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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
100
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 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.
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
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
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
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