Non-Interventional Post-Authorisation Safety Study of NUCEIVA for the Treatment of Moderate-to-Severe Glabellar Lines
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Evolus, Inc.
- 入组人数
- 756
- 试验地点
- 1
- 主要终点
- Treatment Emergent Adverse Events
研究概览
简要总结
Non-interventional PASS of NUCEIVA for the treatment of moderate-to-severe glabellar lines to provide additional characterisation of the long-term safety of NUCEIVA in the real-world clinical practice setting.
详细描述
This is a prospective, multicentre, non-interventional observational Post Authorisation Safety Study; Safety data will be collected from approximately 750 patients at 20 sites throughout the United Kingdom and the European Union over an 18 month evaluation period. Eligible patients will receive an initial treatment of 20 Units of NUCEIVA. Further treatment will not be specified, recommended or required by the protocol. Patients may receive up to 6 treatments of 20 Units of NUCEIVA over the course of the 18-month study.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patient is an adult less than 65 years of age
- •Patient presenting to a participating physician has moderate to severe vertical lines between the eyebrows seen at maximum frown (glabellar lines)
- •Patient finds their glabellar lines have an important psychological impact
- •Written informed consent is obtained from the patient.
排除标准
- •Patient has a legal incapacity or limited legal capacity without legal guardian representation
- •Patient is currently participating in an interventional study of any investigational product, device or procedure
- •Patient has a hypersensitivity to the active substance or to any of the excipients listed in Section 6.1 of the Summary of Product Characteristics
- •Patient has a generalised disorder of muscle activity (e.g. myasthenia gravis or Eaton Lambert Syndrome)
- •Patient has an infection or inflammation at any of the proposed injection sites
- •Patient has a history of dysphagia and/or aspiration
- •Female patient is pregnant, is of childbearing potential and not using contraception, is breast feeding, or is planning to become pregnant during the next 18 months
- •Patient has received prior botulinum toxin for any indication within 3 months of study enrolment.
研究组 & 干预措施
Safety Population
The safety population will consist of all patients who receive at least one treatment of NUCEIVA.
干预措施: prabotulinumtoxinA (Drug)
Botulinum Toxin Exposed
Sub-population of patients that have previously been treated with botulinum toxin
干预措施: prabotulinumtoxinA (Drug)
Botulinum Toxin Naïve
Sub-population of patients that have never been treated with botulinum toxin
干预措施: prabotulinumtoxinA (Drug)
结局指标
主要结局
Treatment Emergent Adverse Events
时间窗: From the time of first dose until participant exits the study at 18 months post initial treatment
Number and percentage of patients with an event that started or worsened in severity at or after the first dose of NUCEIVA
次要结局
- Adverse Events of Particular Interest(From the time of first dose until participant exits the study at 18 months post initial treatment)