Trial Outcomes & Findings for A Safety and Effectiveness Study of JUVÉDERM VOLBELLA® XC Injectable Gel for Lip and Perioral Enhancement (NCT NCT01998581)
NCT ID: NCT01998581
Last Updated: 2019-04-26
Results Overview
Lip fullness is assessed by the Evaluating Investigator on the 5-point Lip Fullness Scale 2. Assessments range from 0=minimal flat or nearly flat contour, minimal red lip show (worse) to 4=very marked very significant red lip show, lower lip pout, and upper lip pout (best). A positive number change from baseline indicates improvement and a negative number change from baseline indicates a worsening.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
225 participants
Primary outcome timeframe
Baseline, Month 3
Results posted on
2019-04-26
Participant Flow
Participant milestones
| Measure |
JUVEDERM VOLBELLA® XC
Lips injected with JUVEDERM VOLBELLA® XC
|
Restylane-L®
Lips injected with Restylane-L®
|
|---|---|---|
|
Overall Study
STARTED
|
169
|
56
|
|
Overall Study
COMPLETED
|
123
|
44
|
|
Overall Study
NOT COMPLETED
|
46
|
12
|
Reasons for withdrawal
| Measure |
JUVEDERM VOLBELLA® XC
Lips injected with JUVEDERM VOLBELLA® XC
|
Restylane-L®
Lips injected with Restylane-L®
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
12
|
4
|
|
Overall Study
Adverse Event
|
1
|
1
|
|
Overall Study
Other reasons
|
3
|
2
|
|
Overall Study
Randomized but withdrew before treatment
|
1
|
0
|
|
Overall Study
Refused repeat treatment
|
20
|
4
|
|
Overall Study
Protocol Violation
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
8
|
1
|
Baseline Characteristics
A Safety and Effectiveness Study of JUVÉDERM VOLBELLA® XC Injectable Gel for Lip and Perioral Enhancement
Baseline characteristics by cohort
| Measure |
JUVEDERM VOLBELLA® XC
n=168 Participants
Lips injected with JUVEDERM VOLBELLA® XC
|
Restylane-L®
n=56 Participants
Lips injected with Restylane-L®
|
Total
n=224 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
<30 year
|
7 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Age, Customized
30 to 50 years
|
57 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
74 Participants
n=5 Participants
|
|
Age, Customized
51 to 65 years
|
88 Participants
n=5 Participants
|
33 Participants
n=7 Participants
|
121 Participants
n=5 Participants
|
|
Age, Customized
>65 years
|
16 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
164 Participants
n=5 Participants
|
53 Participants
n=7 Participants
|
217 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, Month 3Population: Modified Intent-to-Treat: subjects who were randomized with a Lip Fullness Scale 2 baseline score of minimal, mild, or moderate and who received at least 1 treatment
Lip fullness is assessed by the Evaluating Investigator on the 5-point Lip Fullness Scale 2. Assessments range from 0=minimal flat or nearly flat contour, minimal red lip show (worse) to 4=very marked very significant red lip show, lower lip pout, and upper lip pout (best). A positive number change from baseline indicates improvement and a negative number change from baseline indicates a worsening.
Outcome measures
| Measure |
JUVEDERM VOLBELLA® XC
n=165 Participants
Lips injected with JUVEDERM VOLBELLA® XC
|
Restylane-L®
n=53 Participants
Lips injected with Restylane-L®
|
|---|---|---|
|
Change From Baseline in Evaluating Investigator's Assessment of Lip Fullness on a 5-Point Scale
Baseline
|
1.2 Scores on a Scale
Standard Deviation 0.73
|
1.1 Scores on a Scale
Standard Deviation 0.70
|
|
Change From Baseline in Evaluating Investigator's Assessment of Lip Fullness on a 5-Point Scale
Change from Baseline at Month 3 (N=152, 48)
|
1.1 Scores on a Scale
Standard Deviation 0.75
|
1.0 Scores on a Scale
Standard Deviation 0.85
|
SECONDARY outcome
Timeframe: Baseline, Month 3Population: Subjects in the JUVEDERM VOLBELLA® XC group who received treatment in perioral lines with a baseline POLSS score of moderate or severe
The Evaluating Investigator evaluated the perioral lines severity using the 4-point POLSS where None=No lines; Mild=Few, shallow lines; Moderate=Some, moderate lines; and Severe=Many, deep lines or crevices. The percentage of subjects with at least a 1-point improvement is reported. In accordance with the analysis plan, the analysis with responder rate and 95% Confidence Interval was performed for the JUVEDERM VOLBELLA® XC group only.
