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Prospective Clinical Evaluation of the Safety and Performance of the Aesthetic Medical Device MEC REGENERATE® (Injectable Recombinant Collagen-based Product)
Sponsor: 303 Pharma s.r.l.
Summary
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).
Key Details
Gender
All
Age Range
35 Years - 65 Years
Study Type
INTERVENTIONAL
Enrollment
20
Start Date
2026-03
Completion Date
2026-05
Last Updated
2026-02-17
Healthy Volunteers
No
Interventions
Treatment with experimental device
Injection of recombinant collagen-based product
Locations (1)
Ospedale Policlinico San Martino, Istituto di Ricovero e Cura a Carattere Scientifico
Genova, Italy