Please sign in to follow a disease.
New study tests filler for wrinkles around eyes and mouth
NCT ID NCT07492277
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 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: * 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).
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Lateral canthal lines (LCL) are added.
Genom att skicka in godkänner du våra Användarvillkor
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
More trials for these conditions
Other studies related to the condition(s) this trial covers.