A Prospective, Non-interventional Study to Collect Subject and Physician Satisfaction During Long Term Treatment of Glabellar Lines With Dysport® in Subjects of Chinese Origin in Real Clinical Practice
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Galderma R&D
- 入组人数
- 250
- 试验地点
- 1
- 主要终点
- Percentage of Participants in Each Response Category for Overall Participant Satisfaction at Visit 6, Assessed by the Subject Satisfaction Questionnaire
研究概览
简要总结
This is a prospective, longitudinal, non-interventional, multi-center study to collect subject and physician satisfaction, and treatment experience with Dysport in real clinical practice in subjects of Chinese origin.
详细描述
Approximately 250 subjects are planned to be included in the study.
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
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult male or female up to 65 years of age, and of Chinese origin.
- •Moderate (grade 2) or severe (grade 3) glabellar lines at max frown.
- •Prior to and independent of study, subject is seeking long term treatment of their glabellar lines.
- •Prior to and independent of the study participation, physician intended to treat the subject with Dysport.
- •Time and ability to complete the study and comply with instructions.
- •Understands the study requirements and signed the informed consent form (ICF)
排除标准
- •Hypersensitive to Dysport or its excipients.
- •Presence of contraindications to Dysport treatment as specified in the approved leaflet in China.
- •Subject is at risk for precautions, warnings, and/or contraindications to Dysport as specified in the approved leaflet in China.
研究组 & 干预措施
AbobotulinumtoxinA
Participants with moderate to severe GL received a total dose of AbobotulinumtoxinA (Dysport®), 50 U (0.25 mL total; 10 U [0.05 mL per injection site] of study drug into 5 injection sites intramuscularly: 2 injections into each corrugator muscle and 1 injection into the procerus muscle) at Visits 1, 3, and 5.
干预措施: AbobotulinumtoxinA (Biological)
结局指标
主要结局
Percentage of Participants in Each Response Category for Overall Participant Satisfaction at Visit 6, Assessed by the Subject Satisfaction Questionnaire
时间窗: Month 14
The participant's satisfaction with the treatment was assessed using a subject satisfaction questionnaire. At Visit 6 (that is., three weeks, after the 3rd injection) participants were asked "What is your overall satisfaction after three treatment cycles with Dysport?" Participant's response options were noted as: Very Satisfied, Satisfied, Dissatisfied, Very Dissatisfied. Percentage of participants in each response category were reported here.
次要结局
- Percentage of Participants in Each Response Category for Overall Physician Satisfaction at Visit 6, Assessed by the Physician Satisfaction Questionnaire(Month 14)
- Percentage of Participants Satisfied With the Treatment Assessed Using a Subject Satisfaction Questionnaire(Month 20)