Trial Outcomes & Findings for Post-Market Study of JUVÉDERM VOLIFT™ With Lidocaine for the Correction of Nasolabial Folds (NCT NCT01680497)
NCT ID: NCT01680497
Last Updated: 2019-04-16
Results Overview
Nasolabial fold severity is evaluated by the Investigator on the 5-point NLFSS on both the right and left sides. Scores are assessed as 1 (none), 2 (mild), 3 (moderate), 4 (severe), and 5 (extreme).
COMPLETED
NA
70 participants
Month 12
2019-04-16
Participant Flow
Participant milestones
| Measure |
JUVÉDERM VOLIFT™
All subjects receiving treatment with JUVÉDERM VOLIFT™.
|
|---|---|
|
Overall Study
STARTED
|
70
|
|
Overall Study
COMPLETED
|
68
|
|
Overall Study
NOT COMPLETED
|
2
|
Reasons for withdrawal
| Measure |
JUVÉDERM VOLIFT™
All subjects receiving treatment with JUVÉDERM VOLIFT™.
|
|---|---|
|
Overall Study
Lost to Follow-up
|
2
|
Baseline Characteristics
Post-Market Study of JUVÉDERM VOLIFT™ With Lidocaine for the Correction of Nasolabial Folds
Baseline characteristics by cohort
| Measure |
JUVÉDERM VOLIFT™
n=70 Participants
All subjects receiving treatment with JUVÉDERM VOLIFT™.
|
|---|---|
|
Age, Continuous
|
49.3 Years
STANDARD_DEVIATION 9.5 • n=99 Participants
|
|
Sex: Female, Male
Female
|
66 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=99 Participants
|
PRIMARY outcome
Timeframe: Month 12Population: Efficacy Population: all subjects who completed their first treatment session as planned, had no major protocol violations that would potentially affect outcome measures, and had data at the time point
Nasolabial fold severity is evaluated by the Investigator on the 5-point NLFSS on both the right and left sides. Scores are assessed as 1 (none), 2 (mild), 3 (moderate), 4 (severe), and 5 (extreme).
Outcome measures
| Measure |
JUVÉDERM VOLIFT™
n=65 Participants
All subjects receiving treatment with JUVÉDERM VOLIFT™.
|
|---|---|
|
Investigator Assessment of Nasolabial Fold Severity Using the 5-point Nasolabial Fold Severity Scale (NLFSS)
12 Months - Right
|
2.8 Scores on a Scale
Standard Deviation 0.8
|
|
Investigator Assessment of Nasolabial Fold Severity Using the 5-point Nasolabial Fold Severity Scale (NLFSS)
12 Months - Left
|
2.8 Scores on a Scale
Standard Deviation 0.8
|
SECONDARY outcome
Timeframe: Day 0, Day 14, Month 1, Month 9Population: Efficacy Population: all subjects who completed their first treatment session as planned, had no major protocol violations that would potentially affect outcome measures, and had data at the time point
Nasolabial fold severity is evaluated by the Investigator on the 5-point NLFSS on both the right and left sides. Scores are assessed as 1 (none), 2 (mild), 3 (moderate), 4 (severe), and 5 (extreme).
Outcome measures
| Measure |
JUVÉDERM VOLIFT™
n=67 Participants
All subjects receiving treatment with JUVÉDERM VOLIFT™.
