A Study of Subject Satisfaction With BOTOX® Cosmetic Treatment in Facial Rhytides
2019年4月15日 更新者：Allergan
This is a safety and efficacy study of BOTOX® in subjects with facial rhytides (glabellar lines and crow's feet lines).
研究概览
研究类型
介入性
注册 (实际的)
125
阶段
- 第四阶段
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
-
-
Ontario
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Toronto、Ontario、加拿大
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-
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:
- Glabellar lines and crow's feet lines
- No prior use of botulinum toxin therapy of any serotype for any reason
Exclusion Criteria:
- Previous facial cosmetic surgery, tissue grafting, or tissue augmentation with silicone or fat or other permanent fillers
- Planning a facial cosmetic procedure during the study period
- Diagnosis of myasthenia gravis, Eaton-Lambert Syndrome, and/or amyotrophic lateral sclerosis
- Anticipated need for treatment with botulinum toxin of any serotype for any reason during the study (other than study treatment)
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：三倍
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
有源比较器：BOTOX®
BOTOX® (onabotulinumtoxinA) injected into the areas of glabellar lines and crow's feet lines on Day 1.
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BOTOX® (onabotulinumtoxinA) injected into the areas of glabellar lines and crow's feet lines on Day 1.
其他名称：
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安慰剂比较：Placebo
Placebo (normal saline) injected into the areas of glabellar lines and crow's feet lines on Day 1.
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Placebo (normal saline) injected into the areas of glabellar lines and crow's feet lines on Day 1.
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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 |
|---|---|---|
|
Percentage of Participants Satisfied With Treatment of Glabellar Lines Assessed Using the Facial Line Satisfaction Questionnaire (FLSQ)
大体时间：Day 60
|
Participants assessed their overall satisfaction with their glabellar (frown) lines using the FLSQ 5-point scale where: -2=Very dissatisfied, -1=Mostly dissatisfied, 0=Neither dissatisfied nor satisfied, 1=Mostly satisfied and 2=Very satisfied.
The percentage of participants with responses mostly or very satisfied is reported.
|
Day 60
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Percentage of Participants Satisfied With Treatment of Crow's Feet Lines (CFL) and Glabellar Lines Assessed Using the FLSQ
大体时间：Day 60
|
Participants assessed their overall satisfaction with both their CFL and glabellar lines using the FLSQ 5-point scale where: -2=Very dissatisfied, -1=Mostly dissatisfied, 0=Neither dissatisfied nor satisfied, 1=Mostly satisfied and 2=Very satisfied.
The percentage of participants mostly or very satisfied is reported.
|
Day 60
|
|
Percentage of Participants Satisfied With Duration of Treatment of Glabellar Lines Assessed Using the FLSQ
大体时间：Day 90
|
Participants assessed their overall satisfaction with duration of treatment of glabellar lines using the FLSQ 5-point scale where: -2=Very dissatisfied, -1=Mostly dissatisfied, 0=Neither dissatisfied nor satisfied, 1=Mostly satisfied and 2=Very satisfied.
The percentage of participants with responses mostly or very satisfied is reported.
|
Day 90
|
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Percentage of Participants Where Treatment of Glabellar Lines Met Expectation Assessed Using the FLSQ
大体时间：Day 60
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Participants assessed whether treatment of their glabellar lines met expectation using the FLSQ 3-point scale where: 1=Worse than expected, 2=Met expectations and 3=Better than expected.
The percentage of participants with responses Met expectations and Better than expected is reported.
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Day 60
|
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Percentage of Participants Satisfied With Duration of Treatment of CFL and Glabellar Lines Assessed Using the FLSQ
大体时间：Day 90
|
Participants assessed their overall satisfaction with duration of treatment of both CFL and glabellar lines using the FLSQ 5-point scale where: -2=Very dissatisfied, -1=Mostly dissatisfied, 0=Neither dissatisfied nor satisfied, 1=Mostly satisfied and 2=Very satisfied.
