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Patient and Physician's Satisfaction After a Long Term Treatment of Glabellar Lines With Dysport® (APPEAL)

2020年11月4日更新者：Ipsen

An Assessment of Patient and Physician's Satisfaction After a Long Term Treatment of Glabellar Lines With Dysport®.

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.

研究概览

地位

完全的

条件

眉间线

研究类型

观察性的

注册 (实际的)

150

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

乌克兰
- - Kyiv、乌克兰、03087
    - Clinic of Aesthetic medicine "Ankor"
俄罗斯联邦
- - Moscow、俄罗斯联邦、105062
    - Centre of Aesthetic Medicine "Chistie prudi"
  - Moscow、俄罗斯联邦、117630
    - Preventive Medicine Clinic "Vallex M"
  - Moscow、俄罗斯联邦、119002
    - Plastic Surgery Institute
  - Novosibirsk、俄罗斯联邦、630071
    - FI IF & TC & apos; Eye microsurgery & apos
  - St Petersburg、俄罗斯联邦、197110
    - Clinic of Aesthetic Medicine
哈萨克斯坦
- - Almaty、哈萨克斯坦、050022
    - Laser Center DARUS
巴西
- - Botucatu、巴西、18603-390
    - Clinica Laura Bariquelo Buratini
捷克语
- - Brno、捷克语、60200
    - Estetická Dermatologie
  - Praha、捷克语、14000
    - BcD Clinic s.r.o.
澳大利亚
- - Malvern、澳大利亚、3144
    - ERASE
  - Sydney、澳大利亚、2217
    - SouthDerm
火鸡
- - Kocaeli、火鸡、41380
    - Kocaeli University School of Medecine Umuttepe
黎巴嫩
- - Beirut、黎巴嫩、70920
    - Dr Haddad Clinics

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年及以上 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

取样方法

非概率样本

研究人群

Private practices and clinics

描述

Inclusion Criteria:

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.

Exclusion Criteria:

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.

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

研究衡量的是什么？

主要结果指标

结果测量	措施说明	大体时间
To assess patient satisfaction regarding GL after three injection cycles of Dysport. 大体时间：Within 3 weeks ±7 days of visit 3	Assessed by patient auto questionnaire completion	Within 3 weeks ±7 days of visit 3

次要结果测量

结果测量	措施说明	大体时间
To describe patient individual expectations. 大体时间：Within 3 weeks ±7 days of visit 1 and 2	Assessed by patient auto questionnaire completion	Within 3 weeks ±7 days of visit 1 and 2
To assess patient satisfaction after one and two injection cycles of Dysport. 大体时间：Within 3 weeks ±7 days of visit 1 and 2	Assessed by patient auto questionnaire completion	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. 大体时间：Within 3 weeks ±7 days of visit 1 and 2	Assessed by patient auto questionnaire completion	Within 3 weeks ±7 days of visit 1 and 2
To assess the GL severity (at rest and maximum frown) as per usual practice. 大体时间：Baseline (visit 1) and visit 3	Physician assessment using GL severity scale	Baseline (visit 1) and visit 3
To assess physician satisfaction after one and three injection cycles of Dysport. 大体时间：Visit 1 follow up visit and visit 3 follow up visit (if performed)	5 point Likert scale	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. 大体时间：From visit 1 until the end of the study		From visit 1 until the end of the study

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Ipsen

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

Gubanova E, Haddad Tabet M, Bergerova Y, Moiseieva O, Chemeris A, Sanches E, Sharova A, Rodriguez Pose L, Raymond R, Prygova I, Carlisle I. Assessment of Subject and Physician Satisfaction after Long-Term Treatment of Glabellar Lines with AbobotulinumtoxinA (Dysport(R)/Azzalure(R)): Primary Results of the APPEAL Noninterventional Study. Aesthetic Plast Surg. 2018 Dec;42(6):1672-1680. doi: 10.1007/s00266-018-1200-4. Epub 2018 Aug 17.

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2014年10月1日

初级完成 (实际的)

2016年7月1日

研究完成 (实际的)

2016年7月1日

研究注册日期

首次提交

2015年1月29日

首先提交符合 QC 标准的