|
|---|---|
|
Investigator Assessment of Nasolabial Fold Severity Using the 5-point NLFSS
Day 0 - Right
|
3.6 Scores on a Scale
Standard Deviation 0.5
|
|
Investigator Assessment of Nasolabial Fold Severity Using the 5-point NLFSS
Day 0 -Left
|
3.7 Scores on a Scale
Standard Deviation 0.5
|
|
Investigator Assessment of Nasolabial Fold Severity Using the 5-point NLFSS
Day 14 - Right
|
1.7 Scores on a Scale
Standard Deviation 0.5
|
|
Investigator Assessment of Nasolabial Fold Severity Using the 5-point NLFSS
Day 14 - Left
|
1.7 Scores on a Scale
Standard Deviation 0.5
|
|
Investigator Assessment of Nasolabial Fold Severity Using the 5-point NLFSS
Month 1 - Right (N=66)
|
1.8 Scores on a Scale
Standard Deviation 0.6
|
|
Investigator Assessment of Nasolabial Fold Severity Using the 5-point NLFSS
Month 1 - Left (N=66
|
1.9 Scores on a Scale
Standard Deviation 0.6
|
|
Investigator Assessment of Nasolabial Fold Severity Using the 5-point NLFSS
Month 9 - Right (N=66)
|
2.5 Scores on a Scale
Standard Deviation 0.7
|
|
Investigator Assessment of Nasolabial Fold Severity Using the 5-point NLFSS
Month 9 - Left (N=66)
|
2.4 Scores on a Scale
Standard Deviation 0.7
|
SECONDARY outcome
Timeframe: Day 14, Month 1, Month 9, Month 12Population: Efficacy Population: all subjects who completed their first treatment session as planned, had no major protocol violations that would potentially affect outcome measures, and had data at the time point
Investigator satisfaction with aesthetic outcome is assessed on an 11-point scale. Scores range from -5 (definitely not satisfied), 0 (don't know/unsure), and 5 (definitely satisfied).
Outcome measures
| Measure |
JUVÉDERM VOLIFT™
n=67 Participants
All subjects receiving treatment with JUVÉDERM VOLIFT™.
|
|---|---|
|
Investigator Satisfaction With Aesthetic Outcome on an 11-Point Scale
Day 14
|
4.6 Scores on a Scale
Standard Deviation 0.6
|
|
Investigator Satisfaction With Aesthetic Outcome on an 11-Point Scale
Month 1 (N=66)
|
4.5 Scores on a Scale
Standard Deviation 0.7
|
|
Investigator Satisfaction With Aesthetic Outcome on an 11-Point Scale
Month 9 (N=65)
|
4.0 Scores on a Scale
Standard Deviation 1.1
|
|
Investigator Satisfaction With Aesthetic Outcome on an 11-Point Scale
Month 12 (N=65)
|
4.4 Scores on a Scale
Standard Deviation 1.0
|
SECONDARY outcome
Timeframe: Day 0, Day 14Population: Efficacy Population: all subjects who completed their first treatment session as planned, had no major protocol violations that would potentially affect outcome measures, and had data at the time point
Investigator assessment of ease of injection use is assessed on a 10-point scale. Scores range from 0 (easy) to 10 (hard).
Outcome measures
| Measure |
JUVÉDERM VOLIFT™
n=67 Participants
All subjects receiving treatment with JUVÉDERM VOLIFT™.
|
|---|---|
|
Investigator Assessment of Ease of Injection Use on a 10-Point Scale
Day 0
|
1.2 Scores on a Scale
Standard Deviation 1.3
|
|
Investigator Assessment of Ease of Injection Use on a 10-Point Scale
Day 14 (N=27)
|
0.9 Scores on a Scale
Standard Deviation 0.5
|
SECONDARY outcome
Timeframe: Day 0, Day 14, Month 1, Month 9, Month 12Population: Efficacy Population: all subjects who completed their first treatment session as planned, had no major protocol violations that would potentially affect outcome measures, and had data at the time point
Nasolabial fold severity is evaluated by the subject on the 5-point NLFSS on both the right and left sides. Scores are assessed as 1 (none), 2 (mild), 3 (moderate), 4 (severe), and 5 (extreme).
Outcome measures
| Measure |
JUVÉDERM VOLIFT™
n=67 Participants
All subjects receiving treatment with JUVÉDERM VOLIFT™.