Outcome measures
| Measure |
JUVEDERM VOLBELLA® XC
n=81 Participants
Lips injected with JUVEDERM VOLBELLA® XC
|
Restylane-L®
Lips injected with Restylane-L®
|
|---|---|---|
|
Percentage of Subjects in the JUVEDERM VOLBELLA® XC Treatment Arm With at Least a 1 Point Improvement From Baseline on the Perioral Lines Severity Scale (POLSS)
|
65.9 Percentage of Subjects
Interval 54.55 to 75.97
|
—
|
SECONDARY outcome
Timeframe: Baseline, Month 3Population: Modified Intent-to-Treat: subjects who were randomized with data at both time points and received at least 1 treatment
Subjects evaluated satisfaction using the 22 items on the Satisfaction with Lip module of the FACE-Q questionnaire. Scores for each item are combined to create a scale ranging from 0 (worse) to 100 (best). A positive number in change from baseline indicates an improvement, and a negative number in change from baseline indicates a worsening.
Outcome measures
| Measure |
JUVEDERM VOLBELLA® XC
n=153 Participants
Lips injected with JUVEDERM VOLBELLA® XC
|
Restylane-L®
n=51 Participants
Lips injected with Restylane-L®
|
|---|---|---|
|
Change From Baseline in Subject Satisfaction With Lips on the Lip Module of the FACE-Q Questionnaire
|
37.6 Scores on a Scale
Interval 34.0 to 41.1
|
29.0 Scores on a Scale
Interval 21.9 to 36.0
|
Adverse Events
JUVEDERM VOLBELLA® XC Initial Treatment
Serious events: 5 serious events
Other events: 85 other events
Deaths: 0 deaths
Restylane-L®
Serious events: 1 serious events
Other events: 28 other events
Deaths: 0 deaths
JUVEDERM VOLBELLA® Repeat Treatment
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
JUVEDERM VOLBELLA® XC Initial Treatment
n=168 participants at risk
Lips injected with JUVEDERM VOLBELLA® XC
|
Restylane-L®
n=56 participants at risk
Lips injected with Restylane-L®
|
JUVEDERM VOLBELLA® Repeat Treatment
n=30 participants at risk
Lips re-injected with JUVEDERM VOLBELLA® XC
|
|---|---|---|---|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-Small Cell Lung Cancer Stage III
|
0.00%
0/168
The Safety Population included subject who received at least 1 treatment. The Safety Population was used to assess adverse events and serious adverse events. Out of the safety population, 30 subjects were included in the JUVEDERM VOLBELLA® Repeat Treatment Arm for AE reporting. During the repeat treatment period, at the month 12 visit, JUVEDERM VOLBELLA® was administered regardless of the product used for initial treatment.
|
1.8%
1/56
The Safety Population included subject who received at least 1 treatment. The Safety Population was used to assess adverse events and serious adverse events. Out of the safety population, 30 subjects were included in the JUVEDERM VOLBELLA® Repeat Treatment Arm for AE reporting. During the repeat treatment period, at the month 12 visit, JUVEDERM VOLBELLA® was administered regardless of the product used for initial treatment.
