An interventional study of VOLBELLA® with lidocaine in Infra-orbital Skin Depressions, sponsored by Allergan. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-04-16.
Sponsored by Allergan · Not applicable, Interventional, and Treatment
A prospective, open label, study evaluating JUVÉDERM® VOLBELLA with lidocaine treatment for the correction of skin depressions in the infra-orbital area (under the eyes)
8,057 studies on the registry are indexed under Depression; 1,641 are open to participants now.
This study's enrollment of 80 is close to the median of 84 across 6,720 interventional studies indexed under Depression.
Browse Depression studies →Allergan is the lead sponsor of 499 studies on the registry; none are open to participants now.
Of its 91 completed or terminated interventional studies of FDA-regulated products, 89 (98%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Infra-orbital skin depressions injected with VOLBELLA® with lidocaine.
Device: VOLBELLA® with lidocaine
VOLBELLA® with lidocaine administered to correct skin depression during initial treatment and optional top-up treatment 14 days later.
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
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).
Time frame: Baseline, Month 1
Percentage of Subjects With a ≥1 Grade Improvement From Baseline in Infra-Orbital Area on the AIRS on the Right and Left Side
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).
Time frame: Baseline, Day 0, Day 14, Month 6, Momth 9, Month 12
Injector Ease of Use on an 11-Point Scale
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).
Time frame: Day 0
Percentage of Subjects Assessed by the Investigator as Very Well Improved or Well Improved on the 5-Point Global Aesthetic Improvement Scale (GAIS)
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.
Time frame: Day 0, Day 14, Month 1, Month 6, Month 9, Month 12
Percentage of Subjects Assessed by the Subjects as Very Well Improved or Well Improved on the 5-Point Global Aesthetic Improvement Scale (GAIS)
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.
Time frame: Day 0, Day 14, Month 1, Month 6, Month 9, Month 12
Subject Overall Eye Appearance Total Score on the 5-Point Periorbital Aesthetic Appearance Questionnaire (PAAQ)
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).
Time frame: Day 0, Day 14, Month 1, Month 6, Month 9, Month 12
| Milestone | VOLBELLA® With Lidocaine |
|---|---|
| Started | 80 |
| Completed | 75 |
| Not completed | 5 |
| Withdrew: Lost to follow-up | 4 |
| Withdrew: Adverse event | 1 |
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).
| Percentage of Subjects | VOLBELLA® With Lidocaine |
|---|---|
| Right Side | 99 |
| Left Side | 100 |
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).
| Percentage of Subjects | VOLBELLA® With Lidocaine |
|---|---|
| Day 0 Right Side | 99 |
| Day 0 Left Side | 99 |
| Day 14 Right Side (N=60) | 98 |
| Day 14 Left Side (N=60) | 100 |
| Month 6 Right Side (N=73) | 93 |
| Month 6 Left Side (N=73) | 92 |
| Month 9 Right Side (N=72) | 81 |
| Month 9 Left Side (N=72) | 83 |
| Month 12 Right Side (N=71) | 55 |
| Month 12 Left Side (N=71) | 59 |
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).
| Scores on a Scale | VOLBELLA® With Lidocaine |
|---|---|
| Injector Ease of Use on an 11-Point Scale | 9.8 ± 0.0 |
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.
