Safety assessment of TPX-121 for treating 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
This study tests a new treatment called TPX-121 to see if it is safe and effective for reducing wrinkles around the nose and mouth.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 18 (estimated) |
| Ages | 19 Years and up |
| Sex | All |
| Sponsor | Tego Science, Inc. Industry-sponsored |
| Locations | 1 site (Daegu, Jung-gu) |
| Trial ID | NCT06533540 on ClinicalTrials.gov |
What this trial studies
This study evaluates the safety of TPX-115, an allogeneic fibroblast treatment, for correcting nasolabial folds. Participants will be assessed for dose-limiting toxicity and improvements in wrinkle severity over 4 and 12 weeks using established scales. The study aims to provide a safer alternative to current dermal fillers and botulinum toxin treatments. By focusing on safety and efficacy, it seeks to enhance patient satisfaction with aesthetic procedures.
Who should consider this trial
Good fit: Ideal candidates are adults aged 19 and older with significant nasolabial fold severity and dissatisfaction with their appearance.
Not a fit: Patients with inflammatory skin diseases, chronic skin conditions, or a history of certain medical issues may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could offer a safer and more effective option for patients seeking correction of nasolabial folds.
How similar studies have performed: While there is ongoing research in aesthetic treatments, this specific approach using allogeneic fibroblasts is relatively novel and has not been extensively tested in similar studies.
Eligibility criteria
Show full inclusion / exclusion 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).
Where this trial is running
Daegu, Jung-gu
- Kyungpook National University, School of Medicine — Daegu, Jung-gu, Korea, Republic of (Recruiting)
Study contacts
- Principal investigator: Hoyun Chung, M.D. — Kyungpook National University, School of Medicine
- Study coordinator: Jikhyon Han, Ph.D.
- Email: jhhan@tegoscience.com
- Phone: +82-2-818-2900
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.