|
0.00%
0/30
The Safety Population included subject who received at least 1 treatment. The Safety Population was used to assess adverse events and serious adverse events. Out of the safety population, 30 subjects were included in the JUVEDERM VOLBELLA® Repeat Treatment Arm for AE reporting. During the repeat treatment period, at the month 12 visit, JUVEDERM VOLBELLA® was administered regardless of the product used for initial treatment.
|
|
Gastrointestinal disorders
Colitis
|
0.60%
1/168
The Safety Population included subject who received at least 1 treatment. The Safety Population was used to assess adverse events and serious adverse events. Out of the safety population, 30 subjects were included in the JUVEDERM VOLBELLA® Repeat Treatment Arm for AE reporting. During the repeat treatment period, at the month 12 visit, JUVEDERM VOLBELLA® was administered regardless of the product used for initial treatment.
|
0.00%
0/56
The Safety Population included subject who received at least 1 treatment. The Safety Population was used to assess adverse events and serious adverse events. Out of the safety population, 30 subjects were included in the JUVEDERM VOLBELLA® Repeat Treatment Arm for AE reporting. During the repeat treatment period, at the month 12 visit, JUVEDERM VOLBELLA® was administered regardless of the product used for initial treatment.
|
0.00%
0/30
The Safety Population included subject who received at least 1 treatment. The Safety Population was used to assess adverse events and serious adverse events. Out of the safety population, 30 subjects were included in the JUVEDERM VOLBELLA® Repeat Treatment Arm for AE reporting. During the repeat treatment period, at the month 12 visit, JUVEDERM VOLBELLA® was administered regardless of the product used for initial treatment.
|
|
Injury, poisoning and procedural complications
Procedural Pain
|
0.60%
1/168
The Safety Population included subject who received at least 1 treatment. The Safety Population was used to assess adverse events and serious adverse events. Out of the safety population, 30 subjects were included in the JUVEDERM VOLBELLA® Repeat Treatment Arm for AE reporting. During the repeat treatment period, at the month 12 visit, JUVEDERM VOLBELLA® was administered regardless of the product used for initial treatment.
|
0.00%
0/56
The Safety Population included subject who received at least 1 treatment. The Safety Population was used to assess adverse events and serious adverse events. Out of the safety population, 30 subjects were included in the JUVEDERM VOLBELLA® Repeat Treatment Arm for AE reporting. During the repeat treatment period, at the month 12 visit, JUVEDERM VOLBELLA® was administered regardless of the product used for initial treatment.
|
0.00%
0/30
The Safety Population included subject who received at least 1 treatment. The Safety Population was used to assess adverse events and serious adverse events. Out of the safety population, 30 subjects were included in the JUVEDERM VOLBELLA® Repeat Treatment Arm for AE reporting. During the repeat treatment period, at the month 12 visit, JUVEDERM VOLBELLA® was administered regardless of the product used for initial treatment.
|
|
Musculoskeletal and connective tissue disorders
Cervical Spinal Stenosis
|
0.60%
1/168
The Safety Population included subject who received at least 1 treatment. The Safety Population was used to assess adverse events and serious adverse events. Out of the safety population, 30 subjects were included in the JUVEDERM VOLBELLA® Repeat Treatment Arm for AE reporting. During the repeat treatment period, at the month 12 visit, JUVEDERM VOLBELLA® was administered regardless of the product used for initial treatment.
|
0.00%
0/56
The Safety Population included subject who received at least 1 treatment. The Safety Population was used to assess adverse events and serious adverse events. Out of the safety population, 30 subjects were included in the JUVEDERM VOLBELLA® Repeat Treatment Arm for AE reporting. During the repeat treatment period, at the month 12 visit, JUVEDERM VOLBELLA® was administered regardless of the product used for initial treatment.
|
0.00%
0/30
The Safety Population included subject who received at least 1 treatment. The Safety Population was used to assess adverse events and serious adverse events. Out of the safety population, 30 subjects were included in the JUVEDERM VOLBELLA® Repeat Treatment Arm for AE reporting. During the repeat treatment period, at the month 12 visit, JUVEDERM VOLBELLA® was administered regardless of the product used for initial treatment.
