The goal of this clinical trial is to assess the safety and performance of the PTMC Dermal filler for treating moderate to severe nasolabial folds in adult men and women. The main questions it aims to answer are: * Does the PTMC dermal filler maintain its performance for a minimum of 6 months? * Is the treatment considered safe for participants? Participants will: * Before treatment, the investigator will assess your medical history, medication usage, and satisfaction with your wrinkles/folds. * You'll receive one injection of the PTMC Dermal filler during your initial visit. * For 30 days post-injection, you'll keep a diary to note any reactions like pain, redness, or swelling at the injection site. * At the 1-month follow-up, you can request a 'touch-up' of the filler, extending your participation in the study. * Participants will visit the clinic a total of 8 times, including the initial treatment and 7 follow-up visits, spanning up to 18 months. * Each visit will last approximately 60-90 minutes. The visits will be conducted in person.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
120
A total of 120 subjects will receive treatment with PTMC Dermal Filler. The volume of filler injected will vary depending on the severity of the nasolabial fold. Injections will be administered by the investigator at the beginning of the study, with the injection technique, plane, and volume recorded. Touch-up treatments are permitted at the 1-month follow-up visit, if necessary.
Nasolabial fold severity
The nasolabial fold severity is measured using the Wrinkles Severity Rating Scale (WSRS) by the investigator.
Time frame: 6 months after treatment
Safety (Adverse events)
Safety is assessed by the collection of adverse events (incidence and severity), and through subject assessment of injection site responses (ISRs) up to 4 weeks after treatment.
Time frame: until 18 months after treatment
Nasolabial fold severity
Mean change from baseline of the nasolabial fold severity measured using the WSRS by the investigator.
Time frame: 1, 3, 9, 12, and 18 months after treatment
Responder rate
Number of subjects having at least 1-point improvement in the WSRS score compared to the baseline.
Time frame: 1, 3, 6, 9, 12, and 18 months after treatment
Overall aesthetic improvement (by the investigator)
Overall aesthetic improvement is assessed by the investigator using the Global Aesthetic Improvement Scale (GAIS).
Time frame: 1, 3, 6, 9, 12, and 18 months after treatment
Overall aesthetic improvement (by the subject)
Overall aesthetic improvement assessed by the subject using the Global Aesthetic Improvement Scale (GAIS).
Time frame: 1, 3, 6, 9, 12, and 18 months after treatment
Subject satisfaction
Subject satisfaction is measured using a FACE-Q questionnaire.
Time frame: 1, 3, 6, 9, 12, and 18 months after treatment
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