NCT02119793已完成不适用
A Multicenter, 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 Study
LG Life Sciences1 个研究点 分布在 1 个国家目标入组 13 人开始时间: 2015年5月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 13
- 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 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 study.
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
- 20 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Eligible subjects who have completed the LG-HACL014 study
- •Have anteromedial malar region volume loss at least a one-point worse on the MFAS compared with 2 weeks after treatment in the LG-HACL014 study
- •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 repeat 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
研究组 & 干预措施
YVOIRE contour
Experimental
干预措施: YVOIRE contour (Device)
结局指标
主要结局
Mid Face Aesthetic Scale (MFAS) score
时间窗: 2, 26, and 52 weeks after repeat treatment
Mean of MFAS score as assessed by the independent blinded rater
次要结局
- Mid Face Aesthetic Scale (MFAS) score(2, 26, and 52 weeks after repeat treatment)
- Mid Face Aesthetic Scale (MFAS) Responder rate(2, 26, and 52 weeks after repeat treatment)
- Global Aesthetic Improvement Scale (GAIS) score(2, 26, and 52 weeks after repeat treatment)
- Global Aesthetic Improvement Scale (GAIS) Responder rate(2, 26, and 52 weeks after repeat treatment)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
不适用
Observational Study to Evaluate Long-term Safety and Biodegradability of YVOIRE Classic sCorrection of Nasolabial FoldsNCT02334358LG Life Sciences503
已完成
3 期
A Long-Term Safety Study of Repeat Treatment With PurTox® for Frown Lines Between the EyebrowsGlabellar RhytidesNCT00752258Mentor Worldwide, LLC576
已完成
不适用
Observational Study to Evaluate Long-term Safety and Biodegradability of YVOIRE Volume sCorrection of Nasolabial FoldsNCT02661737LG Life Sciences503
已完成
3 期
Dysport® Pediatric Lower Limb Spasticity Follow-on StudyMuscle SpasticityChildrenCerebral PalsyNCT01251380Ipsen216
已完成
2 期
Safety and Efficacy Extension Study of Daclizumab High Yield Process (DAC HYP) in Participants With Multiple Sclerosis Who Have Completed Study 205MS201 (NCT00390221) to Treat Relapsing-Remitting Multiple SclerosisRelapsing-Remitting Multiple SclerosisNCT00870740Biogen517