NCT04112017终止不适用
A Multicenter, Randomized, No-treatment Controlled, Parallel, Evaluator-blind, Medical Device Pivotal Study to Evaluate the Effectiveness and Safety of YVOIRE Y-Solution 360 Injected Into Dorsal Hand for Hand Augmentation to Correct Volume Loss
LG Chem2 个研究点 分布在 1 个国家目标入组 116 人开始时间: 2019年9月27日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 116
- 试验地点
- 2
- 主要终点
- ≥ 1 grade improvement on Hand Volume Rating Scale (HVRS) as assessed by the evaluator-blinded
研究概览
简要总结
The purpose of this study is to evaluate the effectiveness and safety of YVOIRE Y-Solution 360 in the treatment of dorsal hand to correct volume loss.
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
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •19 Years and older
- •Hand Volume Rating Scale (HVRS) of grade 2 or 3 with both hands
- •Participants who are willing to undergo the treatment of dorsal hand to correct volume loss
排除标准
- •Congenital defect, external injuries, lipodystrophy, unhealed wound, disease related-abnormalities, or tumors on the dorsal hands
- •Active inflammation or infection on the dorsal hands
- •Received anti-coagulation therapy, anti-platelet therapy, or expected to require repeated treatment within 2 weeks prior to visit 2 (randomization)
- •Had locally applied ointments (steroid, retinoid, anti-wrinkle production, tanning, or any other form of irritating product) or expected to require repeated treatment within 4 weeks prior to visit 2 (randomization)
- •Received immuno-suppressive medication including systemic glucocorticoids or expected to require repeated treatment within 8 weeks prior to visit 2 (randomization)
- •Received NSAIDs, Vitamin E, or expected to require repeated treatment within 1 week prior to visit 2 (randomization)
- •Had dermal filler injections (HA, CaHA, silicon, PAAG, PMMA etc.), Botulinum toxin therapy, adipose tissue transplantation, or esthetic surgery within 12 months prior to visit 2 (randomization)
结局指标
主要结局
≥ 1 grade improvement on Hand Volume Rating Scale (HVRS) as assessed by the evaluator-blinded
时间窗: 12 weeks after treatment
5-grade photonumeric hand grading scale (grade 0 - grade 4)
次要结局
- ≥ 1 grade improvement on Hand Volume Rating Scale (HVRS) as assessed by the evaluator-blinded and the treating investigator(Up to 52 weeks after treatment)
- ≥ 1 grade improvement on Global Aesthetic Improvement Scale (GAIS) as assessed by the treating investigator and the subject(Up to 52 weeks after treatment)
- Change from baseline on Hand Volume Rating Scale (HVRS) as assessed by the evaluator-blinded and the treating investigator(Up to 52 weeks after treatment)
- Change from baseline on Global Aesthetic Improvement Scale (GAIS) as assessed by the treating investigator and the subject(Up to 52 weeks after treatment)
- Safety profile as assessed by incidence of adverse events(Up to 52 weeks after treatment)
研究者
研究点 (2)
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