Health TrialsbyHealthPanel

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

ConditionNasolabial Folds, Wrinkles
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age19-75
SponsorJetema Co., Ltd.

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • JTM104

    Biological/Vaccine

    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.

  • Juvederm® ULTRA PLUS XC

    Biological/Vaccine

    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.

Treatment groups

100 Participants
are divided into 2 treatment groups
Group A: JTM104Experimental treatment 1 intervention
Group B: Juvederm® ULTRA PLUS XCActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

AE

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

Time frame
From adverse event onset through resolution or stabilization, up to 30 days post-study completion
2

SAE

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

Time frame
From adverse event onset through resolution or stabilization, up to 30 days post-study completion
3

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.

Time frame
Within 2 weeks after device application

Secondary outcomes

Other outcomes

1

Lidocaine-Related AE

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

Time frame
Within 30 minutes after device application

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Jetema Co., Ltd.

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: