New collagen injection aims to smooth wrinkles and plump skin
NCT ID NCT07413445
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This early trial tests an injectable collagen-based product called MEC REGENERATE® in 20 adults aged 35–65 with skin laxity, mid-face volume loss, or wrinkles. Participants receive a single injection session, and researchers check safety and skin hydration after 60 days. The goal is to see if the product is safe and may improve skin appearance.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Injectable recombinant collagen-based product
- What this could lead to
- If it works, this could point toward a non-surgical option to temporarily improve skin hydration and reduce wrinkles.
- What could go wrong
- This is a very small, early study with only 20 people and no control group. Results may not apply to the general population, and long-term safety or effectiveness is unknown.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 20 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Mar 2026
An estimate. Start dates often move.
- Expected to finish
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May 2026
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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35 to 65 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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: * 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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Ospedale Policlinico San Martino, Istituto di Ricovero e Cura a Carattere Scientifico
Genova, Italy
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