Evaluation of the Effectiveness and Safety of Radiesse for the Correction of Moderate to Severe Nasolabial Folds
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 134
- 试验地点
- 7
- 主要终点
- Change From Baseline to Week 24 on the Wrinkle Severity Rating Scale (WSRS)
研究概览
简要总结
Effectiveness: The purpose of this study is to demonstrate the non-inferiority of Radiesse (CaHA) to Restylane (HA) following subdermal implantation for the correction of moderate to severe facial wrinkles and folds, such as NLFs.
Safety: To evaluate the incidence and type of adverse events and serious adverse events.
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
- 22 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Has symmetrical NLFs, with the same WSRS score of 3 or 4 (moderate or severe) for both right and left NLFs, as determined on live assessment by the blinded evaluator.
- •Is ≥ 22 and ≤ 65 years of age.
- •Is willing to abstain from all other aesthetic treatments on any part of the face, including but not limited to injectable fillers, implants, neurotoxin, skin peels, laser treatments, surgical treatments, etc. for the trial's duration.
排除标准
- •Has an acute inflammatory process or active infection at the injection site.
- •Has received mid- and/or lower-facial region treatments with any dermal fillers.
- •Has received facial dermal therapies.
- •Had prior surgery in the mid- and/or lower-facial area, including the NLFs, or has a permanent implant or graft in the mid- and/or lowerfacial area that could interfere with effectiveness assessments.
研究组 & 干预措施
Left side Restylane® / Right side Radiesse®
干预措施: Restylane injectable implant (dermal filler) (Device)
Left side Radiesse® / Right side Restylane®
干预措施: Restylane injectable implant (dermal filler) (Device)
Left side Restylane® / Right side Radiesse®
干预措施: Radiesse injectable implant (dermal filler) (Device)
Left side Radiesse® / Right side Restylane®
干预措施: Radiesse injectable implant (dermal filler) (Device)
结局指标
主要结局
Change From Baseline to Week 24 on the Wrinkle Severity Rating Scale (WSRS)
时间窗: Baseline and Week 24 after last injection, up to 28 weeks
Severity of the nasolabial folds (NLFs) was assessed and measured using the 5-point Wrinkle Severity Rating Scale (WSRS), where 1=absent and 5=extreme. A lower score indicates better outcome.
次要结局
- Number of Subjects With Treatment-emergent Adverse Events (AE) Related to Radiesse(Baseline to week 48 after last injection, up to 52 weeks)
- Proportion of Subjects With Any Improvement on the Subject Global Aesthetic Improvement Scale (sGAIS) for Each Nasolabial Fold (NLF) at Week 24(Week 24 after last injection, up to 28 weeks)
- Proportion of Subjects With Improvement on the Investigator Global Aesthetic Improvement Scale (iGAIS) for Each Nasolabial Fold (NLF) at Week 24(Week 24 after last injection, up to 28 weeks)