A Randomized, Open Label, No-treatment Controlled, Multi-center, Efficacy and Safety Study Using Restylane Perlane to Shape the Nasal Dorsum and/or Nasal Root
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Galderma R&D
- 入组人数
- 132
- 试验地点
- 2
- 主要终点
- Mean Difference of Change in Volume (mL) at 6 Months After Baseline Versus Pre-treatment in the Nasal Dorsum/Nasal Root Between Restylane Perlane Treatment Group and No-treatment Control
研究概览
简要总结
The purpose of this study is to determine the safety and efficacy of using Restylane Perlane to shape the nasal dorsum and/or nasal root in comparison with a no-treatment control group
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
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
- •Chinese origin
- •Subject with desire to shape the nasal dorsum and/or nasal root
- •Subjects who, in the opinion of the investigator, can achieve a clinically meaningful aesthetic correction of their nose with ≤ 1 ml Restylane Perlane
排除标准
- •Subjects with previous nasal surgery, including grafts or implants to the nose area
- •Subjects requiring filler treatment around the tip of the nose or between the eyebrows (glabella region) to achieve a good aesthetic outcome
- •Subjects with a history of chronic sinusitis or rhinitis
- •Subjects who have previously received aesthetic treatment in the forehead, glabellar and/or nose area with a dermal filler
结局指标
主要结局
Mean Difference of Change in Volume (mL) at 6 Months After Baseline Versus Pre-treatment in the Nasal Dorsum/Nasal Root Between Restylane Perlane Treatment Group and No-treatment Control
时间窗: 6 months
The primary objective of the study was to evaluate the efficacy of Restylane Perlane in shaping the nasal dorsum and/or nasal root as compared to no-treatment control, by assessment of the primary endpoint:The change in volume will be measured using 3 D photography technique. The change in volume was calculated as the value at 6 months of treatment group compared with non-treatment group
次要结局
未报告次要终点