Prospective Clinical Evaluation of the Safety and Performance of the Aesthetic Medical Device MEC REGENERATE® (Injectable Recombinant Collagen-based Product)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Treatment with experimental device.
- Who it may be relevant to
- Registry conditions: Laxity; Skin, Volume Deficiency in the Mid-Face, Wrinkles. Basic parameters: 35 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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).
Interventions
- Device Treatment with experimental device
Injection of recombinant collagen-based product
Primary outcome measures
- Safety based on number of adverse events from the enrollment for the 60days till the second visit and study closing. [Time frame: From enrollment to the end of treatment, at 60 days]
Secondary outcome measures (1)
- Efficacy based on skin hydration measured with corneometer and assessment with WSRS [Time frame: At the end of treatment, after 60 days]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Italy · 1 center
- Ospedale Policlinico San Martino, Istituto di Ricovero e Cura a Carattere Scientifico — Genova
Identifiers
NCT: NCT07413445 · NS/MD04/2025/MecReg