NCT00510081撤回3 期
An Open Label Evaluation of the Safety and Efficacy of Calcium Hydroxylapatite (Radiesse®) Injection in the Correction of Jowl-Associated Chin Notches
适应症
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 主要终点
- Correction of wrinkles
研究概览
简要总结
The objective of this study is to determine the effectiveness of a filler in improving wrinkles.
详细描述
The primary objective of this study is to determine whether focal injection of calcium hydroxylapatite (Radiesse®), an injectable biodegradable filler, into jowl-induced chin notches can result in safe, aesthetically pleasing, and long-lasting correction of these.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 40-65
- •Have wrinkles
- •The subjects are in good health.
- •The subject has willingness and the ability to understand and provide informed consent for the use of their tissue and communicate with the investigator.
排除标准
- •Subjects who have received within the past 3 months or are planning to receive in the next 6 months, botulinum toxin injections for correction of wrinkles.
- •Subjects who have received within the past one year any soft tissue augmentation material into the chin and experimental area (defined as any area on the face below the lower lip vermilion, excluding the lateral lip marionette line up to 1 cm below this level).
- •Subjects with prior history of nodule formation or hypersensitivity reactions to lidocaine or medium-term augmentation materials, including hyaluronic acid derivatives, poly-L-lactic acid, and calcium hydroxylapatite.
- •Subjects who are currently using anticoagulation therapy.
- •Subjects who have a history of bleeding disorders.
- •Subjects who are unable to understand the protocol or to give informed consent.
- •Subjects with mental illness.
结局指标
主要结局
Correction of wrinkles
时间窗: 1 week
次要结局
- Development of adverse events(1 week)
研究者
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