Tear Trough Eyelid DeformityPhase 3NCT06197789
Safety and Efficacy Study of TPX-105 for Correction of Nasojugal Groove
A Phase 3 study testing TPX-105 in people with Tear Trough Eyelid Deformity, run by Tego Science, Inc. at 4 sites in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 years and olderHealthy volunteers can take part
- Conditions the study is for
- Tear Trough Eyelid Deformity
- What is being tested?
- TPX-105
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 4 sitesSouth Korea
- Study dates
- 18 Aug 2021to 18 Oct 2023
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.)
Show all 26Show fewer
- 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.)
Trial locations and contacts
4 sites in 1 country.
South Korea4 sites
Soonchunhyang University Hospital Bucheon
Bucheon-si, 14584
Kyungpook National University Hospital
Daegu, 41944
The Catholic University of Korea, Seoul ST. Mary's Hospital
Seoul, 06591
Korea University Guro Hospital
Seoul, 08308
About this study
Official title: 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.
- Conditions
- Tear Trough Eyelid Deformity
- Being tested
- TPX-105, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TPX-105Biological
Also called Autologous human dermal fibroblasts
Subjects will be administered with autologous fibroblasts through injection
PlaceboBiological
Subjects will be administered with Placebo through injection
| Study group | Role | What they receive |
|---|---|---|
| TPX-105 | Experimental | Autologous human dermal fibroblasts Receives: Biological: TPX-105 |
| Placebo | Sham comparator | Suspension media Receives: Biological: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 24 weeks
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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)
Measured: 4, 12, 24, 48 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2024
- Study start18 Aug 2021
- Primary completion5 Jun 2023
- Study completion18 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tear Trough Eyelid DeformityStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tego Science, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ho-yun Jun, Principal investigator, Kyungpook National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06197789
- Sponsor's protocol ID
- TG-TPX-105-18-02
- Status last verified
- Dec 2023
- First submitted
- 17 May 2023
- Last updated
- 9 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06197789
- Acronym / sponsor ID
- TG-TPX-105-18-02
- Conditions
- Tear Trough Eyelid Deformity
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Tego Science, Inc.Industry (pharma, biotech, devices)
- Study start
- 18 Aug 2021 (actual)
- Primary completion
- 5 Jun 2023 (actual)
- Study completion
- 18 Oct 2023 (actual)
- First posted
- 9 Jan 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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TPX-105 | Experimental | Biological: TPX-105Autologous human dermal fibroblasts |
| Placebo | Sham comparator | Biological: PlaceboSuspension media |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (26 listed)
- 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)
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-105Also: Autologous human dermal fibroblastsSubjects will be administered with autologous fibroblasts through injection | Biological | TPX-105 |
| PlaceboSubjects will be administered with Placebo through injection | Biological | Placebo |
Primary outcome
Improvement Rate from Baseline
Time frame: 24 weeks
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
3 secondary outcomes
Improvement Rate from Baseline
Time frame: 4, 12 weeks
Severity Grade Change from Baseline
Time frame: 4, 12, 24 weeks
Overall Appearance Improvement Percentage (%)
Time frame: 4, 12, 24, 48 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2024.
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.
Ho-yun Jun principal investigator
Kyungpook National University Hospital
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing TPX-105 in people with Tear Trough Eyelid Deformity, run by Tego Science, Inc. at 4 sites 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 5 inclusion and 26 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: finished, as of the sponsor's last update on 9 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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. Some participants in this study may receive a placebo. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Improvement Rate from Baseline (time frame: 24 weeks). 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 9 Jan 2024.