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Active, not recruitingNCT07265778Updated Jul 24, 2026

Clinical Investigation for Evaluating the Safety and Efficacy of JTM102 to Mid Face Volume Deficiency

An interventional study of JTM102 and Juvederm VOLUMA with Lidocaine in Mid Face Volume Deficit, sponsored by Jetema Co., Ltd.. Active, not recruiting at 1 site in South Korea. Open to participants aged 19 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-07-24.

Sponsored by Jetema Co., Ltd. · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 1 year 1 month after the study started (first participant enrolled Oct 2024, registered Nov 2025).
Phase
Not applicable
Study type
Interventional
Enrollment
149
Allocation
Randomized
Ages
19 Years to 65 Years
Sex
All
01

Study summary

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

02

Conditions studied

  • Mid Face Volume Deficit

Keywords

  • mid-face volume
  • HA filler
03

In context

Lead sponsor

Jetema Co., Ltd. is the lead sponsor of 4 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
19 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • 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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
149 participants (estimated)

Study arms

  • Experimental
    JTM102

    HA filler with lidocaine

    Device: JTM102

  • Active comparator
    Juverderm Voluma with Lidocaine

    HA filler with lidocaine

    Device: Juvederm VOLUMA with Lidocaine

Interventions

  • DeviceJTM102

    Sodium Hyaluronate 20mg/ml Lidocaine Hydrochloride 03.%

  • DeviceJuvederm VOLUMA with Lidocaine

    Sodium Hyaluronate 20mg/ml Lidocaine Hydrochloride 0.3%

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 24 weeks after final application of the investigational medical device

07

Study locations

1 site
  • Chungang University Hospital
    Seoul, South Korea
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 24, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07265778
Lead sponsor
Jetema Co., Ltd.
Responsible party
Sponsor
First posted
Dec 5, 2025
Start date
Oct 22, 2024
Primary completion
Dec 30, 2026 (estimated)
Completion
Feb 27, 2027 (estimated)
Last update
Jul 24, 2026

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Aug 2025. You cannot join it, but the record below documents what was studied.

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Discussion

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Other studies from this sponsor

Jetema Co., Ltd.

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