A Post-marketing, Prospective, Open-label, Single-group, Multicentre Clinical Investigation to Evaluate the Effectiveness and Safety of a Medical Device Based on Non-cross-linked Hyaluronic Acid in Concentrations of 0.55% ("Electri") and 1.1%, 1.8%, or 2.2% ("XELA REDERM") (Diaco Biofarmaceutici S.r.l., Italy) for Improving the Aesthetic Appearance of Facial Skin.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 77
- 试验地点
- 8
- 主要终点
- Investigator-assessed improvement in facial skin condition using GAIS scale on Day 42 compared to baseline
研究概览
简要总结
The goal of this clinical investigation is to learn whether injectable implants based on non-cross-linked hyaluronic acid (Electri and XELA REDERM) improve the aesthetic appearance of facial skin in adult women. It will also learn about the safety of these medical devices.
The main questions it aims to answer are:
Does skin appearance improve after a series of redermalization procedures? How do the procedures affect skin hydration and elasticity? What side effects or medical issues, if any, do participants experience? Researchers did not use a control group. Instead, they evaluated skin improvements in the same participants over time.
Participants:
Received 3 injections of the hyaluronic acid-based device over 6 weeks (1 injection every 14±1 days).
Had their skin condition assessed by doctors and by themselves using a standardized scale.
Underwent tests to measure skin hydration and elasticity. Reported any adverse events or adverse device effects.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subject agreed to participate in the Investigation and signed the Informed Consent Form.
- •Age over 18 years.
- •The subject is eager to undergo a course of skin redermalization procedures using the medical device(devices) based on non-cross-linked hyaluronic acid in concentrations of 0.55% ("Electri") and 1.1%, 1.8% or 2.2% ("XELA REDERM") (Diaco Biofarmaceutici S. r. l., Italy) in Poland; in concentrations of 1.1%, 1.8% or 2.2% ("XELA REDERM") (Diaco Biofarmaceutici S. r. l., Italy) in Ukraine.
- •Female subject confirm that she is not pregnant or lactating during the study.
排除标准
- •Infection or inflammation in the implant injection site.
- •Pregnancy, lactation.
- •Subject's intention to undergo procedures involving chemical peels, laser irradiation, botulinum toxin injection or other similar procedures in the injection site within the next 45 days after inclusion in the post-marketing investigation.
- •Subject underwent procedures involving chemical peels, laser irradiation, botulinum toxin injection or other similar procedures in the injection site within 35 days prior to inclusion in the post-marketing investigation.
- •Chronic or acute severe or decompensated visceral diseases.
- •Known hypersensitivity to hyaluronic acid, its metabolites, or to the excipients of the injectable implant.
- •Known hypersensitivity to analgesics.
- •Subject took significant doses of vitamin E, NSAIDs or anticoagulants during the last 7 days.
- •Refusal or suspected inability of the subject to comply with the requirements of the CIP.
- •Subject has difficulty in understanding the language in which the informed consent is written.
- •Any other reason that, in the opinion of the investigator, prevents the subject from participating in the post-marketing investigation.
- •Subject takes participation in other clinical investigation.
结局指标
主要结局
Investigator-assessed improvement in facial skin condition using GAIS scale on Day 42 compared to baseline
时间窗: Day 42 ±1 after first injection
The investigator evaluated changes in the aesthetic appearance of facial skin using the Global Aesthetic Improvement Scale (GAIS), a 5-point scale ranging from -1 ("Worse") to 3 ("Very much improved"). The primary endpoint is the mean GAIS score on Day 42 compared to baseline.
次要结局
未报告次要终点