Pan Facial Volume Restoration With a New Hyaluronic Acid Dermal Filler
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Galderma R&D
- 入组人数
- 60
- 试验地点
- 3
- 主要终点
- Mean Change From Baseline in Volume Loss Assessment
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 further to pan-facial volume restoration with a new cross-linked hyaluronic acid dermal filler containing lidocaine 0.3%.
详细描述
Clinical hypothesis: The global approach of the subject pan-facial dermal volume depletion and face soft-tissue contour defects correction using specific dermal filler for all indications to be injected will satisfy both subjects and investigators.
This device will be used for full face correction of volume loss: chin, temporal areas, jawline, cheek, cheekbones, deep to very deep nasolabial folds (only if cheekbones are injected concomitantly).
Study duration will be up to 19 months. Injections will be performed at baseline. If necessary, investigator will perform touch-up injections at the following visit (3 weeks after baseline injection).
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
- •Subjects seeking treatment for correction of volume loss.
- •Subjects presenting a score of at least 2 (visible depression or descent) for whole face on the volume loss scale and at least 2 indications affected by volume loss among the following: chin temporal areas, jawlines, cheeks, cheekbones, deep to very deep nasolabial folds (severity score 4 at least on Lemperle rating scale) if cheekbones are injected.
排除标准
- •Subjects at risk in term of precautions, warnings and contraindication referred in the package insert of the study device,
- •Subjects who underwent previous injection of permanent filler in the injected area.
结局指标
主要结局
Mean Change From Baseline in Volume Loss Assessment
时间窗: Baseline and 18 Months after last injection
Overall loss of volume on full face was graded on a volume loss scale (VLS) of 0 to 3 by the investigator as follow: 0= normal, 1= evidence of early soft tissue ptosis or atrophy slightly visible, 2=visible depression or descent, 3= severe depression or atrophy. Last injections were given either at baseline or touch-up injections (if needed) on previously injected areas at 3 Weeks after baseline.
次要结局
- Percentage of Participants Satisfied or Very Satisfied at 3 Weeks After Last Injection(At 3 Weeks after last injection)
- Percentage of Investigators Satisfied With the Use of Study Hyaluronic Acid Dermal Filler(Baseline up to 18 Months after last injection)
- Number of Participants With Adverse Events (AEs)(Baseline up to 18 Months after last injection)
- Percentage of Participants Satisfied or Very Satisfied at 18 Months After Last Injection(At 18 Months after last injection)