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New collagen injection aims to smooth wrinkles and plump skin

NCT ID NCT07413445

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

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

About 20 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Mar 2026

An estimate. Start dates often move.

Expected to finish

May 2026

An estimate. End dates often move.

Lead sponsor

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

35 to 65 years

Sex

Anyone

Healthy volunteers

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

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.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • Ospedale Policlinico San Martino, Istituto di Ricovero e Cura a Carattere Scientifico

    Genova, Italy

More trials for these conditions

Other studies related to the condition(s) this trial covers.