A Randomized,Blinded,Controlled,Multicenter Study of the Safety and Effectiveness of Dermal Filler, Belotero® Soft, After Superficial to Mid Dermal Implantation for Correction of Mild Facial Wrinkles Over 4 Weeks.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 64
- 试验地点
- 5
- 主要终点
- The severity of the facial wrinkle
研究概览
简要总结
This study is to determine the safety and effectiveness of Belotero® Soft compared to active comparator in the correction of mild facial wrinkles, such as nasolabial folds.
详细描述
The purpose of the study is to see if Belotero® Soft is safe and effective for correction of mild facial wrinkles, such as nasolabial folds. The second objective of the study is to see if Belotero® Soft works better than the active comparator. Subjects will receive Belotero® Soft injection to one side of the face and the active comparator to the other side of the face.
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, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects must have bilateral facial wrinkles, such as nasolabial folds
排除标准
- •Other nasolabial fold correction within 6 months prior to study entry.
研究组 & 干预措施
Belotero® Soft
Comparator will be given into the opposite side of the face that Belotero® Soft was administered for facial wrinkles, such as nasolabial folds.
干预措施: Belotero Soft (Device)
CosmoDerm1
干预措施: CosmoDerm1 (Device)
结局指标
主要结局
The severity of the facial wrinkle
时间窗: 2 weeks and 4 weeks
次要结局
- Investigator and subject assessments(2 weeks and 4 weeks)