NCT04687046已完成不适用
A Real-World Evidence Study of JUVÉDERM VOLUX® Injectable Gel for Chin Enhancement in Chinese Adults
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Allergan
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Change from Baseline in the Glabella-Subnasale-Pogonion (G-Sn-Pog) Angle
研究概览
简要总结
This study will collect effectiveness and safety data on JUVÉDERM VOLUX® Injectable Gel for Chin Enhancement in Chinese Adults based on real world data.
详细描述
There will be 30 participants selected who undergo 3D imaging before and after JUVÉDERM VOLUX® treatment for digital analysis assessments. Up to 90 participants enrolled either prospectively prior to JUVÉDERM VOLUX® treatment or retrospectively after JUVÉDERM VOLUX® treatment.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
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
- •Participant has chin retrusion seeking chin enhancement who have received or plan to receive VOLUX chin treatment in Hainan Boao Super Hospital.
排除标准
- •History of hypersensitivity to lidocaine,HA, or Streptococcal protein
- •History of tendency to develop hypertrophic scarring
- •Untreated epilepsy or porphyria
- •Current cutaneous inflammatory or infectious processes (eg, acne, herpes) in the treatment area
- •Prior chin or jaw surgery, including cartilage grafts or implantation of any biomaterials
- •Permanent filler, semi-permanent filler, or fat injected in the treatment area
- •Temporary filler, other than VOLUX, injected in the treatment area within 12 months before enrollment
- •Females who self-report current pregnancy or breastfeeding
结局指标
主要结局
Change from Baseline in the Glabella-Subnasale-Pogonion (G-Sn-Pog) Angle
时间窗: Baseline, Month 3
次要结局
- Percentage of Responders based on the Participant's Assessment of Improvement in the Chin and Jaw Area using the 5-point GAIS(Month 3)
- The number of Adverse Events (AEs) from physician observation and inquiry at scheduled follow-up visits(Month 1, 3, 6, and 12)
- Percentage of Responders based on the Investigator's Assessment of Improvement in the Chin and Jaw Area using the 5-point Global Aesthetic Improvement Scale (GAIS)(Month 3)
- The presence and severity of ISRs (Injection Site Response) at scheduled follow-up visits(Month 1, 3, 6, and 12)
研究者
研究点 (1)
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