Postmarket Study of JUVÉDERM VOLBELLA™ With Lidocaine in the Lips

Study Overview
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Brief Summary
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A prospective, multicenter postmarket study of the use of JUVÉDERM VOLBELLA™ with Lidocaine in the lips.

Conditions
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Lip Augmentation

Intervention / Treatment
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* Device: Crosslinked hyaluronic acid gel


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Desire and willingness for correction of asymmetry or volume enhancement of his/her lips Females and males ≥ 18 years of age Have established a realistic treatment goal that the Physician agrees is achievable, i.e., have realistic expectations of aesthetic results Exclusion Criteria: Not fulfilling the standard prescribing criteria for JUVÉDERM VOLBELLA™ with Lidocaine as detailed in the Directions for Use Have a condition or be in a situation that, in the Physician's opinion, may put the subject at significant risk, may confound the study results, or may interfere significantly with the subject's participation in 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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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Volbella<br>Subjects treated with JUVÉDERM VOLBELLA™ according to the physician's experience and Directions for Use | Device: Crosslinked hyaluronic acid gel<br>* All treatments are carried out according to the physician's experience and the Directions for Use<br>* Other names: JUVÉDERM VOLBELLA™;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subject Rating of the Natural Look and Feel of the Lips | Percentage of subjects rating the look and feel of their lips as being extremely natural, very natural, slightly natural, and not natural. | 4 weeks | 
| Injector Rating of the Natural Look and Feel of the Lips | Percentage of injectors who rated the look and feel of subjects' lips as being extremely natural, very natural, slightly natural, and not natural. | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bruising of the Lips | Injector assessment of whether there was none, little, some, moderate, or considerable bruising in subjects' lips | 15 minutes after injection | 
| Swelling of the Lips | Injector assessment of whether there was none, little, some, moderate, or considerable swelling in subjects' lips | 15 minutes after injection | 
| Ease of Injection | Injectors rated the ease of injection on a scale ranging from 0 (Very easy) to 10 (Extremely difficult) | 15 minutes after injection | 
| Malleability of Product | Injectors rated the malleability on a scale ranging from 0 (Extremely malleable/Not hard to mold) to 10 (Not malleable/Hard to mold) | 15 minutes after injection | 
| Need for Massage | Injectors rated whether none/minimal, a little, some, or a lot of massage was required to optimize placement of VOLBELLA | 15 minutes after injection | 
| Return to Social Engagement | Time to return to normal daily activities | 4 weeks | 
| Comparative Rating With Previous Treatment | Subject rating of lip improvement with VOLBELLA compared with previous lip enhancement treatments as significantly better, somewhat better, no difference, somewhat worse, or significantly worse | 15 minutes after injection | 
| Rating of Injection Discomfort | The level of discomfort during treatment on a scale of 0 (no discomfort) to 10 (extreme discomfort). | 15 minutes after injection |