Safety and Efficacy Study of TPX-105 for Correction of Nasojugal Groove

NCT06197789 | Completed Phase 3

• 1 other identifier: TG-TPX-105-18-02
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 4

Brief Summary

Nasojugal groove correction is possible through surgical correction procedures, however, due to risks in safety and drawbacks not being able to be done on the young or after surgical procedure, dermal fillers which have the possibility of granulomatous allergic reaction and surface elevation. Therefore, there is a need for a safer procedure for nasojugal groove correction. This study evaluates the safety and efficacy of Autologous human dermal fibroblasts (TPX-105) used for the correction of nasojugal groove. The primary outcome is the improvement of nasojugal groove evaluated by an independent evaluator after administration of TPX-105 at week 24. Secondary outcomes include the improvement of nasojugal groove at week 4 and 12, severity change from baseline at week 4, 12 and 24 evaluated by an independent evaluator, and overall appearance improvement rate rated by subjects using Global Aesthetic Improvement Scale (GAIS) at week 4, 12, 24 and 48.

Conditions

Tear Trough Eyelid Deformity

Outcome Measures

Primary Outcomes (1)

• Improvement Rate from Baseline

  Improvement rate of nasojugal groove from baseline will be evaluated by a independent evaluator based on pictures taken at week 24 after administration of investigational product. \*Improvement rate of nasojugal groove definition: With at least a 2-grade decrease

  24 weeks

Secondary Outcomes (3)

• Improvement Rate from Baseline

  4, 12 weeks

• Severity Grade Change from Baseline

  4, 12, 24 weeks

• Overall Appearance Improvement Percentage (%)

  4, 12, 24, 48 weeks

Study Arms (2)

TPX-105

EXPERIMENTAL

Autologous human dermal fibroblasts

Biological: TPX-105

Placebo

SHAM COMPARATOR

Suspension media

Biological: Placebo

Interventions

TPX-105 BIOLOGICAL

Subjects will be administered with autologous fibroblasts through injection

Also known as: Autologous human dermal fibroblasts

TPX-105

Placebo BIOLOGICAL

Subjects will be administered with Placebo through injection

Placebo

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants must;
• Be 19 years old or older.
• Have confirmed nasojugal groove severity equal to or more than "Moderate" (severity, grade 3) at subject assessment and want correction.
• Consent to undergo skin biopsy on unexposed areas for manufacture of test product.
• Fully understand the study and voluntarily sign the informed consent for participation in the study.

You may not qualify if:

• Participants with any of the following conditions will be excluded unless stated otherwise;
• \. Unsuitable for skin biopsy.
• \. Have prior medical history of the following at the time of screening.
• Keloids
• Chronic skin diseases (psoriasis, atopic dermatis)
• Genetic disorders that affect fibroblasts or collagen (ex. achondroplasia, osteogensis imperfecta, etc.)
• Autoimmune disease
• Human immunodeficiency virus (HIV) positive
• Coagulopathy
• Basal cell carcinoma or history of malignant tumors within the last 5 years
• \. Have any of the following comorbidities at screening.
• Inflammatory lesions or infectious diseases in the nasojugal groove region
• Wounds, scars, or skin disorders that may affect efficacy assessment
• Subjects who require continuous administration (2 weeks or more) of corticosteroid
• Acute chronic infectious diseases

Sponsors & Collaborators

• Tego Science, Inc.: lead

Study Sites (4)

Soonchunhyang University Hospital Bucheon

Bucheon-si, 14584, South Korea

Location

Kyungpook National University Hospital

Daegu, 41944, South Korea

Location

The Catholic University of Korea, Seoul ST. Mary's Hospital

Seoul, 06591, South Korea

Location

Korea University Guro Hospital

Seoul, 08308, South Korea

Location

Study Officials

• Ho-yun Jun

  Kyungpook National University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 17, 2023
• First Posted: January 9, 2024
• Study Start: August 18, 2021
• Primary Completion: June 5, 2023
• Study Completion: October 18, 2023
• Last Updated: January 9, 2024

Record last verified: 2023-12

Locations

KR (4)