NCT07566286招募中不适用
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
干预措施
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
- 16
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
Experimental
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)
研究者
研究点 (16)
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