Trial Outcomes & Findings for A Prospective, Open Label Study Evaluating JUVÉDERM® VOLBELLA With Lidocaine Treatment for the Correction of Skin Depressions in the Infra-orbital Area (NCT NCT02176421)
NCT ID: NCT02176421
Last Updated: 2019-04-16
Results Overview
The Investigator evaluated the severity of skin crease and volume loss in the infra-orbital area on both the right and left sides on the 6-point AIRS ranging from 0 (least severe) to 5 (most severe).
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
80 participants
Primary outcome timeframe
Baseline, Month 1
Results posted on
2019-04-16
Participant Flow
Participant milestones
| Measure |
VOLBELLA® With Lidocaine
Infra-orbital skin depressions injected with VOLBELLA® with lidocaine.
|
|---|---|
|
Overall Study
STARTED
|
80
|
|
Overall Study
COMPLETED
|
75
|
|
Overall Study
NOT COMPLETED
|
5
|
Reasons for withdrawal
| Measure |
VOLBELLA® With Lidocaine
Infra-orbital skin depressions injected with VOLBELLA® with lidocaine.
|
|---|---|
|
Overall Study
Lost to Follow-up
|
4
|
|
Overall Study
Adverse Event
|
1
|
Baseline Characteristics
A Prospective, Open Label Study Evaluating JUVÉDERM® VOLBELLA With Lidocaine Treatment for the Correction of Skin Depressions in the Infra-orbital Area
Baseline characteristics by cohort
| Measure |
VOLBELLA® With Lidocaine
n=80 Participants
Infra-orbital skin depressions injected with VOLBELLA® with lidocaine.
|
|---|---|
|
Age, Continuous
|
46.1 Years
STANDARD_DEVIATION 1 • n=5 Participants
|
|
Sex: Female, Male
Female
|
67 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, Month 1Population: All subjects with data for this outcome measure
The Investigator evaluated the severity of skin crease and volume loss in the infra-orbital area on both the right and left sides on the 6-point AIRS ranging from 0 (least severe) to 5 (most severe).
Outcome measures
| Measure |
VOLBELLA® With Lidocaine
n=74 Participants
Infra-orbital skin depressions injected with VOLBELLA® with lidocaine.
|
|---|---|
|
Percentage of Subjects With a ≥1 Grade Improvement From Baseline in Infra-Orbital Area on the Allergan Infra-Orbital Rating Scale (AIRS) on the Right and Left Side
Right Side
|
99 Percentage of Subjects
|
|
Percentage of Subjects With a ≥1 Grade Improvement From Baseline in Infra-Orbital Area on the Allergan Infra-Orbital Rating Scale (AIRS) on the Right and Left Side
Left Side
|
100 Percentage of Subjects
|
SECONDARY outcome
Timeframe: Baseline, Day 0, Day 14, Month 6, Momth 9, Month 12Population: All subjects with data for this outcome measure
The Investigator evaluated the severity of skin crease and volume loss in the infra-orbital area on both the right and left sides on the 6-point AIRS ranging from 0 (least severe) to 5 (most severe).
Outcome measures
| Measure |
VOLBELLA® With Lidocaine
n=76 Participants
Infra-orbital skin depressions injected with VOLBELLA® with lidocaine.
|
|---|---|
|
Percentage of Subjects With a ≥1 Grade Improvement From Baseline in Infra-Orbital Area on the AIRS on the Right and Left Side
Day 0 Right Side
|
99 Percentage of Subjects
|
|
Percentage of Subjects With a ≥1 Grade Improvement From Baseline in Infra-Orbital Area on the AIRS on the Right and Left Side
Day 0 Left Side
|
99 Percentage of Subjects
|
|
Percentage of Subjects With a ≥1 Grade Improvement From Baseline in Infra-Orbital Area on the AIRS on the Right and Left Side
Day 14 Right Side (N=60)
|
98 Percentage of Subjects
|
|
Percentage of Subjects With a ≥1 Grade Improvement From Baseline in Infra-Orbital Area on the AIRS on the Right and Left Side
Day 14 Left Side (N=60)
|
100 Percentage of Subjects
|
|
Percentage of Subjects With a ≥1 Grade Improvement From Baseline in Infra-Orbital Area on the AIRS on the Right and Left Side
Month 6 Right Side (N=73)
|
93 Percentage of Subjects
|
|
Percentage of Subjects With a ≥1 Grade Improvement From Baseline in Infra-Orbital Area on the AIRS on the Right and Left Side
Month 6 Left Side (N=73)
|
92 Percentage of Subjects
|
|
Percentage of Subjects With a ≥1 Grade Improvement From Baseline in Infra-Orbital Area on the AIRS on the Right and Left Side
Month 9 Right Side (N=72)
|
81 Percentage of Subjects
|
|
Percentage of Subjects With a ≥1 Grade Improvement From Baseline in Infra-Orbital Area on the AIRS on the Right and Left Side
Month 9 Left Side (N=72)
|
83 Percentage of Subjects
|
|
Percentage of Subjects With a ≥1 Grade Improvement From Baseline in Infra-Orbital Area on the AIRS on the Right and Left Side
Month 12 Right Side (N=71)
|
55 Percentage of Subjects
|
|
Percentage of Subjects With a ≥1 Grade Improvement From Baseline in Infra-Orbital Area on the AIRS on the Right and Left Side
Month 12 Left Side (N=71)
|
59 Percentage of Subjects
|
SECONDARY outcome
Timeframe: Day 0Population: All subjects with data for this outcome measure
The injectors rated the ease of injection and ease of modeling of the product on an 11-point scale from 0 (extremely difficult) to 10 (extremely easy).