|
|
Endocrine disorders
Goitre
|
0.60%
1/168
The Safety Population included subject who received at least 1 treatment. The Safety Population was used to assess adverse events and serious adverse events. Out of the safety population, 30 subjects were included in the JUVEDERM VOLBELLA® Repeat Treatment Arm for AE reporting. During the repeat treatment period, at the month 12 visit, JUVEDERM VOLBELLA® was administered regardless of the product used for initial treatment.
|
0.00%
0/56
The Safety Population included subject who received at least 1 treatment. The Safety Population was used to assess adverse events and serious adverse events. Out of the safety population, 30 subjects were included in the JUVEDERM VOLBELLA® Repeat Treatment Arm for AE reporting. During the repeat treatment period, at the month 12 visit, JUVEDERM VOLBELLA® was administered regardless of the product used for initial treatment.
|
0.00%
0/30
The Safety Population included subject who received at least 1 treatment. The Safety Population was used to assess adverse events and serious adverse events. Out of the safety population, 30 subjects were included in the JUVEDERM VOLBELLA® Repeat Treatment Arm for AE reporting. During the repeat treatment period, at the month 12 visit, JUVEDERM VOLBELLA® was administered regardless of the product used for initial treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant Sweat Gland Neoplasm
|
0.60%
1/168
The Safety Population included subject who received at least 1 treatment. The Safety Population was used to assess adverse events and serious adverse events. Out of the safety population, 30 subjects were included in the JUVEDERM VOLBELLA® Repeat Treatment Arm for AE reporting. During the repeat treatment period, at the month 12 visit, JUVEDERM VOLBELLA® was administered regardless of the product used for initial treatment.
|
0.00%
0/56
The Safety Population included subject who received at least 1 treatment. The Safety Population was used to assess adverse events and serious adverse events. Out of the safety population, 30 subjects were included in the JUVEDERM VOLBELLA® Repeat Treatment Arm for AE reporting. During the repeat treatment period, at the month 12 visit, JUVEDERM VOLBELLA® was administered regardless of the product used for initial treatment.
|
0.00%
0/30
The Safety Population included subject who received at least 1 treatment. The Safety Population was used to assess adverse events and serious adverse events. Out of the safety population, 30 subjects were included in the JUVEDERM VOLBELLA® Repeat Treatment Arm for AE reporting. During the repeat treatment period, at the month 12 visit, JUVEDERM VOLBELLA® was administered regardless of the product used for initial treatment.
|
|
Infections and infestations
Staphylococcal Infection
|
0.60%
1/168
The Safety Population included subject who received at least 1 treatment. The Safety Population was used to assess adverse events and serious adverse events. Out of the safety population, 30 subjects were included in the JUVEDERM VOLBELLA® Repeat Treatment Arm for AE reporting. During the repeat treatment period, at the month 12 visit, JUVEDERM VOLBELLA® was administered regardless of the product used for initial treatment.
|
0.00%
0/56
The Safety Population included subject who received at least 1 treatment. The Safety Population was used to assess adverse events and serious adverse events. Out of the safety population, 30 subjects were included in the JUVEDERM VOLBELLA® Repeat Treatment Arm for AE reporting. During the repeat treatment period, at the month 12 visit, JUVEDERM VOLBELLA® was administered regardless of the product used for initial treatment.
|
0.00%
0/30
The Safety Population included subject who received at least 1 treatment. The Safety Population was used to assess adverse events and serious adverse events. Out of the safety population, 30 subjects were included in the JUVEDERM VOLBELLA® Repeat Treatment Arm for AE reporting. During the repeat treatment period, at the month 12 visit, JUVEDERM VOLBELLA® was administered regardless of the product used for initial treatment.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.60%
1/168
The Safety Population included subject who received at least 1 treatment. The Safety Population was used to assess adverse events and serious adverse events. Out of the safety population, 30 subjects were included in the JUVEDERM VOLBELLA® Repeat Treatment Arm for AE reporting. During the repeat treatment period, at the month 12 visit, JUVEDERM VOLBELLA® was administered regardless of the product used for initial treatment.
