Safety Study of TPX-121 on Nasolabial Folds

A Single-center, Single Group, Dose Escalation, Phase 1 Clinical Trial to Investigate the Safety of TPX-121 in Subjects With Moderate-to-Extreme Nasolabial Folds

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Nasolabial Fold, Hypoplastic
• Intervention / Treatment: Biological: TPX-115(allogeneic fibroblasts)

• Study Type: Interventional
• Enrollment (Estimated): 18
• Phase: Phase 1

Contacts and Locations

Study Locations

• Korea, Republic of
  • Jung-gu
    • Daegu, Jung-gu, Korea, Republic of, 41944
      • Kyungpook National University, School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Exclusion Criteria:

Current disease and medical history

1. Inflammatory and infectious skin diseases, unhealed wounds and scars (e.g. Keloids), or benign tumor on nasolabial folds.
2. Chronic skin diseases (e.g. Psoriasis, Atopic dermatitis).
3. Genetic diseases that affect fibroblasts or collagen (e.g. Achondroplasia, Osteogenesis imperfecta).
4. Autoimmune diseases.
5. 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).
6. Human immunodeficiency virus (HIV) positive.
7. Coagulopathy.
8. History of malignant tumors within the last 5 years.
9. Anaphylaxis or severe combined allergy
10. Have allergies to bovine proteins or gentamicin.
11. Acute or chronic infectious diseases.
12. 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).

13. Hypersensitivity to amide-based local anesthetics (However, those who agree not to use local anesthetics can register).

    Prohibited drugs and treatments.

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

19. Planned facial cosmetic surgery to improve nasolabial folds during the study.

    Laboratory inspection

20. 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

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: low dose	Biological: TPX-115(allogeneic fibroblasts); Intradermal injection of TPX-115(allogeneic fibroblasts)
Experimental: high dose	Biological: TPX-115(allogeneic fibroblasts); Intradermal injection of TPX-115(allogeneic fibroblasts)
Experimental: middle dose	Biological: TPX-115(allogeneic fibroblasts); Intradermal injection of TPX-115(allogeneic fibroblasts)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Other Outcome Measures

Outcome Measure	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
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

Collaborators and Investigators

• Sponsor: Tego Science, Inc.
• Investigators: Principal Investigator: Hoyun Chung, M.D., Kyungpook National University, School of Medicine

Study record dates

Study Major Dates

• Study Start (Actual): December 11, 2024
• Primary Completion (Estimated): March 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: July 29, 2024
• First Submitted That Met QC Criteria: July 29, 2024
• First Posted (Actual): August 1, 2024

Study Record Updates

• Last Update Posted (Actual): July 22, 2025
• Last Update Submitted That Met QC Criteria: July 17, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: TG-TPX-121-23-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No