Postmarket Study of JUVÉDERM VOLBELLA™ With Lidocaine in the Lips

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01629134

Enrollment

Registered

2012-06-27

Start date

2012-06-30

Completion date

2012-12-31

Last updated

2014-10-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lip Augmentation

Brief summary

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

Interventions

DEVICECrosslinked hyaluronic acid gel

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

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
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.
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.

Secondary

Measure	Time frame	Description
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)
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
Bruising of the Lips	15 minutes after injection	Injector assessment of whether there was none, little, some, moderate, or considerable bruising in subjects' lips
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
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).
Return to Social Engagement	4 weeks	Time to return to normal daily activities
Swelling of the Lips	15 minutes after injection	Injector assessment of whether there was none, little, some, moderate, or considerable swelling in subjects' lips

Countries

Germany

Participant flow

Participants by arm

Arm	Count
Volbella Subjects treated with JUVÉDERM VOLBELLA™ according to the physician's experience and Directions for Use Crosslinked hyaluronic acid gel : All treatments are carried out according to the physician's experience and the Directions for Use	62
Total	62

Baseline characteristics

Characteristic	Volbella
Age, Categorical <=18 years	0 Participants
Age, Categorical >=65 years	3 Participants
Age, Categorical Between 18 and 65 years	59 Participants
Age, Continuous	39.7 years STANDARD_DEVIATION 12.6
Region of Enrollment Germany	62 participants
Sex: Female, Male Female	55 Participants
Sex: Female, Male Male	7 Participants

Adverse events

Event type	EG000 affected / at risk
deaths Total, all-cause mortality	— / —
other Total, other adverse events	0 / 62
serious Total, serious adverse events	0 / 62

Outcome results

Primary

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