NCT06533540

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18

participants targeted

Target at P25-P50 for phase_1

Timeline
7mo left

Started Dec 2024

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress71%
Dec 2024Dec 2026

First Submitted

Initial submission to the registry

July 29, 2024

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 1, 2024

Completed
4 months until next milestone

Study Start

First participant enrolled

December 11, 2024

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2026

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Expected
Last Updated

July 22, 2025

Status Verified

July 1, 2025

Enrollment Period

1.2 years

First QC Date

July 29, 2024

Last Update Submit

July 17, 2025

Conditions

Nasolabial Fold, Hypoplastic

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • Improvement WSRS grade from baseline

    Week 4 and Week 12

  • WSRS grade change from baseline

    Week 4 and Week 12

  • WSS grade change from baseline

    Week 4 and Week 12

  • +1 more other outcomes

Study Arms (3)

low dose

EXPERIMENTAL
Biological: TPX-115(allogeneic fibroblasts)

middle dose

EXPERIMENTAL
Biological: TPX-115(allogeneic fibroblasts)

high dose

EXPERIMENTAL
Biological: TPX-115(allogeneic fibroblasts)

Interventions

TPX-115(allogeneic fibroblasts)BIOLOGICAL

Intradermal injection of TPX-115(allogeneic fibroblasts)

high doselow dosemiddle dose

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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.
  • +13 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kyungpook National University, School of Medicine

Daegu, Jung-gu, 41944, South Korea

Location

Study Officials

  • Hoyun Chung, M.D.

    Kyungpook National University, School of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 29, 2024

First Posted

August 1, 2024

Study Start

December 11, 2024

Primary Completion

March 1, 2026

Study Completion (Estimated)

December 1, 2026

Last Updated

July 22, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)