Safety Study of TPX-121 on Nasolabial Folds (NCT06533540) | Clinical Trial Compass
Active — Not RecruitingPhase 1
Safety Study of TPX-121 on Nasolabial Folds
South Korea18 participantsStarted 2024-12-11
Plain-language summary
Nasolabial folds augmentation is possible through dermal filler and botulinum toxin, however, safety issues are existed as well as efficacy. Therefore, there is a need for a safer procedure for nasolabial folds correction. This study (Project No. TPX-121) assesses the safety of allogeneic fibroblasts (TPX-115) on nasolabial folds. The safety endpoint is dose-limiting toxicity (DLT). In addition, exploratory endpoints are the improvement of nasolabial folds in Wrinkle Severity Rating Scale (WSRS) at week 4 and 12, change in WSRS and Wrinkle Severity Scale (WSS) at week 4 and 12, and overall appearance improvement rate in Global Aesthetic Improvement Scale (GAIS) at week 4 and 12.
Who can participate
Age range
19 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
. Be 19 years old or older
. Have confirmed nasolabial folds severity equal to or more than grade 3 evaluated by WSRS and WSS at face to face evaluation.
. Have unsatisfied or very unsatisfied nasolabial folds.
. Voluntarily sign the informed consent for participation in the study.
Exclusion criteria
. Inflammatory and infectious skin diseases, unhealed wounds and scars (e.g. Keloids), or benign tumor on nasolabial folds.
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.
. Genetic diseases that affect fibroblasts or collagen (e.g. Achondroplasia, Osteogenesis imperfecta).
. Autoimmune diseases.
. Active hepatitis B or C (However, in the case of simple carriers or hepatitis B, except when the antiviral agent was stably taken for 6 months prior to screening).
. Human immunodeficiency virus (HIV) positive.
. Coagulopathy.
. History of malignant tumors within the last 5 years.