NCT05691972已完成不适用
A Randomized, No-treatment-controlled, Evaluator-blinded, Multi-center Study to Evaluate the Effectiveness and Safety of Restylane Contour in the Treatment of Temple Hollowing
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
- 225
- 试验地点
- 16
- 主要终点
- Responder rate based on the Blinded Evaluators' live assessment of the GTVDS
研究概览
简要总结
This is a randomized, no-treatment-controlled, evaluator-blinded, multi-center study to evaluate the effectiveness and safety of Restylane® Contour in correction of temple hollowing.
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
- 否
入选标准
- •Males or non-pregnant, non-breastfeeding females, 22 years of age or older
- •Intent to undergo treatment for correction of temple hollowing
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 or nerve blocking agents (if intended to be used for that subject)
- •Previous facial surgery (e.g., facelift) above the level of the horizontal line from subnasale that in the Treating Investigator´s opinion could interfere with the study safety and/or effectiveness assessments
- •Any previous aesthetic procedures or implants
- •Recurrent temporal headaches such as temporal tendinitis migraine. Have a history of migraines or frequent headaches, as determined by the (Treating) Investigator, that could interfere with the study safety and/or effectiveness assessments
研究组 & 干预措施
Treatment
Experimental
干预措施: Restylane Contour (Device)
Control
No Intervention
结局指标
主要结局
Responder rate based on the Blinded Evaluators' live assessment of the GTVDS
时间窗: Baseline to 3 months
次要结局
- Responder rates, as assessed by the Blinded Evaluator at 6, 9 and 12 months after baseline for the treatment group(6,9,12 months after baseline)
研究者
研究点 (16)
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