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
- 18
- 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.
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)