Trial Outcomes & Findings for Postmarket Study of JUVÉDERM VOLBELLA™ With Lidocaine in the Lips (NCT NCT01629134)

NCT ID: NCT01629134

Last Updated: 2014-10-13

Results Overview

Percentage of subjects rating the look and feel of their lips as being extremely natural, very natural, slightly natural, and not natural.

• Recruitment status: COMPLETED
• Target enrollment: 62 participants
• Primary outcome timeframe: 4 weeks
• Results posted on: 2014-10-13

Participant Flow

Participant milestones

Measure	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
Overall Study STARTED	62
Overall Study COMPLETED	62
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Postmarket Study of JUVÉDERM VOLBELLA™ With Lidocaine in the Lips

Baseline characteristics by cohort

Measure	Volbella n=62 Participants 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
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	59 Participants n=5 Participants
Age, Categorical >=65 years	3 Participants n=5 Participants
Age, Continuous	39.7 years STANDARD_DEVIATION 12.6 • n=5 Participants
Sex: Female, Male Female	55 Participants n=5 Participants
Sex: Female, Male Male	7 Participants n=5 Participants
Region of Enrollment Germany	62 participants n=5 Participants

PRIMARY outcome

Timeframe: 4 weeks

Population: All subjects who met the criteria and treatment was initiated

Percentage of subjects rating the look and feel of their lips as being extremely natural, very natural, slightly natural, and not natural.

Outcome measures

Measure	Volbella n=59 Participants 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
Subject Rating of the Natural Look and Feel of the Lips Extremely natural	52.5 Percentage of subjects
Subject Rating of the Natural Look and Feel of the Lips Very natural	35.6 Percentage of subjects
Subject Rating of the Natural Look and Feel of the Lips Slightly natural	11.9 Percentage of subjects
Subject Rating of the Natural Look and Feel of the Lips Not natural	0 Percentage of subjects

PRIMARY outcome

Timeframe: 4 weeks

Population: All subjects who met the criteria and treatment was initiated

Percentage of injectors who rated the look and feel of subjects' lips as being extremely natural, very natural, slightly natural, and not natural.

Outcome measures

Measure	Volbella n=61 Participants 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
Injector Rating of the Natural Look and Feel of the Lips Extremely natural	45.9 Percentage of subjects
Injector Rating of the Natural Look and Feel of the Lips Very natural	54.1 Percentage of subjects
Injector Rating of the Natural Look and Feel of the Lips Slightly natural	0 Percentage of subjects
Injector Rating of the Natural Look and Feel of the Lips Not natural	0 Percentage of subjects

SECONDARY outcome

Timeframe: 15 minutes after injection

Population: All subjects who met the criteria and treatment was initiated

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

Outcome measures

Measure	Volbella n=62 Participants 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
Bruising of the Lips None	85.5 Percentage of subjects
Bruising of the Lips Little	12.9 Percentage of subjects
Bruising of the Lips Some	1.6 Percentage of subjects
Bruising of the Lips Moderate	0 Percentage of subjects
Bruising of the Lips Considerable	0 Percentage of subjects

SECONDARY outcome

Timeframe: 15 minutes after injection

Population: All subjects who met the criteria and treatment was initiated

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

Outcome measures

Measure	Volbella n=62 Participants 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
Swelling of the Lips None	38.7 Percentage of subjects
Swelling of the Lips Little	53.2 Percentage of subjects
Swelling of the Lips Some	8.1 Percentage of subjects
Swelling of the Lips Moderate	0 Percentage of subjects
Swelling of the Lips Considerable	0 Percentage of subjects

SECONDARY outcome

Timeframe: 15 minutes after injection

Population: All subjects who met the criteria and treatment was initiated

Injectors rated the ease of injection on a scale ranging from 0 (Very easy) to 10 (Extremely difficult)

Outcome measures

Measure	Volbella n=62 Participants 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
Ease of Injection Score of 0	54.8 Percentage of subjects
Ease of Injection Score of 1	45.2 Percentage of subjects

SECONDARY outcome

Timeframe: 15 minutes after injection

Population: All subjects who met the criteria and treatment was initiated

Injectors rated the malleability on a scale ranging from 0 (Extremely malleable/Not hard to mold) to 10 (Not malleable/Hard to mold)

Outcome measures

Measure	Volbella n=62 Participants 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
Malleability of Product Score of 0	45.2 Percentage of subjects
Malleability of Product Score of 1	54.8 Percentage of subjects

SECONDARY outcome

Timeframe: 15 minutes after injection

Population: All subjects who met the criteria and treatment was initiated

Injectors rated whether none/minimal, a little, some, or a lot of massage was required to optimize placement of VOLBELLA

Outcome measures

Measure	Volbella n=62 Participants 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
Need for Massage None/minimal	41.9 Percentage of subjects
Need for Massage A little	58.1 Percentage of subjects
Need for Massage Some	0 Percentage of subjects
Need for Massage A lot	0 Percentage of subjects

SECONDARY outcome

Timeframe: 4 weeks

Population: All subjects who met the criteria and treatment was initiated

Time to return to normal daily activities

Outcome measures

Measure	Volbella n=61 Participants 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
Return to Social Engagement 4-5 Days	8.2 Percentage of subjects
Return to Social Engagement < 1 Day (same day)	62.3 Percentage of subjects
Return to Social Engagement 1 Day (next day)	19.7 Percentage of subjects
Return to Social Engagement 2-3 Days	9.8 Percentage of subjects
Return to Social Engagement > 6 Days	0 Percentage of subjects

SECONDARY outcome

Timeframe: 15 minutes after injection

Population: All subjects who met the criteria and treatment was initiated

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

Outcome measures

Measure	Volbella n=13 Participants 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
Comparative Rating With Previous Treatment Significantly better	46.2 Percentage of subjects
Comparative Rating With Previous Treatment Somewhat better	53.8 Percentage of subjects
Comparative Rating With Previous Treatment No difference	0 Percentage of subjects
Comparative Rating With Previous Treatment Somewhat worse	0 Percentage of subjects
Comparative Rating With Previous Treatment Significantly worse	0 Percentage of subjects

SECONDARY outcome

Timeframe: 15 minutes after injection

Population: All subjects who met the criteria and treatment was initiated

The level of discomfort during treatment on a scale of 0 (no discomfort) to 10 (extreme discomfort).

Outcome measures

Measure	Volbella n=58 Participants 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
Rating of Injection Discomfort	1.3 scale score Standard Deviation 1.5

Adverse Events

Volbella

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Medical Monitor

Allergan, Inc.

Phone: 714-246-4500

Email: clinicaltrials@allergan.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place