Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TPX-105 | Experimental | Autologous human dermal fibroblasts |
|
| Placebo | Sham Comparator | Suspension media |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TPX-105 | Biological | Subjects will be administered with autologous fibroblasts through injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 4, 12 weeks |
| Severity Grade Change from Baseline |
Not provided
Inclusion Criteria:
Participants must;
Exclusion Criteria:
Participants with any of the following conditions will be excluded unless stated otherwise;
1. Unsuitable for skin biopsy.
2. Have prior medical history of the following at the time of screening.
3. Have any of the following comorbidities at screening.
4. Subjects who have a medical history of the following at the time of screening.
5. Subjects who have received anti-platelet drugs and anticoagulants within 7 days prior to skin biopsy.
6. Subjects with planned facial cosmetic surgery (facial fillers, photorejuvenation, chemical/mechanical peeling) or facial massages during the duration of the study.
7. Subjects who have allergies to investigational drug composition or manufacturing ingredients (bovine proteins, gentamicin, etc.)
8. Be pregnant, breastfeeding, planning pregnancy or unwilling to use of contraceptive* suggested in this study.
*Hormonal contraceptives (oral, transplanted, etc.), intrauterine device, double-barrier method (condom, diaphragm, or cervical occlusive cap with spermicide), surgically sterile partner, etc.
9. Have participated in other clinical trials and received investigational agents within 4 weeks of this study.
10. Be deemed inadequate for the study by investigators. (Serious heart disease, liver disease, kidney disease, etc.)
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Ho-yun Jun | Kyungpook National University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Soonchunhyang University Hospital Bucheon | Bucheon-si | 14584 | South Korea | |||
| Kyungpook National University Hospital |
Not provided
Not provided
Not provided
Not provided
Not provided
| Placebo | Biological | Subjects will be administered with Placebo through injection |
|
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. |
| 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) | 4, 12, 24, 48 weeks |
| Daegu |
| 41944 |
| South Korea |
| The Catholic University of Korea, Seoul ST. Mary's Hospital | Seoul | 06591 | South Korea |
| Korea University Guro Hospital | Seoul | 08308 | South Korea |