|
|---|---|
|
Subject Assessment of Nasolabial Fold Severity Using the 5-point NLFSS
Day 0 - Right
|
3.8 Scores on a Scale
Standard Deviation 0.7
|
|
Subject Assessment of Nasolabial Fold Severity Using the 5-point NLFSS
Day 0 - Left
|
3.9 Scores on a Scale
Standard Deviation 0.7
|
|
Subject Assessment of Nasolabial Fold Severity Using the 5-point NLFSS
Day 14 - Right
|
1.8 Scores on a Scale
Standard Deviation 0.7
|
|
Subject Assessment of Nasolabial Fold Severity Using the 5-point NLFSS
Day 14 - Left
|
1.8 Scores on a Scale
Standard Deviation 0.7
|
|
Subject Assessment of Nasolabial Fold Severity Using the 5-point NLFSS
Month 1 - Right (N=66)
|
2.0 Scores on a Scale
Standard Deviation 0.9
|
|
Subject Assessment of Nasolabial Fold Severity Using the 5-point NLFSS
Month 1 - Left (N=65)
|
2.1 Scores on a Scale
Standard Deviation 0.8
|
|
Subject Assessment of Nasolabial Fold Severity Using the 5-point NLFSS
Month 9 - Right (N=66)
|
2.6 Scores on a Scale
Standard Deviation 0.8
|
|
Subject Assessment of Nasolabial Fold Severity Using the 5-point NLFSS
Month 9 - Left (N=66)
|
2.6 Scores on a Scale
Standard Deviation 0.8
|
|
Subject Assessment of Nasolabial Fold Severity Using the 5-point NLFSS
Month 12 - Right (N=54)
|
2.9 Scores on a Scale
Standard Deviation 0.8
|
|
Subject Assessment of Nasolabial Fold Severity Using the 5-point NLFSS
Month 12 - Left (N=54)
|
3.0 Scores on a Scale
Standard Deviation 0.9
|
SECONDARY outcome
Timeframe: Day 14, Month 1, Month 9, Month 12Population: Efficacy Population: all subjects who completed their first treatment session as planned, had no major protocol violations that would potentially affect outcome measures, and had data at the time point
Subject satisfaction with aesthetic outcome is assessed on an 11-point scale. Scores range from -5 (definitely not satisfied), 0 (don't know/unsure), and 5 (definitely satisfied).
Outcome measures
| Measure |
JUVÉDERM VOLIFT™
n=67 Participants
All subjects receiving treatment with JUVÉDERM VOLIFT™.
|
|---|---|
|
Subject Satisfaction With Aesthetic Outcome on an 11-Point Scale
Day 14
|
4.2 Scores on a Scale
Standard Deviation 1.0
|
|
Subject Satisfaction With Aesthetic Outcome on an 11-Point Scale
Month 1 (N=66)
|
4.2 Scores on a Scale
Standard Deviation 1.0
|
|
Subject Satisfaction With Aesthetic Outcome on an 11-Point Scale
Month 9 (N=66)
|
3.2 Scores on a Scale
Standard Deviation 2.4
|
|
Subject Satisfaction With Aesthetic Outcome on an 11-Point Scale
Month 12 (N=54)
|
3.3 Scores on a Scale
Standard Deviation 1.9
|
SECONDARY outcome
Timeframe: Day 0, Day 14, Month 12, Month 12.5Population: Efficacy Population: all subjects who completed their first treatment session as planned, had no major protocol violations that would potentially affect outcome measures, and had data at the time point
Subject assessment of pain, swelling and bruising intensity on an 11-point scale. Scores range from 0 (No pain/swelling/bruising) to 10 (worst pain/swelling/bruising imaginable).
Outcome measures
| Measure |
JUVÉDERM VOLIFT™
n=67 Participants
All subjects receiving treatment with JUVÉDERM VOLIFT™.
