Mid Face Volume DeficitNCT07265778
Clinical Investigation for Evaluating the Safety and Efficacy of JTM102 to Mid Face Volume Deficiency
A study testing JTM102 and Juvederm VOLUMA with Lidocaine in people with Mid Face Volume Deficit, run by Jetema Co., Ltd. at 1 site in South Korea.
Trial summary
This study is clinical investigation for evaluating safety and efficacy of JTM102 on temporary correction of mid-face volume deficiency Read more about this study
- Who is it for?
- Ages 19 to 65 years
- Conditions the study is for
- Mid Face Volume Deficit
- What is being tested?
- JTM102 and Juvederm VOLUMA with Lidocaine
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 149 participants
- Where
- 1 siteSouth Korea
- Study dates
- 22 Oct 2024to 27 Feb 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects who voluntarily agree to participate in this clinical trial.
- Adults aged 19 to 65 years.
- Subjects who desire temporary improvement of mid-face volume and whose Mid-face volume deficit level meets eligibility criteria
- Subjects who agree to discontinue all dermatological treatments or procedures for the face during the clinical trial period, including wrinkle improvement treatments such as fillers, botulinum toxin, laser therapy, chemical peels, and cosmetic surgeries, except for the investigational medical device application.
- Subjects who use medically acceptable contraception methods throughout the clinical trial period (pregnant or breastfeeding women are excluded).
- Subjects who understand and can comply with the study instructions and can participate for the entire duration of the clinical trial.
Who cannot join
- History or concurrent conditions included in exclusion criteria
- History of procedures (including surgery) included in exclusion criteria
- Use of medications that may affect evaluation of the investigational device:
- Any other conditions judged by the investigator as inappropriate for participation in this clinical trial.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Multicenter, Randomized, Subject & Independent Evaluator-blind, Split-face, Medical Device Pivotal Study to Evaluate the Efficacy and Safety of Injection With JTM102 as Compared to Juvederm VOLUMA With Lidocaine for Temporary Restoring the Mid-face Volume
This study is clinical investigation for evaluating safety and efficacy of JTM102 on temporary correction of mid-face volume deficiency
Read the detailed description
This study is Multicenter, Randomized, Subject \& Independent Evaluator-blind, Split-face, Medical Device Pivotal study to evaluate the efficacy and safety of injection with JTM102 as compared to Juvederm VOLUMA with Lidocaine for temporary restoring the mid-face volume
- Conditions
- Mid Face Volume Deficit
- Being tested
- JTM102, Juvederm VOLUMA with Lidocaine
- Keywords
- mid-face volume, HA filler
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JTM102Device
Sodium Hyaluronate 20mg/ml Lidocaine Hydrochloride 03.%
Juvederm VOLUMA with LidocaineDevice
Sodium Hyaluronate 20mg/ml Lidocaine Hydrochloride 0.3%
| Study group | Role | What they receive |
|---|---|---|
| JTM102 | Experimental | HA filler with lidocaine Receives: Device: JTM102 |
| Juverderm Voluma with Lidocaine | Active comparator | HA filler with lidocaine Receives: Device: Juvederm VOLUMA with Lidocaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement in midface volume
Facial volume deficiency was graded using 6-point Facial Midvolume Measuring Scale with higher scores indicating greater severity of gauntness. The proportion of subjects whose score decreased from baseline, as assessed by independent photographic evaluators, was calculated.
Measured: 24 weeks after final application of the investigational medical device
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 start22 Oct 2024
- Primary completion30 Dec 2026 (estimated)
- Study completion27 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mid Face Volume DeficitStudies 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
- 149 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
- NCT07265778
- Sponsor's protocol ID
- JT-D-102-01
- Status last verified
- Aug 2025
- First submitted
- 24 Nov 2025
- Last updated
- 24 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter, Randomized, Subject & Independent Evaluator-blind, Split-face, Medical Device Pivotal Study to Evaluate the Efficacy and Safety of Injection With JTM102 as Compared to Juvederm VOLUMA With Lidocaine for Temporary Restoring the Mid-face Volume
- ClinicalTrials.gov ID
- NCT07265778
- Acronym / sponsor ID
- JT-D-102-01
- Conditions
- Mid Face Volume Deficit
- Keywords
- mid-face volume, HA filler
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 149 participants (estimated)
- Lead sponsor
- Jetema Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 22 Oct 2024 (actual)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 27 Feb 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.
This study is clinical investigation for evaluating safety and efficacy of JTM102 on temporary correction of mid-face volume deficiency
Detailed description
This study is Multicenter, Randomized, Subject \& Independent Evaluator-blind, Split-face, Medical Device Pivotal study to evaluate the efficacy and safety of injection with JTM102 as compared to Juvederm VOLUMA with Lidocaine for temporary restoring the mid-face volume
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| JTM102 | Experimental | Device: JTM102HA filler with lidocaine |
| Juverderm Voluma with Lidocaine | Active comparator | Device: Juvederm VOLUMA with LidocaineHA filler with lidocaine |
Who may qualify
- Ages
- 19 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Subjects who voluntarily agree to participate in this clinical trial.
- Adults aged 19 to 65 years.
- Subjects who desire temporary improvement of mid-face volume and whose Mid-face volume deficit level meets eligibility criteria
- Subjects who agree to discontinue all dermatological treatments or procedures for the face during the clinical trial period, including wrinkle improvement treatments such as fillers, botulinum toxin, laser therapy, chemical peels, and cosmetic surgeries, except for the investigational medical device application.
- Subjects who use medically acceptable contraception methods throughout the clinical trial period (pregnant or breastfeeding women are excluded).
Key exclusion criteria (4 listed)
- History or concurrent conditions included in exclusion criteria
- History of procedures (including surgery) included in exclusion criteria
- Use of medications that may affect evaluation of the investigational device:
- Any other conditions judged by the investigator as inappropriate for participation in this clinical trial.
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 |
|---|---|---|
| JTM102Sodium Hyaluronate 20mg/ml Lidocaine Hydrochloride 03.% | Device | JTM102 |
| Juvederm VOLUMA with LidocaineSodium Hyaluronate 20mg/ml Lidocaine Hydrochloride 0.3% | Device | Juverderm Voluma with Lidocaine |
Primary outcome
Improvement in midface volume
Time frame: 24 weeks after final application of the investigational medical device
Facial volume deficiency was graded using 6-point Facial Midvolume Measuring Scale with higher scores indicating greater severity of gauntness. The proportion of subjects whose score decreased from baseline, as assessed by independent photographic evaluators, was calculated.
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 24 Jul 2026.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing JTM102 and Juvederm VOLUMA with Lidocaine in people with Mid Face Volume Deficit, run by Jetema Co., Ltd. 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 6 inclusion and 4 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 24 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 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.
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?
Improvement in midface volume (time frame: 24 weeks after final application of the investigational medical device). 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 24 Jul 2026.