Dermal Evaluation of Facetem™ S in Nasolabial Folds Esthetics Improvement: DEFINE Study

NCT07855224 | Not Yet Recruiting

• 1 other identifier: CGFTSPS-PMCF-01
• Study Type: interventional
• Target: 100
• Locations: 2 countries
• Sites: 5

Brief 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. 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

Keywords

Dermal Filler

Outcome Measures

Primary Outcomes (1)

• 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.

  Week 12 (Week 16 for subjects receiving touch-up treatment)

Secondary Outcomes (5)

• Proportion of Subjects With ≥1-Point Improvement in WSRS

  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

  Week 12, Week 24, and Week 52

• Subject-Assessed GAIS Response Rate

  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

  Throughout the study period, up to Week 52 (Week 56 for subjects receiving touch-up treatment)

• Safety Outcomes According to Fitzpatrick Skin Type

  Throughout the study period, up to Week 52 (Week 56 for subjects receiving touch-up treatment)

Study Arms (1)

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.

Device: Facetem S

Interventions

Facetem S DEVICE

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.

Facetem S

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• CGBio Inc.: lead

Study Sites (5)

Medical office

Cannes, 06400, France

Location

MEDITI Center

Nice, 060000, France

Location

Aesthe.com

Paris, 75004, France

Location

Medical office

Paris, 75006, France

Location

Clínicas Uzuri

Madrid, 28006, Spain

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 28, 2026
• First Posted: October 2, 2026
• Study Start (Estimated): January 1, 2027
• Primary Completion (Estimated): April 1, 2028
• Study Completion (Estimated): January 1, 2029
• Last Updated: October 2, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1); FR (4)