Clinical trial NCT06533540: Safety Study of TPX-121 on Nasolabial Folds
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Nasolabial Fold, Hypoplastic
Lead sponsor: Tego Science, Inc.
Sponsor class: INDUSTRY
First posted: 2024-08-01
Enrollment: 18
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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).

Primary outcomes:
measure: Dose-limiting toxicity
timeFrame: Week 4
Secondary outcomes:
Other outcomes:
measure: Improvement WSRS grade from baseline
timeFrame: Week 4 and Week 12
measure: WSRS grade change from baseline
timeFrame: Week 4 and Week 12
measure: WSS grade change from baseline
timeFrame: Week 4 and Week 12
measure: Overall appearance improvement percentage(%) using GAIS
timeFrame: Week 4 and Week 12
Locations:
city: Daegu
country: Korea, Republic of
facility: Kyungpook National University, School of Medicine
state: Jung-gu
Study officials:
affiliation: Kyungpook National University, School of Medicine
name: Hoyun Chung, M.D.
role: PRINCIPAL_INVESTIGATOR
References: