Prospective Clinical Evaluation of the Safety and Performance of the Aesthetic Medical Device MEC REGENERATE® (Injectable Recombinant Collagen-based Product)

Обзор

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).

Вмешательства

• Устройство Treatment with experimental device
  Injection of recombinant collagen-based product

Первичные конечные точки

• Safety based on number of adverse events from the enrollment for the 60days till the second visit and study closing. [Срок оценки: From enrollment to the end of treatment, at 60 days]

Вторичные конечные точки (1)

• Efficacy based on skin hydration measured with corneometer and assessment with WSRS [Срок оценки: At the end of treatment, after 60 days]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• Pregnancy (applicable only to non-menopausal female subjects);
• Breastfeeding (applicable only to non-menopausal female subjects);
• Smokers;
• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Италия · 1 центр

• Ospedale Policlinico San Martino, Istituto di Ricovero e Cura a Carattere Scientifico — Genova

Идентификаторы

NCT: NCT07413445 · NS/MD04/2025/MecReg

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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