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New study tests filler for wrinkles around eyes and mouth

NCT ID NCT07492277

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
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Jul 29, 2026 · Updated 3 times

Summary

This study is observing 70 adults who are already planning to get treatment with a dermal filler called Croma Revitalis for fine lines around the eyes (crow's feet) or mouth. Researchers will track how much the lines improve over 24 weeks using a doctor's rating scale. The goal is to see how well the filler works in everyday practice, not in a strict research setting.

What this could mean

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

Active substance
Croma Revitalis (dermal filler device)
What this could lead to
If successful, this study could confirm that Croma Revitalis effectively reduces fine lines around the eyes and mouth in routine practice.
What could go wrong
This is a small, non-interventional observational study with no control group, so results may not prove cause and effect. Individual results vary, and risks like bruising or swelling are possible with any injectable filler.

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.

Participants

About 70 people

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

Started

Jan 2026

Expected to finish

Sep 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.

Who is studied

Adults seeking aesthetic treatment for fine lines, such as crow's feet and smile lines. Participants will be generally healthy and representative of typical dermal filler users in routine clinical practice.

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: * Participants deemed by the treating physician to have LCL and/or PR of sufficient severity to merit treatment with croma revitalis to be corrected and treatment decision is reached independent of this study. * Male or female, 18 years of age or older at Visit 1 (Day 0). * Healthy skin in the facial area and free of diseases that could interfere in cutaneous aging evaluation, based on the physician's judgment. * Participants who, according to routine clinical advice, are willing to refrain from undergoing any aesthetic or surgical procedures in the treatment area during the observation period. * Participants who understand the purpose and nature of the observational data documentation and willingness to participate in the routine follow-up after 3, 5, 8, 12, and 24 weeks as judged by the treating physician. * Written signed and dated informed consent. Exclusion Criteria: * Participants who tend to develop hypertrophic scars, have pigment disorders, or have susceptibility to keloid formation. * Participants with a history of autoimmune disease or who are receiving therapy for modification of immune response, e.g., biologics, systemic corticosteroids, cytostatic drugs (from Visit 1 \[Day 0\] until the end of the study). * Participants who are known to be hypersensitive to components of the device as HA, glycerol, or gram-positive bacterial proteins. * Participants who are pregnant or breast feeding. * Participants who are anticoagulated or with history of bleeding disorder. * Participants receiving daily treatment with platelet aggregation inhibitors (e.g., acetylsalicylic acid) unless previously cleared by their primary care physician. * Participants who have cutaneous, inflammatory, and/or infectious processes (e.g., acne, herpes) present at Visit 1 (Day 0), recurrent herpes simplex or (pre) cancerous lesions in the areas to be treated. * Previous permanent implant or treatment with non-HA or non-collagen filler or non-absorbable sutures in the treatment area(s) any time prior to or planned during the observation period. * Participants who have received dermabrasion, mesotherapy, chemical peeling, or micro-needling within 3 months prior first treatment and planned during the observation period. * Participant has received any of the following (aesthetic) treatments in the treatment area within the last 12 months prior to the first routine treatment or planned during the observation period: 1. Energy based device treatments that target collagen remodeling and/or production of collagen (e.g. laser therapy). 2. Absorbable sutures (threads). 3. HA or collagen dermal fillers. 4. Botulinum toxin treatment. 5. Facial lipolysis, including submental fat treatments. 6. Facial plastic surgery. 7. Bariatric surgery. * Participants with uncontrolled (or unstable) systemic diseases as per the treating physician's discretion. * Prior surgery, scars, or tattoos in the treatment area(s), that could interfere with clinical evaluation. Participants planning such procedures during the observation period will not be included. * Beard, or facial hair that could interfere in evaluation of treatment as judged by the physician. * Participants who have had or are planning to undergo bariatric surgery or facial plastic surgery in the area to be treated within less than 12 months before the first treatment in and planned during the observation period. * Planned dental/oral surgery or modification (bridge-work, implants) within 4 weeks before the first treatment in and planned during the observation period. * Current participation in another clinical study, or treatment with any investigational drug/MD/device within 30 days prior to the first treatment. * Any medical condition or treatment potentially interfering with the clinical evaluation, according to the judgment of the treating physician. * Participants whose participation in clinical trials is prohibited by the Austrian Medical Devices Act (MPG) (e.g., persons with a legal custodian appointed due to mental disability, prisoners, soldiers, and other members of the armed forces, civil servants).

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As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Yuvell

    Vienna, 1010, Austria

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