A Prospective, Multicenter, Within-subject Controlled Study of the Safety and Effectiveness of JUVÉDERM VOLIFT® XC Versus Control for the Correction of Moderate to Severe Nasolabial Folds
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Allergan
- 入组人数
- 126
- 试验地点
- 11
- 主要终点
- Mean Change From Baseline in Nasolabial Fold Severity Using the 5-Point Nasolabial Fold Severity Scale (NLFSS)
研究概览
简要总结
A prospective, multicenter, within-subject controlled study of the safety and effectiveness of JUVÉDERM VOLIFT® XC versus Control for the correction of moderate to severe 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
- 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
- •2 visible moderate to severe nasolabial folds
- •Agree to refrain from undergoing other anti-wrinkle/volumizing treatments in the lower two-thirds of the face for the duration of the study
排除标准
- •Undergone facial tissue augmentation with dermal fillers in the lower two-thirds of the face within the past 12 months
- •Undergone facial tissue augmentation with fat injections, botulinum toxin injections in the lower two-thirds of the face, mesotherapy, or cosmetic facial procedures in the face or neck within the past 6 months
- •Received semi-permanent fillers or permanent facial implants anywhere in the lower face
研究组 & 干预措施
Control NLFs
Nasolabial folds treated with Control.
干预措施: Control (Device)
VOLIFT® XC NLFs
Nasolabial folds treated with JUVEDERM VOLIFT® XC.
干预措施: JUVEDERM VOLIFT® XC (Device)
结局指标
主要结局
Mean Change From Baseline in Nasolabial Fold Severity Using the 5-Point Nasolabial Fold Severity Scale (NLFSS)
时间窗: Baseline, Month 6
Nasolabial fold severity is assessed by the Evaluating Investigator on the 5-point Nasolabial Fold Severity Scale (ranging from 0=None \[no wrinkle\] to 4=Extreme \[very deep wrinkle, redundant fold\]). Mean change from baseline in NFLSS is defined as score at baseline minus score at Month 6. A negative number change from baseline indicated improvement and a positive number change from baseline indicated worsening.
Percentage of Nasolabial Folds With ≥1-Point Improvement
时间窗: Baseline, Month 6
Nasolabial fold severity is evaluated by the Evaluating Investigator on the 5-point Nasolabial Fold Severity Scale (ranging from 0=None \[no wrinkle\] to 4=Extreme \[very deep wrinkle, redundant fold\]). The percentage of nasolabial folds with ≥1-point improvement from baseline (i.e., decrease in severity) are reported.
次要结局
- Percentage of Nasolabial Folds With ≥1-Point Improvement(Baseline, Month 12)
- Mean Change From Baseline in Overall Nasolabial Folds FACE-Q Score(Baseline, Month 12)