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Randomized Controlled Trial Multicenter Study
Duration of effect by injection volume and facial subregion for a volumizing hyaluronic acid filler in treating midface volume deficit.
- Dee Anna Glaser, Jeffrey M Kenkel, Deepali Paradkar-Mitragotri, Diane K Murphy, Linda Romagnano, and Adrienne Drinkwater.
- *Department of Dermatology, St. Louis University, St. Louis, Missouri; †Department of Plastic Surgery, University of Texas Southwestern, Dallas, Texas; ‡Allergan, Inc., Irvine, California; §Peloton Advantage, Parsippany, New Jersey.
- Dermatol Surg. 2015 Aug 1; 41 (8): 942-9.
BackgroundJuvéderm Voluma XC (VYC-20L) is approved in the United States for correction of age-related volume loss in the midface region in adults.ObjectiveTo characterize the effects of VYC-20L in 3 midface subregions based on injection volumes.MethodsIn this single-blind controlled trial, subjects with midface volume deficit received VYC-20L in ≥1 of 3 facial subregions (zygomaticomalar, anteromedial cheek, and submalar), with touch-up treatment available 30 days later. Responders achieved ≥1-point improvement on the Mid-Face Volume Deficit Scale (MFVDS), analyzed by facial subregion and stratified by injection volume quartiles. Subject satisfaction and safety were assessed.ResultsThe treatment arm comprised 235 subjects aged 35 to 65 years. Month 6 MFVDS responder rates were 75.5% for zygomaticomalar, 83.2% for anteromedial cheek, and 76.9% for submalar subregions. Higher responder rates were observed with increasing injection volume quartiles for each subregion. Similar median injection volumes (≈2.0 mL total) of VYC-20L provided correction durations of 15 to 24 months: 24 months for anteromedial cheek, 19 months for zygomaticomalar, and 15 months for submalar subregions. Subject satisfaction was high across injection volume quartiles. No unanticipated treatment-site adverse reactions occurred.ConclusionVYC-20L is effective at restoring midface volume, with high subject satisfaction and an acceptable safety profile.
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