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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| JTM104 | Experimental | HA Filler |
|
| Juvederm® ULTRA PLUS XC | Active Comparator | HA Filler |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| JTM104 | Biological | 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. |
| 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 |
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| 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 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jetema_clinical | Contact | +820317889520 | joohee@jetema.com |
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| 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. The product will be injected into the nasolabial folds, with a maximum volume of 1 mL per side. |
|