An Open-label, Multi-Center, Prospective, Post Market Study to Assess the Safety and Effectiveness of EVOLENCE® in Facial Augmentation of Subjects With Fitzpatrick Skin Color Types IV, V, and VI
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 172
- 试验地点
- 22
- 主要终点
- Safety Endpoint
研究概览
简要总结
Approximately 165 subjects with Fitzpatrick Skin Color Types IV, V, and VI and a moderate to deep wrinkle between the corner of the nose and the corner of the mouth, will be treated with EVOLENCE® (an approved collagen filler) to smooth and flatten that wrinkle. They will be observed for 6 months to establish safety of the product as it relates to scarring and changes in skin pigment, and long term effectiveness.
详细描述
This is an open-label, multi-center, prospective, postmarket study to assess the safety and effectiveness of EVOLENCE® (DP101) in Subjects with Fitzpatrick Skin Color Types IV, V, and VI seeking correction of bilateral facial wrinkles and folds of the nasolabial area.
The study will enroll and treat a total of 165 subjects with Fitzpatrick Skin Color Types IV, V and VI who have clinical evidence of moderate to deep bilateral wrinkles in the nasolabial area.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •>18 years of age
- •moderate to deep wrinkle in the Naso-Labial fold
- •Fitzpatrick Skin Type IV, V or VI
排除标准
- •Pregnant or nursing females
- •Hx of allergies to related products
- •history of keloids, active skin disease, or previous augmentation of the treatment area
研究组 & 干预措施
Device
Treatment with EVOLENCE®
干预措施: EVOLENCE® (Device)
结局指标
主要结局
Safety Endpoint
时间窗: 6 months post injection
Safety Endpoint includes three categories: 1) composite determination of success (no pigmentation change or keloid formation); 2) pigmentation changes; and 3) keloid formation
次要结局
- Reduction in Wrinkle Severity Score(Baseline, 1, 3 and 6 months post injection)
- Subject's Satisfaction of the Overall Treatment(1, 3 and 6 months post injection)
- Investigator's Satisfaction of the Overall Treatment(1, 3 and 6 months post injection)