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

Tear Trough Eyelid Deformity Clinical Trial

Official title: 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

Clinical Trial 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.

Clinical Trial Description

n/a

Related Conditions & MeSH terms

• Congenital Abnormalities
• Tear Trough Eyelid Deformity

• NCT number: NCT06197789
• Study type: Interventional
• Source: Tego Science, Inc.
• Status: Completed
• Phase: Phase 3
• Start date: August 18, 2021
• Completion date: October 18, 2023