A Multi-center Retrospective Chart Review to Evaluate the Safety of Sculptra Aesthetic When Used in Non-facial Areas
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Galderma R&D
- 入组人数
- 498
- 试验地点
- 8
- 主要终点
- Number of Participants With Adverse Events (AEs) Related to the Sculptra Aesthetic Reported in the Medical Chart
研究概览
简要总结
Multi-center retrospective chart review to evaluate the safety of Sculptra Aesthetic when used in non-facial areas
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Retrospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants who have been treated at the site with Sculptra Aesthetic in non-facial areas
- •Participants with available information about treatment dates and treatment procedures
排除标准
- •Participant that have actively asked not to be involved in a study or registry
- •Other conditions that in the Investigator's opinion would exclude the participant from participation ; the condition should be recorded.
研究组 & 干预措施
Sculptra Aesthetic
Participants who had been treated with at least 2 vials in each of at least 2 different treatment sessions of Sculptra Aesthetic injections in non-facial areas.
干预措施: Sculptra Aesthetic (Device)
结局指标
主要结局
Number of Participants With Adverse Events (AEs) Related to the Sculptra Aesthetic Reported in the Medical Chart
时间窗: Retrospective data was retrieved and observed during the period from January 2018 to 24 September 2022 (up to 1728 days)
Related AE was defined as a reasonable possibility that Sculptra Aesthetic or the injection procedure might have caused the event. AEs related to Sculptra Aesthetic or the injection procedure in non-facial areas were identified by review of the medical charts of between January 2018 to December 2020 and reported in this outcome measure.
次要结局
未报告次要终点