New filler study aims to see if COLD-X™ technology keeps wrinkles away longer
NCT ID NCT07255261
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
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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 460 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jul 2025
- Expected to finish
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Jul 2028
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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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
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: * 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.
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The places running it
8 sites. 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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Aesthé - Marais.
RECRUITINGParis, 75004, France
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Cabinet médical
RECRUITINGLyon, 69005, France
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Cabinet médical
RECRUITINGParis, 75008, France
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Cabinet médical
RECRUITINGParis, 75116, France
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Cabinet médical
RECRUITINGSaint-Maur-des-Fossés, 94100, France
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Centre Laser Palaiseau
RECRUITINGPalaiseau, 91120, France
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Centre Médical Saint Jean
RECRUITINGArras, 62000, France
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Palais de Flore
RECRUITINGLyon, 69006, France
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- New device aims to smooth wrinkles without surgery
- New study tracks wrinkle and lip changes after cosmetic filler treatment
- New gel aims to smooth wrinkles around the mouth
- Stem cells injected into wrinkles: a new Anti-Aging hope?
- Can a cream and tiny needles erase lip lines? new study aims to find out
- New injectable filler aims to smooth wrinkles and restore facial volume