Lips EnhancementNCT07255261
Evaluation of Facial HA Dermal Fillers in Real-Life Conditions
A study testing Facial injection of hyaluronic acid-based dermal fillers. in people with Lips Enhancement and Perioral Wrinkles, run by Symatese at 8 sites in France.
Trial summary
The goal of this post-market interventional study is to confirm, under real-life conditions, the safety and performance of hyaluronic acid-based dermal fillers intended to modify skin anatomy and facial appearance. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Lips Enhancement, Perioral Wrinkles, Nasolabial Fold Wrinkles
- What is being tested?
- Facial injection of hyaluronic acid-based dermal fillers.
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 460 participants
- Where
- 8 sitesFrance
- Study dates
- 2 Jul 2025to Jul 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
8 sites in 1 country. Contact the study team or a site near you to ask about taking part.
8 sites in 1 country
France8 sites, 8 recruiting
- Recruiting
Centre Médical Saint Jean
Arras, 62000
Cyril Maire, +33 3 21 71 34 34, maire.dermatologie@hotmail.fr
- Recruiting
Cabinet médical
Lyon, 69005
Amandine CATELAIN-LAMY, +33 4 78 36 85 85, amandinelamy28@icloud.com
- Recruiting
Palais de Flore
Lyon, 69006
Sophie Converset, +33 4 78 41 88 85, drconverset@gmail.com
- Recruiting
Centre Laser Palaiseau
Palaiseau, 91120
Diala Haykal, +33 1 60 10 64 55, docteur.haykal@gmail.com
- Recruiting
Aesthé - Marais.
Paris, 75004
Arnaud Lambert, +33 1 40 61 91 58, aldermoaesthetic@gmail.com
- Recruiting
Cabinet médical
Paris, 75008
Jean-Jacques DEUTSCH, +33 1 47 20 05 03, deutschjj@gmail.com
- Recruiting
Cabinet médical
Paris, 75116
Sylvie Poignonec, +33 1 45 63 13 20, sylvie@poignonec.com
- Recruiting
Cabinet médical
Saint-Maur-des-Fossés, 94100
Elisabeth DOMERGUE THAN TRONG, +33 1 42 83 38 18, elisabeth.domergue.than.trong@gmail.com
About this study
Official title: Post-Marketing Clinical Follow Up On Hyaluronic Acid-Based Dermal Fillers Using COLD-X™ Technology By Symatese
The goal of this post-market interventional study is to confirm, under real-life conditions, the safety and performance of hyaluronic acid-based dermal fillers intended to modify skin anatomy and facial appearance. Subjects aged 18 years or older seeking aesthetic treatment of the lips, perioral lines, nasolabial folds, cheeks, and/or infraorbital hollows may be included. The main question the study aims to answer is: How long does the effect of the products last?
Participants will attend follow-up visits every 6 months after the initial injection, until the end of follow-up at 24 months. During each visit, the investigator will assess performance and safety through a simple clinical examination. At each follow-up visit, subjects will also evaluate the aesthetic improvement compared with their pre-injection appearance. Subjects will be asked about the level of pain experienced during the initial injection.
If the subject wishes, a retreatment may be performed at the 12-month or 18-month follow-up visit, provided that the treated area(s) have returned to the pre-injection state.
- Conditions
- Lips Enhancement, Perioral Wrinkles, Nasolabial Fold Wrinkles, Cheek Augmentation, Infraorbital Hollows
- Being tested
- Facial injection of hyaluronic acid-based dermal fillers.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Facial injection of hyaluronic acid-based dermal fillers.Device
Facial injection of hyaluronic acid-based dermal fillers USING COLD-X™ TECHNOLOGY by Symatese.
| Study group | Role | What they receive |
|---|---|---|
| Aesthetic treatment with hyaluronic acid (HA) of one or more regions of the face. | Experimental | Based on their preferences and with the agreement of the healthcare professional, subjects may receive aesthetic treatments of the lips, perioral lines, nasolabial folds, cheeks, and/or infraorbital hollows. Receives: Device: Facial injection of hyaluronic acid-based dermal fillers. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients returning to their baseline (pre-injection) state for each treated area, based on the investigator's assessment using 5- or 6-point area-specific scales.
Measured: At each follow-up visit (6 months, 12 months, 18 months and 24 months)
Secondary outcomes (6)
Injection site reactions (ISR) assessed by the investigators.
Measured: D0 (post-first injection), M1 (post optional touch-up), M12/M18 (post optional retreatment)
Number of adverse device effects (ADEs) and serious adverse device effects (SADEs) assessed by the investigators.
Measured: From the injection (day 0) to the end of the follow-up period (24 months).
Subject-assessed aesthetic improvement of each treated area, measured using the Global Aesthetic Improvement Scale (GAIS), a 5-point scale ranging from "worse" to "very much improved.
Measured: At each visit (Day 0 after injection, day 30 (if any visit), 6 months, 12 months, 18 months and 24 months)
Investigator-assessed aesthetic improvement of each treated area, measured using the Global Aesthetic Improvement Scale (GAIS), a 5-point scale ranging from "worse" to "very much improved.
Measured: At each visit (Day 0 after injection, day 30 (if any visit), 6 months, 12 months, 18 months and 24 months)
Investigator-assessed wrinkle severity or volume using 5- or 6-point area-specific scales for each treated area.