| Percentage of Subjects | VOLBELLA® With Lidocaine |
|---|---|
| Day 0 Very Well Improved Right Side | 45 |
| Day 0 Very Well Improved Left Side | 43 |
| Day 0 Well Improved Right Side | 34 |
| Day 0 Well Improved Left Side | 37 |
| Day 14 Very Well Improved Right Side (N=60) | 68 |
| Day 14 Very Well Improved Left Side (N=60) | 63 |
| Day 14 Well Improved Right Side (N=60) | 27 |
| Day 14 Well Improved Left Side (N=60) | 30 |
| Month 1 Very Well Improved Right Side (N=76) | 57 |
| Month 1 Very Well Improved Left Side (N=75) | 65 |
| Month 1 Well Improved Right Side (N=76) | 38 |
| Month 1 Well Improved Left Side (N=75) | 31 |
| Month 6 Very Well Improved Right Side (N=73) | 40 |
| Month 6 Very Well Improved Left Side (N=73) | 37 |
| Month 6 Well Improved Right Side (N=73) | 38 |
| Month 6 Well Improved Left Side (N=73) | 42 |
| Month 9 Very Well Improved Right Side (N=72) | 18 |
| Month 9 Very Well Improved Left Side (N=72) | 18 |
| Month 9 Well Improved Right Side (N=72) | 25 |
| Month 9 Well Improved Left Side (N=72) | 26 |
| Month 12 Very Well Improved Right Side (N=71) | 6 |
| Month 12 Very Well Improved Left Side (N=71) | 6 |
| Month 12 Well Improved Right Side (N=71) | 23 |
| Month 12 Well Improved Left Side (N=71) | 27 |
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.
| Percentage of Subjects | VOLBELLA® With Lidocaine |
|---|---|
| Day 0 Very Well Improved Right Side | 21 |
| Day 0 Very Well Improved Left Side | 18 |
| Day 0 Well Improved Right Side | 38 |
| Day 0 Well Improved Left Side | 36 |
| Day 14 Very Well Improved Right Side (N=60) | 43 |
| Day 14 Very Well Improved Left Side (N=60) | 40 |
| Day 14 Well Improved Right Side (N=60) | 35 |
| Day 14 Well Improved Left Side (N=60) | 38 |
| Month 1 Very Well Improved Right Side (N=76) | 39 |
| Month 1 Very Well Improved Left Side (N=75) | 43 |
| Month 1 Well Improved Right Side (N=76) | 32 |
| Month 1 Well Improved Left Side (N=75) | 30 |
| Month 6 Very Well Improved Right Side (N=73) | 22 |
| Month 6 Very Well Improved Left Side (N=73) | 18 |
| Month 6 Well Improved Right Side (N=73) | 29 |
| Month 6 Well Improved Left Side (N=73) | 30 |
| Month 9 Very Well Improved Right Side (N=72) | 19 |
| Month 9 Very Well Improved Left Side (N=72) | 17 |
| Month 9 Well Improved Right Side (N=72) | 26 |
| Month 9 Well Improved Left Side (N=72) | 25 |
| Month 12 Very Well Improved Right Side (N=73) | 16 |
| Month 12 Very Well Improved Left Side (N=73) | 12 |
| Month 12 Well Improved Right Side (N=73) | 23 |
| Month 12 Well Improved Left Side (N=73) | 25 |
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).
| Scores on a Scale | VOLBELLA® With Lidocaine |
|---|---|
| Day 0 | 19.3 ± 7.1 |
| Day 14 | 7.4 ± 6.4 |
| Month 1 | 6.0 ± 7.2 |
| Month 6 | 9.5 ± 7.7 |
| Month 9 | 9.9 ± 7.9 |
| Month 12 | 10.7 ± 8.4 |
Collected over Adverse event (AE) and serious adverse event (SAE) data were collected for 1 month for each subject. ). Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| VOLBELLA® With Lidocaine | — | 1/80 (1.3%) | 77/80 (96.3%) |
| Event | VOLBELLA® With Lidocaine |
|---|---|
| Uterine LeiomyomaReproductive system and breast disorders | 1/67 |
| Event | VOLBELLA® With Lidocaine |
|---|---|
| Injection Site BruisingGeneral disorders | 44/80 |
| Injection Site ErythemaGeneral disorders | 39/80 |
| Injection Site ReactionGeneral disorders | 33/80 |
| Injection Site OedemaGeneral disorders | 32/80 |
| Injection Site PainGeneral disorders | 26/80 |
| HeadacheNervous system disorders | 25/80 |
| Back PainMusculoskeletal and connective tissue disorders | 5/80 |
| Age, Continuous(Years) | VOLBELLA® With Lidocaine |
|---|---|
| Mean | 46.1 ± 1 |
| Sex: Female, Male(Participants) | VOLBELLA® With Lidocaine |
|---|---|
| Female | 67 |
| Male | 13 |
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