Nasolabial FoldsDEFINENCT07855224
Dermal Evaluation of Facetem™ S in Nasolabial Folds Esthetics Improvement: DEFINE Study
A study testing Facetem S in people with Nasolabial Folds, run by CGBio Inc. at 5 sites in 2 countries.
Trial summary
This is a multicenter, prospective, non-randomized, uncontrolled post-market clinical follow-up (PMCF) study designed to evaluate the performance and safety of Facetem S dermal filler for the correction of moderate-to-severe nasolabial folds in adult subjects. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Nasolabial Folds
- What is being tested?
- Facetem S
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 5 sitesin 2 countries
- Study dates
- Jan 2027to Jan 2029
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female, over the age of 18.
- Subjects with moderate-to-severe nasolabial folds (WSRS Grade 3-4) on both sides of the face.
- Signed informed consent.
- Women of childbearing potential must be using a highly effective method of contraception throughout the study period.
- Agrees not to undergo any other facial aesthetic procedure that may interfere with the evaluation of nasolabial folds during study participation.
- Is willing and able to attend all scheduled follow-up visits and comply with all study requirements.
Who cannot join
- Any history of treatment with permanent or non-absorbable facial fillers, including silicone, polymethyl methacrylate (PMMA), polytetrafluoroethylene (PTFE), hydroxyethyl methacrylate (HEMA), dextran-based fillers, or other non-resorbable filler materials. Prior treatment with biostimulatory fillers, including poly-L-lactic acid (PLLA), poly-D,L-lactic acid (PDLLA), or other polylactic acid-based fillers, within the past 24 months is also exclusionary. The presence of any foreign particulate material at the treatment site, including liquid silicone or residual filler material, is exclusionary.
- Prior botulinum toxin treatment in the treatment area within the past 12 months.
- Any prior facial surgical procedures, including plastic surgery or thread lift, or the presence of a permanent surgical implant that could interfere with performance assessments.
- Prior treatment within the past 12 months with any dermal filler (e.g., hyaluronic acid, CaHA, collagen-based fillers) in the area to be treated.
- Prior treatment within the past 6 months with facial dermal therapies, including but not limited to ablative or non-ablative laser therapy, radiofrequency treatment, chemical or mechanical peels, non-invasive skin-tightening procedures, or planned treatments of this nature during the study period.
- History of severe allergic reactions, including anaphylaxis, or known hypersensitivity to any components of the study treatment.
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- Known bleeding disorder or anticoagulant, antiplatelet, or thrombolytic therapy within 2 weeks prior to treatment that may increase the risk of bleeding, bruising, or other injection-related complications.
- Active inflammation, infection, or skin conditions at or near the injection site.
- History of keloid or hypertrophic scar formation, or any condition that predisposes the subject to abnormal wound healing, subjects prone to inflammatory skin diseases, or presence of foreign materials at the treatment site.
- Pregnant or nursing women, or those planning to become pregnant during the study.
- Autoimmune diseases, immunodeficiency disorders, or ongoing immunosuppressive therapy.
- Use of immunosuppressive agents or other systemic medications within the past 3 months.
- Active infectious disease, including viral hepatitis or syphilis.
- Current chronic systemic corticosteroid therapy, defined as continuous systemic corticosteroid use for ≥4 weeks at a dose equivalent to ≥10 mg/day of prednisone.
- Participation in another drug or medical device clinical trial within the past 3 months.
- Any other condition that, in the investigator's judgment, makes the subject unsuitable for study participation.
- Subjects who are incarcerated or under legal guardianship and are unable to understand the study or provide informed consent.
- Subjects with clinically significant severe facial asymmetry, scars, deformities, or other conditions involving the nasolabial fold area that, in the opinion of the investigator, may compromise standardized photographic documentation or reliable assessment of WSRS and GAIS outcomes.
Trial locations and contacts
5 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
5 sites in 2 countries
France4 sites
Medical office
Cannes, 06400
Isaac Bodokh
MEDITI Center
Nice, 060000
Philippe Kestemont
Aesthe.com
Paris, 75004
Medical office
Paris, 75006
About this study
Official title: A Multicenter, Prospective, Non-randomized, Uncontrolled, Post-market Clinical Follow-up (PMCF) Study to Evaluate the Performance and Safety of Facetem™ S Dermal Fillers for the Correction of Nasolabial Folds
This is a multicenter, prospective, non-randomized, uncontrolled post-market clinical follow-up (PMCF) study designed to evaluate the performance and safety of Facetem S dermal filler for the correction of moderate-to-severe nasolabial folds in adult subjects.
