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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)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| VOLBELLA® with lidocaine | Experimental | Infra-orbital skin depressions injected with VOLBELLA® with lidocaine. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| VOLBELLA® with lidocaine | Device | VOLBELLA® with lidocaine administered to correct skin depression during initial treatment and optional top-up treatment 14 days later. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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). | Baseline, Month 1 |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | Baseline, Day 0, Day 14, Month 6, Momth 9, Month 12 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Monitor | Allergan Medical | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lyon | Auvergne-Rhône-Alpes | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28858926 | Background | Niforos F, Acquilla R, Ogilvie P, Safa M, Signorini M, Creutz L, Kerson G, Silberberg M. A Prospective, Open-Label Study of Hyaluronic Acid-Based Filler With Lidocaine (VYC-15L) Treatment for the Correction of Infraorbital Skin Depressions. Dermatol Surg. 2017 Oct;43(10):1271-1280. doi: 10.1097/DSS.0000000000001127. |
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| ID | Title | Description |
|---|---|---|
| FG000 | VOLBELLA® With Lidocaine | Infra-orbital skin depressions injected with VOLBELLA® with lidocaine. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| 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). | 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. | 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. | 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). | Day 0, Day 14, Month 1, Month 6, Month 9, Month 12 |
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| ID | Title | Description |
|---|---|---|
| BG000 | VOLBELLA® With Lidocaine | Infra-orbital skin depressions injected with VOLBELLA® with lidocaine. |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
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| Age, Continuous | Mean | Standard Deviation | Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||
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| Primary | 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). | All subjects with data for this outcome measure | Posted | Number | Percentage of Subjects | Baseline, Month 1 |
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| Secondary | 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). | All subjects with data for this outcome measure | Posted | Number | Percentage of Subjects | Baseline, Day 0, Day 14, Month 6, Momth 9, Month 12 |
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| Secondary | 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). | All subjects with data for this outcome measure | Posted | Mean | Standard Deviation | Scores on a Scale | Day 0 |
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| Secondary | 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. | All subjects with data for this outcome measure | Posted | Number | Percentage of Subjects | Day 0, Day 14, Month 1, Month 6, Month 9, Month 12 |
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| Secondary | 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. | All subjects with data for this outcome measure | Posted | Number | Percentage of Subjects | Day 0, Day 14, Month 1, Month 6, Month 9, Month 12 |
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| Secondary | 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). | All subjects with data for this outcome measure | Posted | Mean | Standard Deviation | Scores on a Scale | Day 0, Day 14, Month 1, Month 6, Month 9, Month 12 |
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Adverse event (AE) and serious adverse event (SAE) data were collected for 1 month for each subject. )
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | VOLBELLA® With Lidocaine | Infra-orbital skin depressions injected with VOLBELLA® with lidocaine. | 1 | 80 | 77 | 80 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Uterine Leiomyoma | Reproductive system and breast disorders | MedDRA version 18.0 | Systematic Assessment | Females Only |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Injection Site Bruising | General disorders | MedDRA version 18.0 | Non-systematic Assessment |
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| Injection Site Erythema | General disorders | MedDRA version 18.0 | Non-systematic Assessment |
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| Injection Site Oedema | General disorders | MedDRA version 18.0 | Non-systematic Assessment |
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| Injection Site Pain | General disorders | MedDRA version 18.0 | Non-systematic Assessment |
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| Injection Site Reaction | General disorders | MedDRA version 18.0 | Non-systematic Assessment |
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| Back Pain | Musculoskeletal and connective tissue disorders | MedDRA version 18.0 | Non-systematic Assessment |
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| Headache | Nervous system disorders | MedDRA version 18.0 | Non-systematic Assessment |
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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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Allergan Inc., | Allergan, Inc | clinicaltrials@allergan.com |
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