Evaluation of Effectiveness and Safety of Belotero Balance® (+) Lidocaine for Volume Augmentation of the Infraorbital Hollow
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 150
- 试验地点
- 9
- 主要终点
- Responder Rate Based on Merz Infraorbital Hollow Assessment Scale (MIHAS) at Week 8
研究概览
简要总结
- Confirm the effectiveness of Belotero Balance® (+) Lidocaine (BBL) injection for the correction of volume loss in the infraorbital hollow (IOH) area by demonstrating superiority to untreated control.
- Confirm the safety of BBL injection for the correction of volume loss in the IOH area.
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
- •Is a candidate for bilateral IOH treatment.
- •Has symmetrical right and left IOHs with the same MIHAS score of 2 or 3 (moderate or severe), as assessed live by the blinded evaluator.
排除标准
- •Prior lower-eyelid surgery, including orbital or midface surgery, or a permanent implant or graft in the midfacial region that could interfere with effectiveness assessments.
- •Previous treatment with fat injections or permanent and/or semi-permanent dermal fillers in the midfacial region.
- •Previous lower-eyelid and/or malar-region treatments with any dermal fillers (e.g., collagen, hyaluronic acid (HA), calcium hydroxyapatite, poly L-lactic acid (PLLA)) within the past 24 months.
- •Any other medical condition with the potential to interfere with the study outcome assessments or compromise subject safety.
研究组 & 干预措施
Treatment, needle
干预措施: Belotero Balance (+) Lidocaine, needle (Device)
Treatment, cannula
干预措施: Belotero Balance (+) Lidocaine, cannula (Device)
Untreated-control / delayed-treatment, needle
干预措施: Untreated-control / delayed-treatment, needle (Device)
Untreated-control / delayed-treatment, cannula
干预措施: Untreated-control / delayed-treatment, cannulas (Device)
结局指标
主要结局
Responder Rate Based on Merz Infraorbital Hollow Assessment Scale (MIHAS) at Week 8
时间窗: Week 8
Responder rate was defined as percentage of subjects with treatment response at Week 8 on MIHAS, as assessed live by a blinded evaluator. Responders were defined as subjects who achieved greater than or equal to (\>=) 1 grade improvement on both IOHs on the MIHAS. MIHAS (to assess infraorbital hollow) was a 5-point scale ranging as: Grade 0 (none to minimal), Grade 1 (mild), Grade 2 (moderate), Grade 3 (severe), Grade 4 (extreme). A higher score indicated extreme signs of hollowing. This analysis was done using multiple imputation method to impute missing MIHAS scores. Percentage of subjects with response at Week 8 and corresponding confidence intervals were average values obtained from the multiple imputation approach.
次要结局
- Percentage of Subjects With Global Aesthetic Improvement Scale (GAIS) Score at Week 8, as Assessed by the Treating Investigator(Week 8)
- Change From Baseline in Rasch-Transformed Score for the Face-Q Satisfaction With Eyes at Week 8(Baseline, Week 8)
- Number of Subjects With Treatment-Emergent Adverse Events (TEAEs) Related to BBL(BBL Treatment (Needle and Cannula): Up to 80 weeks; Control/Delayed-treatment BBL (Needle and Cannula): Up to 56 weeks)
- Percentage of Subjects With GAIS Score at Week 8, as Assessed by the Subject(Week 8)
- Number of Subjects With Treatment-Emergent Serious Adverse Events (TESAEs) Related to BBL(BBL Treatment (Needle and Cannula): Up to 80 weeks; Control/Delayed-treatment BBL (Needle and Cannula): Up to 56 weeks)