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

A Multi-center, Randomized, Independent Evaluator-Subject Blinded, Placebo-controlled, Phase 3 Clinical Study to Evaluate Safety and Efficacy of TPX-105 for Correction of Nasojugal Groove

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.

Study Overview

• Status: Completed
• Conditions: Tear Trough Eyelid Deformity
• Intervention / Treatment: Biological: TPX-105; Biological: Placebo

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Phase 3

Contacts and Locations

Study Locations

• Korea, Republic of
  • Bucheon, Korea, Republic of, 14584
    • Soonchunhyang University Hospital Bucheon
  • Daegu, Korea, Republic of, 41944
    • Kyungpook National University Hospital
  • Seoul, Korea, Republic of, 06591
    • The Catholic University of Korea, Seoul St. Mary's Hospital
  • Seoul, Korea, Republic of, 08308
    • Korea University Guro Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

Participants must;

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

Exclusion Criteria:

Participants with any of the following conditions will be excluded unless stated otherwise;

1. Unsuitable for skin biopsy.

2. Have prior medical history of the following at the time of screening.

1. Keloids
2. Chronic skin diseases (psoriasis, atopic dermatis)
3. Genetic disorders that affect fibroblasts or collagen (ex. achondroplasia, osteogensis imperfecta, etc.)
4. Autoimmune disease
5. Human immunodeficiency virus (HIV) positive
6. Coagulopathy
7. Basal cell carcinoma or history of malignant tumors within the last 5 years

3. Have any of the following comorbidities at screening.

1. Inflammatory lesions or infectious diseases in the nasojugal groove region
2. Wounds, scars, or skin disorders that may affect efficacy assessment
3. Subjects who require continuous administration (2 weeks or more) of corticosteroid
4. Acute chronic infectious diseases
5. Subjects with bleeding requiring medical intervention including blood transfusions

4. Subjects who have a medical history of the following at the time of screening.

1. Surgical procedures or surgeries such as fillers or fat grafting on nasojugal groove or tear through deformity.
2. Surgical procedures or wrinkle corrections around the eyes within 24 weeks from screening. (Ex. botulinum toxin injection, face lift surgery, soft tissue augmentation, semi-intercalated peel, dermal photorejuvenation, or etc.)

5. Subjects who have received anti-platelet drugs and anticoagulants within 7 days prior to skin biopsy.

6. Subjects with planned facial cosmetic surgery (facial fillers, photorejuvenation, chemical/mechanical peeling) or facial massages during the duration of the study.

7. Subjects who have allergies to investigational drug composition or manufacturing ingredients (bovine proteins, gentamicin, etc.)

8. Be pregnant, breastfeeding, planning pregnancy or unwilling to use of contraceptive* suggested in this study.

*Hormonal contraceptives (oral, transplanted, etc.), intrauterine device, double-barrier method (condom, diaphragm, or cervical occlusive cap with spermicide), surgically sterile partner, etc.

9. Have participated in other clinical trials and received investigational agents within 4 weeks of this study.

10. Be deemed inadequate for the study by investigators. (Serious heart disease, liver disease, kidney disease, etc.)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: TPX-105; Autologous human dermal fibroblasts	Biological: TPX-105; Subjects will be administered with autologous fibroblasts through injection; Other Names: Autologous human dermal fibroblasts
Sham Comparator: Placebo; Suspension media	Biological: Placebo; Subjects will be administered with Placebo through injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Improvement Rate from Baseline	Improvement rate of nasojugal groove from baseline evaluated by an independent evaluator based on pictures taken at week 4 and 12 after administration of investigational product.	4, 12 weeks
Severity Grade Change from Baseline	Severity grade change from baseline evaluated by an independent evaluator based on pictures taken at week 4, 12 and 24 after administration of investigational product.	4, 12, 24 weeks
Overall Appearance Improvement Percentage (%)	Overall appearance improvement percentage (%) rated by subjects using GAIS* at week 4, 12, 24 and 48 after administration of investigational product. *In the case of overall appearance improvement rate using GAIS being +2 points (Much Improved) or +1 (Improved)	4, 12, 24, 48 weeks

Collaborators and Investigators

• Sponsor: Tego Science, Inc.
• Investigators: Principal Investigator: Ho-yun Jun, Kyungpook National University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): August 18, 2021
• Primary Completion (Actual): June 5, 2023
• Study Completion (Actual): October 18, 2023

Study Registration Dates

• First Submitted: May 17, 2023
• First Submitted That Met QC Criteria: December 26, 2023
• First Posted (Actual): January 9, 2024

Study Record Updates

• Last Update Posted (Actual): January 9, 2024
• Last Update Submitted That Met QC Criteria: December 26, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Congenital Abnormalities
• Other Study ID Numbers: TG-TPX-105-18-02

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No