NCT00797459已完成不适用
A Randomized, Double-Blind Study Comparing Safety and Tolerability of Restylane® With and Without Addition of 0.3% Lidocaine HCL During Correction of Nasolabial Folds
Medicis Global Service Corporation6 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2008年11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
- 6
- 主要终点
- Treatment Difference in Pain as Measured by a Visual Analogue Scale
研究概览
简要总结
Safety & tolerability study that compares Restylane to Restylane with Lidocaine (Restylane-L) while correcting wrinkles in the area around your nose.
详细描述
A Randomized, Double-Blind Study Comparing Safety and Tolerability of Restylane® With and Without Addition of 0.3% Lidocaine HCL During Correction of Nasolabial Folds
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
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
- 是
入选标准
- •Subjects seeking augmentation therapy for correction of bilateral NLFs
- •Same WSRS score at both NLFs (either both Moderate [3] or both Severe [4])
- •Subjects willing to give written informed consent to participate in the study
- •Women of childbearing potential willing to use an acceptable form of birth control during the study period
排除标准
- •Active or chronic skin disease, inflammation or related conditions, near or on the NLFs
- •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 NLF area
结局指标
主要结局
Treatment Difference in Pain as Measured by a Visual Analogue Scale
时间窗: After Injection on Day of Treatment
No pain is noted at 0 mm and worst pain is noted at 100 mm.
次要结局
- Wrinkle Improvement at Day 14(14 days after treatment when compared to baseline)
研究者
研究点 (6)
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