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

NCT07413445 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2026-02-17

No results posted yet for this study

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

DEVICE

Treatment with experimental device

Injection of recombinant collagen-based product

Sponsors & Collaborators

  • Nextrasearch S.r.l.s.

    collaborator OTHER

  • 303 Pharma s.r.l.

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
35 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-03-31
Primary Completion
2026-04-30
Completion
2026-05-31

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07413445 on ClinicalTrials.gov