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New filler study aims to see if COLD-X™ technology keeps wrinkles away longer

NCT ID NCT07255261

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 study follows 460 adults who choose to get hyaluronic acid-based dermal fillers for their lips, cheeks, or wrinkles around the mouth and eyes. Researchers will check every 6 months for up to 2 years to see how long the effects last and whether any side effects occur. Participants can get a repeat treatment at 12 or 18 months if the area returns to its original state.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
hyaluronic acid-based dermal fillers (COLD-X™ technology)
What this could lead to
If successful, this study could confirm that these fillers provide lasting aesthetic improvement for up to 24 months with a good safety profile.
What could go wrong
This is a post-market observational study, not a controlled trial, so results may not prove superiority over other fillers. Side effects like swelling or bruising are possible.

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 460 people

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

Started

Jul 2025

Expected to finish

Jul 2028

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

18 years and older

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

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: * Subject seeking an aesthetic correction of the infraorbital hollows with FASY P and/ or an aesthetic correction of the lips with ESTYME® LIPS, and/ or an aesthetic correction of the perioral lines with ESTYME® SMOOTH, and/ or an aesthetic correction of nasolabial folds with ESTYME® SMOOTH, and/ or an aesthetic correction of cheeks with ESTYME® SCULPT. * Subject who agreed to participate and have signed an informed consent. * Age: over 18 years old. * Subject being affiliated to a health social security system. Exclusion Criteria: * Minors * Subjects with a known allergy to hyaluronic acid, lidocaine or amide local anesthetics. * Subjects with porphyria. * Subjects with an autoimmune disorder, or using an immunosuppressant medication. * Pregnant or breastfeeding women. * Subjects with inflammation, infection or cutaneous disorders, at the treatment site or nearby. * Subjects with bleeding disorders or in subjects receiving thrombolytic or anticoagulant treatment. * Areas other than those recommended by the IFU. * Subject deprived of liberty by judicial or administrative decision. * Adults under a legal protection measure (guardianship/curatorship). * Subject under legal protection order.

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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

    8 sites. 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

  • Aesthé - Marais.

    RECRUITING

    Paris, 75004, France

  • Cabinet médical

    RECRUITING

    Lyon, 69005, France

  • Cabinet médical

    RECRUITING

    Paris, 75008, France

  • Cabinet médical

    RECRUITING

    Paris, 75116, France

  • Cabinet médical

    RECRUITING

    Saint-Maur-des-Fossés, 94100, France

  • Centre Laser Palaiseau

    RECRUITING

    Palaiseau, 91120, France

  • Centre Médical Saint Jean

    RECRUITING

    Arras, 62000, France

  • Palais de Flore

    RECRUITING

    Lyon, 69006, France

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