Clinical Trial

Safety Study of TPX-121 on Nasolabial Folds

Active, Not Recruiting Phase 1

Record status

This record was last updated July 22, 2025 (before its estimated March 2026 completion). Its status may not reflect the trial's current state.

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.

Protocol Amendment History 4 amendments

This ClinicalTrials.gov record has been amended 4 times since 2024-07-29; most recent amendment 2025-07-17.

Status change: Recruiting → Active, Not Recruiting 2025-07-17

Status change: Not Yet Recruiting → Recruiting 2024-11-22

Trial Details

NCT Number	NCT06533540
Lead Sponsor	Tego Science, Inc.
Conditions	Nasolabial Fold, Hypoplastic
Enrollment	18 participants
Start Date	2024-12-11
Primary Completion	2026-03 (estimated)
Study Completion	2026-12 (estimated)
Updated on ClinicalTrials.gov	2025-07-22