Postmarket Study of JUVÉDERM VOLBELLA™ With Lidocaine in the Lips

Completed

• Conditions: Lip Augmentation
• Interventions: Device: Crosslinked hyaluronic acid gel

• Registration Number: NCT01629134
• Lead Sponsor: Allergan Medical

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2012-06
• Study First Submitted: 2012-06-25
• Study First Submitted QC: 2012-06-26
• Study First Posted: 2012-06-27
• Primary Completion: 2012-12
• Study Completion: 2012-12
• Results First Submitted: 2013-03-21
• Results First Submitted QC: 2013-03-21
• Results First Posted: 2013-05-14
• Status Verified: 2014-10
• Last Update Submitted: 2014-10-03
• Last Update Posted: 2014-10-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 62

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Volbella	Crosslinked hyaluronic acid gel	Subjects treated with JUVÉDERM VOLBELLA™ according to the physician's experience and Directions for Use

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Ease of Injection	15 minutes after injection	Injectors rated the ease of injection on a scale ranging from 0 (Very easy) to 10 (Extremely difficult)
Bruising of the Lips	15 minutes after injection	Injector assessment of whether there was none, little, some, moderate, or considerable bruising in subjects' lips
Malleability of Product	15 minutes after injection	Injectors rated the malleability on a scale ranging from 0 (Extremely malleable/Not hard to mold) to 10 (Not malleable/Hard to mold)
Need for Massage	15 minutes after injection	Injectors rated whether none/minimal, a little, some, or a lot of massage was required to optimize placement of VOLBELLA
Return to Social Engagement	4 weeks	Time to return to normal daily activities
Comparative Rating With Previous Treatment	15 minutes after injection	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
Swelling of the Lips	15 minutes after injection	Injector assessment of whether there was none, little, some, moderate, or considerable swelling in subjects' lips
Rating of Injection Discomfort	15 minutes after injection	The level of discomfort during treatment on a scale of 0 (no discomfort) to 10 (extreme discomfort).