NCT00911872已完成不适用
EVOLENCE® Assessment of Recovery Time and Impact of Dermal Filler Selection: The E-ART™ Study
Solish, Nowell, M.D.1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2008年1月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Is to document recovery time/return to daily activities following facial soft-tissue augmentation with an EVOLENCE dermal filler
研究概览
简要总结
The purpose of this study is to gather information about the immediate effects and recovery time for treatment with EVOLENCE/EVOLENCE BREEZE for soft tissue augmentation. The time it takes for patients to feel comfortable with the results, and return to their normal daily routine is also of important interest
详细描述
The primary objective of this Investigator Initiated Study is to document recovery time/return to daily activities following facial soft-tissue augmentation with an EVOLENCE dermal filler. In addition, the immediate effects such as swelling, bleeding, bruising will be assessed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or Female > 18 years of age
- •Need for soft tissue augmentation as evidenced by any of the following:
- •Bilateral-aging defects > 1 on the Modified Fitzpatrick Wrinkle Scale
- •Decrease in soft tissue volume in other areas of the face
排除标准
- •History of positive hypersensitivity to porcine collagen-based products History of multiple food, drug, and substance allergies Autoimmune or collagen vascular disease Facial tissue augmentation within 6 months (HA) or 12 months Evolence/Evolence Breeze Botulinum-toxin A within 6 weeks Ablative laser treatments within 12 months Permanent facial implants Investigational product use within 30 days Pregnant and/or nursing woman or woman who plan to become pregnant during the study.
结局指标
主要结局
Is to document recovery time/return to daily activities following facial soft-tissue augmentation with an EVOLENCE dermal filler
时间窗: 7 Days
次要结局
- the immediate effects such as swelling, bleeding, bruising will be assessed(7 Days)
研究者
研究点 (1)
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