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

NCT07265778 | Active Not Recruiting

• 1 other identifier: JT-D-102-01
• Study Type: interventional
• Target: 149
• Locations: 1 country
• Sites: 1

Brief Summary

This study is clinical investigation for evaluating safety and efficacy of JTM102 on temporary correction of mid-face volume deficiency

Conditions

Mid Face Volume Deficit

Keywords

mid-face volume; HA filler

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

JTM102

EXPERIMENTAL

HA filler with lidocaine

Device: JTM102

Juverderm Voluma with Lidocaine

ACTIVE COMPARATOR

HA filler with lidocaine

Device: Juvederm VOLUMA with Lidocaine

Interventions

JTM102 DEVICE

Sodium Hyaluronate 20mg/ml Lidocaine Hydrochloride 03.%

JTM102

Juvederm VOLUMA with Lidocaine DEVICE

Sodium Hyaluronate 20mg/ml Lidocaine Hydrochloride 0.3%

Juverderm Voluma with Lidocaine

Eligibility Criteria

• Age: 19 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Jetema Co., Ltd.: lead

Study Sites (1)

Chungang University Hospital

Seoul, South Korea

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 24, 2025
• First Posted: December 5, 2025
• Study Start: October 22, 2024
• Primary Completion: April 30, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: December 5, 2025

Record last verified: 2025-08

Locations

KR (1)