Status:
COMPLETED
Safety and Effectiveness of Juvéderm® VOLUMA XC Injectable Gel for Cheek Augmentation
Lead Sponsor:
Allergan
Conditions:
Mid-facial Volume Deficit Related to Aging
Eligibility:
All Genders
35-65 years
Phase:
NA
Brief Summary
Multicenter, single-blind, randomized, "no-treatment" control study to demonstrate the safety and effectiveness of VOLUMA XC for deep injection for cheek augmentation to correct age-related volume def...
Eligibility Criteria
Inclusion
- Male or female, 35-65 years of age
- Zygomaticomalar region, anteromedial cheek, submalar region, and/or overall mid-facial volume deficit assessed by the Treating Investigator as grade 3, 4, or 5 on the photometric Mid-Face Volume Deficit Scale (MFVDS)
- Desire cheek augmentation to correct age-related volume deficit in the mid-face
- Accept the obligation not to receive any other facial procedures or treatments affecting facial volume deficit at any time during the study
Exclusion
- Received (or is planning to receive) anti-coagulation, anti-platelet, or thrombolytic medications (e.g., warfarin), anti-inflammatory drugs \[oral/injectable corticosteroids or Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)\], or other substances known to increase coagulation time from 10 days pre- to 3 days post injection \[Study device injections may be delayed as necessary to accommodate this 10-day wash-out period.\]
- Have undergone facial plastic surgery (with the exception of rhinoplasty more than 2 years prior to enrollment), tissue grafting, or tissue augmentation with silicone, fat, or other permanent, or semi-permanent dermal fillers or be planning to undergo any of these procedures at any time during the study
- Have undergone temporary facial dermal filler injections with hyaluronic acid-based fillers within 12 months, porcine-based collagen fillers within 24 months, or neuromodulator injections, mesotherapy, or resurfacing within 6 months prior to entry in the study or be planning to undergo any of these procedures at any time during the study
- Have begun use of any new over-the-counter or prescription, oral or topical, anti-wrinkle products in the treatment area within 90 days prior to enrollment or be planning to begin use of such products at any time during the study.
- Have very thin skin in the mid-facial region, tendency to accumulate fluid in the lower eyelids, or large infraorbital fat pads
- Have mid-face volume deficit due to congenital defect, trauma, abnormalities in adipose tissue related to immune-mediated diseases such as generalized lipodystrophy, partial lipodystrophy, inherited disease, or HIV-related disease
- Have a history of anaphylaxis, multiple severe allergies, atopy, or allergy to lidocaine (or any amide-based anesthetic), hyaluronic acid products, or Streptococcal protein, or have plans to undergo desensitization therapy during the term of the study
- Have noticeable acne scarring, an active inflammation, infection, cancerous or pre-cancerous lesion, or unhealed wound or have undergone radiation treatment in the area to be treated
Key Trial Info
Start Date :
August 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2014
Estimated Enrollment :
345 Patients enrolled
Trial Details
Trial ID
NCT00978042
Start Date
August 1 2009
End Date
April 1 2014
Last Update
November 3 2015
Active Locations (2)
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1
Los Angeles, California, United States
2
Vancouver, British Columbia, Canada