A Randomized, Evaluator-blinded, Parallel Group, No-treatment Controlled, Multicenter Study to Evaluate Effectiveness and Safety of Restylane® Shaype™ for Improvement of Jawline Definition in Chinese Subjects
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- Galderma R&D
- 入组人数
- 162
- 试验地点
- 1
- 主要终点
- Primary Outcome Measure
研究概览
简要总结
This is a randomized, evaluator-blinded, parallel group, no-treatment controlled, multicenter study to evaluate effectiveness and the safety of Restylane Shaype for improvement of jawline definition in China. Subjects of Chinese origin, age 18 years, who are eligible for treatment to improve jawline definition. Study sites is approximately 6.
A total of approximately 162 subjects will be randomized (2:1) to either treatment with Restylane Shaype Treatment Group (approximately 108subjects) or no-treatment Control Group (approximately 54 subjects).
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
A blind evaluator to assess study primary endpoint.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males and non-pregnant, non-breastfeeding females of Chinese origin and aged 18 years or older.
- •Intent to receive bilateral jawline definition treatment.
排除标准
- •Known/previous allergy or hypersensitivity to any injectable hyaluronic acid (HA) gel or to gram positive bacterial proteins.
- •Known/previous allergy or hypersensitivity to local anesthetics, e.g. lidocaine or other amide-type anesthetics.
- •Previous or present multiple allergies or severe allergies, such as manifested by anaphylaxis or angioedema, or family history of these conditions.
- •Prior surgery in the treatment area that in the Treatment investigator's opinion could interfere with the study safety and/or effectiveness assessments.
- •Any previous aesthetic procedures or implants.
- •Presence of any disease or lesions near or in the area to be treated.
研究组 & 干预措施
Control group
No treatment Control Group
Treatment Group
Restylane Shaype Subjects in the Treatment Group will be treated with Restylane Shaype at Baseline, Week 4(optional touch-up).
干预措施: Restylane Shaype (Device)
结局指标
主要结局
Primary Outcome Measure
时间窗: 6 months after the last treatment for the Treatment group and at 6 months after baseline for the Control group.
Responder rate based on the Blind Evaluators' live assessment using the Galderma Jawline Scale(GJS, a 5-grade scale ranging from none to severe Jawline definition deficiency). A responder is defined as ≥1 grade improvement on the GJS from baseline on both jawlines concurrently.
Responder rate based on the Blind Evaluators' live assessment using the Galderma Jawline Scale(GJS) .
时间窗: At 6 months after the last treatment for the Treatment group and at 6 months after baseline for the Control group.
A responder is defined as ≥1 grade improvement on the GJS from baseline on both jawlines concurrently. GJS is a 5-grade scale ranging from none to severe Jawline definition deficiency.
次要结局
- Secondary Outcome Measure(At 3, 9 and 12 months after last treatment for Treatment group and at 3 months after baseline, as well as at 3 and 6 months after optional treatment for the Control group.)
- Responder rate based on the Blinded Evaluators' live assessment using the GJS(At 3, 9 and 12 months after last treatment for Treatment group and at 3 months after baseline, as well as at 3 and 6 months after optional treatment for the Control group.)