Measured: At each visit (Day 0 before and after injection, at 30 Days (if any visit), 6 months, 12 months, 18 months, and 24 months)
Subject-reported pain per treated area, rated on an 11-point scale (0 = no pain, 10 = worst pain).
Measured: During the initial injection procedure at day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2025
- Study start2 Jul 2025
- Primary completionJul 2028 (estimated)
- Study completionJul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lips EnhancementStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 460 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Symatese
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07255261
- Sponsor's protocol ID
- CLIN2108_CIP
- Status last verified
- Dec 2025
- First submitted
- 14 Nov 2025
- Last updated
- 8 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-Marketing Clinical Follow Up On Hyaluronic Acid-Based Dermal Fillers Using COLD-X™ Technology By Symatese
- ClinicalTrials.gov ID
- NCT07255261
- Acronym / sponsor ID
- CLIN2108_CIP
- Conditions
- Lips Enhancement, Perioral Wrinkles, Nasolabial Fold Wrinkles, Cheek Augmentation, Infraorbital Hollows
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 460 participants (estimated)
- Lead sponsor
- SymateseIndustry (pharma, biotech, devices)
- Study start
- 2 Jul 2025 (actual)
- Primary completion
- Jul 2028 (estimated)
- Study completion
- Jul 2028 (estimated)
- First posted
- 1 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this post-market interventional study is to confirm, under real-life conditions, the safety and performance of hyaluronic acid-based dermal fillers intended to modify skin anatomy and facial appearance. Subjects aged 18 years or older seeking aesthetic treatment of the lips, perioral lines, nasolabial folds, cheeks, and/or infraorbital hollows may be included. The main question the study aims to answer is: How long does the effect of the products last?
Participants will attend follow-up visits every 6 months after the initial injection, until the end of follow-up at 24 months. During each visit, the investigator will assess performance and safety through a simple clinical examination. At each follow-up visit, subjects will also evaluate the aesthetic improvement compared with their pre-injection appearance. Subjects will be asked about the level of pain experienced during the initial injection.
If the subject wishes, a retreatment may be performed at the 12-month or 18-month follow-up visit, provided that the treated area(s) have returned to the pre-injection state.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Aesthetic treatment with hyaluronic acid (HA) of one or more regions of the face. | Experimental | Device: Facial injection of hyaluronic acid-based dermal fillers.Based on their preferences and with the agreement of the healthcare professional, subjects may receive aesthetic treatments of the lips, perioral lines, nasolabial folds, cheeks, and/or infraorbital hollows. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Facial injection of hyaluronic acid-based dermal fillers.Facial injection of hyaluronic acid-based dermal fillers USING COLD-X™ TECHNOLOGY by Symatese. | Device | Aesthetic treatment with hyaluronic acid (HA) of one or more regions of the face. |
Primary outcome
Number of patients returning to their baseline (pre-injection) state for each treated area, based on the investigator's assessment using 5- or 6-point area-specific scales.
Time frame: At each follow-up visit (6 months, 12 months, 18 months and 24 months)
6 secondary outcomes
Injection site reactions (ISR) assessed by the investigators.
Time frame: D0 (post-first injection), M1 (post optional touch-up), M12/M18 (post optional retreatment)
Number of adverse device effects (ADEs) and serious adverse device effects (SADEs) assessed by the investigators.
Time frame: From the injection (day 0) to the end of the follow-up period (24 months).
Subject-assessed aesthetic improvement of each treated area, measured using the Global Aesthetic Improvement Scale (GAIS), a 5-point scale ranging from "worse" to "very much improved.
Time frame: At each visit (Day 0 after injection, day 30 (if any visit), 6 months, 12 months, 18 months and 24 months)
Investigator-assessed aesthetic improvement of each treated area, measured using the Global Aesthetic Improvement Scale (GAIS), a 5-point scale ranging from "worse" to "very much improved.
Time frame: At each visit (Day 0 after injection, day 30 (if any visit), 6 months, 12 months, 18 months and 24 months)
Investigator-assessed wrinkle severity or volume using 5- or 6-point area-specific scales for each treated area.
Time frame: At each visit (Day 0 before and after injection, at 30 Days (if any visit), 6 months, 12 months, 18 months, and 24 months)
Subject-reported pain per treated area, rated on an 11-point scale (0 = no pain, 10 = worst pain).
Time frame: During the initial injection procedure at day 0
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2025.
- Individual participant dataSharing planned: No
Related trials for Lips Enhancement
Recruiting
THE EVALUATION OF THE SAFETY AND PERFORMANCE OF AN INJECTABLE HYALURONIC ACID FILLER
Lips Enhancement Nasolabial Fold Correction Midface Volume Deficit
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Facial injection of hyaluronic acid-based dermal fillers. in people with Lips Enhancement and Perioral Wrinkles, run by Symatese at 8 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Valentin BONVALET (+33 (0)4 78 56 72 80, v.bonvalet@symatese.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients returning to their baseline (pre-injection) state for each treated area, based on the investigator's assessment using 5- or 6-point area-specific scales. (time frame: At each follow-up visit (6 months, 12 months, 18 months and 24 months)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Dec 2025; AzTrials last refreshed its copy on 8 Nov 2026.