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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age35-65
Sponsor303 Pharma s.r.l.

About this trial

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).

Eligibility criteria

Qualifiers

Both sexes;

Caucasian race;

Aged between 35 and 65 years;

Non-smokers;

Disqualifiers

Pregnancy (applicable only to non-menopausal female subjects);

Breastfeeding (applicable only to non-menopausal female subjects);

Smokers;

Alcohol abuse and/or drug use;

Trial design

Treatments tested in this trial

  • Treatment with experimental device

Treatment groups

20 Participants
are divided into 1 treatment group

Sponsors and collaborators

303 Pharma s.r.l.

Lead sponsor

Nextrasearch S.r.l.s.

Collaborator