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

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.