Postmarket Study of JUVÉDERM VOLBELLA™ With Lidocaine in the Lips

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

62 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-06-30

Study Completion Date

2012-12-31

Brief Summary

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

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Detailed Description

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Conditions

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Lip Augmentation

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Volbella

Subjects treated with JUVÉDERM VOLBELLA™ according to the physician's experience and Directions for Use

Crosslinked hyaluronic acid gel

Intervention Type DEVICE

All treatments are carried out according to the physician's experience and the Directions for Use

Interventions

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Crosslinked hyaluronic acid gel

All treatments are carried out according to the physician's experience and the Directions for Use

Intervention Type DEVICE

Other Intervention Names

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JUVÉDERM VOLBELLA™

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes