NCT06197789

Safety and Efficacy Study of TPX-105 for Correction of Nasojugal Groove

A Multi-center, Randomized, Independent Evaluator-Subject Blinded, Placebo-controlled, Phase 3 Clinical Study to Evaluate Safety and Efficacy of TPX-105 for Correction of Nasojugal Groove

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Tego Science, Inc. · Industry
• Sex: All
• Age: 19 Years
• Healthy volunteers: Accepted

Summary

Nasojugal groove correction is possible through surgical correction procedures, however, due to risks in safety and drawbacks not being able to be done on the young or after surgical procedure, dermal fillers which have the possibility of granulomatous allergic reaction and surface elevation. Therefore, there is a need for a safer procedure for nasojugal groove correction. This study evaluates the safety and efficacy of Autologous human dermal fibroblasts (TPX-105) used for the correction of nasojugal groove. The primary outcome is the improvement of nasojugal groove evaluated by an independent evaluator after administration of TPX-105 at week 24. Secondary outcomes include the improvement of nasojugal groove at week 4 and 12, severity change from baseline at week 4, 12 and 24 evaluated by an independent evaluator, and overall appearance improvement rate rated by subjects using Global Aesthetic Improvement Scale (GAIS) at week 4, 12, 24 and 48.

Conditions

• Tear Trough Eyelid Deformity

Interventions

Type	Name	Description
BIOLOGICAL	TPX-105	Subjects will be administered with autologous fibroblasts through injection
BIOLOGICAL	Placebo	Subjects will be administered with Placebo through injection

Timeline

• Start date: 2021-08-18
• Primary completion: 2023-06-05
• Completion: 2023-10-18
• First posted: 2024-01-09
• Last updated: 2024-01-09

Locations

4 sites across 1 country: South Korea