Nasolabial Folds, WrinklesNCT07265791
Study of JTM104 Injection vs. Juvederm in Treating Moderate to Severe Nasolabial Folds
A study testing JTM104 and Juvederm® ULTRA PLUS XC in people with Nasolabial Folds, Wrinkles, run by Jetema Co., Ltd. at 2 sites in South Korea.
Trial summary
Study of JTM104 Injection vs. Juvederm in Treating Moderate to Severe Nasolabial Folds Read more about this study
- Who is it for?
- Ages 19 to 75 years
- Conditions the study is for
- Nasolabial Folds, Wrinkles
- What is being tested?
- JTM104 and Juvederm® ULTRA PLUS XC
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 2 sitesSouth Korea
- Study dates
- 21 Jan 2026to 31 Jan 2027
- Phase
- Interventional
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults aged 19 to 75 years
- Voluntarily provided written informed consent
- Moderate to severe symmetrical nasolabial folds (score 3 or 4 on a 5-point severity scale on both sides)
- Agree to discontinue other facial dermatologic treatments (e.g., fillers, botulinum toxin, laser) during the study
- Able to understand instructions and comply with study procedures
Who cannot join
- Untreated scars or facial skin infections/diseases affecting the mid/lower face within the past year
- History of severe allergy or hypersensitivity to device components
- Facial invasive procedures within the past 6 months (including surgery, laser, botulinum toxin)
- Use of certain medications (anticoagulants, immunosuppressants, steroids) within specified washout periods
- Participation in other interventional clinical trials within 4 weeks before screening or during study
- Non-compliance with contraception requirements or pregnancy/lactation during study
- Deemed unsuitable by investigator for any other reason
Trial locations and contacts
2 sites in 1 country.
South Korea2 sites
Dankook University Hospital
Cheonan, Chungcheongnam-do
Inje University Sanggye Paik Hospital
Seoul
About this study
Official title: Multicenter, Randomized, Subject & Independent Evaluator-blind, Matched Pairs, Active-controlled, Non-inferiority, Pivotal Study to Evaluate the Efficacy and Safety of Injection With JTM104 as Compared to Juvederm® ULTRA PLUS XC in Temporary Correction of Moderate to Severe Nasolabial Folds
Study of JTM104 Injection vs. Juvederm in Treating Moderate to Severe Nasolabial Folds
Read the detailed description
Multicenter, Randomized, Subject \& Independent Evaluator-blind, Matched pairs, Active-controlled, Non-inferiority, Pivotal study to evaluate the Efficacy and Safety of Injection with JTM104 as Compared to Juvederm® ULTRA PLUS XC in temporary correction of Moderate to Severe Nasolabial folds
- Conditions
- Nasolabial Folds, Wrinkles
- Being tested
- JTM104, Juvederm® ULTRA PLUS XC
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JTM104Biological
JTM104 contains 22.8 mg/mL cross-linked hyaluronic acid, 1.2 mg/mL hyaluronic acid, and 3 mg/mL lidocaine.
Juvederm® ULTRA PLUS XCBiological
Juvederm® ULTRA PLUS XC contains 22.8 mg/mL cross-linked hyaluronic acid, 1.2 mg/mL hyaluronic acid, and 3 mg/mL lidocaine.
| Study group | Role | What they receive |
|---|---|---|
| JTM104 | Experimental | HA Filler Receives: Biological: JTM104 |
| Juvederm® ULTRA PLUS XC | Active comparator | HA Filler Receives: Biological: Juvederm® ULTRA PLUS XC |
What is being measured
The primary outcome is the main question the study is designed to answer.
AE
Continuous follow-up of adverse events until resolution, stabilization, or cause identification; includes 30-day follow-up after study completion if unresolved.
Measured: From adverse event onset through resolution or stabilization, up to 30 days post-study completion
SAE
Continuous follow-up of adverse events until resolution, stabilization, or cause identification; includes 30-day follow-up after study completion if unresolved.
Measured: From adverse event onset through resolution or stabilization, up to 30 days post-study completion
Solicited local AE
Local adverse events occurring at the application site within 2 weeks after device use, including pain, swelling, redness, bruising, and other injection site reactions.
