NCT02119780Unknown不适用
Clinical Study to Evaluate the Efficacy and Safety of YVOIRE® Contour Compared With Restylane SubQ™ Injected Into the Anteromedial Malar Region
LG Life Sciences1 个研究点 分布在 1 个国家目标入组 83 人开始时间: 2014年5月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 83
- 试验地点
- 1
- 主要终点
- Mid Face Aesthetic Scale (MFAS) score
研究概览
简要总结
This study is purposed to evaluate the efficacy and safety of YVOIRE® contour compared with Restylane SubQ™ injected into the anteromedial malar region.
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
- 20 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Be male or female, 20-65 years of age
- •Have anteromedial malar region volume loss as grade 2, 3, or 4 on the Mid Face Aesthetic Scale (MFAS) symmetrically on both sides
- •Desire filler treatment to correct volume loss in the anteromedial malar region
- •Accept the obligation not to receive any other mid facial procedures or treatments during the study
- •Signed informed consent
- •Those who fall under one of the following 3 cases
- •Males or females who are surgically sterile
- •Post-menopausal females who are above 45 years of age and 2 years after the last menstruation
- •Fertile premenopausal females or males without having a surgical sterilization, who have agreed to use at least two contraception methods (one of the barrier methods must be included) for up to 14 days after the last treatment of the investigational device to avoid pregnancy
排除标准
- •Have a history of hypertrophic scars or keloids
- •Other criteria as identified in the protocol
结局指标
主要结局
Mid Face Aesthetic Scale (MFAS) score
时间窗: 26 weeks after treatment
Mean of MFAS score as assessed by the independent blinded rater
次要结局
- Global Aesthetic Improvement Scale (GAIS) Responder rate(2, 14, 26, and 52 weeks after treatment)
- Mid Face Aesthetic Scale (MFAS) score(2, 14, 26, and 52 weeks after treatment)
- Mid Face Aesthetic Scale (MFAS) Responder rate(2, 14, 26, and 52 weeks after treatment)
- Global Aesthetic Improvement Scale (GAIS) score(2, 14, 26, and 52 weeks after treatment)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
不适用
Clinical Study to Evaluate the Correction of Facial Wrinkles and Folds and Safety of YVOIRE Volume Versus Perlane in Nasolabial Fold InjectionTemporary Correction of WrinklesNCT03738007LG Life Sciences57
已完成
不适用
Extension Clinical Study to Evaluate the Long-term Efficacy and Safety of Repeat Treatment of YVOIRE Contour Injected Into the Anteromedial Malar Region in Subjects Who Have Completed the LG-HACL014 StudyNormal, Healthy Adults With Moderate, Severe, or Very Severe Volume Loss of Anteromedial Malar Region Who Have Completed the LG-HACL014 StudyNCT02119793LG Life Sciences13
终止
不适用
To Evaluate the Performance and Safety of YVOIRE Y Solution 360 Versus Comparator for Lips and Perioral Area.Lip AugmentationNCT04299295LG Chem118
终止
不适用
A Study of YVOIRE Y-Solution 360 for Hand Augmentation to Correct Volume LossDorsal Hand Volume LossNCT04112017LG Chem116
已完成
不适用
Restylane Shaype Versus Juvederm Volux for Chin AugmentationChin RetrusionNCT06336772Erevna Innovations Inc.40