Postmarket Study of JUVÉDERM VOLBELLA™ With Lidocaine in the Lips

N/ACompletedNCT01629134

Allergan Medical62 enrolled

Overview

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

Study Type

OBSERVATIONAL

Enrollment

Conditions

Lip Augmentation

Interventions

Crosslinked hyaluronic acid gelDEVICE

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

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Unnamed facility

Düsseldorf, North Rhine-Westphalia, Germany

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: 4 weeks

Secondary Outcomes

Bruising of the Lips

Injector assessment of whether there was none, little, some, moderate, or considerable bruising in subjects' lips