Evaluation of Pain With the Use of Lidocaine-Mixed Radiesse® Injectable Dermal Filler for the Treatment of Nasolabial Folds
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Pain Score Using a 10-cm Visual Analog Pain Scale (1 = 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 mixed with lidocaine.
详细描述
To assess pain immediately after nasolabial fold treatment with Radiesse® Injectable Dermal Filler mixed 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.
- •Understands and accepts the obligation not to receive any other facial procedures in the lower half of the face for 1 month.
- •Understands and accepts the obligation to present for all scheduled follow-up visits and is logistically able to meet all study requirements.
- •Has approximately symmetrical nasolabial folds.
排除标准
- •Has received any type of treatment or procedures including surgery in the nasolabial folds.
- •Has received neurotoxins in the lower half of the face in the past 6 months.
- •Has received hyaluronic acid, calcium hydroxylapatite (CaHA) or collagen injections in the lower half of the face within past 1 ½ years.
- •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 a history of chronic or recurrent infection or inflammation that would preclude participation in the study.
- •Has a known bleeding disorder or is receiving medication that will likely increase the risk of bleeding.
- •Is female and of child bearing potential and is pregnant or not using acceptable method of birth control.
- •Has had any history of hypersensitivity to Lidocaine or anesthetics of the amide type.
- •Has a history of anaphylaxis or multiple severe allergies.
- •Has received any investigational product within 30 days prior to study enrollment or is planning to participate in another investigation during the course of this study.
研究组 & 干预措施
Radiesse® Mixed with Lidocaine
Injectable Dermal Filler. The same 50 participants received both the treatment device and the control device at the same time (left and right sides of face).
干预措施: Radiesse® Injectable Dermal Filler Mixed with Lidocaine (Device)
Radiesse® without Lidocaine
Injectable Dermal Filler. The same 50 participants received both the treatment device and the control 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 Pain Scale (1 = no Pain, 10 = Very Severe Pain)
时间窗: Immediately after injection (Time 0)
Assessment of difference in pain score in the Radiesse Dermal Filler Mixed with Lidocaine nasolabial fold v. the Radiesse Dermal Filler without Lidocaine nasolabial fold using a 10-cm visual analog pain scale (1 = no pain, 10 = very severe pain).
Patients With Clinically Significant Reduction in Pain
时间窗: Immediately after injection (Time 0)
Assessment of clinical significance of pain reduction in the Radiesse Injectable Dermal Filler Mixed with Lidocaine nasolabial fold v. Radiesse Injectable Dermal Filler without Lidocaine nasolabial fold defined as number of participants with \>/= 2cm difference on a visual analog pain scale (1 = no pain, 10 = very severe pain).
次要结局
未报告次要终点