NCT03583359已完成不适用
Evaluation of Effectiveness and Safety of Radiesse (+) to Improve the Contour of Jawline by Adding Volume to the Jawline
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 180
- 试验地点
- 28
- 主要终点
- Responder Rate According to the Merz Jawline Assessment Scale (MJAS)
研究概览
简要总结
To demonstrate the effectiveness and safety of Radiesse (+) following deep (subdermal and/or supraperiosteal) injection to improve the contour of jawline by adding volume to the jawline.
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 (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 right and left jawline ratings of 2 or 3 (moderate or severe) on the Merz Jawline Assessment Scale (MJAS).
- •Has the same MJAS score on both jawlines (that is, jawlines are symmetrical).
- •Is greater than or equal to (>=) 22 and less than or equal to (<=) 65 years of age.
排除标准
- •Ever been treated with fat injections or permanent fillers (example, silicone, polymethylmethacrylate (PMMA)) in the lower face and/or jawline area or plans to receive such treatments during participation in the study.
- •Been treated with semi-permanent dermal fillers (example, poly L-lactic acid) in the lower face and/or jawline area in the past 5 years or plans to receive such treatments during participation in the study.
结局指标
主要结局
Responder Rate According to the Merz Jawline Assessment Scale (MJAS)
时间窗: At Week 12
MJAS was a 5-point scale (0-4 scores; higher scores mean worse outcome). Responder rate was defined as percentage of participants with a greater than or equal to (\>=) 1-point improvement.
Number of Participants Reporting One or More Device and/or Injection Related Treatment-emergent Adverse Events (TEAEs) and Device and/or Injection Related Serious TEAEs
时间窗: Baseline up to end of study (Week 60)
次要结局
- GAIS Scores as Assessed by Participants(At Week 12)
- Percent Change From Baseline in Face-Q Satisfaction(Baseline up to Week 12)
- Responder Rate According to the MJAS as Assessed by Independent Panel Reviewers (IPRs)(At Week 12)
- Global Aesthetic Improvement Scale (GAIS) Scores as Assessed by the Treating Investigator(At Week 12)
研究者
研究点 (28)
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