Study of JTM104 Injection vs. Juvederm in Treating Moderate to Severe Nasolabial Folds

NCT07265791 | Not Yet Recruiting DMC

• 1 other identifier: JT-D-104-01
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief Summary

Study of JTM104 Injection vs. Juvederm in Treating Moderate to Severe Nasolabial Folds

Conditions

Nasolabial Folds, Wrinkles

Outcome Measures

Primary Outcomes (3)

• AE

  Continuous follow-up of adverse events until resolution, stabilization, or cause identification; includes 30-day follow-up after study completion if unresolved.

  From adverse event onset through resolution or stabilization, up to 30 days post-study completion

• SAE

  Continuous follow-up of adverse events until resolution, stabilization, or cause identification; includes 30-day follow-up after study completion if unresolved.

  From adverse event onset through resolution or stabilization, up to 30 days post-study completion

• Solicited local AE

  Local adverse events occurring at the application site within 2 weeks after device use, including pain, swelling, redness, bruising, and other injection site reactions.

  Within 2 weeks after device application

Other Outcomes (1)

• Lidocaine-Related AE

  Within 30 minutes after device application

Study Arms (2)

JTM104

EXPERIMENTAL

HA Filler

Biological: JTM104

Juvederm® ULTRA PLUS XC

ACTIVE COMPARATOR

HA Filler

Biological: Juvederm® ULTRA PLUS XC

Interventions

JTM104 BIOLOGICAL

JTM104 contains 22.8 mg/mL cross-linked hyaluronic acid, 1.2 mg/mL hyaluronic acid, and 3 mg/mL lidocaine. The product will be injected into the nasolabial folds, with a maximum volume of 1 mL per side.

JTM104

Juvederm® ULTRA PLUS XC BIOLOGICAL

Juvederm® ULTRA PLUS XC contains 22.8 mg/mL cross-linked hyaluronic acid, 1.2 mg/mL hyaluronic acid, and 3 mg/mL lidocaine. The product will be injected into the nasolabial folds, with a maximum volume of 1 mL per side.

Juvederm® ULTRA PLUS XC

Eligibility Criteria

• Age: 19 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults aged 19 to 75 years
• Voluntarily provided written informed consent
• Moderate to severe symmetrical nasolabial folds (WSRS score 3 or 4 on both sides)
• Agree to discontinue other facial dermatologic treatments (e.g., fillers, botulinum toxin, laser) during the study
• Able to understand instructions and comply with study procedures

You may not qualify if:

• Untreated scars or facial skin infections/diseases affecting the mid/lower face within the past year
• History of severe allergy or hypersensitivity to device components
• Facial invasive procedures within the past 6 months (including surgery, laser, botulinum toxin)
• Use of certain medications (anticoagulants, immunosuppressants, steroids) within specified washout periods
• Participation in other interventional clinical trials within 4 weeks before screening or during study
• Non-compliance with contraception requirements or pregnancy/lactation during study
• Deemed unsuitable by investigator for any other reason

Sponsors & Collaborators

• Jetema Co., Ltd.: lead

Central Study Contacts

Jetema_clinical

CONTACT

+820317889520; joohee@jetema.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, 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: January 3, 2026
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): January 31, 2027
• Last Updated: December 5, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share