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Clinical Trials in South Korea / NCT07265791
Active, not recruiting Not applicable

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

NCT07265791 · tracked via the Priya Life Science South Korea tracker
Sponsor
Jetema Co., Ltd
Phase
Not applicable
Started
2026-01-21
Last updated
2026-07-27

Condition(s) studied

Nasolabial Folds, Wrinkles

Investigational drug(s) / intervention(s)

JTM104Juvederm® ULTRA PLUS XC

JTM104: JTM104 contains 22.8 mg/mL cross-linked hyaluronic acid, 1.2 mg/mL hyaluronic acid, and 3 mg/mL lidocaine.

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.

Study summary

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

Eligibility

Sex
ALL
Min age
19 Years
Max age
75 Years
Healthy volunteers
No
Inclusion Criteria: * Adults aged 19 to 75 years * Voluntarily provided written informed consent * Moderate to severe symmetrical nasolabial folds (score 3 or 4 on a 5-point severity scale 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

Primary outcome measure(s)

  • AE — From adverse event onset through resolution or stabilization, up to 30 days post-study completion
    Continuous follow-up of adverse events until resolution, stabilization, or cause identification; includes 30-day follow-up after study completion if unresolved.
  • SAE — From adverse event onset through resolution or stabilization, up to 30 days post-study completion
    Continuous follow-up of adverse events until resolution, stabilization, or cause identification; includes 30-day follow-up after study completion if unresolved.
  • Solicited local AE — Within 2 weeks after device application
    Local adverse events occurring at the application site within 2 weeks after device use, including pain, swelling, redness, bruising, and other injection site reactions.

Trial sites (2)

FacilityCityRegionStatus
Dankook University Hospital Cheonan Chungcheongnam-do
Inje University Sanggye Paik Hospital Seoul South Korea

More Jetema Co., Ltd. trials in South Korea

Clinical Investigation for Evaluating the Safety and Efficacy of JTM102 to Mid Face Volume Deficiency Active, not recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07265791 on ClinicalTrials.gov ↗ ← All trials in South Korea