A Multicenter, Single-blind, Randomized, Controlled Study of the Safety and Effectiveness of JUVÉDERM VOLUMA® XC Injectable Gel for Cheek Augmentation Using Cannula
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Allergan
- 入组人数
- 66
- 试验地点
- 14
- 主要终点
- Change From Baseline in Mid-Face Volume Deficit Scale (MFVDS) Score
研究概览
简要总结
The objective of this study is to evaluate the safety and effectiveness of JUVÉDERM VOLUMA® XC injectable gel using cannula in participants seeking correction of age-related volume deficit in the mid-face.
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
- 35 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female aged 35 to 65 (inclusive) years of age with overall mid-face severity of Moderate, Significant, or Severe for both cheeks on the Mid-Face Volume Deficit Scale (MFVDS);
排除标准
- •Has any facial procedures or trauma that may interfere with the study procedures and results;
- •Has a history of anaphylaxis or allergy to lidocaine (or any amide-based anesthetics), hyaluronic acid (HA) products, or Streptococcal protein, or is planning to undergo allergen desensitization therapy during the term of the study;
- •Has active autoimmune disease;
- •Has current cutaneous or mucosal inflammatory or infectious processes.
研究组 & 干预措施
JUVÉDERM VOLUMA® XC Injectable Gel with Cannula
Participants had 1 cheek treated with JUVÉDERM VOLUMA® XC injectable gel with cannula.
干预措施: JUVÉDERM VOLUMA® XC injectable gel with cannula (Device)
JUVÉDERM VOLUMA® XC Injectable Gel with Needle
Participants had 1 cheek treated with JUVÉDERM VOLUMA® XC injectable gel with a needle.
干预措施: JUVÉDERM VOLUMA® XC injectable gel with needle (Device)
结局指标
主要结局
Change From Baseline in Mid-Face Volume Deficit Scale (MFVDS) Score
时间窗: Baseline (Screening) to Month 1
The evaluating investigator (EI) assessed the participant's overall mid-face volume deficit for each cheek using a 6-point photonumeric scale, where: 0=None (moon face; fullness) \[best\] to 5=Severe (wasting) \[worst\]. A negative change from Baseline indicates improvement.
次要结局
- Percentage of Participants With at Least a 1-Point Improvement (Decrease From Baseline) in MFVDS Score(Baseline (Screening) to Month 1)
- Number of Participants With Treatment-Emergent Adverse Events (TEAEs)(Up to 3 months)
- Change From Baseline in FACE-Q Satisfaction With Cheeks Questionnaire Score(Baseline (Screening) to Month 1)