Nasolabial Fold, HypoplasticPhase 1NCT06533540
Safety Study of TPX-121 on Nasolabial Folds
A Phase 1 study testing TPX-115(allogeneic fibroblasts) in people with Nasolabial Fold, Hypoplastic, run by Tego Science, Inc. at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Nasolabial Fold, Hypoplastic
- What is being tested?
- TPX-115(allogeneic fibroblasts)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteSouth Korea
- Study dates
- 11 Dec 2024to Dec 2026
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
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- 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).
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Kyungpook National University, School of Medicine
Daegu, Jung-gu, 41944
About this study
Official title: A Single-center, Single Group, Dose Escalation, Phase 1 Clinical Trial to Investigate the Safety of TPX-121 in Subjects With Moderate-to-Extreme Nasolabial Folds
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.
- Conditions
- Nasolabial Fold, Hypoplastic
- Being tested
- TPX-115(allogeneic fibroblasts)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TPX-115(allogeneic fibroblasts)Biological
Intradermal injection of TPX-115(allogeneic fibroblasts)
| Study group | Role | What they receive |
|---|---|---|
| low dose | Experimental | Not described Receives: Biological: TPX-115(allogeneic fibroblasts) |
| middle dose | Experimental | Not described Receives: Biological: TPX-115(allogeneic fibroblasts) |
| high dose | Experimental | Not described Receives: Biological: TPX-115(allogeneic fibroblasts) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2024
- Study start11 Dec 2024
- Primary completionMar 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nasolabial Fold, HypoplasticStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 18 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tego Science, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Hoyun Chung, M.D., Principal investigator, Kyungpook National University, School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06533540
- Sponsor's protocol ID
- TG-TPX-121-23-01
- Status last verified
- Jul 2025
- First submitted
- 29 Jul 2024
- Last updated
- 22 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-center, Single Group, Dose Escalation, Phase 1 Clinical Trial to Investigate the Safety of TPX-121 in Subjects With Moderate-to-Extreme Nasolabial Folds
- ClinicalTrials.gov ID
- NCT06533540
- Acronym / sponsor ID
- TG-TPX-121-23-01
- Conditions
- Nasolabial Fold, Hypoplastic
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- Tego Science, Inc.Industry (pharma, biotech, devices)
- Study start
- 11 Dec 2024 (actual)
- Primary completion
- Mar 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 1 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| low dose | Experimental | Biological: TPX-115(allogeneic fibroblasts) |
| middle dose | Experimental | Biological: TPX-115(allogeneic fibroblasts) |
| high dose | Experimental | Biological: TPX-115(allogeneic fibroblasts) |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (28 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TPX-115(allogeneic fibroblasts)Intradermal injection of TPX-115(allogeneic fibroblasts) | Biological | high dose, low dose, middle dose |
Primary outcome
Dose-limiting toxicity
Time frame: Week 4
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2025.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hoyun Chung, M.D. principal investigator
Kyungpook National University, School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing TPX-115(allogeneic fibroblasts) in people with Nasolabial Fold, Hypoplastic, run by Tego Science, Inc. at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 28 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 22 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dose-limiting toxicity (time frame: Week 4). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2025; AzTrials last refreshed its copy on 8 Nov 2026.