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

NCT ID: NCT02176421

Last Updated: 2019-04-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-05-15
• Study Completion Date: 2015-07-03

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

VOLBELLA® with lidocaine

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

Group Type: EXPERIMENTAL

VOLBELLA® with lidocaine

Intervention Type: DEVICE

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

Interventions

VOLBELLA® with lidocaine

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

Intervention Type: DEVICE

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Allergan

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Monitor

Role: STUDY_DIRECTOR

Allergan Medical

Locations

Lyon, Auvergne-Rhône-Alpes, France

Countries

France

References

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.

Reference Type: BACKGROUND

PMID: 28858926 (View on PubMed)

Other Identifiers

MAF-AGN-MED-FIL-020

Identifier Type: -

Identifier Source: org_study_id