Status:
ACTIVE_NOT_RECRUITING
Safety Study of TPX-121 on Nasolabial Folds
Lead Sponsor:
Tego Science, Inc.
Conditions:
Nasolabial Fold, Hypoplastic
Eligibility:
All Genders
19+ years
Phase:
PHASE1
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 nasola...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
- Administered systemic corticosteroids within 12 weeks prior to screening or is scheduled to be administered for at least 2 weeks during the study.
- Treated cell therapy or stem cell therapy within 1 year prior to screening.
- Surgical procedures or surgeries such as fillers or fat grafting on facial part within 1 year prior to screening.
- Surgical procedures or surgeries of permanent fillers on facial part prior to screening.
- Surgical procedures or surgeries of botulinum toxin injection or face lift surgery on facial part within 6 months prior to screening.
- Planned facial cosmetic surgery to improve nasolabial folds during the study.
- Laboratory inspection
- Those who fall under the following figures during screening. 1) White blood cell \< 4.5x10\^3/ul and \> 11.0x10\^3/ul 2) Platelet count \< 100,000/mm\^3 3) Hemoglobin \< 9g/dL
- Other
- Disagree to take pictures of nasolabial folds
- Be pregnant, breastfeeding, planning pregnancy or unwilling to use of contraceptice.
- Have participated in other clinical trials and recevied investigational products/devices within 30 days of this study.
- Be deemed inadequate for the study by investigators(e.g. A person with severe asymmetry in the lower echocardiogram).
Key Trial Info
Start Date :
December 11 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2026
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT06533540
Start Date
December 11 2024
End Date
December 1 2026
Last Update
July 22 2025
Active Locations (1)
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1
Kyungpook National University, School of Medicine
Daegu, Jung-gu, South Korea, 41944