Outcome measures
| Measure |
VOLBELLA® With Lidocaine
n=76 Participants
Infra-orbital skin depressions injected with VOLBELLA® with lidocaine.
|
|---|---|
|
Injector Ease of Use on an 11-Point Scale
|
9.8 Scores on a Scale
Standard Deviation 0.0
|
SECONDARY outcome
Timeframe: Day 0, Day 14, Month 1, Month 6, Month 9, Month 12Population: All subjects with data for this outcome measure
The Investigator evaluated the subjects global aesthetic improvement on right and left sides using the 5-point GAIS (1=Very Well Improved, 2=Well Improved, 3=Improved, 4=Not Improved, 5=Worsened State). The percentage of subjects assessed as Very Well Improved and Well Improved are reported.
Outcome measures
| Measure |
VOLBELLA® With Lidocaine
n=76 Participants
Infra-orbital skin depressions injected with VOLBELLA® with lidocaine.
|
|---|---|
|
Percentage of Subjects Assessed by the Investigator as Very Well Improved or Well Improved on the 5-Point Global Aesthetic Improvement Scale (GAIS)
Day 0 Very Well Improved Right Side
|
45 Percentage of Subjects
|
|
Percentage of Subjects Assessed by the Investigator as Very Well Improved or Well Improved on the 5-Point Global Aesthetic Improvement Scale (GAIS)
Day 0 Very Well Improved Left Side
|
43 Percentage of Subjects
|
|
Percentage of Subjects Assessed by the Investigator as Very Well Improved or Well Improved on the 5-Point Global Aesthetic Improvement Scale (GAIS)
Day 0 Well Improved Right Side
|
34 Percentage of Subjects
|
|
Percentage of Subjects Assessed by the Investigator as Very Well Improved or Well Improved on the 5-Point Global Aesthetic Improvement Scale (GAIS)
Day 0 Well Improved Left Side
|
37 Percentage of Subjects
|
|
Percentage of Subjects Assessed by the Investigator as Very Well Improved or Well Improved on the 5-Point Global Aesthetic Improvement Scale (GAIS)
Day 14 Very Well Improved Right Side (N=60)
|
68 Percentage of Subjects
|
|
Percentage of Subjects Assessed by the Investigator as Very Well Improved or Well Improved on the 5-Point Global Aesthetic Improvement Scale (GAIS)
Day 14 Very Well Improved Left Side (N=60)
|
63 Percentage of Subjects
|
|
Percentage of Subjects Assessed by the Investigator as Very Well Improved or Well Improved on the 5-Point Global Aesthetic Improvement Scale (GAIS)
Day 14 Well Improved Right Side (N=60)
|
27 Percentage of Subjects
|
|
Percentage of Subjects Assessed by the Investigator as Very Well Improved or Well Improved on the 5-Point Global Aesthetic Improvement Scale (GAIS)
Day 14 Well Improved Left Side (N=60)
|
30 Percentage of Subjects
|
|
Percentage of Subjects Assessed by the Investigator as Very Well Improved or Well Improved on the 5-Point Global Aesthetic Improvement Scale (GAIS)
Month 1 Very Well Improved Right Side (N=76)
|
57 Percentage of Subjects
|
|
Percentage of Subjects Assessed by the Investigator as Very Well Improved or Well Improved on the 5-Point Global Aesthetic Improvement Scale (GAIS)
Month 1 Very Well Improved Left Side (N=75)
|
65 Percentage of Subjects
|
|
Percentage of Subjects Assessed by the Investigator as Very Well Improved or Well Improved on the 5-Point Global Aesthetic Improvement Scale (GAIS)
Month 1 Well Improved Right Side (N=76)
|
38 Percentage of Subjects
|
|
Percentage of Subjects Assessed by the Investigator as Very Well Improved or Well Improved on the 5-Point Global Aesthetic Improvement Scale (GAIS)
