A Randomized, Double-Blind, Multicenter Comparison of the Safety and Efficacy of CosmetaLife™ Versus Control for the Correction of Nasolabial Folds
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Cosmeta
- 入组人数
- 145
- 试验地点
- 10
- 主要终点
- Change in Wrinkle Severity Rating Scale
研究概览
简要总结
This is a randomized, double-blind pivotal study to evaluate the safety and effectiveness of CosmetaLife injectable dermal filler for the correction of wrinkles and folds, such as nasolabial folds (i.e., smile lines).
详细描述
Patients with negative reaction skin test results will be randomized to receive CosmetaLife in one nasolabial fold and Control in the nasolabial fold on the opposite side of the face (split face design). Each subject will serve as his or her own control, allowing for comparison of the outcome between the contralateral sides. Patients will be followed at 2 weeks and 3, 6, 9 and 12 months post treatment for assessment of safety and effectiveness.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients 18 years of age or older
- •Patients with moderate nasolabial folds (3-4 WSRS scale)
- •Patients willing to provide written informed consent for their participation in the study
- •Patients willing to abstain from other facial cosmetic procedures through the 12 month follow-up visit
排除标准
- •Patients with any aesthetic facial therapy within 6 months prior to
- •Patients with an any reaction to the skin test
- •Patients with a history of autoimmune disorder, lidocaine reactions, allergy to heparin, other severe or chronic allergies
- •Patients with a current disease state that can effect the immunoresponse, or patients on immunosuppressive therapy
- •Patients with an active infection of any kind, skin disease, connective tissue disorder
- •Patients who are pregnant or lactating
- •Patients enrolled in another investigational clinical trial
结局指标
主要结局
Change in Wrinkle Severity Rating Scale
时间窗: baseline and 6 months
To determine if the mean change in the 5-point Wrinkle Severity Rating Scale (WSRS) score at 6 months was non-inferior to the contralateral Control Restylane treated side, where on this 5-point scale 1 has no measurable nasolabial fold, 2 has some fold, 3 has moderate fold, 4 has heavier moderate fold, and a 5 has deep to a very deep nasolabial fold. For this study only moderate nasolabial folds were included (i.e., 3 or 4), where subjects scored as 5 were excluded.
Adverse Event Reporting
时间窗: 6 months
次要结局
- Safety and Effectiveness of CosmetaLife at 3, 9 and 12 Months(3, 9 and 12 months)