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 range
18 Years – 67 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.