NCT00977704已完成4 期
An Open-label Study of the Safety of Restylane and Perlane in the Correction of Peri-oral Wrinkles.
Medicis Global Service Corporation3 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2009年9月1日最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 3
- 主要终点
- Local and Systemic Adverse Events
研究概览
简要总结
This is an open-label study to assess safety using Restylane and Perlane in the correction of facial wrinkles.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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 (either both Moderate [3] or both Severe [4]) of marionette lines and upper peri-oral rhytids
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
Local and Systemic Adverse Events
时间窗: 2-weeks
To examine the safety of Restylane and Perlane when used in the treatment of facial wrinkles and folds by identification of the point incidence of: * All local adverse events as reported by healthcare professional * All systemic adverse events (related and unrelated)
次要结局
未报告次要终点
研究者
研究点 (3)
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