Subjects will receive Facetem S treatment at baseline, with an optional touch-up treatment approximately 4 weeks later if clinically necessary. Subjects will be followed for up to 12 months after the final injection to assess wrinkle severity improvement, overall aesthetic improvement, and safety.
- Conditions
- Nasolabial Folds
- Being tested
- Facetem S
- Keywords
- Dermal Filler
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Facetem SDevice
Facetem S is a calcium hydroxylapatite (CaHA) dermal filler administered for the correction of moderate-to-severe nasolabial folds. Treatment will be performed in accordance with the Instructions for Use (IFU). An optional touch-up treatment may be performed approximately 4 weeks after the initial treatment if clinically necessary.
| Study group | Role | What they receive |
|---|---|---|
| Facetem S | Experimental | Participants will receive Facetem S injection in the nasolabial folds at baseline. An optional touch-up treatment may be performed approximately 4 weeks after the initial treatment if deemed clinically necessary by the investigator. Receives: Device: Facetem S |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of Subjects With ≥1-Point Improvement in WSRS
Proportion of subjects with ≥1-point improvement from baseline (Week 0) in the Wrinkle Severity Rating Scale (WSRS) for nasolabial folds. The WSRS ranges from Grade 1 (Absent) to Grade 5 (Extreme), with lower scores indicating less severe nasolabial folds.
Measured: Week 12 (Week 16 for subjects receiving touch-up treatment)
Secondary outcomes (5)
Proportion of Subjects With ≥1-Point Improvement in WSRS
Proportion of subjects with ≥1-point improvement from baseline (Week 0) in the Wrinkle Severity Rating Scale (WSRS) for nasolabial folds. The WSRS ranges from Grade 1 (Absent) to Grade 5 (Extreme), with lower scores indicating less severe nasolabial folds.
Measured: Week 24 and Week 52 (Week 28 and Week 56, respectively, for subjects receiving touch-up treatment)
Independent Evaluator- and Investigator-Assessed GAIS Response Rate
Global Aesthetic Improvement Scale (GAIS) response rate as assessed by independent evaluators and investigators. A responder is defined as a subject with a GAIS score of +1 (Improved), +2 (Much improved), or +3 (Very much improved), using the pre-treatment baseline photograph as the reference.
Measured: Week 12, Week 24, and Week 52
Subject-Assessed GAIS Response Rate
Global Aesthetic Improvement Scale (GAIS) response rate as assessed by subjects. A responder is defined as a subject with a GAIS score of +1 (Improved), +2 (Much improved), or +3 (Very much improved), with baseline appearance used as the reference.
Measured: Week 12, Week 24, and Week 52 (Week 16, Week 28, and Week 56, respectively, for subjects receiving touch-up treatment)
Incidence and Characteristics of Adverse Events and Serious Adverse Events
Incidence, severity, seriousness, causality, and outcome of adverse events (AEs) and serious adverse events (SAEs) occurring throughout the study period.
Measured: Throughout the study period, up to Week 52 (Week 56 for subjects receiving touch-up treatment)
Safety Outcomes According to Fitzpatrick Skin Type
Descriptive evaluation of safety outcomes according to Fitzpatrick skin type, including a prospectively defined safety subgroup of subjects with Fitzpatrick skin types IV-VI.
Measured: Throughout the study period, up to Week 52 (Week 56 for subjects receiving touch-up treatment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2026
- Study startJan 2027 (estimated)
- Primary completionApr 2028 (estimated)
- Study completionJan 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nasolabial FoldsStudies 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
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CGBio Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07855224
- Sponsor's protocol ID
- CGFTSPS-PMCF-01
- Acronym
- DEFINE
- Status last verified
- Sep 2026
- First submitted
- 28 Sep 2026
- Last updated
- 2 Oct 2026
- 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 2 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Prospective, Non-randomized, Uncontrolled, Post-market Clinical Follow-up (PMCF) Study to Evaluate the Performance and Safety of Facetem™ S Dermal Fillers for the Correction of Nasolabial Folds
- ClinicalTrials.gov ID
- NCT07855224
- Acronym / sponsor ID
- DEFINE / CGFTSPS-PMCF-01
- Conditions
- Nasolabial Folds
- Keywords
- Dermal Filler
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- CGBio Inc.Industry (pharma, biotech, devices)
- Study start
- Jan 2027 (estimated)
- Primary completion
- Apr 2028 (estimated)
- Study completion
- Jan 2029 (estimated)
- First posted
- 2 Oct 2026 (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.
