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

NCT06533540•Tego Science, Inc.

View on ClinicalTrials.gov

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

Age

19 - No limit years

Sex

ALL

Healthy Volunteers

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
+18 more criteria

Locations (1)

Kyungpook National University, School of Medicine

Daegu, Jung-gu, South Korea

Key Dates

Start Date

December 11, 2024

Primary Completion Date

March 1, 2026

Completion Date

December 1, 2026

Last Updated

July 22, 2025

Enrollment

ESTIMATED participants

Conditions

Nasolabial Fold, Hypoplastic

Interventions

TPX-115(allogeneic fibroblasts)

BIOLOGICAL