N/A
N=80
A Prospective, Open Label Study Evaluating JUVÉDERM® VOLBELLA With Lidocaine Treatment for the Correction of Skin Depressions in the Infra-orbital Area
Infra-orbital Skin Depressions
Bottom Line
View on ClinicalTrials.gov: NCT02176421 ↗Enrolled (actual)
80
Serious AEs
1.3%
Results posted
Jul 2015
Primary outcome: 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 — 99; 100 Percentage of Subjects
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- VOLBELLA® with lidocaine (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Allergan
- Primary completion
- Aug 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| 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 |
99; 100 | — |
| SECONDARY Percentage of Subjects With a ≥1 Grade Improvement From Baseline in Infra-Orbital Area on the AIRS on the Right and Left Side |
99; 99; 98; 100; 93; 92 | — |
| SECONDARY Injector Ease of Use on an 11-Point Scale |
9.8 | — |
| SECONDARY Percentage of Subjects Assessed by the Investigator as Very Well Improved or Well Improved on the 5-Point Global Aesthetic Improvement Scale (GAIS) |
45; 43; 34; 37; 68; 63 | — |
| SECONDARY Percentage of Subjects Assessed by the Subjects as Very Well Improved or Well Improved on the 5-Point Global Aesthetic Improvement Scale (GAIS) |
21; 18; 38; 36; 43; 40 | — |
| SECONDARY Subject Overall Eye Appearance Total Score on the 5-Point Periorbital Aesthetic Appearance Questionnaire (PAAQ) |
19.3; 7.4; 6.0; 9.5; 9.9; 10.7 | — |
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)
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)
Data sourced from ClinicalTrials.gov (NCT02176421). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.