A Prospective, Multicenter Study to Evaluate the Safety of Retreatment With Restylane® Lyft With Lidocaine for Augmentation of the Chin Region to Improve the Chin Profile
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- Galderma R&D
- 入组人数
- 100
- 试验地点
- 8
- 主要终点
- Number of Participants With Treatment-Emergent Adverse Events (TEAEs) Related to Device And/Or Injection Procedure After the Month 12 Optional Retreatment
研究概览
简要总结
The primary objective of this study is to evaluate the safety of Restylane Lyft with Lidocaine for augmentation of the chin region 3 months after retreatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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 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.
- •Previous facial surgery (including facial aesthetic surgery and liposuction), below the level of the horizontal line from subnasale.
- •Any previous aesthetic procedures or implants.
- •Presence of any disease or lesions near or on the area to be treated.
研究组 & 干预措施
Dermal Filler for Indication: Restylane Lyft with Lidocaine
Participants will receive initial treatment with Restylane Lyft with Lidocaine in the chin region at Baseline with an optional touch-up treatment at 1 month after initial treatment and an optional retreatment 12 months after the last treatment.
干预措施: Restylane Lyft with Lidocaine (Device)
结局指标
主要结局
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) Related to Device And/Or Injection Procedure After the Month 12 Optional Retreatment
时间窗: From Month 12 up to 3 months after optional retreatment (i.e. Month 15)
An adverse event (AE) is any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in participants, users or other persons, in the context of a clinical investigation, whether or not related to the investigational product (IP). TEAEs that are related to the device and/or injection procedure after the Month 12 optional retreatment will be reported.
次要结局
未报告次要终点