Safety Study of TPX-121 on Nasolabial Folds

Inclusion criteria

• Be 19 years old or older
• Have confirmed nasolabial folds severity equal to or more than grade 3 evaluated by WSRS and WSS at face to face evaluation.
• Have unsatisfied or very unsatisfied nasolabial folds.
• Voluntarily sign the informed consent for participation in the study.

Exclusion criteria

Current disease and medical history

• Inflammatory and infectious skin diseases, unhealed wounds and scars (e.g. Keloids), or benign tumor on nasolabial folds.
• Chronic skin diseases (e.g. Psoriasis, Atopic dermatitis).
• Genetic diseases that affect fibroblasts or collagen (e.g. Achondroplasia, Osteogenesis imperfecta).
• Autoimmune diseases.
• Active hepatitis B or C (However, in the case of simple carriers or hepatitis B, except when the antiviral agent was stably taken for 6 months prior to screening).
• Human immunodeficiency virus (HIV) positive.
• Coagulopathy.
• History of malignant tumors within the last 5 years.
• Anaphylaxis or severe combined allergy
• Have allergies to bovine proteins or gentamicin.
• Acute or chronic infectious diseases.
• Severe heart diseases (e.g. Myocardial infarction, Heart failure), severe liver diseases (e.g. Cirrhosis, Liver failure), or severe renal diseases (e.g. Kidney failure).
• Hypersensitivity to amide-based local anesthetics (However, those who agree not to use local anesthetics can register).

Prohibited drugs and treatments.

• Administered systemic corticosteroids within 12 weeks prior to screening or is scheduled to be administered for at least 2 weeks during the study.
• Treated cell therapy or stem cell therapy within 1 year prior to screening.
• Surgical procedures or surgeries such as fillers or fat grafting on facial part within 1 year prior to screening.
• Surgical procedures or surgeries of permanent fillers on facial part prior to screening.
• Surgical procedures or surgeries of botulinum toxin injection or face lift surgery on facial part within 6 months prior to screening.
• Planned facial cosmetic surgery to improve nasolabial folds during the study.

Laboratory inspection

• Those who fall under the following figures during screening. 1) White blood cell < 4.5x10^3/ul and > 11.0x10^3/ul 2) Platelet count < 100,000/mm^3 3) Hemoglobin < 9g/dL

Other

• Disagree to take pictures of nasolabial folds
• Be pregnant, breastfeeding, planning pregnancy or unwilling to use of contraceptice.
• Have participated in other clinical trials and recevied investigational products/devices within 30 days of this study.
• Be deemed inadequate for the study by investigators(e.g. A person with severe asymmetry in the lower echocardiogram).