The percentage of participants with responses mostly or very satisfied is reported.
|
Day 90
|
|
Percentage of Participants Where Treatment of CFL and Glabellar Lines Met Expectation Assessed Using the FLSQ
大体时间：Day 60
|
Participants assessed whether treatment of glabellar lines met expectations using the FLSQ 3-point scale where: 1=Worse than expected, 2=Met expectations and 3=Better than expected.
The percentage of participants with responses Met expectations and Better than expected is reported.
|
Day 60
|
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Percentage of Participants Who Were Likely to Continue Treatment of Glabellar Lines Assessed Using the FLSQ
大体时间：Day 90
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Participants assessed how likely they were to continue treatment of glabellar Lines using the FLSQ 5-point scale where: 1=Not at all, 2=A little bit, 3=Moderately, 4=Quite a bit and 5=Extremely.
The percentage of participants with responses Moderately, Quite a bit and Extremely is reported.
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Day 90
|
|
Percentage of Participants Who Were Likely to Continue Treatment of CFL and Glabellar Lines Assessed Using the FLSQ
大体时间：Day 90
|
Participants assessed how likely they were to continue treatment of CFL and glabellar Lines using the FLSQ 5-point scale where: 1=Not at all, 2=A little bit, 3=Moderately, 4=Quite a bit and 5=Extremely.
The percentage of participants with responses Moderately, Quite a bit and Extremely is reported.
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Day 90
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Percentage of Participants With a Score of None or Mild in the Investigator's Assessment of the Severity of Glabellar Lines at Maximum Frown Assessed Using the FWS
大体时间：Day 30
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The Investigator assessed the severity of the patient's glabellar lines at maximum frown using the 4-point Facial Wrinkle Scale (FWS) where: 0=none, 1=mild, 2=moderate, and 3=severe.
The percentage of participants with a score of none or mild is reported.
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Day 30
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Percentage of Participants With at Least a 1-Grade Improvement in the Investigator's Assessment of the Severity of CFL at Maximum Smile Assessed Using the FWS
大体时间：Baseline, Day 30
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The Investigator assessed the severity of the patient's CFL at maximum smile using the 4-point FWS where: 0=none, 1=mild, 2=moderate, and 3=severe.
The percentage of participants with at least a 1-Grade improvement from Baseline is reported.
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Baseline, Day 30
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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
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。
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 (实际的)
2013年1月31日
初级完成 (实际的)
2013年5月29日
研究完成 (实际的)
2013年7月31日
研究注册日期
首次提交
2013年1月25日
首先提交符合 QC 标准的
2013年1月25日
首次发布 (估计)
2013年1月29日
研究记录更新
最后更新发布 (实际的)
2019年4月17日
上次提交的符合 QC 标准的更新
2019年4月15日
最后验证
2019年4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.
面部皱纹的临床试验
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Lisa M. Guay-WoodfordNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)招聘中肾炎 | 茹伯特综合症 | Bardet Biedl 综合症 | 常染色体隐性多囊肾病 | 先天性肝纤维化 | 肝/肾纤维囊性疾病 | 梅克尔-格鲁伯综合症 | 卡罗利综合症 | Oro-Facial-Digital 综合症 I 型 | 肾小球囊性肾病美国
onabotulinumtoxinA的临床试验
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Dartmouth-Hitchcock Medical CenterPatient-Centered Outcomes Research Institute; University of Alabama at Birmingham; University... 和其他合作者招聘中
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Seoul National University HospitalIpsen; Medical Research Collaborating Center, Seoul, Korea完全的
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University of California, IrvineKaiser Permanente; St. Joseph Hospital of Orange主动，不招人
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William Beaumont Hospitals终止
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Northwestern UniversityFriends of Prentice完全的
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Medstar Health Research InstituteColumbia University; University of Michigan; University of New Mexico; Methodist Urology Associates...终止