Month 1 Well Improved Left Side (N=75)
|
31 Percentage of Subjects
|
|
Percentage of Subjects Assessed by the Investigator as Very Well Improved or Well Improved on the 5-Point Global Aesthetic Improvement Scale (GAIS)
Month 6 Very Well Improved Right Side (N=73)
|
40 Percentage of Subjects
|
|
Percentage of Subjects Assessed by the Investigator as Very Well Improved or Well Improved on the 5-Point Global Aesthetic Improvement Scale (GAIS)
Month 6 Very Well Improved Left Side (N=73)
|
37 Percentage of Subjects
|
|
Percentage of Subjects Assessed by the Investigator as Very Well Improved or Well Improved on the 5-Point Global Aesthetic Improvement Scale (GAIS)
Month 6 Well Improved Right Side (N=73)
|
38 Percentage of Subjects
|
|
Percentage of Subjects Assessed by the Investigator as Very Well Improved or Well Improved on the 5-Point Global Aesthetic Improvement Scale (GAIS)
Month 6 Well Improved Left Side (N=73)
|
42 Percentage of Subjects
|
|
Percentage of Subjects Assessed by the Investigator as Very Well Improved or Well Improved on the 5-Point Global Aesthetic Improvement Scale (GAIS)
Month 9 Very Well Improved Right Side (N=72)
|
18 Percentage of Subjects
|
|
Percentage of Subjects Assessed by the Investigator as Very Well Improved or Well Improved on the 5-Point Global Aesthetic Improvement Scale (GAIS)
Month 9 Very Well Improved Left Side (N=72)
|
18 Percentage of Subjects
|
|
Percentage of Subjects Assessed by the Investigator as Very Well Improved or Well Improved on the 5-Point Global Aesthetic Improvement Scale (GAIS)
Month 9 Well Improved Right Side (N=72)
|
25 Percentage of Subjects
|
|
Percentage of Subjects Assessed by the Investigator as Very Well Improved or Well Improved on the 5-Point Global Aesthetic Improvement Scale (GAIS)
Month 9 Well Improved Left Side (N=72)
|
26 Percentage of Subjects
|
|
Percentage of Subjects Assessed by the Investigator as Very Well Improved or Well Improved on the 5-Point Global Aesthetic Improvement Scale (GAIS)
Month 12 Very Well Improved Right Side (N=71)
|
6 Percentage of Subjects
|
|
Percentage of Subjects Assessed by the Investigator as Very Well Improved or Well Improved on the 5-Point Global Aesthetic Improvement Scale (GAIS)
Month 12 Very Well Improved Left Side (N=71)
|
6 Percentage of Subjects
|
|
Percentage of Subjects Assessed by the Investigator as Very Well Improved or Well Improved on the 5-Point Global Aesthetic Improvement Scale (GAIS)
Month 12 Well Improved Right Side (N=71)
|
23 Percentage of Subjects
|
|
Percentage of Subjects Assessed by the Investigator as Very Well Improved or Well Improved on the 5-Point Global Aesthetic Improvement Scale (GAIS)
Month 12 Well Improved Left Side (N=71)
|
27 Percentage of Subjects
|
SECONDARY outcome
Timeframe: Day 0, Day 14, Month 1, Month 6, Month 9, Month 12Population: All subjects with data for this outcome measure
The subjects evaluated their global aesthetic improvement on the right and left sides using the 5-point GAIS (1=Very Well Improved, 2=Well Improved, 3=Improved, 4=Not Improved, 5=Worsened State). The percentage of subjects assessed as Very Well Improved and Well Improved are reported.
Outcome measures
| Measure |
VOLBELLA® With Lidocaine
n=76 Participants
Infra-orbital skin depressions injected with VOLBELLA® with lidocaine.
