A Study to Evaluate the Performance and Safety of YVOIRE Y-Solution 360 Versus Comparator for Temporary Enhancement and Pouting of the Lips for Lip Augmentation and Correction of Perioral Area.
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 118
- 试验地点
- 1
- 主要终点
- Responder rate calculated using Lip Fullness Rating Scale (LFRS) for overall lip at Week12.
研究概览
简要总结
A Study to Evaluate the Performance and Safety of YVOIRE Y-Solution 360 on Lips and Perioral Area.
详细描述
This is a Randomized, Multicenter, Evaluator-Blinded, Active-Controlled, Parallel-Group Study to Evaluate the Performance and Safety of YVOIRE Y-Solution 360 Versus Comparator for Temporary Enhancement and Pouting of the Lips for Lip Augmentation and Correction of Perioral 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
- 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 or above age.
- •1 or 2 of the 5-point (0-4) LFRS (Lip Fullness Rating Scale).
- •Agree to use proper contraception as guided in the protocol.
- •Signed for Informed Consent.
排除标准
- •have lip tattoos, piercings, facial hair, or scars that would interfere with visualization of the lips and perioral area
- •who have dentures or any device covering all or part of the upper palate, and/or severe malocclusion or dentofacial or maxillofacial deformities
- •have undergone oral surgery within 6 weeks
- •have received permanent facial implants in the face or neck, or are planning to be implanted with any of these products
- •have undergone semi-permanent filler in lower face within 24 months
- •have undergone temporary dermal filler treatment in the lower face within 12 months
- •Have undergone facial tissue augmentation or facial treatment with fat or botulinum injections in the lower face within 6 months
- •Have undergone mesotherapy, face lift, laser, photo modulation, intense pulsed light, radio frequency, dermabrasion, moderate or greater depth chemical peel, or other ablative procedures in face or neck within 6 months
- •have used lip plumping products within 10 days
结局指标
主要结局
Responder rate calculated using Lip Fullness Rating Scale (LFRS) for overall lip at Week12.
时间窗: 12 weeks from baseline
To evaluate the performance of YVOIRE Y-Solution 360 on overall Lip 12 weeks after treatment, the responder rate defined as ≥ 1-point improvement on the 5-point Lip Fullness Rating Scale (LFRS) from baseline to 12 weeks will be calculated.
Mean change on the overall Lip Fullness Rating Scale (LFRS) from baseline to Week12.
时间窗: 12 weeks from baseline
To evaluate the performance of YVOIRE Y-Solution 360 on overall Lip 12 weeks after treatment, the mean change from baseline to 12 weeks will be measured using 5-point Lip Fullness Rating Scale (LFRS). LFRS Grades are 0 (None/Minimal), 1 (Mild), 2 (Moderate), 3 (Pronounced), and 4 (Very Pronounced).
次要结局
- Mean change on Vertical Perioral Lip lines Rating Scale - At rest(VPLRS) from baseline to Week2, 4, 12 and 24.(2, 4, 12, 24 weeks from baseline)
- Mean change on Lip Fullness Rating Scale (LFRS) from baseline to Week2, 4, 12 and 24.(2, 4, 12, 24 weeks from baseline)
- Responder rate on Lip Fullness Rating Scale (LFRS) from baseline to Week2, 4, 12 and 24.(2, 4, 12, 24 weeks from baseline)
- Responder rate on Vertical Perioral Lip lines Rating Scale - At rest(VPLRS) from baseline to Week2, 4, 12 and 24.(2, 4, 12, 24 weeks from baseline)
- Global Aesthetic Improvement Scale (GAIS) evaluation by subject and investigator.(2, 4, 12, 24 weeks from baseline)