NCT01629134已完成不适用
Postmarket Study of JUVÉDERM VOLBELLA™ With Lidocaine in the Lips
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 62
- 主要终点
- Injector Rating of the Natural Look and Feel of the Lips
研究概览
简要总结
A prospective, multicenter postmarket study of the use of JUVÉDERM VOLBELLA™ with Lidocaine in the lips.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Desire and willingness for correction of asymmetry or volume enhancement of his/her lips
- •Females and males ≥ 18 years of age
- •Have established a realistic treatment goal that the Physician agrees is achievable, i.e., have realistic expectations of aesthetic results
排除标准
- •Not fulfilling the standard prescribing criteria for JUVÉDERM VOLBELLA™ with Lidocaine as detailed in the Directions for Use
- •Have a condition or be in a situation that, in the Physician's opinion, may put the subject at significant risk, may confound the study results, or may interfere significantly with the subject's participation in the study
结局指标
主要结局
Injector Rating of the Natural Look and Feel of the Lips
时间窗: 4 weeks
Percentage of injectors who rated the look and feel of subjects' lips as being extremely natural, very natural, slightly natural, and not natural.
Subject Rating of the Natural Look and Feel of the Lips
时间窗: 4 weeks
Percentage of subjects rating the look and feel of their lips as being extremely natural, very natural, slightly natural, and not natural.
次要结局
- Ease of Injection(15 minutes after injection)
- Bruising of the Lips(15 minutes after injection)
- Malleability of Product(15 minutes after injection)
- Need for Massage(15 minutes after injection)
- Return to Social Engagement(4 weeks)
- Comparative Rating With Previous Treatment(15 minutes after injection)
- Swelling of the Lips(15 minutes after injection)
- Rating of Injection Discomfort(15 minutes after injection)
研究者
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