NCT02661737已完成不适用
A Multi-center, Prospective and Observational Study to Evaluate Long-term Safety and Biodegradability of Modified Sodium Hyaluronate Gel (YVOIRE Volume s) Injected for Correction of Nasolabial Folds
LG Life Sciences0 个研究点目标入组 503 人开始时间: 2015年5月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 503
- 主要终点
- Incidence of Device-related Adverse Events
研究概览
简要总结
To evaluate long-term safety of YVOIRE volume s by incidence of adverse events including injection site local reactions and biodegradability.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects whose age is over 18 years old and under 65 years old
- •Subjects whose WSRS grade is equal or greater than 2
- •Subjects must be willing and able to provide written informed consent form
- •Subjects who are scheduled to be treated with YVOIRE volumes for facial tissue augmentation to correct the nasolabial folds
排除标准
- •Subjects who are sensitive to hyaluronic acid or any excipients of YVOIRE volume s
- •Subjects who have received permanent implantation (silicone, PAAG, PMMA, CaHA etc) on the nasolabial folds
- •Subjects who have received nonpermanent aesthetic treatments, such as botulinum toxin injection or filler on the nasolabial folds within 9 months before screening
- •Subjects who have received face lifting or plastic surgery on face within 9 months before screening
- •Subjects who have received laser therapy on the nasolabial folds, chemical peeling or peeling on face within 3 months before the screening
- •Subjects who have any skin diseases (including inflammation and skin cancer) or infectious diseases on the injection sites
- •Subjects who tend to have hypertrophic scars
- •Subjects with a history of streptococcal disease, severe allergy or anaphylaxis or bleeding disorders.
- •Women in pregnancy or lactation
结局指标
主要结局
Incidence of Device-related Adverse Events
时间窗: Until subject reaching total biodegradation criterion (WSRS change) ; an expected average of 2 years
次要结局
未报告次要终点
研究者
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