A Multi-center, Evaluator-blinded Study to Evaluate Effectiveness and Safety of HA Fillers for Lifting, Contouring and Correcting Volume Deficiency of the Midface Using an Individualized Treatment Algorithm
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Galderma R&D
- 入组人数
- 90
- 试验地点
- 3
- 主要终点
- Percentage of Participants With Aesthetic Improvement of Midface
研究概览
简要总结
The purpose of the study is to investigate the degree of improvement in appearance after treatment with different hyaluronic acid (HA) fillers. Product selection is based on Investigator assessment of participant tissue coverage and main treatment goal (volumizing, lifting or contouring).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 25 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male/Female 25 to 55 years old that needs lifting, contouring or volumization of the midface
- •Signed and dated informed consent
排除标准
- •Known/previous allergy or hypersensitivity to any injectable hyaluronic acid (HA) gel and lidocain
- •Previous use of any permanent or semi-permanent facial tissue augmentation therapy or contouring with, lifting threads, permanent implants, or autologous fat in the treatment area
- •Previous use of any HA or collagen based facial tissue augmentation therapy in the facial area, any previous use of neurotoxin or any previous facial surgery
- •Any medical condition that in the opinion of the Investigator would make the participant unsuitable for inclusion
研究组 & 干预措施
Restylane Volyme
According to the treatment algorithm, treated with Restylane Volyme
干预措施: Restylane Volyme (Device)
Restylane Lyft Lidocaine
According to the treatment algorithm, treated with Restylane Lyft Lidocaine
干预措施: Restylane Lyft Lidocaine (Device)
Restylane Defyne
According to the treatment algorithm, treated with Restylane Defyne
干预措施: Restylane Defyne (Device)
结局指标
主要结局
Percentage of Participants With Aesthetic Improvement of Midface
时间窗: 8 weeks
A blinded evaluator assesses the improvement compared to baseline (pre-treatment) using a 5-graded scale; Worse, No change, Improved, Much improved or Very much improved. Aesthetic improvement of midface is defined as those participants assessed as Improved, Much improved or Very much improved.
次要结局
- Percentage of Participants With Improved Midface Volume(8 weeks)
- Percentage of Participants Assessed as Having Natural Treatment Results(8 weeks)