A Safety and Efficacy Study of JUVÉDERM® VOLIFT® With Lidocaine and Restylane® for Nasolabial Folds in Chinese Adults
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Allergan
- 入组人数
- 175
- 试验地点
- 5
- 主要终点
- Investigator's Assessment of Severity of Each Nasolabial Fold (NLF) on the 5-Point NLF Severity Scale (NLFSS)
研究概览
简要总结
This is a safety and efficacy study of JUVÉDERM® VOLIFT® with Lidocaine and Restylane® in Chinese adults with nasolabial folds.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Presence of nasolabial folds
- •Agree to refrain from treatment with other anti-wrinkle/volumizers below the eye for the duration of the study
排除标准
- •Ever received semi-permanent fillers or permanent facial implants below the eyes, or plans to receive these treatments during the study
- •Undergone temporary dermal filler treatment (eg, hyaluronic acid or collagen) below the eyes within 12 months, or plans to undergo these treatments during the study
- •Undergone facial tissue augmentation with fat injections, botulinum toxin injections, mesotherapy, or cosmetic facial procedures in the face or neck within 6 months, or plans to undergo these treatments during the study
研究组 & 干预措施
JUVÉDERM® VOLIFT® with Lidocaine - Right Side
JUVÉDERM® VOLIFT® with lidocaine injected into the right nasolabial fold on Day 1, with optional touch-up injections into the right nasolabial fold on Month 1.
干预措施: JUVÉDERM® VOLIFT® with Lidocaine (Device)
Restylane® - Right Side
Restylane® injected into the right nasolabial fold on Day 1, with optional touch-up injections into the right nasolabial fold on Month 1.
干预措施: Restylane® (Device)
JUVÉDERM® VOLIFT® with Lidocaine - Left Side
JUVÉDERM® VOLIFT® with lidocaine injected into the left nasolabial fold on Day 1, with optional touch-up injections into the left nasolabial fold on Month 1.
干预措施: JUVÉDERM® VOLIFT® with Lidocaine (Device)
Restylane® - Left Side
Restylane® injected into the left nasolabial fold on Day 1, with optional touch-up injections into the left nasolabial fold on Month 1.
干预措施: Restylane® (Device)
结局指标
主要结局
Investigator's Assessment of Severity of Each Nasolabial Fold (NLF) on the 5-Point NLF Severity Scale (NLFSS)
时间窗: Month 6
次要结局
- Subject's Assessment of Procedural Pain on an 11-Point Scale(Day 1)
- Investigator's Assessment of Each NLF on the 5-Point Global Aesthetic Improvement Scale (GAIS)(Month 6)
- Subject's Assessment of Each NLF on the 5-Point GAIS(Month 6)