NCT05777759已完成不适用
A Randomized, Evaluator-blinded, Parallel Group, Comparator-controlled, Multicenter Study to Evaluate the Safety and Effectiveness of Restylane Lyft With Lidocaine for Augmentation of the Chin Region to Improve the Chin Profile
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Galderma R&D
- 入组人数
- 175
- 试验地点
- 14
- 主要终点
- Primary Effectiveness Objective
研究概览
简要总结
The primary objective of the study was to demonstrate non-inferiority of Restylane Lyft with Lidocaine versus a comparator-control for augmentation of the chin region to improve the chin profile.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Males or non-pregnant, non-breastfeeding females, 22 years of age or older
- •Intent to receive treatment for augmentation and correction of retrusion in the chin region.
排除标准
- •Known/previous allergy of hypersensitivity to any injectable hyaluronic acid (HA) gel or gram-positive bacterial proteins.
- •Known/previous allergy or hypersensitivity to local anesthetics, e.g., lidocaine or other amide-type anesthetics.
- •Previous or present multiple severe allergies or severe allergies, such as manifested by anaphylaxis or angioedema or family history of angioedema.
- •Previous facial surgery (including facial aesthetic surgery and liposuction), below the level of the horizontal line from the subnasale.
- •Any previous aesthetic procedures or implants
- •Presence of any disease or lesion near or on the area to be treated.
研究组 & 干预措施
Active Comparator: FDA approved Dermal Filler: Juvederm Voluma XC
Active Comparator
hyaluronic acid dermal filler
干预措施: Juvederm Voluma XC (Device)
New Dermal Filler for indication: Restylane Lyft with Lidocaine
Experimental
hyaluronic acid dermal filler
干预措施: Restylane Lyft with Lidocaine (Device)
结局指标
主要结局
Primary Effectiveness Objective
时间窗: 3 months after last treatment
Change from Baseline in the Blinded Evaluators' live assessment using the GCRS (Galderma Chin Retrusion Scale).
次要结局
- Secondary Effectiveness Objective(6, 9, and 12 months after last treatment.)
研究者
研究点 (14)
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