A Randomized, Multicenter, No-treatment Controlled Study of the Safety and Effectiveness of JUVÉDERM® VOLBELLA® With Lidocaine for Lip Enhancement in Chinese Adults
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Allergan
- 入组人数
- 176
- 试验地点
- 7
- 主要终点
- Percentage of Participants With a ≥1-point Increase (Improvement) on the Evaluating Investigator's (EI's) Assessed 5-point Lip Fullness Scale (LFS)
研究概览
简要总结
This study will evaluate the safety and effectiveness of VOLBELLA with Lidocaine injectable gel in Chinese adults seeking lip enhancement.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or female, 18 years of age or older with an overall baseline Lip Fullness Scale (LFS) score of minimal, mild or moderate on the 5-point LFS scale.
- •Has the ability to follow study instructions and is likely to complete all required visits
排除标准
- •Has had any facial procedures or trauma that may interfere with the study procedures and results
- •Is on anti-coagulation therapy or other contraindicated treatments
- •Has current cutaneous inflammatory or infectious processes or lesions in the mouth area
结局指标
主要结局
Percentage of Participants With a ≥1-point Increase (Improvement) on the Evaluating Investigator's (EI's) Assessed 5-point Lip Fullness Scale (LFS)
时间窗: Baseline to Month 3 Post Last Treatment (JUVÉDERM® VOLBELLA® XC with Lidocaine arm) or Month 3 Post Randomization (No-treatment Control arm)
The investigator assessed the participant's lip fullness using the 5-point LFS where: 0=Minimal (Flat or nearly flat contour, minimal red lip show), 1=Mild (Some red lip show; no lower lip pout), 2=Moderate (Moderate red lip show with slight lower lip pout), 3=Marked (Significant red lip show and lower lip pout), and 4=Very Marked (Very significant red lip show, lower lip pout, and upper lip pout). Improvement was defined as a ≥1-point increase in fullness from Baseline. Number analyzed is the number of participants with data available for analysis at Baseline and Month 3.
次要结局
- Procedural Pain Score(Up to 30 days after initial treatment with JUVÉDERM® VOLBELLA® XC with Lidocaine)
- Number of Participants With Injection Site Responses (ISRs)(Up to 30 days after each treatment with JUVÉDERM® VOLBELLA® XC with Lidocaine)
- Number of Participants With Treatment-emergent Adverse Events (TEAEs)(Baseline to Month 12 Post Treatment)
- Percentage of Participants With a ≥1-point Increase (Improvement) Based on the Participant's Assessed 5-point LFS(Baseline to Month 3 Post Treatment)
- Change From Baseline in Overall Lip Volume(Baseline to Month 3 Post Treatment ( JUVÉDERM® VOLBELLA® XC with Lidocaine arm) or Month 3 Post Randomization (No-treatment Control arm))
- Percentage Change From Baseline in Lip Surface Area(Baseline to Month 3 Post Treatment ( JUVÉDERM® VOLBELLA® XC with Lidocaine arm) or Month 3 Post Randomization (No-treatment Control arm))