|
|---|---|
|
Subject Assessments of Pain, Swelling, and Bruising Intensity on an 11-Point Scale
Pain Intensity Day 0 - Right
|
2.0 Scores on a Scale
Standard Deviation 1.8
|
|
Subject Assessments of Pain, Swelling, and Bruising Intensity on an 11-Point Scale
Pain Intensity Day 0 - Left
|
2.0 Scores on a Scale
Standard Deviation 1.8
|
|
Subject Assessments of Pain, Swelling, and Bruising Intensity on an 11-Point Scale
Pain Intensity Day 14 - Right (N=66)
|
0.8 Scores on a Scale
Standard Deviation 1.7
|
|
Subject Assessments of Pain, Swelling, and Bruising Intensity on an 11-Point Scale
Pain Intensity Day 14 - Left (N=66)
|
0.7 Scores on a Scale
Standard Deviation 1.5
|
|
Subject Assessments of Pain, Swelling, and Bruising Intensity on an 11-Point Scale
Pain Intensity Month 12 - Right (N=51)
|
1.5 Scores on a Scale
Standard Deviation 1.8
|
|
Subject Assessments of Pain, Swelling, and Bruising Intensity on an 11-Point Scale
Pain Intensity Month 12 - Left (N=51)
|
1.5 Scores on a Scale
Standard Deviation 2.1
|
|
Subject Assessments of Pain, Swelling, and Bruising Intensity on an 11-Point Scale
Pain Intensity Month 12.5 - Right (N=12)
|
0.0 Scores on a Scale
Standard Deviation 0.0
|
|
Subject Assessments of Pain, Swelling, and Bruising Intensity on an 11-Point Scale
Pain Intensity Month 12.5 - Left (N=12)
|
0.0 Scores on a Scale
Standard Deviation 0.0
|
|
Subject Assessments of Pain, Swelling, and Bruising Intensity on an 11-Point Scale
Swelling Intensity Day 0 - Right
|
1.7 Scores on a Scale
Standard Deviation 1.6
|
|
Subject Assessments of Pain, Swelling, and Bruising Intensity on an 11-Point Scale
Swelling Intensity Day 0 - Left
|
1.7 Scores on a Scale
Standard Deviation 1.6
|
|
Subject Assessments of Pain, Swelling, and Bruising Intensity on an 11-Point Scale
Swelling Intensity Day 14 - Right (N=66)
|
1.5 Scores on a Scale
Standard Deviation 2.2
|
|
Subject Assessments of Pain, Swelling, and Bruising Intensity on an 11-Point Scale
Swelling Intensity Day 14 - Left (N=66)
|
1.4 Scores on a Scale
Standard Deviation 2.2
|
|
Subject Assessments of Pain, Swelling, and Bruising Intensity on an 11-Point Scale
Swelling Intensity Month 12 - Right (N=51)
|
1.4 Scores on a Scale
Standard Deviation 1.5
|
|
Subject Assessments of Pain, Swelling, and Bruising Intensity on an 11-Point Scale
Swelling Intensity Month 12 - Left (N=51)
|
1.4 Scores on a Scale
Standard Deviation 1.6
|
|
Subject Assessments of Pain, Swelling, and Bruising Intensity on an 11-Point Scale
Swelling Intensity Month 12.5 - Right (N=12)
|
0.1 Scores on a Scale
Standard Deviation 0.3
|
|
Subject Assessments of Pain, Swelling, and Bruising Intensity on an 11-Point Scale
Swelling Intensity Month 12.5 - Left (N=12)
|
0.2 Scores on a Scale
Standard Deviation 0.4
|
|
Subject Assessments of Pain, Swelling, and Bruising Intensity on an 11-Point Scale
Bruising Intensity Day 0 - Right
|
0.3 Scores on a Scale
Standard Deviation 0.9
|
|
Subject Assessments of Pain, Swelling, and Bruising Intensity on an 11-Point Scale
Bruising Intensity Day 0 - Left
|
0.3 Scores on a Scale
Standard Deviation 0.9
|
|
Subject Assessments of Pain, Swelling, and Bruising Intensity on an 11-Point Scale
Bruising Intensity Day 14 - Right (N=66)
|
0.9 Scores on a Scale
Standard Deviation 1.9
|
|
Subject Assessments of Pain, Swelling, and Bruising Intensity on an 11-Point Scale
Bruising Intensity Day 14 - Left (N=66)
|
0.5 Scores on a Scale
Standard Deviation 1.3
|
|
Subject Assessments of Pain, Swelling, and Bruising Intensity on an 11-Point Scale
Bruising Intensity Month 12 - Right (N=51)
|
0.4 Scores on a Scale
Standard Deviation 0.8
|
|
Subject Assessments of Pain, Swelling, and Bruising Intensity on an 11-Point Scale
Bruising Intensity Month 12 - Left (N=51)
|
0.4 Scores on a Scale
Standard Deviation 0.9
|
|
Subject Assessments of Pain, Swelling, and Bruising Intensity on an 11-Point Scale
Bruising Intensity Month 12.5 - Right (N=12)
|
0.3 Scores on a Scale
Standard Deviation 0.7
|
|
Subject Assessments of Pain, Swelling, and Bruising Intensity on an 11-Point Scale
Bruising Intensity Month 12.5 - Left (N=12)
|
0.5 Scores on a Scale
Standard Deviation 0.8
|
Adverse Events
JUVÉDERM VOLIFT™
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
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