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 range19 Years
SexALL
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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.
✕. 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).