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ACTIVE NOT RECRUITING
NCT06533540
PHASE1

Safety Study of TPX-121 on Nasolabial Folds

Sponsor: Tego Science, Inc.

View on ClinicalTrials.gov

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

Interventions

BIOLOGICAL

TPX-115(allogeneic fibroblasts)

Intradermal injection of TPX-115(allogeneic fibroblasts)

Locations (1)

Kyungpook National University, School of Medicine

Daegu, Jung-gu, South Korea