A Prospective, Multicenter, Randomized, Comparator-controlled, Evaluator-blinded Study to Evaluate the Safety and Effectiveness of Belotero® Intense Lidocaine for Lip Augmentation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 220
- 试验地点
- 14
- 主要终点
- Responder Rate at Week 8, According to the MLFAS
研究概览
简要总结
The purpose of this study is to demonstrate the safety and effectiveness of Belotero Intense Lidocaine (BIL) for lip augmentation in subjects with upper and/or lower lip deficit.
详细描述
For all subjects, standardized photographs of the lips will be taken at the screening visit (prior to treatment) and at multiple intervals throughout the study to be used for comparisons and study assessments.
Subjects will receive an injection of either BIL or Restylane Silk (RS) in the upper and/or lower lips. A touch-up injection will be given 4 weeks after the initial treatment if the subject fails to show improvement in 1 or both lips or if the subject does not achieve optimal aesthetic correction. Subjects treated with BIL have the option of a retreatment with BIL 48 weeks post last injection.
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
- 21 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Desires lip augmentation to correct volume and has very thin to medium upper and/or lower lip deficit
排除标准
- •Any previous surgery, including plastic surgery or permanent implant or graft in the lower third part of the face
- •Any previous treatment with fat injections or permanent and/or semi-permanent dermal fillers in the face
- •Any treatment with porcine-based collagen fillers or with Juvéderm® Voluma XC, Restylane® Lyft Lidocaine, Calcium hydroxyapatite (CaHA) within the past 24 months and/or other dermal fillers within the past 12 months in the lips, in the lower third part of the face, and/or the nose
- •Any previous treatment with dermal therapies within the past 3 months in the lower third part of the face
- •Has undergone oral surgery in the past 30 days
- •Lip volume deficit due to medical conditions
- •Known history of allergic/anaphylactic reactions/hypersensitivity to lidocaine or any of the device components
研究组 & 干预措施
Belotero® Intense Lidocaine
Lips injected with BIL.
干预措施: Belotero® Intense Lidocaine (Device)
Restylane® Silk
Lips injected with RS.
干预措施: Restylane® Silk (Device)
结局指标
主要结局
Responder Rate at Week 8, According to the MLFAS
时间窗: At Week 8
Responder rate was defined as percentage of subjects with greater than or equal to (\>=) 1-point improvement on subject's treated lips compared to baseline as assessed live by a blinded evaluator. MLFAS was a validated 5-grade scale used to assess the volume of the upper and lower lips, where Grade 0=very thin lips with minimal volume and Grade 4=very full lips with significant volume. A positive number change from baseline indicated improvement.
Mean Change of Treated Lips From Baseline to Week 8, According to the Merz Lip Fullness Assessment Scale (MLFAS)
时间窗: Baseline, Week 8
MLFAS was a validated 5-grade scale used to assess the volume of the upper and lower lips, where Grade 0=very thin lips with minimal volume and Grade 4=very full lips with significant volume, as assessed live by a blinded evaluator. A positive number change from baseline indicated improvement.
次要结局
- Percentage of Subjects With Investigator's Global Aesthetic Improvement Scale (iGAIS) Scores(At Week 8)
- Percentage of Subjects With Subject's GAIS Scores (sGAIS)(At Week 8)
- Change From Baseline in Rasch-transformed Score of the FACE-Q Satisfaction With Lips(Baseline, Week 8)
- Number of Subjects With Related Serious or Related Delayed-onset Treatment Emergent Adverse Events (TEAEs)(Up to 48 weeks)