A Prospective Evaluation of Infraorbital Filler Injection
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 11
- 试验地点
- 2
- 主要终点
- Volumetric Change in Infraorbital Treatment Baseline to Each Post-intervention Timepoint Day 14, Day 30, and Day 90
研究概览
简要总结
The goal of this clinical trial is to measure the facial volumetric changes over time in patients injected with hyaluronic acid dermal filler (Juvéderm Volbella XC) in the infraorbital (under eye) region. Participants will be injected with Juvéderm Volbella XC filler and asked to return for 3D photography at 2 weeks, 1 month, and 3 months post-injection.
详细描述
Undereye or infraorbital hollowing is a result of a loss of volume causing shadowing and darkness of the infraorbital region often interpreted as a tired, stressed, and aged appearance.
The goal of this clinical trial is to measure the facial volumetric changes over time in patients injected with hyaluronic acid dermal filler (Juvéderm Volbella XC) in the infraorbital (under eye) region. Participants will be injected with Juvéderm Volbella XC filler and asked to return for 3D photography and to complete a validated patient satisfaction questionnaire at 2 weeks, 1 month, and 3 months post-injection. 3D photogrammetry technology allows for high level feature enhancement and microscopic anatomical evaluation that was not previously possible and can be used to make volumetric measurements at injection sites to evaluating minimally invasive injection efficacy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 22 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •age 22 to 65
- •interested in filler injections to reduce undereye volume loss
排除标准
- •age <22 or >65
- •prior undereye filler
- •filler/neurotoxin injection within the past 12 months
- •prior facial cosmetic surgery
- •prior facial trauma
- •planned dental work within next 2 weeks
- •travel 1 week prior or 2 weeks after injection
研究组 & 干预措施
Infraorbital Filler
Receives 1-2mL injection of approved filler in infraorbital region
干预措施: Juvederm Volbella XC hyaluronic acid dermal filler injection (Procedure)
结局指标
主要结局
Volumetric Change in Infraorbital Treatment Baseline to Each Post-intervention Timepoint Day 14, Day 30, and Day 90
时间窗: Post-intervention, Day 14, Day 30, Day 90
3D facial imaging to measure volumetric changes in the infraorbital region
次要结局
- Patient Satisfaction With Validated the Questionnaire FACE-Q(Day 0 pre-intervention, Day 0 post-intervention, Day 14, Day 30, Day 90)
研究者
Ivona Percec
Principal Investigator
University of Pennsylvania