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

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.

Inclusion Criteria:

Participants must;

1. Be 19 years old or older.
2. Have confirmed nasojugal groove severity equal to or more than "Moderate" (severity, grade 3) at subject assessment and want correction.
3. Consent to undergo skin biopsy on unexposed areas for manufacture of test product.
4. Fully understand the study and voluntarily sign the informed consent for participation in the study.

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.

1. Keloids
2. Chronic skin diseases (psoriasis, atopic dermatis)
3. Genetic disorders that affect fibroblasts or collagen (ex. achondroplasia, osteogensis imperfecta, etc.)
4. Autoimmune disease
5. Human immunodeficiency virus (HIV) positive
6. Coagulopathy
7. Basal cell carcinoma or history of malignant tumors within the last 5 years

3. Have any of the following comorbidities at screening.

1. Inflammatory lesions or infectious diseases in the nasojugal groove region
2. Wounds, scars, or skin disorders that may affect efficacy assessment
3. Subjects who require continuous administration (2 weeks or more) of corticosteroid
4. Acute chronic infectious diseases
5. Subjects with bleeding requiring medical intervention including blood transfusions

4. Subjects who have a medical history of the following at the time of screening.

1. Surgical procedures or surgeries such as fillers or fat grafting on nasojugal groove or tear through deformity.
2. Surgical procedures or wrinkle corrections around the eyes within 24 weeks from screening. (Ex. botulinum toxin injection, face lift surgery, soft tissue augmentation, semi-intercalated peel, dermal photorejuvenation, or etc.)

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.)