Back to resultsA Prospective, Open Label Study Evaluating JUVÉDERM® VOLBELLA With Lidocaine Treatment for the Correction of Skin Depressions in the Infra-orbital Area
Primary Purpose
Infra-orbital Skin Depressions
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
VOLBELLA® with lidocaine
Sponsored by
About this trial
This is an interventional treatment trial for Infra-orbital Skin Depressions
Eligibility Criteria
Inclusion Criteria:
- Has Grade > 0 at screening within each eye (bilateral skin depression in the infra-orbital area), as evaluated by the Evaluating Investigator (EI) using AIRS
- Agree to refrain from undergoing other antiwrinkle/volumizing treatments in the upper two-thirds of the face (eyebrow to cheeks/cheekbones) for the duration of the study
Exclusion Criteria:
- Has undergone cosmetic facial procedures [e.g., face-lift, or other surgeries which may alter the appearance of the infra-orbital area (laser, photomodulation, intense pulsed light, radio frequency, dermabrasion, moderate or greater depth chemical peel, or other ablative procedures), tissue augmentation with dermal fillers or fat injections, or mesotherapy] anywhere in the face, or Vistabel® cosmetic injections in the peri-orbital area, within 6 months prior to entry in the study or be planning to undergo any of these procedures at any time during the study. NOTE: Prior treatment with HA fillers and/or collagen is allowed, provided the treatment was administered more than 12 months prior to study entry
- Has undergone volumizing of the mid face within 12 months prior to study entry
- Has ever received semi-permanent fillers or permanent facial implants (e.g., calcium hydroxylapatite, poly-L-lactic acid, polymethylmethacrylate, silicone, expanded polytetrafluoroethylene) anywhere in the infra-orbital area, or be planning to be implanted with any of these products at any time during the study
- Have a history of skin cancer
- Have a history of hypertrophic scarring
- Have a subcutaneous retaining structure on the face (e.g., meshing, gold strand)
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
VOLBELLA® with lidocaine
Arm Description
Infra-orbital skin depressions injected with VOLBELLA® with lidocaine.
Outcomes
Primary Outcome Measures
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).
Secondary Outcome Measures
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).
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).
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.
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.
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).
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02176421
Brief Title
A Prospective, Open Label Study Evaluating JUVÉDERM® VOLBELLA With Lidocaine Treatment for the Correction of Skin Depressions in the Infra-orbital Area
Study Type
Interventional
2. Study Status
Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
May 15, 2014 (Actual)
Primary Completion Date
August 18, 2014 (Actual)
Study Completion Date
July 3, 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Allergan
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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)
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infra-orbital Skin Depressions
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
80 (Actual)
8. Arms, Groups, and Interventions
Arm Title
VOLBELLA® with lidocaine
Arm Type
Experimental
Arm Description
Infra-orbital skin depressions injected with VOLBELLA® with lidocaine.
Intervention Type
Device
Intervention Name(s)
VOLBELLA® with lidocaine
Intervention Description
VOLBELLA® with lidocaine administered to correct skin depression during initial treatment and optional top-up treatment 14 days later.
Primary Outcome Measure Information:
Title
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
Description
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
Secondary Outcome Measure Information:
Title
Percentage of Subjects With a ≥1 Grade Improvement From Baseline in Infra-Orbital Area on the AIRS on the Right and Left Side
Description
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
Title
Injector Ease of Use on an 11-Point Scale
Description
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
Title
Percentage of Subjects Assessed by the Investigator as Very Well Improved or Well Improved on the 5-Point Global Aesthetic Improvement Scale (GAIS)
Description
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
Title
Percentage of Subjects Assessed by the Subjects as Very Well Improved or Well Improved on the 5-Point Global Aesthetic Improvement Scale (GAIS)
Description
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
Title
Subject Overall Eye Appearance Total Score on the 5-Point Periorbital Aesthetic Appearance Questionnaire (PAAQ)
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Has Grade > 0 at screening within each eye (bilateral skin depression in the infra-orbital area), as evaluated by the Evaluating Investigator (EI) using AIRS
Agree to refrain from undergoing other antiwrinkle/volumizing treatments in the upper two-thirds of the face (eyebrow to cheeks/cheekbones) for the duration of the study
Exclusion Criteria:
Has undergone cosmetic facial procedures [e.g., face-lift, or other surgeries which may alter the appearance of the infra-orbital area (laser, photomodulation, intense pulsed light, radio frequency, dermabrasion, moderate or greater depth chemical peel, or other ablative procedures), tissue augmentation with dermal fillers or fat injections, or mesotherapy] anywhere in the face, or Vistabel® cosmetic injections in the peri-orbital area, within 6 months prior to entry in the study or be planning to undergo any of these procedures at any time during the study. NOTE: Prior treatment with HA fillers and/or collagen is allowed, provided the treatment was administered more than 12 months prior to study entry
Has undergone volumizing of the mid face within 12 months prior to study entry
Has ever received semi-permanent fillers or permanent facial implants (e.g., calcium hydroxylapatite, poly-L-lactic acid, polymethylmethacrylate, silicone, expanded polytetrafluoroethylene) anywhere in the infra-orbital area, or be planning to be implanted with any of these products at any time during the study
Have a history of skin cancer
Have a history of hypertrophic scarring
Have a subcutaneous retaining structure on the face (e.g., meshing, gold strand)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Monitor
Organizational Affiliation
Allergan Medical
Official's Role
Study Director
Facility Information:
City
Lyon
State/Province
Rhône-Alpes
Country
France
12. IPD Sharing Statement
Citations:
PubMed Identifier
28858926
Citation
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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A Prospective, Open Label Study Evaluating JUVÉDERM® VOLBELLA With Lidocaine Treatment for the Correction of Skin Depressions in the Infra-orbital Area
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