NCT07413445尚未招募不适用
Prospective Clinical Evaluation of the Safety and Performance of the Aesthetic Medical Device MEC REGENERATE® (Injectable Recombinant Collagen-based Product)
303 Pharma s.r.l.1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2026年3月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Safety based on number of adverse events from the enrollment for the 60days till the second visit and study closing.
研究概览
简要总结
Prospective, spontaneous, open-label pre-market clinical trial with a single injection session; monitoring visits at baseline and 60 days post-treatment.
Two visits will be conducted during the study:
- a baseline visit, during which the first injection will be administered
- a final visit, 60 days after the baseline visit, for final assessment
The experimental design involves injection into the deep subdermal layer with the investigational product during the baseline visit, following the study procedure assessments.
Typically, 0.9 ml per side of the face is administered using the retrograde fan technique.
The study duration is 2 months; safety evaluation will be conducted using non-invasive instrumental assessments such as skin hydration (corneometry) and medical device safety and subjective assessments (see below).
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
- 35 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Both sexes;
- •Caucasian race;
- •Aged between 35 and 65 years;
- •Non-smokers;
- •Willing and able to return to the study site for post-procedural assessments;
- •Agree to attend all study visits without makeup;
- •Agree not to change their habits regarding diet, physical activity, facial makeup, cosmetics, and facial cleansing products;
- •Agree to avoid intense UV exposure (UV sessions or sunbathing) during the entire study period without adequate sun protection;
- •Agree to take precautions to prevent pregnancy (applicable only to non-menopausal female subjects), including abstinence, intrauterine device (IUD), progestin implants, combined estrogen-progestin contraceptives, or condom use;
- •Agree to sign the informed consent form.
排除标准
- •Pregnancy (applicable only to non-menopausal female subjects);
- •Breastfeeding (applicable only to non-menopausal female subjects);
- •Alcohol abuse and/or drug use;
- •Non-menopausal female subjects not using the specified contraceptive measures to prevent pregnancy during the study;
- •Body mass index (BMI) variation of ±1 during the study period;
- •History of aesthetic skin treatments (biomaterial implants, facelift, botulinum toxin injections, laser therapy, chemical peels) within 6 months prior to the study start;
- •Previous permanent filler treatments;
- •Changes in normal habits related to diet, physical activity, facial cosmetics, facial cleansing, and makeup within one month prior to the study;
- •Sensitivity or allergy to the investigational product or its components (to be assessed by the investigator at baseline);
- •Predicted poor compliance with study protocol;
- •Participation in a similar study currently or within the past 9 months;
- •Dermatological clinical conditions that could interfere with aesthetic outcomes;
- •Chronic neurological, immunological, metabolic, cardiovascular, pulmonary, renal, or oncological diseases;
- •Current pharmacological treatment with: Anticoagulants, antiplatelet agents, antihistamines, topical or systemic corticosteroids, narcotics, antidepressants, immunosuppressants (except contraceptive or hormonal treatment started more than 1 year prior); Medications that may affect test results as deemed by the investigator.
研究组 & 干预措施
Injectable device with recombenant collagen, PCL and amino acids
Experimental
干预措施: Treatment with experimental device (Device)
结局指标
主要结局
Safety based on number of adverse events from the enrollment for the 60days till the second visit and study closing.
时间窗: From enrollment to the end of treatment, at 60 days
The AE will be monitored in terms on number by severity compared to standard
次要结局
- Efficacy based on skin hydration measured with corneometer and assessment with WSRS(At the end of treatment, after 60 days)
研究者
研究点 (1)
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