Safety and Efficacy Study of TPX-105 for Correction of Nasojugal Groove (NCT06197789) | Clinical Trial Compass
CompletedPhase 3
Safety and Efficacy Study of TPX-105 for Correction of Nasojugal Groove
South Korea60 participantsStarted 2021-08-18
Plain-language 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.
Who can participate
Age range19 Years
SexALL
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Inclusion criteria
✓. Be 19 years old or older.
✓. Have confirmed nasojugal groove severity equal to or more than "Moderate" (severity, grade 3) at subject assessment and want correction.
✓. Consent to undergo skin biopsy on unexposed areas for manufacture of test product.
✓. Fully understand the study and voluntarily sign the informed consent for participation in the study.