|
|---|---|
|
Percentage of Subjects Assessed by the Subjects as Very Well Improved or Well Improved on the 5-Point Global Aesthetic Improvement Scale (GAIS)
Day 0 Very Well Improved Right Side
|
21 Percentage of Subjects
|
|
Percentage of Subjects Assessed by the Subjects as Very Well Improved or Well Improved on the 5-Point Global Aesthetic Improvement Scale (GAIS)
Day 0 Very Well Improved Left Side
|
18 Percentage of Subjects
|
|
Percentage of Subjects Assessed by the Subjects as Very Well Improved or Well Improved on the 5-Point Global Aesthetic Improvement Scale (GAIS)
Day 0 Well Improved Right Side
|
38 Percentage of Subjects
|
|
Percentage of Subjects Assessed by the Subjects as Very Well Improved or Well Improved on the 5-Point Global Aesthetic Improvement Scale (GAIS)
Day 0 Well Improved Left Side
|
36 Percentage of Subjects
|
|
Percentage of Subjects Assessed by the Subjects as Very Well Improved or Well Improved on the 5-Point Global Aesthetic Improvement Scale (GAIS)
Day 14 Very Well Improved Right Side (N=60)
|
43 Percentage of Subjects
|
|
Percentage of Subjects Assessed by the Subjects as Very Well Improved or Well Improved on the 5-Point Global Aesthetic Improvement Scale (GAIS)
Day 14 Very Well Improved Left Side (N=60)
|
40 Percentage of Subjects
|
|
Percentage of Subjects Assessed by the Subjects as Very Well Improved or Well Improved on the 5-Point Global Aesthetic Improvement Scale (GAIS)
Day 14 Well Improved Right Side (N=60)
|
35 Percentage of Subjects
|
|
Percentage of Subjects Assessed by the Subjects as Very Well Improved or Well Improved on the 5-Point Global Aesthetic Improvement Scale (GAIS)
Day 14 Well Improved Left Side (N=60)
|
38 Percentage of Subjects
|
|
Percentage of Subjects Assessed by the Subjects as Very Well Improved or Well Improved on the 5-Point Global Aesthetic Improvement Scale (GAIS)
Month 1 Very Well Improved Right Side (N=76)
|
39 Percentage of Subjects
|
|
Percentage of Subjects Assessed by the Subjects as Very Well Improved or Well Improved on the 5-Point Global Aesthetic Improvement Scale (GAIS)
Month 1 Very Well Improved Left Side (N=75)
|
43 Percentage of Subjects
|
|
Percentage of Subjects Assessed by the Subjects as Very Well Improved or Well Improved on the 5-Point Global Aesthetic Improvement Scale (GAIS)
Month 1 Well Improved Right Side (N=76)
|
32 Percentage of Subjects
|
|
Percentage of Subjects Assessed by the Subjects as Very Well Improved or Well Improved on the 5-Point Global Aesthetic Improvement Scale (GAIS)
Month 1 Well Improved Left Side (N=75)
|
30 Percentage of Subjects
|
|
Percentage of Subjects Assessed by the Subjects as Very Well Improved or Well Improved on the 5-Point Global Aesthetic Improvement Scale (GAIS)
Month 6 Very Well Improved Right Side (N=73)
|
22 Percentage of Subjects
|
|
Percentage of Subjects Assessed by the Subjects as Very Well Improved or Well Improved on the 5-Point Global Aesthetic Improvement Scale (GAIS)
Month 6 Very Well Improved Left Side (N=73)
|
18 Percentage of Subjects
|
|
Percentage of Subjects Assessed by the Subjects as Very Well Improved or Well Improved on the 5-Point Global Aesthetic Improvement Scale (GAIS)
Month 6 Well Improved Right Side (N=73)
|
29 Percentage of Subjects
|
|
Percentage of Subjects Assessed by the Subjects as Very Well Improved or Well Improved on the 5-Point Global Aesthetic Improvement Scale (GAIS)
Month 6 Well Improved Left Side (N=73)
|
30 Percentage of Subjects
|
|
Percentage of Subjects Assessed by the Subjects as Very Well Improved or Well Improved on the 5-Point Global Aesthetic Improvement Scale (GAIS)
Month 9 Very Well Improved Right Side (N=72)
|
19 Percentage of Subjects
|
|
Percentage of Subjects Assessed by the Subjects as Very Well Improved or Well Improved on the 5-Point Global Aesthetic Improvement Scale (GAIS)
Month 9 Very Well Improved Left Side (N=72)
|
17 Percentage of Subjects
|
|
Percentage of Subjects Assessed by the Subjects as Very Well Improved or Well Improved on the 5-Point Global Aesthetic Improvement Scale (GAIS)
Month 9 Well Improved Right Side (N=72)
|
26 Percentage of Subjects
|
|
Percentage of Subjects Assessed by the Subjects as Very Well Improved or Well Improved on the 5-Point Global Aesthetic Improvement Scale (GAIS)
Month 9 Well Improved Left Side (N=72)
|
25 Percentage of Subjects
|
|
Percentage of Subjects Assessed by the Subjects as Very Well Improved or Well Improved on the 5-Point Global Aesthetic Improvement Scale (GAIS)
Month 12 Very Well Improved Right Side (N=73)
|
16 Percentage of Subjects
|
|
Percentage of Subjects Assessed by the Subjects as Very Well Improved or Well Improved on the 5-Point Global Aesthetic Improvement Scale (GAIS)
Month 12 Very Well Improved Left Side (N=73)
|
12 Percentage of Subjects
|
|
Percentage of Subjects Assessed by the Subjects as Very Well Improved or Well Improved on the 5-Point Global Aesthetic Improvement Scale (GAIS)
Month 12 Well Improved Right Side (N=73)
|
23 Percentage of Subjects
|
|
Percentage of Subjects Assessed by the Subjects as Very Well Improved or Well Improved on the 5-Point Global Aesthetic Improvement Scale (GAIS)
Month 12 Well Improved Left Side (N=73)
|
25 Percentage of Subjects
|
SECONDARY outcome
Timeframe: Day 0, Day 14, Month 1, Month 6, Month 9, Month 12Population: All subjects with data for this outcome measure
Subjects assessed their overall eye appearance on the PAAQ. The PAAQ includes 9 questions about how the subject's overall eye appearance affected them over the past 7 days. Each question is assessed on a 5-point scale from 0 (never/best) to 4 (all of the time/worse), with the total score ranging from 0 (best) to 36 (worse).