|
0.00%
0/56
The Safety Population included subject who received at least 1 treatment. The Safety Population was used to assess adverse events and serious adverse events. Out of the safety population, 30 subjects were included in the JUVEDERM VOLBELLA® Repeat Treatment Arm for AE reporting. During the repeat treatment period, at the month 12 visit, JUVEDERM VOLBELLA® was administered regardless of the product used for initial treatment.
|
0.00%
0/30
The Safety Population included subject who received at least 1 treatment. The Safety Population was used to assess adverse events and serious adverse events. Out of the safety population, 30 subjects were included in the JUVEDERM VOLBELLA® Repeat Treatment Arm for AE reporting. During the repeat treatment period, at the month 12 visit, JUVEDERM VOLBELLA® was administered regardless of the product used for initial treatment.
|
Other adverse events
| Measure |
JUVEDERM VOLBELLA® XC Initial Treatment
n=168 participants at risk
Lips injected with JUVEDERM VOLBELLA® XC
|
Restylane-L®
n=56 participants at risk
Lips injected with Restylane-L®
|
JUVEDERM VOLBELLA® Repeat Treatment
n=30 participants at risk
Lips re-injected with JUVEDERM VOLBELLA® XC
|
|---|---|---|---|
|
General disorders
Injection Site Mass
|
32.1%
54/168
The Safety Population included subject who received at least 1 treatment. The Safety Population was used to assess adverse events and serious adverse events. Out of the safety population, 30 subjects were included in the JUVEDERM VOLBELLA® Repeat Treatment Arm for AE reporting. During the repeat treatment period, at the month 12 visit, JUVEDERM VOLBELLA® was administered regardless of the product used for initial treatment.
|
26.8%
15/56
The Safety Population included subject who received at least 1 treatment. The Safety Population was used to assess adverse events and serious adverse events. Out of the safety population, 30 subjects were included in the JUVEDERM VOLBELLA® Repeat Treatment Arm for AE reporting. During the repeat treatment period, at the month 12 visit, JUVEDERM VOLBELLA® was administered regardless of the product used for initial treatment.
|
40.0%
12/30
The Safety Population included subject who received at least 1 treatment. The Safety Population was used to assess adverse events and serious adverse events. Out of the safety population, 30 subjects were included in the JUVEDERM VOLBELLA® Repeat Treatment Arm for AE reporting. During the repeat treatment period, at the month 12 visit, JUVEDERM VOLBELLA® was administered regardless of the product used for initial treatment.
|
|
General disorders
Injection Site Bruising
|
17.9%
30/168
The Safety Population included subject who received at least 1 treatment. The Safety Population was used to assess adverse events and serious adverse events. Out of the safety population, 30 subjects were included in the JUVEDERM VOLBELLA® Repeat Treatment Arm for AE reporting. During the repeat treatment period, at the month 12 visit, JUVEDERM VOLBELLA® was administered regardless of the product used for initial treatment.
|
19.6%
11/56
The Safety Population included subject who received at least 1 treatment. The Safety Population was used to assess adverse events and serious adverse events. Out of the safety population, 30 subjects were included in the JUVEDERM VOLBELLA® Repeat Treatment Arm for AE reporting. During the repeat treatment period, at the month 12 visit, JUVEDERM VOLBELLA® was administered regardless of the product used for initial treatment.
|
0.00%
0/30
The Safety Population included subject who received at least 1 treatment. The Safety Population was used to assess adverse events and serious adverse events. Out of the safety population, 30 subjects were included in the JUVEDERM VOLBELLA® Repeat Treatment Arm for AE reporting. During the repeat treatment period, at the month 12 visit, JUVEDERM VOLBELLA® was administered regardless of the product used for initial treatment.
