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

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).

NCT Number	NCT07413445
Lead Sponsor	303 Pharma s.r.l. Collaborators: Nextrasearch S.r.l.s.
Conditions	Laxity; Skin, Volume Deficiency in the Mid-Face, Wrinkles
Enrollment	20 participants
Start Date	2026-03
Primary Completion	2026-04 (estimated)
Study Completion	2026-05 (estimated)
Updated on ClinicalTrials.gov	2026-02-17