United States, Canada345 participantsStarted 2009-08
Plain-language 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 deficit in the mid-face.
Who can participate
Age range35 Years – 65 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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 Criteria:
* 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…
What they're measuring
1
Responder Rate Based on Improvement in Score on Validated 6-point Mid-Face Volume Deficit Scale (MFVDS)