|
|
General disorders
Injection Site Pain
|
12.5%
21/168
The Safety Population included subject who received at least 1 treatment. The Safety Population was used to assess adverse events and serious adverse events. Out of the safety population, 30 subjects were included in the JUVEDERM VOLBELLA® Repeat Treatment Arm for AE reporting. During the repeat treatment period, at the month 12 visit, JUVEDERM VOLBELLA® was administered regardless of the product used for initial treatment.
|
21.4%
12/56
The Safety Population included subject who received at least 1 treatment. The Safety Population was used to assess adverse events and serious adverse events. Out of the safety population, 30 subjects were included in the JUVEDERM VOLBELLA® Repeat Treatment Arm for AE reporting. During the repeat treatment period, at the month 12 visit, JUVEDERM VOLBELLA® was administered regardless of the product used for initial treatment.
|
0.00%
0/30
The Safety Population included subject who received at least 1 treatment. The Safety Population was used to assess adverse events and serious adverse events. Out of the safety population, 30 subjects were included in the JUVEDERM VOLBELLA® Repeat Treatment Arm for AE reporting. During the repeat treatment period, at the month 12 visit, JUVEDERM VOLBELLA® was administered regardless of the product used for initial treatment.
|
|
General disorders
Injection Site Induration
|
8.9%
15/168
The Safety Population included subject who received at least 1 treatment. The Safety Population was used to assess adverse events and serious adverse events. Out of the safety population, 30 subjects were included in the JUVEDERM VOLBELLA® Repeat Treatment Arm for AE reporting. During the repeat treatment period, at the month 12 visit, JUVEDERM VOLBELLA® was administered regardless of the product used for initial treatment.
|
7.1%
4/56
The Safety Population included subject who received at least 1 treatment. The Safety Population was used to assess adverse events and serious adverse events. Out of the safety population, 30 subjects were included in the JUVEDERM VOLBELLA® Repeat Treatment Arm for AE reporting. During the repeat treatment period, at the month 12 visit, JUVEDERM VOLBELLA® was administered regardless of the product used for initial treatment.
|
0.00%
0/30
The Safety Population included subject who received at least 1 treatment. The Safety Population was used to assess adverse events and serious adverse events. Out of the safety population, 30 subjects were included in the JUVEDERM VOLBELLA® Repeat Treatment Arm for AE reporting. During the repeat treatment period, at the month 12 visit, JUVEDERM VOLBELLA® was administered regardless of the product used for initial treatment.
|
|
General disorders
Injection Site Swelling
|
8.3%
14/168
The Safety Population included subject who received at least 1 treatment. The Safety Population was used to assess adverse events and serious adverse events. Out of the safety population, 30 subjects were included in the JUVEDERM VOLBELLA® Repeat Treatment Arm for AE reporting. During the repeat treatment period, at the month 12 visit, JUVEDERM VOLBELLA® was administered regardless of the product used for initial treatment.
|
12.5%
7/56
The Safety Population included subject who received at least 1 treatment. The Safety Population was used to assess adverse events and serious adverse events. Out of the safety population, 30 subjects were included in the JUVEDERM VOLBELLA® Repeat Treatment Arm for AE reporting. During the repeat treatment period, at the month 12 visit, JUVEDERM VOLBELLA® was administered regardless of the product used for initial treatment.
|
0.00%
0/30
The Safety Population included subject who received at least 1 treatment. The Safety Population was used to assess adverse events and serious adverse events. Out of the safety population, 30 subjects were included in the JUVEDERM VOLBELLA® Repeat Treatment Arm for AE reporting. During the repeat treatment period, at the month 12 visit, JUVEDERM VOLBELLA® was administered regardless of the product used for initial treatment.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee A disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 90 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo.
- Publication restrictions are in place
Restriction type: OTHER