NCT04154930已完成不适用
A Randomized, Evaluator-blinded, Parallel Group, No-treatment Controlled, Multi-center Study to Evaluate the Safety and Effectiveness of Restylane-L® for Correction of Infraorbital Hollows
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
- 333
- 试验地点
- 16
- 主要终点
- Responder Rate Based on the Blinded Evaluator's Live Assessment of the Galderma Infraorbital Hollows Scale (GIHS)
研究概览
简要总结
This is a prospective, randomized, evaluator-blinded, no-treatment controlled, parallel group, multi-center US study to evaluate the safety and effectiveness of Restylane-L® for correction of Infraorbital Hollows.
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
- •Moderate or severe infraorbital hollows with no more than one grade difference between the left and right side at baseline as assessed by the blinded evaluator.
- •Males or non-pregnant, non-breastfeeding females, over the age of
- •Intent to undergo correction of both orbital hollows.
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 deep and/or superficial facial dermal therapies.
- •Active or a history of recurrent or chronic infraorbital edema or rosacea or uncontrolled severe seasonal allergies.
研究组 & 干预措施
Restylane-L Treatment
Experimental
Restylane-L® injected with optional touch-up at 1 month and optional retreatment at 12 months.
干预措施: Restylane-L® (Device)
No Treatment Control
No Intervention
No treatment control with optional treatment at 12 months.
结局指标
主要结局
Responder Rate Based on the Blinded Evaluator's Live Assessment of the Galderma Infraorbital Hollows Scale (GIHS)
时间窗: At 3 months after Baseline
Responder rate was defined as the percentage of participants with at least a 1-point improvement from baseline on the Galderma Infraorbital Hollows Scale (GIHS), on both sides of the face, concurrently. GIHS is a validated 4-point scale used to assess Infraorbital Hollows: 0 (none \[hollowness\]), 1 (mild \[hollowness\]), 2 (moderate \[hollowness\]), 3 (severe \[hollowness\]). Higher score means more severe (worse) hollowness in the infraorbital Hollows.
次要结局
- Percentage of Participants With At Least "Improved" on the GAIS Based on the Treating Investigator Live Assessment(At 1, 3, 6, 9, and 12 months after randomization, at 1 month after optional touch-up, and at 1, 3 and 6 months after optional treatment)
- Responder Rate Based on the Blinded Evaluator's Live Assessment of the GIHS at 6, 9, and 12 Months After Baseline And at 3 and 6 Months After Optional Treatment(At 6, 9, and 12 months after Baseline and at 3 and 6 months after optional treatment)
- Percentage of Participants With At Least "Improved" on the Global Aesthetic Improvement Scale (GAIS) Based on the Participants Live Assessment(At 1, 3, 6, 9, and 12 months after randomization, at 1 month after optional touch-up, and at 1, 3 and 6 months after optional treatment)
研究者
研究点 (16)
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