Global Management of Facial Rejuvenation With a New Range of Hyaluronic Acid Dermal Fillers - Investigator and Subject Satisfaction
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Galderma R&D
- 入组人数
- 77
- 试验地点
- 5
- 主要终点
- Full Face Global Aesthetic Improvement
研究概览
简要总结
The aim of this study is to assess performance and tolerance as well as investigator and subject satisfaction linked to the global management of facial rejuvenation with a new range of hyaluronic acid dermal fillers.
详细描述
The range of fillers tested in this study includes 5 different hyaluronic acid dermal fillers: Emervel Touch, Emervel Classic, Emervel Deep, Emervel Volume and Emervel Lips.
The study will last 6 month.
Injections will be performed at baseline. If necessary, the investigator will perform touch-up injections at the following visit (3 weeks later).
Investigator and subject satisfaction will be collected through questionnaires.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Seeking tissue augmentation treatment on the face,
- •Presenting a score of 3 (Moderately deep wrinkle)or 4 (Deep wrinkle) on the Lemperle Rating Scale (LRS) of both nasolabial folds.
排除标准
- •At risk in term of precautions, warnings and contra-indication referred in the package insert of the study devices,
- •Who underwent previous injection of permanent filler in the injected area.
结局指标
主要结局
Full Face Global Aesthetic Improvement
时间窗: 6 months after last injection
Global aesthetic improvement scale score from baseline: -1: worse 0: no change 1. improved 2. much improved 3. very much improved
次要结局
- PERIORBITAL LINES SEVERITY ASSESSMENT(6 MONTHS AFTER LAST INJECTION)
- CHEEK FOLDS SEVERITY ASSESSMENT(6 MONTHS AFTER LAST INJECTION)
- NASOLABIAL FOLDS SEVERITY ASSESSMENT(6 months after last injection)
- UPPER LIP LINES SEVERITY ASSESSMENT(6 MONTHS AFTER LAST INJECTION)
- MARIONETTE LINES SEVERITY ASSESSMENT(6 MONTHS AFTER LAST INJECTION)
- LIP ENHANCEMENT ASSESSMENT(6 MONTHS AFTER LAST INJECTION)