A Post-marketing, Open-label, Non-comparative, Multi-center Investigation to Evaluate the Effectiveness and Safety of a Medical Device "Alexa Volume" (DIACO BIOFARMACEUTICI S.r.l., Italy) Based on Cross-linked Hyaluronic Acid for Correction of the Midface Volume Los
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 68
- 试验地点
- 8
- 主要终点
- Investigator-evaluated change in midface volume using the Global Aesthetic Improvement Scale (GAIS) from baseline (Visit 1) to Day 28 (Visit 3).
研究概览
简要总结
This is a post-marketing, open-label, non-comparative, multi-center clinical investigation to evaluate the effectiveness and safety of the medical device "Alexa Volume" (DIACO BIOFARMACEUTICI S.r.l., Italy), based on cross-linked hyaluronic acid, for the correction of midface volume loss. The study involved 68 female subjects across Poland and Ukraine who received Alexa Volume injections in the midface area. Effectiveness was assessed using the Global Aesthetic Improvement Scale (GAIS), Wrinkle Severity Rating Scale (WSRS), and Medicis Midface Volume Scale (MMVS). The study demonstrated statistically significant improvements in aesthetic outcomes and confirmed a favorable safety profile with minimal adverse events
详细描述
This clinical investigation evaluated the effectiveness and safety of the CE-marked medical device "Alexa Volume," a cross-linked hyaluronic acid filler, for correction of midface volume loss in adult subjects. Conducted at multiple centers in Poland and Ukraine, the open-label, non-comparative study collected post-marketing data under routine clinical conditions.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 25 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Twenty-five (25) years of age or older at time of consent.
- •Desire and willingness for correction or enhancement of his/her mid-face area.
- •Subjects presenting with loss of volume and contour of the midface area 2 or more score according to MMVS bilaterally.
- •Nasolabial folds severity grade 2 or more according to WSRS bilaterally.
- •Treatment-naive subjects for fillers in the areas to be treated in the last 12 months, otherwise as decided by the Investigator.
- •Subjects with signed informed consent and photo consent.
- •Medical history and physical examination which, based on the Investigator's opinion, do not prevent the subject from taking part in the investigation and use the investigational medical device (IMD).
- •Subjects not pregnant, non-breastfeeding.
- •Subject must be willing to complete the entire course of the investigation.
排除标准
- •Pregnant, planning pregnancy during the investigation or breastfeeding women.
- •Subjects with known hypersensitivity to any compound of the IMD.
- •Subjects with history of any other adverse effect, which could prevent the subject from participating in the investigation according to the Investigator's opinion.
- •Any prior surgery, any prior cosmetic procedures or side effects from previous procedures in the injected area, including permanent fillers, that may interfere with the results.
- •Subjects with presence of autoimmune disease or other chronic disease that in the opinion of the Investigator may interfere with the outcome of the investigation.
- •Subjects with active inflammation or infection in the areas of Alexa administration.
- •Subjects with tattoo and/or scar in the area of Alexa Volume administration that in the Investigator's opinion would interfere with investigation assessments.
- •Subjects who tend to develop hypertrophic scarring.
- •Subjects with impaired hemostatic function, which could prevent the subject from participating in the investigation according to the Investigator's opinion.
- •Subjects with fibrosis, birthmark, or residual material in the area of intended use of Alexa Volume.
- •Subjects participating in other clinical investigations within 30 days prior to the Visit 1.
结局指标
主要结局
Investigator-evaluated change in midface volume using the Global Aesthetic Improvement Scale (GAIS) from baseline (Visit 1) to Day 28 (Visit 3).
时间窗: 28 days (from baseline Visit 1 to Visit 3)
The GAIS (Global Aesthetic Improvement Scale) is a 5-point ordinal scale used to assess improvement in facial aesthetics. The scale ranges from 1 (Very Much Improved) to 5 (Worse), where lower scores indicate better outcomes. Investigators evaluated standardized photographs taken before and after treatment. A reduction of ≥1 point from baseline was considered a clinically meaningful improvement.
次要结局
未报告次要终点