A Randomized, Evaluator-Blinded, Parallel, Comparator-Controlled Study to Evaluate the Safety and Effectiveness of GAL1704 for Cheek Augmentation and Correction of Midface Contour Deficiencies
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Galderma R&D
- 入组人数
- 270
- 试验地点
- 15
- 主要终点
- Assess Efficacy of Study Treatment Using Medicis Midface Volume Score (MMVS)
研究概览
简要总结
An interventional study to evaluate the safety and effectiveness of GAL1704 for cheek augmentation and the correction of midface volume deficiencies by demonstrating non-inferiority in change from baseline, relative to an active comparator.
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
- 22 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •- Subjects assessed at baseline by the Blinded Evaluator as Grade 2, 3, or 4 on the MMVS on each side of the midface.
排除标准
- •- Previous use of any HA based or collagen based biodegradable tissue augmentation therapy within 12 months prior to the baseline visit
研究组 & 干预措施
GAL1704 (needle)
Subjects randomized (2:1) to GAL1704 or Control for cheek augmentation and the correction of midface contour deficiencies.
干预措施: GAL1704 (Device)
GAL1704 (cannula/needle)
GAL1704 treatment using a split face design - one cheek treated using cannula and the other cheek treated using needle.
干预措施: GAL1704 (Device)
Juvederm Voluma
Subjects randomized to control.
干预措施: Juvederm Voluma (Device)
结局指标
主要结局
Assess Efficacy of Study Treatment Using Medicis Midface Volume Score (MMVS)
时间窗: 12 weeks
Change in midface fullness from Baseline to 12 weeks using the Medicis Midface Volume Score (MMVS), where a decreasing score correlates with increasing midface fullness, namely a score of 1 being the most full and a score of 4 being the least full.
次要结局
未报告次要终点