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

November 24, 2025 updated by: Jetema Co., Ltd.

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

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

149

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • South Korea
      • Seoul, South Korea
        • Chungang University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Scale (MFVDS, 5-point scale) score for the mid-face volume restoration 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:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: JTM102
HA filler with lidocaine
Device: JTM102
Sodium Hyaluronate 20mg/ml Lidocaine Hydrochloride 03.%
Active Comparator: Juverderm Voluma with Lidocaine
HA filler with lidocaine
Device: Juvederm VOLUMA with Lidocaine
Sodium Hyaluronate 20mg/ml Lidocaine Hydrochloride 0.3%

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
MFVDS
Time Frame: 24 weeks after final application of the investigational medical device
Improvement rate in the Mid-Face Volume Deficit Scale (MFVDS), as assessed by independent photographic evaluators, compared to baseline.
24 weeks after final application of the investigational medical device

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jetema Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 22, 2024

Primary Completion (Estimated)

April 30, 2026

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

November 24, 2025

First Submitted That Met QC Criteria

November 24, 2025

First Posted (Actual)

December 5, 2025

Study Record Updates

Last Update Posted (Actual)

December 5, 2025

Last Update Submitted That Met QC Criteria

November 24, 2025

Last Verified

August 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • JT-D-102-01

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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