NCT00823069已完成不适用
A Randomized, Double-Blind Study Comparing Safety and Tolerability of Perlane® With and Without Addition of 0.3% Lidocaine HCL During Correction of Nasolabial Folds
Medicis Global Service Corporation3 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2009年1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
- 60
- 试验地点
- 3
- 主要终点
- Treatment Difference in VAS (Perlane Side - Perlane-L Side) With Difference in VAS >= 10 mm
研究概览
简要总结
Safety study that compares Perlane to Perlane with Lidocaine while correcting wrinkles in the area around your nose.
详细描述
This is a split-face design. All 60 subjects receive Perlane on one side of their face, and Perlane-L on the other. Subjects and the investigator is blinded to which side of face receives which product. These are one time injections.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Same Wrinkle Severity Rating Scale score at both Nasolabial Folds (either both Moderate [3] or both Severe [4])
排除标准
- •Active or chronic skin disease, inflammation or related conditions, near or on the Nasolabial Folds
- •Subjects who had undergone procedures based on active dermal response (e.g., laser or chemical peeling procedures) within 6 months prior to study entry
- •Use of any facial tissue augmenting therapy with non-permanent filler or aesthetic facial surgical therapy within 9 months prior to study entry
- •Permanent implant placed in the Nasolabial Fold area
结局指标
主要结局
Treatment Difference in VAS (Perlane Side - Perlane-L Side) With Difference in VAS >= 10 mm
时间窗: After Injection on Day of Treatment
次要结局
- Number of Subjects Showing Wrinkle Improvement at Day 14(14 days after treatment when compared to baseline)
研究者
研究点 (3)
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