NCT02353897已完成不适用
An Assessment of Patient and Physician's Satisfaction After a Long Term Treatment of Glabellar Lines With Dysport®.
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Ipsen
- 入组人数
- 150
- 试验地点
- 14
- 主要终点
- To assess patient satisfaction regarding GL after three injection cycles of Dysport.
研究概览
简要总结
This study aims to look at patient and physician satisfaction of long term Glabellar lines (GL) treatment with Dysport in a real life setting. It will also allow better understanding of what patients expect from the treatment, and the injection practices used by doctors.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patient with moderate to severe GL naïve of any type of aesthetic treatment/procedure (invasive and non-invasive) for GL who provided written informed consent to take part.
- •Patient who has prior to and independent of the study decided to undergo long term treatment of GL only (at least three cycles).
- •Patient able to comply with the protocol (completion of web questionnaires).
- •Patient whom physician intended to treat with Dysport independent of participation in the study.
排除标准
- •Patient already included in this study.
- •Participation in an interventional trial within 30 days prior to study entry.
- •Patient who is at risk in terms of precautions, warnings, and contraindication (follow local Summary of Product Characteristics (SmPC) of Dysport).
- •Female patient who is pregnant, nursing or planning a pregnancy during the study.
- •Hypersensitivity to Dysport® or to its excipients.
- •Presence of infection at the proposed injection sites.
- •Presence of myasthenia gravis, Eaton Lambert syndrome or amyotrophic lateral sclerosis.
结局指标
主要结局
To assess patient satisfaction regarding GL after three injection cycles of Dysport.
时间窗: Within 3 weeks ±7 days of visit 3
Assessed by patient auto questionnaire completion
次要结局
- To describe patient individual expectations.(Within 3 weeks ±7 days of visit 1 and 2)
- To assess patient satisfaction after one and two injection cycles of Dysport.(Within 3 weeks ±7 days of visit 1 and 2)
- To describe factors associated with patient satisfaction such as attractiveness, self-esteem, self-perceived age, desire to receive another injection.(Within 3 weeks ±7 days of visit 1 and 2)
- To assess the GL severity (at rest and maximum frown) as per usual practice.(Baseline (visit 1) and visit 3)
- To assess physician satisfaction after one and three injection cycles of Dysport.(Visit 1 follow up visit and visit 3 follow up visit (if performed))
- To describe Dysport injection practices: muscles injected, total injected units, total volume injected, number of injection points and interval between injections.(From visit 1 until the end of the study)
研究者
研究点 (14)
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