Dermal Evaluation of Facetem™ S in Nasolabial Folds Esthetics Improvement: DEFINE Study
ConditionNasolabial Folds
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorCGBio Inc.
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Single group
Treatments tested in this trial
Facetem S
DeviceFacetem 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.
Treatment groups
100 Participants
are divided into 1 treatment groupGroup A: Facetem SExperimental treatment 1 intervention
Trial outcomes
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.
Time frame
Week 12 (Week 16 for subjects receiving touch-up treatment)Secondary 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.
Time frame
Week 24 and Week 52 (Week 28 and Week 56, respectively, for subjects receiving touch-up treatment)2
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.
Time frame
Week 12, Week 24, and Week 523
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.
Time frame
Week 12, Week 24, and Week 52 (Week 16, Week 28, and Week 56, respectively, for subjects receiving touch-up treatment)4
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.
Time frame
Throughout the study period, up to Week 52 (Week 56 for subjects receiving touch-up treatment) Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: