A Randomized, Evaluator-blinded, Parallel Group, no Treatment Controlled, Multicenter Study to Evaluate Effectiveness and Safety of Restylane Lyft Lidocaine for Jawline Definition
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Galderma R&D
- 入组人数
- 140
- 试验地点
- 10
- 主要终点
- Percentage of Responders Having At Least a 1-Grade Improvement From Baseline on Both Jawlines Concurrently Based on Galderma Jawline Scale (GJS) at Month 3 as Assessed by Blinded Evaluator
研究概览
简要总结
This study is designed to evaluate effectiveness and safety of Restylane Lyft Lidocaine for Jawline definition
详细描述
A randomized, evaluator-blinded, parallel group, no treatment controlled, multicenter study to evaluate effectiveness and safety of Restylane Lyft Lidocaine for Jawline definition in Canada
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)
盲法说明
Investigator blinding will be accomplished by having a Treating Investigator administer the treatments and having a Blinded Evaluator, to whom randomization and treatment are concealed, conduct blinded assessments.
Investigator blinding will be accomplished by having a Treating Investigator administer the treatments and having a Blinded Evaluator, to whom randomization and treatment are concealed, conduct blinded assessments. Safety assessments will be performed by non-blinded personnel.
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 and female adults willing to comply with the requirements of the study and providing a signed written informed consent
- •Consent the use of facial images for marketing purposes and educational material
- •Subject with moderate to very severe (Grade 2 to 4) on the GJS
- •Subject is willing to abstain from any other facial, submental, and/or neck aesthetic procedure(s) or implant
- •Female of childbearing potential with a negative urine pregnancy test before treatment
排除标准
- •Subjects presenting with known/previous allergy or hypersensitivity to hyaluronic acid (HA) filler, lidocaine or other amide-type local anesthetics
- •Subjects presenting with known/previous allergy or hypersensitivity to streptococcal proteins
- •Subject with bleeding disorders or taking thrombolytics or anticoagulants
- •Prior surgical procedure in the treatment area
- •History of other facial treatment/procedure in the previous 6 months HA in or near the intended treatment site
- •Presence of any disease or lesions near or on the area to be treated
- •Presence of any condition, in the opinion of the Treating Investigator, makes the subject unable to complete the study per protocol
- •Women who are pregnant or breast feeding, or women of childbearing potential who are not practicing adequate contraception or planning to become pregnant during the study period
- •Study site personnel, close relatives of the study site personnel, employees, or close relatives of employees at the Sponsor Company
- •Participation in any other interventional clinical study within 30 days before treatment
结局指标
主要结局
Percentage of Responders Having At Least a 1-Grade Improvement From Baseline on Both Jawlines Concurrently Based on Galderma Jawline Scale (GJS) at Month 3 as Assessed by Blinded Evaluator
时间窗: Baseline, Month 3
The GJS is a validated 5-point scale (ranges 0-4) for assessment of the jawline. Each score in the GJS is represented by photographic images of the scale, where 0 = none to minimal, 1 = mild, 2 = moderate, 3 = severe and 4 = very severe volume deficiency posterior to the jowl along the jawline. The Blinded Evaluator performed live assessment of the participant's left and right jawline separately. Here, a higher score indicated more volume deficiency in the treatment area. A responder was defined as participants having at least a 1-grade improvement from baseline on both jawlines concurrently.
次要结局
- Percentage of Responders Having at Least a 1-Grade Improvement From Baseline on Both Jawlines Concurrently Based on GJS at Month 6, 9 and 12 as Assessed by Blinded Evaluator(Baseline, Months 6, 9 and 12)
- Percentage of Participants Having at Least "Improved" on the Global Aesthetic Improvement Scale (GAIS) on Both Jawlines Concurrently, as Assessed Live by the Treating Investigator at Months 3, 6, 9 and 12(Baseline, Months 3, 6, 9 and 12)
- Percentage of Participants Having at Least "Improved" on the GAIS on Both Jawlines Concurrently, as Assessed Live by the Participant at Months 3, 6, 9 and 12(Baseline, Months 3, 6, 9 and 12)