Clinical Investigation for Evaluating the Safety and Effi... | NCT07265778

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

NCT07265778

Sponsor

Jetema Co., Ltd.

Status

Active, not recruiting

Last Update Posted

Dec 5, 2025Actual

Enrollment

149Estimated

Phase

Not Applicable

Conditions

Mid Face Volume Deficit

Interventions

JTM102
Juvederm VOLUMA with Lidocaine

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2025

Overall Recruitment Status or Expanded Access Status

Active, not recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 22, 2024Actual

Primary Completion Date

Apr 30, 2026Estimated

Completion Date

Dec 31, 2026Estimated

First Submitted Date

Nov 24, 2025

First Submission Date that Met QC Criteria

Nov 24, 2025

First Posted Date

Dec 5, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 24, 2025

Last Update Posted Date

Dec 5, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

149Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
JTM102	Experimental	HA filler with lidocaine	Device: JTM102
Juverderm Voluma with Lidocaine	Active Comparator	HA filler with lidocaine	Device: Juvederm VOLUMA with Lidocaine

Interventions

Name	Type	Description	Arm Group Labels	Other Names
JTM102	Device	Sodium Hyaluronate 20mg/ml Lidocaine Hydrochloride 03.%	JTM102

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
MFVDS	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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

19 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided