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NCT Number: NCT07265791

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

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

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Nasolabial Folds, Wrinkles

Age range

19 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dankook University Hospital, Cheonan, Chungcheongnam-do, South Korea

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About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

JTM104

Biological

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

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.

Primary outcomes

  1. AE

    Time frame: 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.

  2. SAE

    Time frame: 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.

  3. Solicited local AE

    Time frame: 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.

Other outcomes

  1. Lidocaine-Related AE

    Time frame: Within 30 minutes after device application

    Adverse events related to lidocaine occurring within 30 minutes after device application, including hypersensitivity, shock, and toxicity symptoms.

Sponsors and collaborators

Lead sponsor

Jetema Co., Ltd.

Industry

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2027
First posted
Dec 5, 2025
Registry last updated
Jul 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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