The Volumizing Effect of Juvéderm VOLUMA® in the Mid-Face

Allergan

Status

Completed

Conditions

Age-related Volume Deficit in the Mid-face

Treatments

Device: Crosslinked hyaluronic acid gel (Juvéderm VOLUMA®)

Study type

Observational

Funder types

Industry

Identifiers

NCT01559064

MAF/AGN/MED/FIL/017

Details and patient eligibility

About

This is a prospective, observational study of the volumizing effect of aesthetic use of Juvéderm VOLUMA® with lidocaine in the mid-face area.

Enrollment

115 patients

Sex

All

Ages

30+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Desire and willingness for correction of asymmetry or enhancement of his/her mid-face area.
Be willing to undergo treatment for volume loss in the face area
Females and males ≥30 years of age
Be in good health as of the opinion of the Investigator
Sign the Informed Consent Form prior to any study-related procedures being performed
Have established a realistic treatment goal that the Investigator agrees is achievable i.e., have realistic expectations of aesthetic results

Exclusion criteria

Have extensive tissue damage that could affect the aesthetic outcome
Have a known allergy to any component of VOLUMA® with lidocaine injections
Have an abscess or infection at the time of treatment that in the opinion of the Investigator does not make the subject eligible for the procedure.
Have undergone cosmetic facial [e.g., face-lift, or other surgeries, which may alter the appearance of the mid-face region (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 meso-therapy] anywhere in the mid-face region, or Botox® Cosmetic injections in the lower face (below the orbital rim), within the 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 hyaluronic acid (HA) fillers and/or collagen is allowed, provided the treatment was administered more than 6 months prior to study entry
Have ever received semi-permanent fillers or permanent facial implants, e.g., calcium hydroxyapatite, L-polylactic acid, polymethylmethacrylate (PMMA), silicone, expanded polytetrafluoroethylene (ePTFE) anywhere in the lips, or be planning to be implanted with any of these products at any time during the study
Have a history of anaphylaxis, multiple severe allergies, atopy, allergy to lidocaine (or any amide-based anesthetics), HA products, or Streptococcal protein, or be planning to undergo a desensitization therapy during the term of the study
Suffer from an uncontrolled personality disorder (e.g., body dysmorphia, depression)
Have a history of or currently suffer from an autoimmune disease (e.g., Rheumatoid arthritis, Crohn's disease)
Have a history of streptococcal disease (e.g., strep throat or rheumatic fever with or without heart complications)
Have a history of skin cancer
Suffer from Porphyria
Have epilepsy which is not controlled by anti-epilepsy therapy
Current cutaneous inflammatory and/or infectious processes (e.g., acne, herpes, etc.)
Have a history of treatment with interferon therapy (e.g., warfarin) or have taken non-steroidal anti-inflammatory drugs (NSAIDs) (e.g., aspirin, ibuprofen) or other substances known to increase coagulation time (e.g., herbal supplements with garlic or ginko biloba) within 10 days of undergoing study device injection. NOTE: Study device injection may be delayed as necessary to accommodate this 10-day washout period
Be on a concurrent regimen of high doses of lidocaine (more than 400 mg) which may cause acute toxic reactions
Be on a concurrent regimen of other local anesthetics structurally related to amide-type local anesthetics
Have impaired cardiac conduction, severly impaired hepatic function, or severe renal dysfunction
Have a condition or be in a situation that, in the Investigator's opinion, may put the subject at significant risk, may confound the study results, or may interfere significantly with the subject's participation in the study