TCRM for Correction of Cheek Including Fine Lines (NCT07145905) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
TCRM for Correction of Cheek Including Fine Lines
Spain130 participantsStarted 2023-11-30
Plain-language summary
The purpose of this clinical study is to evaluate benefits and risks of injecting TCRM in the cheek including fine lines. The goal is to show that treatment with TCRM will result in correcting the cheek area including the fine lines at 4 weeks after last treatment (initial injection or touch up) on subjects.
Who can participate
Age range
18 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:
* Healthy adult subjects over 18 years old seeking correction of the cheek area including fine lines.
* Subject scored grade 1 to 3 on the CFLDS.
* For women: not pregnant, not breast feeding
* Female subjects of childbearing potential must have a negative UPT and practice a reliable method of contraception throughout the study.
* Willing to abstain from facial aesthetic procedures/therapies that could interfere with study evaluations
* Able to follow study instructions and complete all required visits.
* Having given its signed informed consent.
Exclusion Criteria:
* Known hypersensitivity or previous allergic reaction to any component of the study devices
* Known sensitivity to local anesthetics of the amide type, history of multiple severe allergies, or history of anaphylactic shock.
* History of active chronic debilitating systemic disease that, in the opinion of the investigator, would make the subject a poor candidate in the study.
* Subject exhibits any physical attribute that may prevent assessment or treatment of the cheek area including fine lines as judged by the PI
* Clinically significant alcohol or drug abuse.
* Subject has received any investigational product within 90 days prior to Visit 1 or planning to participate in another investigation during the course of the study.
* Subject has unstable weight, as judged by the PI.
* Subject has no teeth or misses significant portion of dentition that changes the face appearance (subjects with de…
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.
1This trial is labeled 'Phase NA' and is no longer actively recruiting — what does that mean for my chances of being involved, and could the results from this study still inform my treatment options?
2The study is measuring improvement in cheek wrinkles and fine lines at just 4 weeks after the last injection using a scale called GAIS — is 4 weeks enough time to know whether a treatment like this is truly effective and safe for me?
3Since the trial uses a Global Aesthetic Improvement Scale rated by both the patient and the doctor, how subjective is that kind of measurement, and does it give us reliable information about how well TCRM actually works?
4Are there existing, already-approved treatments for cheek wrinkles and fine lines that have longer track records of safety data, and how would those compare to what this trial is studying?
5Given that this study is no longer enrolling new participants, is there any way my doctor could access the emerging results or findings from this trial to guide decisions about my own care?
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.
What they're measuring
1
To demonstrate the efficacy of TCRM in the treatment of the cheek area including fine lines at 4 weeks after last injection (initial injection or touch up) using Global Aesthetic Improvement Scale (GAIS) as assessed by both subject and PI.