Clinical trial NCT01559064: The Volumizing Effect of Juvéderm VOLUMA® in the Mid-Face
Official title: A Prospective, Observational Study of the Volumizing Effect of Open-Label Aesthetic Use of VOLUMA® in the Mid-Face Area
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Age-related Volume Deficit in the Mid-face
Lead sponsor: Allergan
Sponsor class: INDUSTRY
First posted: 2012-03-21
Enrollment: 115
Sex: ALL
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Normal, healthy subjects desiring aesthetic improvement

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


Eligibility criteria: 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

Primary outcomes:
measure: Subject Experience Measured by Patient Satisfaction Questionnaire
timeFrame: 3 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Aalst
country: Belgium
city: Koln
country: Germany
state: North Rhine-Westphalia
city: Naarden
country: Netherlands
city: Mere Green
country: United Kingdom
Study officials:
affiliation: Allergan Medical
name: Medical Monitor
role: STUDY_DIRECTOR
References:
citation: Philipp-Dormston WG, Eccleston D, De Boulle K, Hilton S, van den Elzen H, Nathan M. A prospective, observational study of the volumizing effect of open-label aesthetic use of Juvederm(R) VOLUMA(R) with Lidocaine in mid-face area. J Cosmet Laser Ther. 2014 Aug;16(4):171-9. doi: 10.3109/14764172.2014.910079. Epub 2014 May 5.