Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This is a safety and efficacy study of JUVÉDERM® VOLIFT® with Lidocaine and Restylane® in Chinese adults with nasolabial folds.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| JUVÉDERM® VOLIFT® with Lidocaine - Right Side | Experimental | JUVÉDERM® VOLIFT® with lidocaine injected into the right nasolabial fold on Day 1, with optional touch-up injections into the right nasolabial fold on Month 1. |
|
| Restylane® - Right Side | Active Comparator | Restylane® injected into the right nasolabial fold on Day 1, with optional touch-up injections into the right nasolabial fold on Month 1. |
|
| JUVÉDERM® VOLIFT® with Lidocaine - Left Side | Experimental | JUVÉDERM® VOLIFT® with lidocaine injected into the left nasolabial fold on Day 1, with optional touch-up injections into the left nasolabial fold on Month 1. |
|
| Restylane® - Left Side | Active Comparator | Restylane® injected into the left nasolabial fold on Day 1, with optional touch-up injections into the left nasolabial fold on Month 1. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| JUVÉDERM® VOLIFT® with Lidocaine | Device | JUVÉDERM® VOLIFT® with lidocaine injected into the nasolabial fold on Day 1, with optional touch-up injections into the nasolabial fold on Month 1. |
| Measure | Description | Time Frame |
|---|---|---|
| Investigator's Assessment of Severity of Each Nasolabial Fold (NLF) on the 5-Point NLF Severity Scale (NLFSS) | Month 6 |
| Measure | Description | Time Frame |
|---|---|---|
| Subject's Assessment of Procedural Pain on an 11-Point Scale | Day 1 | |
| Investigator's Assessment of Each NLF on the 5-Point Global Aesthetic Improvement Scale (GAIS) | Month 6 | |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Yi Jia | Allergan | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| China Japan Friendship Hospital | Beijing | China | ||||
| Peking University Third Hospital |
Not provided
Not provided
Not provided
Not provided
Not provided
| Restylane® | Device | Restylane® injected into the nasolabial fold on Day 1, with optional touch-up injections into the nasolabial fold on Month 1. |
|
| Subject's Assessment of Each NLF on the 5-Point GAIS |
| Month 6 |
| Beijing |
| China |
| General Hospital of Guangzhou Military Command of PLA | Guangzhou | China |
| Union Hospital Tongji Medical College Huazhong University of Science and Technology | Guangzhou | China |
| Shanghai 9th Hospital | Shanghai | China |