NCT00407914已完成不适用
A Double-Masked, Randomized, Multi-Center, 2-Arm Parallel Study Comparing the Safety and Effectiveness of Aquamid and Restylane for the Aesthetic Treatment of Nasolabial Folds
Contura1 个研究点 分布在 1 个国家目标入组 315 人开始时间: 2006年12月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 315
- 试验地点
- 1
- 主要终点
- Wrinkle Assessment Scale
研究概览
简要总结
The purpose of this study is to compare the effectiveness of Aquamid and Restylane in aesthetically enhancing nasolabial folds 6 months after treatment and to evaluate the safety of Aquamid through 12 months after treatment.
The study includes an extended follow up to 24 months.
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
- Double (Participant, Investigator)
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
- •interested on soft tissue augmentation for the nasolabial folds
- •moderate to severe nasolabial fold
排除标准
- •sensitivity to anesthetics
- •allergy to hyaluronic acid
- •previous treatment with permanent fillers in the treated area
- •recent previous aesthetic procedure in the treatment area
- •infected skin areas or autoimmune diseases affecting the skin
结局指标
主要结局
Wrinkle Assessment Scale
时间窗: Baseline, 3, 6, 9, 12 Months
Adverse device effects
时间窗: continuosly
次要结局
- Global Aesthetic Improvement Scale(Optimal treatment, 3, 6, 9 and 12 Months)
- Injection site reactions(After injection)
- Adverse events(continuosly)
研究者
研究点 (1)
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