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

Multicenter, Randomized, Subject & Independent Evaluator-blind, Matched Pairs, Active-controlled, Non-inferiority, Pivotal Study to Evaluate the Efficacy and Safety of Injection With JTM104 as Compared to Juvederm® ULTRA PLUS XC in Temporary Correction of Moderate to Severe Nasolabial Folds

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

Study Overview

• Status: Not yet recruiting
• Conditions: Nasolabial Folds, Wrinkles
• Intervention / Treatment: Biological: JTM104; Biological: Juvederm® ULTRA PLUS XC

Detailed Description

Multicenter, Randomized, Subject & Independent Evaluator-blind, Matched pairs, Active-controlled, Non-inferiority, Pivotal study to evaluate the Efficacy and Safety of Injection with JTM104 as Compared to Juvederm® ULTRA PLUS XC in temporary correction of Moderate to Severe Nasolabial folds

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jetema_clinical; Phone Number: +820317889520; Email: joohee@jetema.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: JTM104; HA Filler	Biological: JTM104; 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.
Active Comparator: Juvederm® ULTRA PLUS XC; HA Filler	Biological: Juvederm® ULTRA PLUS XC; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Lidocaine-Related AE	Adverse events related to lidocaine occurring within 30 minutes after device application, including hypersensitivity, shock, and toxicity symptoms.	Within 30 minutes after device application

Collaborators and Investigators

• Sponsor: Jetema Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Estimated): January 3, 2026
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): January 31, 2027

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: November 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: JT-D-104-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No