Laxity; SkinNCT07413445
Prospective Clinical Evaluation of the Safety and Performance of the Aesthetic Medical Device MEC REGENERATE® (Injectable Recombinant Collagen-based Product)
A study testing Treatment with experimental device in people with Laxity; Skin and Volume Deficiency in the Mid-Face, run by 303 Pharma s.r.l. at 1 site in Italy.
Trial 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… Read more about this study
- Who is it for?
- Ages 35 to 65 years
- Conditions the study is for
- Laxity; Skin, Volume Deficiency in the Mid-Face, Wrinkles
- What is being tested?
- Treatment with experimental device
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteItaly
- Study dates
- Mar 2026to May 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
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- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site
Ospedale Policlinico San Martino, Istituto di Ricovero e Cura a Carattere Scientifico
Genova
Edoardo Raposio, PhD, +39 0105558825, edoardo.raposio@hsanmartino.it
About this study
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:
Read more
- 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
- Being tested
- Treatment with experimental device
- Medical subject headings
- Cutis Laxa
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Treatment with experimental deviceDevice
Injection of recombinant collagen-based product
| Study group | Role | What they receive |
|---|---|---|
| Injectable device with recombenant collagen, PCL and amino acids | Experimental | Not described Receives: Device: Treatment with experimental device |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: At the end of treatment, after 60 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2026
- Study startMar 2026 (estimated)
- Primary completionApr 2026 (estimated)
- Study completionMay 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Laxity; SkinStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- 303 Pharma s.r.l.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Nextrasearch S.r.l.s.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07413445
- Sponsor's protocol ID
- NS/MD04/2025/MecReg
- Status last verified
- Feb 2026
- First submitted
- 27 Jan 2026
- Last updated
- 17 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Clinical Evaluation of the Safety and Performance of the Aesthetic Medical Device MEC REGENERATE® (Injectable Recombinant Collagen-based Product)
- ClinicalTrials.gov ID
- NCT07413445
- Acronym / sponsor ID
- NS/MD04/2025/MecReg
- Conditions
- Laxity; Skin, Volume Deficiency in the Mid-Face, Wrinkles
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- 303 Pharma s.r.l.Industry (pharma, biotech, devices)
- Collaborators
- Nextrasearch S.r.l.s.
- Study start
- Mar 2026 (estimated)
- Primary completion
- Apr 2026 (estimated)
- Study completion
- May 2026 (estimated)
- First posted
- 17 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Injectable device with recombenant collagen, PCL and amino acids | Experimental | Device: Treatment with experimental device |
Who may qualify
- Ages
- 35 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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;
Key exclusion criteria (15 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Treatment with experimental deviceInjection of recombinant collagen-based product | Device | Injectable device with recombenant collagen, PCL and amino acids |
Primary outcome
Safety based on number of adverse events from the enrollment for the 60days till the second visit and study closing.
Time frame: From enrollment to the end of treatment, at 60 days
The AE will be monitored in terms on number by severity compared to standard
1 secondary outcome
Efficacy based on skin hydration measured with corneometer and assessment with WSRS
Time frame: At the end of treatment, after 60 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Treatment with experimental device in people with Laxity; Skin and Volume Deficiency in the Mid-Face, run by 303 Pharma s.r.l. at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 17 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Edoardo Raposio, PhD (+39 0105558825, edoardo.raposio@hsanmartino.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety based on number of adverse events from the enrollment for the 60days till the second visit and study closing. (time frame: From enrollment to the end of treatment, at 60 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2026.