Outcome measures
| Measure |
VOLBELLA® With Lidocaine
n=76 Participants
Infra-orbital skin depressions injected with VOLBELLA® with lidocaine.
|
|---|---|
|
Subject Overall Eye Appearance Total Score on the 5-Point Periorbital Aesthetic Appearance Questionnaire (PAAQ)
Day 0
|
19.3 Scores on a Scale
Standard Deviation 7.1
|
|
Subject Overall Eye Appearance Total Score on the 5-Point Periorbital Aesthetic Appearance Questionnaire (PAAQ)
Day 14
|
7.4 Scores on a Scale
Standard Deviation 6.4
|
|
Subject Overall Eye Appearance Total Score on the 5-Point Periorbital Aesthetic Appearance Questionnaire (PAAQ)
Month 1
|
6.0 Scores on a Scale
Standard Deviation 7.2
|
|
Subject Overall Eye Appearance Total Score on the 5-Point Periorbital Aesthetic Appearance Questionnaire (PAAQ)
Month 6
|
9.5 Scores on a Scale
Standard Deviation 7.7
|
|
Subject Overall Eye Appearance Total Score on the 5-Point Periorbital Aesthetic Appearance Questionnaire (PAAQ)
Month 9
|
9.9 Scores on a Scale
Standard Deviation 7.9
|
|
Subject Overall Eye Appearance Total Score on the 5-Point Periorbital Aesthetic Appearance Questionnaire (PAAQ)
Month 12
|
10.7 Scores on a Scale
Standard Deviation 8.4
|
Adverse Events
VOLBELLA® With Lidocaine
Serious events: 1 serious events
Other events: 77 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
VOLBELLA® With Lidocaine
n=80 participants at risk
Infra-orbital skin depressions injected with VOLBELLA® with lidocaine.
|
|---|---|
|
Reproductive system and breast disorders
Uterine Leiomyoma
|
1.5%
1/67 • Adverse event (AE) and serious adverse event (SAE) data were collected for 1 month for each subject. )
|
Other adverse events
| Measure |
VOLBELLA® With Lidocaine
n=80 participants at risk
Infra-orbital skin depressions injected with VOLBELLA® with lidocaine.
|
|---|---|
|
General disorders
Injection Site Bruising
|
55.0%
44/80 • Adverse event (AE) and serious adverse event (SAE) data were collected for 1 month for each subject. )
|
|
General disorders
Injection Site Erythema
|
48.8%
39/80 • Adverse event (AE) and serious adverse event (SAE) data were collected for 1 month for each subject. )
|
|
General disorders
Injection Site Oedema
|
40.0%
32/80 • Adverse event (AE) and serious adverse event (SAE) data were collected for 1 month for each subject. )
|
|
General disorders
Injection Site Pain
|
32.5%
26/80 • Adverse event (AE) and serious adverse event (SAE) data were collected for 1 month for each subject. )
|
|
General disorders
Injection Site Reaction
|
41.2%
33/80 • Adverse event (AE) and serious adverse event (SAE) data were collected for 1 month for each subject. )
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
6.2%
5/80 • Adverse event (AE) and serious adverse event (SAE) data were collected for 1 month for each subject. )
|
|
Nervous system disorders
Headache
|
31.2%
25/80 • Adverse event (AE) and serious adverse event (SAE) data were collected for 1 month for each subject. )
|
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