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Nasolabial folds augmentation is possible through dermal filler and botulinum toxin, however, safety issues are existed as well as efficacy. Therefore, there is a need for a safer procedure for nasolabial folds correction. This study (Project No. TPX-121) assesses the safety of allogeneic fibroblasts (TPX-115) on nasolabial folds. The safety endpoint is dose-limiting toxicity (DLT). In addition, exploratory endpoints are the improvement of nasolabial folds in Wrinkle Severity Rating Scale (WSRS) at week 4 and 12, change in WSRS and Wrinkle Severity Scale (WSS) at week 4 and 12, and overall appearance improvement rate in Global Aesthetic Improvement Scale (GAIS) at week 4 and 12.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| low dose | Experimental |
| |
| middle dose | Experimental |
| |
| high dose | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TPX-115(allogeneic fibroblasts) | Biological | Intradermal injection of TPX-115(allogeneic fibroblasts) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Dose-limiting toxicity | The number of subjects evaluated grade 3 or higher adverse drug reactions according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) v5.0 | Week 4 |
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| Measure | Description | Time Frame |
|---|---|---|
| Improvement WSRS grade from baseline | Improvement Wrinkle Severity Rating Scale (WSRS) grade of nasolabial folds from baseline evaluated by an investigator based on pictures taken at week 4 and 12. The WSRS ranges from 1 (absent) to 5 (Extreme). A negative change from baseline indicates improvement. | Week 4 and Week 12 |
Inclusion Criteria:
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).
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| Name | Affiliation | Role |
|---|---|---|
| Hoyun Chung, M.D. | Kyungpook National University, School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kyungpook National University, School of Medicine | Daegu | Jung-gu | 41944 | South Korea |
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| WSRS grade change from baseline |
Wrinkle Severity Rating Scale (WSRS) grade change from baseline evaluated by an investigator based on pictures taken at week 4 and 12. The WSRS ranges from 1 (absent) to 5 (Extreme). A negative change from baseline indicates improvement. |
| Week 4 and Week 12 |
| WSS grade change from baseline | Wrinkle Severity Scale (WSS) grade change from baseline evaluated by an investigator based on pictures taken at week 4 and 12. The WSS ranges from 0 (absent) to 5 (Extreme). A negative change from baseline indicates improvement. | Week 4 and Week 12 |
| Overall appearance improvement percentage(%) using GAIS | Overall appearance improvement percentage(%) rated by subjects using Global Aesthetic Improvement Scale (GAIS) at week 4 and 12. In the case of overall appearance improvement rate using GAIS being +3 point (Very much improved), +2 (Much improved), or +1 (Improved) | Week 4 and Week 12 |