Clinical trial NCT02176421: 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
Overall status: COMPLETED
Phase: NA
Conditions: Infra-orbital Skin Depressions
Lead sponsor: Allergan
Sponsor class: INDUSTRY
First posted: 2014-06-27
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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)


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)

Primary outcomes:
measure: 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
timeFrame: Baseline, Month 1
Secondary outcomes:
measure: Percentage of Subjects With a ≥1 Grade Improvement From Baseline in Infra-Orbital Area on the AIRS on the Right and Left Side
timeFrame: Baseline, Day 0, Day 14, Month 6, Momth 9, Month 12
measure: Injector Ease of Use on an 11-Point Scale
timeFrame: Day 0
measure: Percentage of Subjects Assessed by the Investigator as Very Well Improved or Well Improved on the 5-Point Global Aesthetic Improvement Scale (GAIS)
timeFrame: Day 0, Day 14, Month 1, Month 6, Month 9, Month 12
measure: Percentage of Subjects Assessed by the Subjects as Very Well Improved or Well Improved on the 5-Point Global Aesthetic Improvement Scale (GAIS)
timeFrame: Day 0, Day 14, Month 1, Month 6, Month 9, Month 12
measure: Subject Overall Eye Appearance Total Score on the 5-Point Periorbital Aesthetic Appearance Questionnaire (PAAQ)
timeFrame: Day 0, Day 14, Month 1, Month 6, Month 9, Month 12
Other outcomes:
Locations:
city: Lyon
country: France
state: Rhône-Alpes
Study officials:
affiliation: Allergan Medical
name: Medical Monitor
role: STUDY_DIRECTOR
References:
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.