A Multicenter, Randomized, Evaluator-Blinded, No-Treatment Control Design Clinical Study to Evaluate the Effectiveness and Safety of YVOIRE Y-Solution 720 Injected for Jawline Contouring
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 72
- 试验地点
- 3
- 主要终点
- The primary effectiveness endpoint is the Jawline Contour Rating Scale (JCRS) responder rate at 26 weeks after the last injection
研究概览
简要总结
A Multicenter, Evaluator-Blinded, No-Treatment Control Design Clinical Study to Evaluate the Effectiveness and Safety of YVOIRE Y-Solution 720 Injected for Jawline Contouring
详细描述
This is a Multicenter, Randomized, Evaluator-Blinded, No-Treatment Control Design Clinical Study to Evaluate the Effectiveness and Safety of YVOIRE Y-Solution 720 Injected for Jawline Contouring.
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
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or female adults 18 - 75 years of age (inclusive)
- •2 (moderate) or 3 (severe) on Jawline Contour Rating Scale (JCRS)
- •want a filler injection procedure for the replacement of volume loss in the jawlines
排除标准
- •have an active or infective skin disease
- •have lower-face volume deficit due to congenital defect, trauma, abnormalities in adipose tissue related to immune-mediated diseases
- •have a tattoo or excessive facial hair in the evaluation area
- •have received permanent facial implants
- •have undergone semi-permanent filler within 24 months
- •have undergone temporary dermal filler treatment in the lower face (below the orbital rim) within 12 months
- •have streptococcal disease
- •have a medical history of hypertrophic cicatrix, hyperpigmentation or keloid
- •have a history of anaphylaxis, multiple severe allergies, or allergy to lidocaine (or any amide-based anesthetic), or hyaluronic acid products
- •have history of bleeding disorder
- •have severe cardiovascular, hepatic or renal diseases considered as per Investigator's discretion
- •have known malignant tumors or cancerous or precancerous lesion
- •positive pregnancy test indicating pregnancy
- •active COVID-19 infection and suspected COVID-19 infection within the past 14 days
结局指标
主要结局
The primary effectiveness endpoint is the Jawline Contour Rating Scale (JCRS) responder rate at 26 weeks after the last injection
时间窗: 26 weeks from baseline
The primary effectiveness endpoint is the Jawline Contour Rating Scale (JCRS) responder rate at 26 weeks after the last injection for the test group and at Week 26 for the control group, i.e., the proportion of subjects with ≥1 grade improvement on the JCRS score (both jawlines) rated by independent blinded Evaluators at the site (Evaluating Investigator) at Visit 5, compared to that at Baseline (Visit 1).
次要结局
未报告次要终点