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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
60
Subjects will be administered with autologous fibroblasts through injection
Subjects will be administered with Placebo through injection
Soonchunhyang University Hospital Bucheon
Bucheon-si, South Korea
Kyungpook National University Hospital
Daegu, South Korea
The Catholic University of Korea, Seoul ST. Mary's Hospital
Seoul, South Korea
Korea University Guro Hospital
Seoul, South Korea
Improvement Rate from Baseline
Improvement rate of nasojugal groove from baseline will be evaluated by a independent evaluator based on pictures taken at week 24 after administration of investigational product. \*Improvement rate of nasojugal groove definition: With at least a 2-grade decrease
Time frame: 24 weeks
Improvement Rate from Baseline
Improvement rate of nasojugal groove from baseline evaluated by an independent evaluator based on pictures taken at week 4 and 12 after administration of investigational product.
Time frame: 4, 12 weeks
Severity Grade Change from Baseline
Severity grade change from baseline evaluated by an independent evaluator based on pictures taken at week 4, 12 and 24 after administration of investigational product.
Time frame: 4, 12, 24 weeks
Overall Appearance Improvement Percentage (%)
Overall appearance improvement percentage (%) rated by subjects using GAIS\* at week 4, 12, 24 and 48 after administration of investigational product. \*In the case of overall appearance improvement rate using GAIS being +2 points (Much Improved) or +1 (Improved)
Time frame: 4, 12, 24, 48 weeks
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