Status:
COMPLETED
Safety and Efficacy Study of TPX-105 for Correction of Nasojugal Groove
Lead Sponsor:
Tego Science, Inc.
Conditions:
Tear Trough Eyelid Deformity
Eligibility:
All Genders
19+ years
Phase:
PHASE3
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...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
- 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
- 3\. 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
- Subjects with bleeding requiring medical intervention including blood transfusions
- 4\. Subjects who have a medical history of the following at the time of screening.
- Surgical procedures or surgeries such as fillers or fat grafting on nasojugal groove or tear through deformity.
- 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.)
Key Trial Info
Start Date :
August 18 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 18 2023
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT06197789
Start Date
August 18 2021
End Date
October 18 2023
Last Update
January 9 2024
Active Locations (4)
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1
Soonchunhyang University Hospital Bucheon
Bucheon-si, South Korea, 14584
2
Kyungpook National University Hospital
Daegu, South Korea, 41944
3
The Catholic University of Korea, Seoul ST. Mary's Hospital
Seoul, South Korea, 06591
4
Korea University Guro Hospital
Seoul, South Korea, 08308