Safety and Performance of PTMC Dermal Filler (NCT06316479) | Clinical Trial Compass
UnknownNot Applicable
Safety and Performance of PTMC Dermal Filler
120 participantsStarted 2024-08
Plain-language summary
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.
Who can participate
Age range18 Years – 67 Years
SexALL
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Inclusion criteria
✓. Male or female ≥18 years and £67 old.
✓. Two fully visible bilateral nasolabial folds each with a Wrinkle Severity Rating Scale (WSRS) score of 3 or 4 that may be corrected with an injectable dermal filler.
✓. If female and of childbearing potential: a negative urine pregnancy test + agreement to use adequate contraception.
✓. Ability to understand and comply with the study requirements.
✓. Willingness and ability to provide written informed consent.
✓. Agree to refrain from seeking other treatment of nasolabial folds during the study.
✓. Over the counter (OTC) wrinkle products or prescription wrinkle treatments, if used, shall be continued throughout the study in similar manner as performed prior to participation.
Exclusion criteria
✕. Wrinkle Severity Rating Scale (WSRS) score of ≤ 2 on the right or left nasolabial fold.