Safety and Effectiveness of Juvéderm® Volbella With Lidocaine Versus Restylane-L® for Lip Volume Enhancement

Study Overview
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Brief Summary
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The purpose of this study is evaluate lip fullness 3 months following treatment with Juvéderm® Volbella with Lidocaine or Restylane-L®

Conditions
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Lip Volume Enhancement

Intervention / Treatment
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* Device: Juvéderm® Volbella with Lidocaine
* Device: Restylane-L®


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Desire enhancement of his/her vermilion borders and/or vermilion mucosa Have a baseline score of Minimal or Mild, as assessed by the Investigator, according to the 5-point LFS (Minimal, Mild, Moderate, Marked, Very Marked) Have established a realistic Lip Fullness treatment goal that the Investigator agrees is achievable Exclusion Criteria: Have undergone cosmetic facial, lip or perioral procedures [e.g., face-lift, or other surgeries, which may alter the appearance of the lips or perioral area (laser, photomodulation, intense pulsed light, radio frequency, dermabrasion, moderate or greater depth chemical peel, or other ablative procedures), tissue augmentation with dermal fillers or fat injections, or mesotherapy] anywhere in the face or neck, or Botox® Cosmetic injections in the lower face (below the orbital rim), within 6 months prior to entry in the study or be planning to undergo any of these procedures at any time during the study. NOTE: Prior treatment with HA fillers and/or collagen is allowed, provided the treatment was administered more than 6 months prior to study entry Have ever received semi-permanent fillers or permanent facial implants, e.g., calcium hydroxyapatite, L-polylactic acid, polymethylmethacrylate (PMMA), silicone, expanded polytetrafluoroethylene (ePTFE) anywhere in the lips, or be planning to be implanted with any of these products at any time 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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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Juvéderm® Volbella with Lidocaine<br>Subjects injected with Juvéderm® Volbella with Lidocaine in their lips | Device: Juvéderm® Volbella with Lidocaine<br>* Up to 4.0 mL at the discretion of the Investigator to achieve optimal results<br>|
| Active Comparator: Restylane-L®<br>Subjects injected with Restylane-L® in their lips | Device: Restylane-L®<br>* Up to 4.0 mL at the discretion of the Investigator to achieve optimal results<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Month 3 Overall Lip Fullness Scale Responder Rate Based on Independent Central Reviewer's Assessment | The primary effectiveness variable is the responder rate (percentage of subjects who show ≥ 1-point improvement on the 5-point Lip Fullness Scale (Minimal, Mild, Moderate, Marked, Very Marked) compared to baseline assessment, as determined by Independent Central Reviewer evaluation of 3D photographic images). | 3 months |