A Safety and Efficacy Study of JUVÉDERM® VOLIFT® With Lidocaine and Restylane® for Nasolabial Folds in Chinese Adults

Study Overview
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Brief Summary
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This is a safety and efficacy study of JUVÉDERM® VOLIFT® with Lidocaine and Restylane® in Chinese adults with nasolabial folds.

Official Title
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A Safety and Efficacy Study of JUVÉDERM® VOLIFT® With Lidocaine and Restylane® for Nasolabial Folds in Chinese Adults

Conditions
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Nasolabial Fold

Intervention / Treatment
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* Device: JUVÉDERM® VOLIFT® with Lidocaine
* Device: Restylane®


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Presence of nasolabial folds Agree to refrain from treatment with other anti-wrinkle/volumizers below the eye for the duration of the study Exclusion Criteria: Ever received semi-permanent fillers or permanent facial implants below the eyes, or plans to receive these treatments during the study Undergone temporary dermal filler treatment (eg, hyaluronic acid or collagen) below the eyes within 12 months, or plans to undergo these treatments during the study Undergone facial tissue augmentation with fat injections, botulinum toxin injections, mesotherapy, or cosmetic facial procedures in the face or neck within 6 months, or plans to undergo these treatments during the study

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: JUVÉDERM® VOLIFT® with Lidocaine - Right Side<br>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. | Device: JUVÉDERM® VOLIFT® with Lidocaine<br>* JUVÉDERM® VOLIFT® with lidocaine injected into the nasolabial fold on Day 1, with optional touch-up injections into the nasolabial fold on Month 1.<br>|
| Active Comparator: Restylane® - Right Side<br>Restylane® injected into the right nasolabial fold on Day 1, with optional touch-up injections into the right nasolabial fold on Month 1. | Device: Restylane®<br>* Restylane® injected into the nasolabial fold on Day 1, with optional touch-up injections into the nasolabial fold on Month 1.<br>|
| Experimental: JUVÉDERM® VOLIFT® with Lidocaine - Left Side<br>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. | Device: JUVÉDERM® VOLIFT® with Lidocaine<br>* JUVÉDERM® VOLIFT® with lidocaine injected into the nasolabial fold on Day 1, with optional touch-up injections into the nasolabial fold on Month 1.<br>|
| Active Comparator: Restylane® - Left Side<br>Restylane® injected into the left nasolabial fold on Day 1, with optional touch-up injections into the left nasolabial fold on Month 1. | Device: Restylane®<br>* Restylane® injected into the nasolabial fold on Day 1, with optional touch-up injections into the nasolabial fold on Month 1.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Investigator's Assessment of Severity of Each Nasolabial Fold (NLF) on the 5-Point NLF Severity Scale (NLFSS) |  | Month 6 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 
| Subject's Assessment of Each NLF on the 5-Point GAIS |  | Month 6 |