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临床试验/NCT06283316
NCT06283316招募中不适用

Systemic Treatments for Alopecia Areata Registry

Erasmus Medical Center1 个研究点 分布在 1 个国家目标入组 10,000 人开始时间: 2024年1月17日最近更新:
适应症

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

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

DirkJan Hijnen

Principal Investigator

Erasmus Medical Center

研究点 (1)

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