New gel injection aims to smooth cheek wrinkles
NCT ID NCT07153237
First seen Jun 25, 2026 · Last updated Sep 04, 2026 · Updated 3 times
Summary
This study tests STYLAGE® HydroMax, a gel made of hyaluronic acid, to see how well it reduces superficial wrinkles on the cheeks. About 81 adults aged 35 to 70 with mild to moderate wrinkles will receive three injection sessions over 24 weeks. The main goal is to measure wrinkle improvement using a standard scale.
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 gel (STYLAGE® HydroMax)
- What this could lead to
- If it works, this could offer a safe and effective option for reducing superficial cheek wrinkles.
- What could go wrong
- This is a post-market study, so the product is already available. The main risk is that results may not show significant improvement over existing treatments.
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 81 people
The number the study aims to enrol. It can still change while the study runs.
- Started
-
Sep 2025
- Expected to finish
-
Nov 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 70 years
- 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: 1. Subjects without any pathology aged between 35 and 70 years old at inclusion. 2. Subjects wishing treatment for the aesthetic improvement of facial wrinkles. 3. Subject having given freely and expressly their informed consent. 4. Subject with a Grade 2 to 5 score on the Bazin cheek wrinkle scale. 5. Subject with the same wrinkle score according to the Bazin cheek wrinkle scale for both cheeks (i.e., symmetrical cheeks). 6. Subject psychologically able to understand investigation related information and to give written informed consent. 7. Subject affiliated to a health social security system. 8. Female of childbearing potential must use a medically accepted contraceptive regimen for at least 12 weeks prior to the start of the investigation and for the duration of the investigation. 9. Subject agreeing not to change any hormonal treatment (including contraceptive treatment and hormone replacement therapy) for the duration of the investigation. 10. Subject agreeing to keep their usual cleansing / care products for the duration of the investigation. 11. Subject agreeing to apply a SPF50 cream when exposed to non-intensive sunlight (i.e., excluding prolonged sun exposure such as sunbathing or extended beach exposure). 12. Subject able to comply with investigation requirements and complete all required visits. 13. Subject agreeing not to receive any other plastic surgery or cosmetic procedure on the face (e.g. dermal fillers, toxin-based treatment, fractional or ablative laser, micro-dermabrasion, chemical peel, noninvasive procedures for skin laxity) for the duration of the investigation. 14. Subject agreeing not to have any planned dental surgery during the investigation. Exclusion Criteria: 1. Pregnant or breastfeeding woman or woman planning a pregnancy during the investigation. 2. Woman less than a year past menopause. 3. Subject with a tattoo, a scar, moles, too many hairs or body hairs (i.e. beard), or anything on the studied zones which might interfere with outcome evaluations. 4. Subject who has been deprived of their freedom by administrative or legal decision or who is under guardianship. 5. Member of the investigating team or family member of a member of the investigating team. 6. Subject in a social or sanitary establishment. 7. Subject having received 6000 euros indemnities for participation in research involving human beings in the 12 previous months, including participation in the present investigation. 8. Subject participating in another research on human beings or who is in an exclusion period of one. 9. Subject who had intensive exposure to sunlight (i.e., prolonged sun exposure such as sunbathing or extended beach exposure) or UV-rays within the previous month and/or for whom intensive exposure to sunlight or UV-rays is foreseen during the clinical investigation. 10. Subject suffering from severe or progressive disease or any other pathology that may interfere with the evaluation of the investigation results. 11. Subject with known history of, or suffering from, autoimmune disease and/or immune deficiency. 12. Subject suffering from inflammatory and/or infectious cutaneous disorders in or near the studied zones (herpes, acne, mycosis, papilloma…). Subject with recurrent herpes in the midface area is eligible if asymptomatic at time of inclusion. 13. Subject having a history of severe allergy or anaphylactic shock including hypersensitivity to HA or to one of the components of the tested device, to antiseptic solution or anesthesia products if applicable. 14. Subject with a history of streptococcal disease, such as acute rheumatic fever or recurrent sore throats. 15. Subject predisposed to keloids or hypertrophic scarring. 16. Subject prone to develop inflammatory skin conditions or has a tendency to bleeding disorders. 17. Subject with a fructose intolerance. 18. Subject who had dental surgery within the 6 weeks prior to the start of the investigation. 19. Subject having received treatment with laser, dermabrasion, surgery, deep chemical peeling, or other ablative procedure on the investigated areas within the 12 months prior to start of the investigation. 20. Subject having received injections of botulinum toxin within the 9 months prior to the start of the investigation. 21. Subject having received an injection with a resorbable filling product in the investigated areas within the 18 months prior to the start of the investigation. 22. Subject having previously received at any time in the past 24 months an injection with a slowly resorbable filling product (polylactic acid, calcium hydroxyapatite, combinations of HA and hypromellose, HA and dextran microbeads or HA and TriCalcium Phosphate…) or with a non-resorbable filling product (polyacrylamide, silicone, combination of methacrylic polymers and collagen, polymer particles …). 23. Subject having previously received at any time in the past 24 months a treatment with tensor threads on the face. 24. Subject having taken medication such as aspirin, non-steroidal anti-inflammatory drugs (NSAIDs) (ibuprofen, naproxen…), antiplatelet agents, anticoagulants, vitamin C in the week prior each injection session or who is a chronic user of these medications. 25. Subject undergoing a topical treatment on the test areas or taking either of the following systemic treatments: 1. Antihistamines within the 2 weeks prior to the start of the investigation. 2. Immunosuppressors and/or corticoids within the 4 weeks prior to the start of the investigation. 3. Retinoids within the 6 months prior to the start of the investigation
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Aesthetic 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
-
Eurofins DERMSCAN
Aix-en-Provence, 13290, France
-
Eurofins DERMSCAN PHARMASCAN
Villeurbanne, 69100, France
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can sharing old memories boost mental Well-Being in old age?
- Can a Hands-On reflex therapy steady an older Person's stance?
- Scientists ask: when does a balance test score really improve?
- Gut check: can poop pills from young donors turn back the biological clock?
- Your smartwatch could soon warn you before you crash
- Can a tablet game rewire an aging brain to ignore distractions?