NCT06694857已完成4 期
3-Dimensional Volumetric Analysis of a Hyaluronic Filler Injection for Jaw Contouring
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 14
- 试验地点
- 1
- 主要终点
- Volume change of the lower face area at 30 days post-intervention
研究概览
简要总结
The goal of this prospective study is to analyze volumetric changes in the lower face after hyaluronic acid filler injections over 90 days. The main question it aims to answer is:
To quantify volume change of the lower face area over time after injection of filler
- Participants will receive hyaluronic acid filler injections (Juvéderm Volux XC) for contouring of the jawline. Each patient will receive FDA approved dosages of filler to the lower face region to treat facial contour or asymmetry, as per FDA approved indications.
- Prior to injection patients will be imaged with 3-dimensional photogrammetry. Subjects will return post-injection in 2 weeks, 1 month, and 3 months for re-imaging.
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 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients interested in jaw contouring
- •Participants must sign the informed consent form.
排除标准
- •1Prior filler for facial contouring 2) Filler injection within the past 12 months or during duration of study 3) Prior facial cosmetic surgery (ie. facelift) 4) Prior facial trauma (ie. orbital fracture) 5) Pregnant or breastfeeding 6) Planned dental work within next 2 weeks 7) The following contraindications: patients with severe allergies manifested by a history of anaphylaxis or history or presence of multiple severe allergies, gram-positive bacterial protein allergies and lidocaine allergies
研究组 & 干预措施
Filler
Experimental
HA Filler to jaw line
干预措施: HA filler (Drug)
结局指标
主要结局
Volume change of the lower face area at 30 days post-intervention
时间窗: 30 days
3D- images will be collected to determine change in volume following from pre-intervention to post-intervention (30 days)
次要结局
- PRO(90 Days)
- Volume Change of the Lower Face 14 days Post-intervention(14 days)
- Volume changes of the lower face at 90 days post-intervention(90 days)
研究者
Ivona Percec
Associate Director, Cosmetic Surgery
University of Pennsylvania
研究点 (1)
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