A Randomized, Split-face Clinical Study on Comparative Ultrasound Analysis of Two Hyaluronic Acid Fillers for Midface Correction
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Galderma R&D
- 入组人数
- 11
- 试验地点
- 2
- 主要终点
- Assess and compare tissue aggregation and visualization of Hyaluronic Acid fillers using ultrasound
研究概览
简要总结
To assess and compare tissue aggregation and visualization of two Hyaluronic Acid fillers via ultrasound
详细描述
This is a randomized, split-face, subject-blinded, comparative study to assess and compare tissue aggregation and visualization of two Hyaluronic Acid fillers via ultrasound.
This study is designed to enroll and randomize approximately 15 subjects in a 1:1 ratio of treatment to Restylane Contour or Juvederm Voluma. All subjects are to have midface volume loss and contour deficiency.
Eligible subjects are randomized to receive treatment were injected by the Treating Investigator at Baseline. The method of injection is at the discretion of the Treating Investigator. A sufficient amount of product is injected to achieve optimal correction of the midface, in the opinion of the Treating Investigator and subject.
At the 4-week visit, after all study procedures for the visit are completed, treated subjects have the option of receiving a touch-up treatment to achieve optimal aesthetic improvement. At the 6-month, 9-month, and 12-month visits, similar study procedures are performed.
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 (Participant)
盲法说明
Subjects are blinded to treatment assignment to each side of their faces.
入排标准
- 年龄范围
- 22 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subject with midface volume loss and contour deficiency
- •Ability of giving consent for participation in the study
- •Agreement to adhere to the procedures and requirements of the study and to report to the institute on the day(s) and at the time(s) scheduled for the assessments
排除标准
- •History of allergy or hypersensitivity to lidocaine and/or injectable hyaluronic acid
- •Previous permanent or semi-permanent implant in proposed treatment area
- •Previous biodegradable tissue augmentation therapy in the proposed treatment area within 12 months prior to the baseline visit
- •History of other facial treatment/procedure at the study area (midface) in the previous 6 months that would potentially interfere with study injections (e.g., facial surgery, oral surgery, resurfacing, mesotherapy, lipolytic injections, botulinum toxin injections)
研究组 & 干预措施
Restylane Contour
Form: transparent gel of Hyaluronic Acid with the addition of lidocaine hydrochloride.
Mode of administration: injection Dosage: at investigator's discretion for optimal outcome. Frequency and duration: injection at baseline and optional touch-up at week 4.
干预措施: Restylane Contour (Device)
Juvederm Voluma
Form: sterile, biodegradable, non-pyrogenic, viscoelastic, clear, colorless, homogenous gel implant of Hyaluronic Acid crosslinked with BDDE, formulated with lidocaine.
Mode of administration: injection Dosage: at investigator's discretion for optimal outcome. Frequency and duration: injection at baseline and optional touch-up at week 4.
干预措施: Juvederm Voluma (Device)
结局指标
主要结局
Assess and compare tissue aggregation and visualization of Hyaluronic Acid fillers using ultrasound
时间窗: Immediately post-treatment, 4 weeks, 6 months, 9 months, and 12 months after baseline
Change in filler properties within the skin tissues. Filler properties include size, shape, and aggregation at different facial expressions.
Assess and Compare Tissue Aggregation and Visualization of Hyaluronic Acid Fillers by Investigator Using Ultrasound
时间窗: Immediately post-treatment
Investigator visually reviewed ultrasound scans to determine filler flexibility and aggregation once injected into skin tissues.
Assess and Compare Tissue Aggregation and Visualization of Hyaluronic Acid Fillers by Investigator Using Ultrasound
时间窗: 12 months
Investigator visually reviewed ultrasound scans to determine filler flexibility and aggregation once injected into skin tissues.
次要结局
- Evaluate subject satisfaction using self-assessment questionnaire(4 weeks, 6 months, 9 months, and 12 months after baseline)
- Evaluate volume change in the treated areas using 3D imaging(4 weeks, 6 months, 9 months, and 12 months after baseline)
- Evaluate Volume Change in the Treated Areas Using 3D Imaging(4 weeks)
- Evaluate Volume Change in the Treated Areas Using 3D Imaging(6 months)
- Evaluate Volume Change in the Treated Areas Using 3D Imaging(9 months)
- Evaluate Volume Change in the Treated Areas Using 3D Imaging(12 months)
- Evaluate Subject Satisfaction Using Self-assessment Questionnaire(4 weeks)
- Evaluate Subject Satisfaction Using Self-assessment Questionnaire(6 months)
- Evaluate Subject Satisfaction Using Self-assessment Questionnaire(9 months)
- Evaluate Subject Satisfaction Using Self-assessment Questionnaire(12 months)