Measured: Within 2 weeks after device application
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2025
- Study start21 Jan 2026
- Primary completion30 Nov 2026 (estimated)
- Study completion31 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nasolabial Folds, WrinklesStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jetema Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07265791
- Sponsor's protocol ID
- JT-D-104-01
- Status last verified
- Jul 2026
- First submitted
- 24 Nov 2025
- Last updated
- 27 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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 27 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter, Randomized, Subject & Independent Evaluator-blind, Matched Pairs, Active-controlled, Non-inferiority, Pivotal Study to Evaluate the Efficacy and Safety of Injection With JTM104 as Compared to Juvederm® ULTRA PLUS XC in Temporary Correction of Moderate to Severe Nasolabial Folds
- ClinicalTrials.gov ID
- NCT07265791
- Acronym / sponsor ID
- JT-D-104-01
- Conditions
- Nasolabial Folds, Wrinkles
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Jetema Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 21 Jan 2026 (actual)
- Primary completion
- 30 Nov 2026 (estimated)
- Study completion
- 31 Jan 2027 (estimated)
- First posted
- 5 Dec 2025 (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.
Study of JTM104 Injection vs. Juvederm in Treating Moderate to Severe Nasolabial Folds
Detailed description
Multicenter, Randomized, Subject \& Independent Evaluator-blind, Matched pairs, Active-controlled, Non-inferiority, Pivotal study to evaluate the Efficacy and Safety of Injection with JTM104 as Compared to Juvederm® ULTRA PLUS XC in temporary correction of Moderate to Severe Nasolabial folds
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| JTM104 | Experimental | Biological: JTM104HA Filler |
| Juvederm® ULTRA PLUS XC | Active comparator | Biological: Juvederm® ULTRA PLUS XCHA Filler |
Who may qualify
- Ages
- 19 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adults aged 19 to 75 years
- Voluntarily provided written informed consent
- Moderate to severe symmetrical nasolabial folds (score 3 or 4 on a 5-point severity scale on both sides)
- Agree to discontinue other facial dermatologic treatments (e.g., fillers, botulinum toxin, laser) during the study
- Able to understand instructions and comply with study procedures
Key exclusion criteria (7 listed)
- Untreated scars or facial skin infections/diseases affecting the mid/lower face within the past year
- History of severe allergy or hypersensitivity to device components
- Facial invasive procedures within the past 6 months (including surgery, laser, botulinum toxin)
- Use of certain medications (anticoagulants, immunosuppressants, steroids) within specified washout periods
- Participation in other interventional clinical trials within 4 weeks before screening or during study
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 |
|---|---|---|
| JTM104JTM104 contains 22.8 mg/mL cross-linked hyaluronic acid, 1.2 mg/mL hyaluronic acid, and 3 mg/mL lidocaine. | Biological | JTM104 |
| Juvederm® ULTRA PLUS XCJuvederm® ULTRA PLUS XC contains 22.8 mg/mL cross-linked hyaluronic acid, 1.2 mg/mL hyaluronic acid, and 3 mg/mL lidocaine. | Biological | Juvederm® ULTRA PLUS XC |
Primary outcome
AE
Time frame: From adverse event onset through resolution or stabilization, up to 30 days post-study completion
Continuous follow-up of adverse events until resolution, stabilization, or cause identification; includes 30-day follow-up after study completion if unresolved.
SAE
Time frame: From adverse event onset through resolution or stabilization, up to 30 days post-study completion
Continuous follow-up of adverse events until resolution, stabilization, or cause identification; includes 30-day follow-up after study completion if unresolved.
Solicited local AE
Time frame: Within 2 weeks after device application
Local adverse events occurring at the application site within 2 weeks after device use, including pain, swelling, redness, bruising, and other injection site reactions.
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 27 Jul 2026.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing JTM104 and Juvederm® ULTRA PLUS XC in people with Nasolabial Folds, Wrinkles, run by Jetema Co., Ltd. at 2 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 7 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 27 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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?
AE (time frame: From adverse event onset through resolution or stabilization, up to 30 days post-study completion). The study lists 3 primary outcomes in all. 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 27 Jul 2026.