dermatology Life Quality Index (DLQI, 10 items)(A minimum of 10 years from last patient enrolled (every 3-6 months))
- Alopecia Areata Symptom Impact Scale (AASIS, 13 items)(A minimum of 10 years from last patient enrolled (every 3-6 months))
研究者
DirkJan Hijnen
Principal Investigator
Erasmus Medical Center
