A Prospective, Open Label Study Evaluating JUVÉDERM® VOLBELLA With Lidocaine Treatment for the Correction of Skin Depressions in the Infra-orbital Area

NCT02176421 | Completed Results

• 1 other identifier: MAF-AGN-MED-FIL-020
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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)

Conditions

Infra-orbital Skin Depressions

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (5)

• Percentage of Subjects With a ≥1 Grade Improvement From Baseline in Infra-Orbital Area on the AIRS on the Right and Left Side

  Baseline, Day 0, Day 14, Month 6, Momth 9, Month 12

• Injector Ease of Use on an 11-Point Scale

  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)

  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)

  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)

  Day 0, Day 14, Month 1, Month 6, Month 9, Month 12

Study Arms (1)

VOLBELLA® with lidocaine

EXPERIMENTAL

Infra-orbital skin depressions injected with VOLBELLA® with lidocaine.

Device: VOLBELLA® with lidocaine

Interventions

VOLBELLA® with lidocaine DEVICE

VOLBELLA® with lidocaine administered to correct skin depression during initial treatment and optional top-up treatment 14 days later.

VOLBELLA® with lidocaine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Allergan: lead

Study Sites (1)

Unknown Facility

Lyon, Auvergne-Rhône-Alpes, France

Location

Related Publications (1)

• 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.

  PMID: 28858926 BACKGROUND

Results Point of Contact

• Title: Allergan Inc.,
• Organization: Allergan, Inc

clinicaltrials@allergan.com

Study Officials

• Medical Monitor

  Allergan Medical

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 25, 2014
• First Posted: June 27, 2014
• Study Start: May 15, 2014
• Primary Completion: August 18, 2014
• Study Completion: July 3, 2015
• Last Updated: April 16, 2019
• Results First Posted: July 16, 2015

Record last verified: 2019-04

Locations

FR (1)