A Multi-Center Study Of CD07743 for the Improvement of Lateral Canthal Lines (CROW'S FEET)
2020年4月21日 更新者:Galderma R&D
A Multi-center Randomized, Double-blind, Placebo Controlled, Parallel-group Study of CD07743 for the Improvement of Lateral Canthal Lines (Crow's Feet)
This double-blind study has two parts for each subject (same population):
Part A: initial treatment in Lateral Canthal Lines (LCL) (placebo-controlled):
- To assess the efficacy and safety of Azzalure® compared to placebo in the improvement of moderate to severe LCLs.
- To assess the subjects' level of satisfaction with the appearance of their LCLs compared to placebo.
Part B: repeated treatment in LCL with or without Glabellar Lines (GL) (active treatment, up to 1 year):
- To assess safety of Azzalure® following repeated administration in the improvement of moderate to severe LCLs.
- To assess the safety of Azzalure® when used concomitantly for improvement of moderate to severe LCLs and GLs.
- To assess the subjects' level of satisfaction with the appearance of their LCLs.
研究概览
研究类型
介入性
注册 (实际的)
335
阶段
- 第三阶段
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 至 65年 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- Male or female subjects, 18 to 65 years of age (Screening visit),
- Moderate or severe (grade 2 or 3, Hund 2006) Lateral Canthal Lines "at maximum smile" determined by investigator at screening and baseline
- Mild to severe (grade 1, 2 or 3, Hund 2006) Lateral Canthal Lines "at rest" determined by investigator at screening and baseline
- The subject is a female of childbearing potential and has a negative urine pregnancy test (UPT) at screening and baseline
- Subjects who are not satisfied with their appearance at screening and baseline
- The subject is willing and able to comply with the requirements of the protocol and agree to adhere to the visit schedule, concomitant therapy prohibitions and must be compliant to the study instruction.
- The subject agrees to participate in the study, verified by dating and signing an approved written Informed Consent Form (ICF) and Photography Consent Form (PCF) (selected sites only if applicable) at the enrolment visit before any study procedures at screening
Exclusion Criteria:
- Any prior surgery affecting the orbicularis oculi muscle, prior blepharoplasty or brow lift, or any prior cosmetic procedures or scars that may interfere with the evaluation of the investigator.
- Previous insertion of any permanent, semi-permanent or biodegradable material in the periorbital region or facial treatment with augmentation material (e.g. silicon injections, collagen type implants, hyaluronic acid, lactic acid, etc.) within 12 months prior to screening.
- Any prior treatment with botulinum toxin (of any serotype)
- Previous treatment with lasers for skin resurfacing (e.g. CO2 (carbon dioxide)-laser) or treatment with deep chemical peels and any other esthetic or dermatologic treatments or procedures in any area of the face within 12 months prior to screening.
- Any planned facial cosmetic surgery or procedures during the study period.
- Presence of any bleeding disorders
- Pregnant or lactating women or women who are planning pregnancy during the study.
- Known hypersensitivity to any of the test materials or related compounds.
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
- 主要用途:治疗
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的:Botulinum Toxin type A
During part A, efficacy and safety parameters will be assessed for Azzalure vs. placebo
|
During part A, Azzalure will be administered at Baseline 60 Speywood units at canthal lines and compared with placebo.
|
|
安慰剂比较:Placebo
During part A, efficacy and safety parameters will be assessed for Azzalure vs. placebo
|
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 |
|---|---|---|
|
Number of Responders on the Severity of Lateral Canthal Lines "at Maximum Smile".
大体时间:Week 4
|
A positive response (responder) is defined as a grade of 0 or 1 (none or mild), as assessed by the investigator.
|
Week 4
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Number of Participants Satisfied With the Appearance of Their Lateral Canthal Lines
大体时间:Week 4
|
Participants were asked to assess their degree of satisfaction with the appearance of their lateral canthal lines using a 4-point scale with the grades Very satisfied, Satisfied, Dissatisfied, and Very dissatisfied.
A participant is considered satisfied if he/she answers Very satisfied or Satisfied.
|
Week 4
|
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
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
2011年1月1日
初级完成 (实际的)
2012年5月1日
研究完成 (实际的)
2012年5月1日
研究注册日期
首次提交
2011年3月2日
首先提交符合 QC 标准的
2011年3月2日
首次发布 (估计)
2011年3月3日
研究记录更新
最后更新发布 (实际的)
2020年5月1日
上次提交的符合 QC 标准的更新
2020年4月21日
最后验证
2012年8月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.