Evaluation of Pain With the Use of Radiesse® With Lidocaine for the Treatment of Nasolabial Folds
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 102
- 试验地点
- 2
- 主要终点
- Pain Score Using a 10-cm Visual Analog Scale (VAS) for Pain (0 = no Pain, 10 = Very Severe Pain)
研究概览
简要总结
To assess pain during nasolabial fold treatment using Radiesse® Injectable Dermal Filler with lidocaine
详细描述
To assess pain immediately after nasolabial fold treatment with Radiesse® Injectable Dermal Filler with lidocaine in one nasolabial fold compared to Radiesse® Injectable Dermal Filler without lidocaine in the contralateral nasolabial fold
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
- Single (Participant)
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
- •Is at least 18 years of age
- •Is a candidate for nasolabial fold treatment using Radiesse
- •Has approximately symmetrical nasolabial folds
- •Understands and accepts the obligation not to receive any other facial procedures in the lower half of the face for 1 month
排除标准
- •Has received any type of treatment or procedures including surgery in the nasolabial folds
- •Has received neurotoxin, hyaluronic acid, calcium hydroxylapatite (CaHA) or collagen injections in the lower half of the face within past 6 months
- •Has received polylactic acid, polymethyl methacrylate (PMMA), silicone or any other permanent filler in the lower half of the face
- •Has nasolabial folds that are too severe to be corrected in one treatment session
- •Has any history of hypersensitivity to lidocaine or anesthetics of the amide type
研究组 & 干预措施
Radiesse® Mixed with Lidocaine
Injectable Dermal Filler. The same participants received the experimental device and the active comparator device at the same time (left and right sides of face).
干预措施: Radiesse® Injectable Dermal Filler with Lidocaine (Device)
Radiesse® without Lidocaine
Injectable Dermal Filler. The same participants received the experimental device and the active comparator device at the same time (left and right sides of face).
干预措施: Radiesse® Injectable Dermal Filler without Lidocaine (Device)
结局指标
主要结局
Pain Score Using a 10-cm Visual Analog Scale (VAS) for Pain (0 = no Pain, 10 = Very Severe Pain)
时间窗: Immediately after injection (Time 0)
Assessment of whether a statistically significant reduction in pain score in the Radiesse® Mixed with Lidocaine nasolabial fold was observed when compared to the Radiesse® without Lidocaine nasolabial fold using a 10-cm visual analog pain scale (0 = no pain, 10 = very severe pain). In the study protocol, the assessment of achieving a statistically significant reduction in pain at time zero was selected a priori to be analyzed using a paired t-test to test the null hypothesis that the mean of the differences in VAS scores between the Treatment and Control folds is equal to zero.
次要结局
- Visual Analogue Scale (VAS) Pain Score 1 Week Post Injection(1 week post injection)
- Assess Subject Preference to Pain(Immediately after injection (Time 0))
- Visual Analogue Scale (VAS) Pain Score 15 Minutes Post Injection(15 minutes post injection)
- Visual Analogue Scale (VAS) Pain Score 2 Weeks Post Injection(2 weeks post injection)
- Visual Analogue Scale (VAS) Pain Score 30 Minutes Post Injection(30 minutes post injection)
- Visual Analogue Scale (VAS) Pain Score 45 Minutes Post Injection(45 minutes post injection)
- Number of Participants With a Clinically Meaningful Reduction in Pain As Defined by a ≥ 2.0-cm Reduction in VAS(Immediately after injection (Time 0))
- Visual Analogue Scale (VAS) Pain Score 60 Minutes Post Injection(60 minutes post injection)
- Visual Analogue Scale (VAS) Pain Score 4 Weeks Post Injection(4 weeks post injection)