NCT05987163进行中（未招募）不适用
A Randomized, Evaluator-blinded, Parallel Group, Comparator-controlled, Multicenter Study to Evaluate the Safety and Effectiveness of GP0116 for Correction of Moderate to Severe Dynamic Facial Wrinkles and Folds, Such as Nasolabial Folds.
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- Galderma R&D
- 入组人数
- 186
- 试验地点
- 38
- 主要终点
- To demonstrate non-inferiority of GP0116 versus a comparator control
研究概览
简要总结
This is a prospective, randomized, evaluator-blinded, comparator-controlled, parallel group, multicenter study in the U.S. for correction of moderate to severe dynamic facial wrinkles and folds, such as nasolabial folds (NLFs).
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
- •Men and non-pregnant, non-breastfeeding women aged 22 years or older.
- •WSRS grade of 3 or 4 (moderate to severe folds) on each NLF as assessed by the Blinded Evaluator. The WSRS for each NLF does not need to be equal.
- •Intent to undergo treatment for correction of both left and right NLF.
排除标准
- •Known/previous allergy or hypersensitivity to any injectable hyaluronic acid (HA) gel
- •Known/previous allergy or hypersensitivity to local anesthetics
- •Previous or present severe or multiple allergies manifested by severe reactions
- •Previous facial surgery near the treatment area
结局指标
主要结局
To demonstrate non-inferiority of GP0116 versus a comparator control
时间窗: At 3 months after Baseline
To demonstrate non-inferiority of GP0116 versus a comparator control in correction of NLFs by comparing change from baseline based on the Blinded Evaluator's live assessment of NLF correction at Month 3 using the Wrinkle Severity Rating Scale (WSRS).
次要结局
未报告次要终点
研究者
研究点 (38)
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