Lateral Canthal Rhytides With Medium Depth Chemical Peel With or Without Pretreatment With Botulinum Toxin A
2017年8月8日 更新者：Rebecca Tung、Loyola University
Treatment of Lateral Canthal Rhytides With Medium Depth Chemical Peel With or Without Pretreatment With Botulinum Toxin A: A Split-face, Rater-blinded Randomized Control Trial
This study is being done to find out if the use of botulinum toxin prior to a medium strength combination chemical peel (Jessner's peel followed by 35% Trichloroacetic acid peel) will improve the appearance of crow's feet wrinkles when compared to a chemical peel alone.
Botulinum toxin type A is a purified substance, derived from a bacteria that block muscular nerve signals.
Jessner's Peel, a combination of resorcinol (14g), salicylic acid (14g), and lactic acid (85%) in ethanol (95%), is a superficial chemical peel.
These two products/procedures have been FDA approved to improve the appearance of facial wrinkles.
研究概览
详细说明
Wrinkling in the skin is caused by habitual facial expressions, aging, sun damage, smoking, poor hydration, and various other factors.
There are two major types of wrinkles-dynamic and static.
Dynamic wrinkles, which are due to excessive muscle activity, usually of the face, tend to disappear when you relax your facial muscles.
The most common of these dynamic wrinkles are frown lines, forehead wrinkles, and eye wrinkles (or crow's feet).
However, if the excessive muscle activity is carried on for too long, these do not disappear completely on relaxation, and are thus called static wrinkles.
Static wrinkles are formed either by chronic excessive muscle activity or are due to the effects of age and gravity, with a loss of subcutaneous fat.
Examples of static wrinkles are the nasolabial folds, which are the deep grooves running from the sides of the nose to the corners of the mouth.
研究类型
介入性
注册 (实际的)
26
阶段
- 第三阶段
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
-
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Illinois
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La Grange Park、Illinois、美国、60526
- Loyola Dermatology
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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
30年 至 75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:
- Age 30 to 75 years old
- In good health
- Has static and dynamic lateral canthal wrinkles ("crow's feet")
- Has the willingness and the ability to understand and provide informed consent and communicate with the investigator
Exclusion Criteria:
- Pregnant or lactating
Has received the following treatments:
- botulinum toxin injections in the past 6 months
- ablative laser procedure in the past 6 months
- radiofrequency device treatment in the past 6 months
- ultrasound device treatment in the past 6 months
- medium to deep chemical peel in the past 6 months
- temporary soft tissue augmentation material in the past year
- semi-permanent soft tissue augmentation material in the past 2 years
- permanent soft tissue augmentation material
- Is planning to receive within the next 3 months, any cosmetic procedure (such as any chemical peels, botulinum toxin injections, ablative or non-ablative laser procedures, filler injections, radiofrequency procedures, dermabrasion, ultrasound and face lifting procedures)
- Has an active infection on their face (excluding mild acne
- Has a history of neuromuscular disorders
- Has an allergy to albumin
- Has an allergy to Aquaphor AND petroleum jelly
- Has a history of bleeding disorders
- Is unable to understand the protocol or to give informed consent
- Has a mental illness
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：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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有源比较器：Botulinum Toxin
The botulinum toxin will be injected into the wrinkles.
The injections will take about 10 minutes to complete.
Five follow-up visits will be scheduled at 1-7 days, 7-10 days, 2.5-3 weeks, and 12-14 weeks.
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The botulinum toxin will be injected into the wrinkles "crow's feet".
The injections will take about 10 minutes to complete.
其他名称：
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有源比较器：Chemical Peel Only
After cleansing the face with a pre-treatment cleansed composed of water and alcohol, the Jessner's peel solution will be applied to the entire face with a large cotton swab. The mixture will be left in place for a few minutes, and then the face will be wiped clean with water. Next, the TCA peel will be applied around the eyes. After leaving in place for a few minutes, cool, iced washcloths will be applied and the face will be wiped clean with water. Wound care regimen will consist of dilute acetic acid and either Aquaphor or petroleum jelly. |
After cleansing the face with a pre-treatment cleansed composed of water and alcohol, the Jessner's peel solution [a combination of resorcinol (14g), salicylic acid (14g), and lactic acid (85%) in ethanol (95%)] will be applied to the entire face with a large cotton swab.
The mixture will be left in place for a few minutes, and then the face will be wiped clean with water.
Next, the TCA peel [35% Trichloroacetic acid] will be applied around the eyes.
After leaving in place for a few minutes, cool, iced washcloths will be applied and the face will be wiped clean with water.
Wound care regimen will consist of dilute acetic acid and either Aquaphor or petroleum jelly.
其他名称：
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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 |
|---|---|---|
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Posttreament Results of Chemical Peel if Botox A is Added as Pre-treatment
大体时间：Baseline and 12 weeks
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The primary objective of this study is to determine if pre-treating the orbicularis oculi muscles with botulinum toxin A improves the results of medium depth chemical peels when treating lateral canthal rhytides.
The primary dependent variable is the four-point Facial Wrinkle Severity Scale (FWSS): Grade 0 = no wrinkles; Grade 1 = mild wrinkles; Grade 2 = moderate wrinkles; and Grade 3 = severe wrinkles.
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Baseline and 12 weeks
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Change From Pre- to Post-treatment Scores of Chemical Peel if Botox A is Added as Pre-treatment
大体时间：Baseline and 12 weeks
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The primary objective of this study is to determine if there is a significant difference between the change from pre- to post-treatment scores on the facial wrinkle severity scale between the chemical peel control group and the chemical peel plus Botox A treatment group.
The primary dependent variable is the four-point Facial Wrinkle Severity Scale (FWSS): Grade 0 = no wrinkles; Grade 1 = mild wrinkles; Grade 2 = moderate wrinkles; and Grade 3 = severe wrinkles.
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Baseline and 12 weeks
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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。
调查人员
- 首席研究员：Rebecca Tung, MD、Loyola University
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)
2011年9月1日
初级完成 (实际的)
2013年5月1日
研究完成 (实际的)
2013年5月1日
研究注册日期
首次提交
2011年11月22日
首先提交符合 QC 标准的
2012年4月26日
首次发布 (估计)
2012年4月27日
研究记录更新
最后更新发布 (实际的)
2017年9月11日
上次提交的符合 QC 标准的更新
2017年8月8日
最后验证
2017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.