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

Inclusion criteria

Participants must;

• 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.

Exclusion criteria

Participants with any of the following conditions will be excluded unless stated otherwise;

• Unsuitable for skin biopsy.

• Have prior medical history of the following at the time of screening.

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

• Have any of the following comorbidities at screening.

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

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

• Surgical procedures or surgeries such as fillers or fat grafting on nasojugal groove or tear through deformity.
• 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.)

• Subjects who have received anti-platelet drugs and anticoagulants within 7 days prior to skin biopsy.

• Subjects with planned facial cosmetic surgery (facial fillers, photorejuvenation, chemical/mechanical peeling) or facial massages during the duration of the study.

• Subjects who have allergies to investigational drug composition or manufacturing ingredients (bovine proteins, gentamicin, etc.)

• 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.

• Have participated in other clinical trials and received investigational agents within 4 weeks of this study.

• Be deemed inadequate for the study by investigators. (Serious heart disease, liver disease, kidney disease, etc.)