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Safety Study of TPX-121 on Nasolabial Folds
Sponsor: Tego Science, Inc.
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.
Official title: A Single-center, Single Group, Dose Escalation, Phase 1 Clinical Trial to Investigate the Safety of TPX-121 in Subjects With Moderate-to-Extreme Nasolabial Folds
Key Details
Gender
All
Age Range
19 Years - Any
Study Type
INTERVENTIONAL
Enrollment
18
Start Date
2024-12-11
Completion Date
2026-12
Last Updated
2025-07-22
Healthy Volunteers
No
Conditions
Interventions
TPX-115(allogeneic fibroblasts)
Intradermal injection of TPX-115(allogeneic fibroblasts)
Locations (1)
Kyungpook National University, School of Medicine
Daegu, Jung-gu, South Korea