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Not yet recruitingNCT07413445Updated Feb 17, 2026

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

An interventional study of Treatment with experimental device in Laxity; Skin, Volume Deficiency in the Mid-Face and Wrinkles, sponsored by 303 Pharma s.r.l.. Not yet recruiting at 1 site in Italy. Open to participants aged 35 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-02-17.

Sponsored by 303 Pharma s.r.l. · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
20
Allocation
Not applicable
Ages
35 Years to 65 Years
Sex
All
01

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).

02

Conditions studied

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

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03

Who can participate

Ages eligible
35 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Both sexes;
  • Caucasian race;
  • Aged between 35 and 65 years;
  • Non-smokers;
  • Willing and able to return to the study site for post-procedural assessments;
  • Agree to attend all study visits without makeup;
  • Agree not to change their habits regarding diet, physical activity, facial makeup, cosmetics, and facial cleansing products;
  • Agree to avoid intense UV exposure (UV sessions or sunbathing) during the entire study period without adequate sun protection;
  • Agree to take precautions to prevent pregnancy (applicable only to non-menopausal female subjects), including abstinence, intrauterine device (IUD), progestin implants, combined estrogen-progestin contraceptives, or condom use;
  • Agree to sign the informed consent form.

Exclusion criteria

Exclusion Criteria:

  • Pregnancy (applicable only to non-menopausal female subjects);
  • Breastfeeding (applicable only to non-menopausal female subjects);
  • Smokers;
  • Alcohol abuse and/or drug use;
  • Non-menopausal female subjects not using the specified contraceptive measures to prevent pregnancy during the study;
  • Body mass index (BMI) variation of ±1 during the study period;
  • History of aesthetic skin treatments (biomaterial implants, facelift, botulinum toxin injections, laser therapy, chemical peels) within 6 months prior to the study start;
  • Previous permanent filler treatments;
  • Changes in normal habits related to diet, physical activity, facial cosmetics, facial cleansing, and makeup within one month prior to the study;
  • Sensitivity or allergy to the investigational product or its components (to be assessed by the investigator at baseline);
  • Predicted poor compliance with study protocol;
  • Participation in a similar study currently or within the past 9 months;
  • Dermatological clinical conditions that could interfere with aesthetic outcomes;
  • Chronic neurological, immunological, metabolic, cardiovascular, pulmonary, renal, or oncological diseases;
  • Current pharmacological treatment with: Anticoagulants, antiplatelet agents, antihistamines, topical or systemic corticosteroids, narcotics, antidepressants, immunosuppressants (except contraceptive or hormonal treatment started more than 1 year prior); Medications that may affect test results as deemed by the investigator.
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
20 participants (estimated)

Study arms

  • Experimental
    Injectable device with recombenant collagen, PCL and amino acids

    Device: Treatment with experimental device

Interventions

  • DeviceTreatment with experimental device

    Injection of recombinant collagen-based product

05

What researchers measure

Primary outcomes

  1. Safety based on number of adverse events from the enrollment for the 60days till the second visit and study closing.

    The AE will be monitored in terms on number by severity compared to standard

    Time frame: From enrollment to the end of treatment, at 60 days

Secondary outcomes

  1. Efficacy based on skin hydration measured with corneometer and assessment with WSRS

    Wrinkle severity rate scale used to check efficacy

    Time frame: At the end of treatment, after 60 days

06

Study locations

1 site
  • Ospedale Policlinico San Martino, Istituto di Ricovero e Cura a Carattere Scientifico
    Genova, Italy
07

Registry details

Key details

Study ID
NCT07413445
Lead sponsor
303 Pharma s.r.l.
Collaborators
Nextrasearch S.r.l.s.
Responsible party
Sponsor
First posted
Feb 17, 2026
Start date
Mar 2026 (estimated)
Primary completion
Apr 2026 (estimated)
Completion
May 2026 (estimated)
Last update
Feb 17, 2026

Study contacts

Edoardo Raposio, PhD
Contact
edoardo.raposio@hsanmartino.it
+39 0105558825

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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