NCT07413445

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

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: 303 Pharma s.r.l. · Industry
• Sex: All
• Age: 35 Years – 65 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Laxity; Skin
• Volume Deficiency in the Mid-Face
• Wrinkles

Interventions

Type	Name	Description
DEVICE	Treatment with experimental device	Injection of recombinant collagen-based product

Timeline

• Start date: 2026-03-01
• Primary completion: 2026-04-01
• Completion: 2026-05-01
• First posted: 2026-02-17
• Last updated: 2026-02-17

Locations

1 site across 1 country: Italy