This is a multicenter, prospective, non-randomized, uncontrolled post-market clinical follow-up (PMCF) study designed to evaluate the performance and safety of Facetem S dermal filler for the correction of moderate-to-severe nasolabial folds in adult subjects.
Subjects will receive Facetem S treatment at baseline, with an optional touch-up treatment approximately 4 weeks later if clinically necessary. Subjects will be followed for up to 12 months after the final injection to assess wrinkle severity improvement, overall aesthetic improvement, and safety.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Facetem S | Experimental | Device: Facetem SParticipants will receive Facetem S injection in the nasolabial folds at baseline. An optional touch-up treatment may be performed approximately 4 weeks after the initial treatment if deemed clinically necessary by the investigator. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Male or female, over the age of 18.
- Subjects with moderate-to-severe nasolabial folds (WSRS Grade 3-4) on both sides of the face.
- Signed informed consent.
- Women of childbearing potential must be using a highly effective method of contraception throughout the study period.
- Agrees not to undergo any other facial aesthetic procedure that may interfere with the evaluation of nasolabial folds during study participation.
Key exclusion criteria (18 listed)
- Any history of treatment with permanent or non-absorbable facial fillers, including silicone, polymethyl methacrylate (PMMA), polytetrafluoroethylene (PTFE), hydroxyethyl methacrylate (HEMA), dextran-based fillers, or other non-resorbable filler materials. Prior treatment with biostimulatory fillers, including poly-L-lactic acid (PLLA), poly-D,L-lactic acid (PDLLA), or other polylactic acid-based fillers, within the past 24 months is also exclusionary. The presence of any foreign particulate material at the treatment site, including liquid silicone or residual filler material, is exclusionary.
- Prior botulinum toxin treatment in the treatment area within the past 12 months.
- Any prior facial surgical procedures, including plastic surgery or thread lift, or the presence of a permanent surgical implant that could interfere with performance assessments.
- Prior treatment within the past 12 months with any dermal filler (e.g., hyaluronic acid, CaHA, collagen-based fillers) in the area to be treated.
- Prior treatment within the past 6 months with facial dermal therapies, including but not limited to ablative or non-ablative laser therapy, radiofrequency treatment, chemical or mechanical peels, non-invasive skin-tightening procedures, or planned treatments of this nature during the study period.
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 |
|---|---|---|
| Facetem SFacetem S is a calcium hydroxylapatite (CaHA) dermal filler administered for the correction of moderate-to-severe nasolabial folds. Treatment will be performed in accordance with the Instructions for Use (IFU). An optional touch-up treatment may be performed approximately 4 weeks after the initial treatment if clinically necessary. | Device | Facetem S |
Primary outcome
Proportion of Subjects With ≥1-Point Improvement in WSRS
Time frame: Week 12 (Week 16 for subjects receiving touch-up treatment)
Proportion of subjects with ≥1-point improvement from baseline (Week 0) in the Wrinkle Severity Rating Scale (WSRS) for nasolabial folds. The WSRS ranges from Grade 1 (Absent) to Grade 5 (Extreme), with lower scores indicating less severe nasolabial folds.
5 secondary outcomes
Proportion of Subjects With ≥1-Point Improvement in WSRS
Time frame: Week 24 and Week 52 (Week 28 and Week 56, respectively, for subjects receiving touch-up treatment)
Independent Evaluator- and Investigator-Assessed GAIS Response Rate
Time frame: Week 12, Week 24, and Week 52
Subject-Assessed GAIS Response Rate
Time frame: Week 12, Week 24, and Week 52 (Week 16, Week 28, and Week 56, respectively, for subjects receiving touch-up treatment)
Incidence and Characteristics of Adverse Events and Serious Adverse Events
Time frame: Throughout the study period, up to Week 52 (Week 56 for subjects receiving touch-up treatment)
Safety Outcomes According to Fitzpatrick Skin Type
Time frame: Throughout the study period, up to Week 52 (Week 56 for subjects receiving touch-up treatment)
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 2 Oct 2026.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
5 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Facetem S in people with Nasolabial Folds, run by CGBio Inc. at 5 sites in 2 countries.
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 6 inclusion and 18 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: opening soon, as of the sponsor's last update on 2 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in France, Spain. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of Subjects With ≥1-Point Improvement in WSRS (time frame: Week 12 (Week 16 for subjects receiving touch-up treatment)). 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 2 Oct 2026.