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A Multicenter, Single-Blind Randomized, Controlled Study of a Volumizing Hyaluronic Acid Filler for Midface Volume Deficit: Patient-Reported Outcomes at 2 Years.

Few J, Cox SE, Paradkar-Mitragotri D, Murphy DK - Aesthet Surg J (2015)

Bottom Line: The effectiveness of Juvéderm Voluma XC was examined from the patient perspective.Increased satisfaction with outer and lower cheek areas and cheek-bone projection and clinically significant improvements in LAFM were noted through month 24.Juvéderm Voluma XC for age-related MVD is effective and well-tolerated from the patient perspective, with results lasting up to 2 years. 4 Therapeutic.

View Article: PubMed Central - PubMed

Affiliation: Dr Few is Clinical Professor of Surgery, Division of Plastic Surgery, University of Chicago Pritzker School of Medicine, Chicago, Illinois. Dr Cox is Assistant Clinical Professor, University of North Carolina, Chapel Hill, North Carolina; and is Supervising Physician, Dermatology Program, Duke University, Durham, North Carolina. Dr Paradkar-Mitragotri was the Manager of Biostatistics at the time of this study and is a former employee of Allergan, Inc., Irvine, California, and Ms Murphy is the Director of Clinical Development Submissions at Allergan, Inc., Irvine, California.

No MeSH data available.


Related in: MedlinePlus

Diagram showing the midface treatment areas.
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SJV050F1: Diagram showing the midface treatment areas.

Mentions: Patients were randomized to 20 mg/mL Juvéderm Voluma XC (n = 235) or to a no-treatment control (n = 47). A no-treatment control was chosen because there were no products approved by the US FDA for an age-related MVD-treatment indication that could serve as an injection control. As each subsequent patient qualified for study entry, the investigator contacted Allergan for treatment assignment based on a previously generated randomization schedule. Control patients received treatment after month 6 (ie, after the primary study endpoint evaluation). Initial treatment was followed by an optional touch-up 1 month later if optimal cheek augmentation was not achieved based on investigator and patient assessment. Areas of treatment included the zygomaticomalar region, the anteromedial cheek, and the submalar region (Figure 1).20,21 The study protocol was registered at www.clinicaltrials.gov (NCT00978042) and was approved by applicable institutional review boards (ie, Quorum Review IRB, Seattle, WA; Saint Louis University, St. Louis, MO; The University of Texas Southwestern Medical Center at Dallas IRB, Dallas, TX). All patients provided written informed consent prior to any study-related procedures.Figure 1.


A Multicenter, Single-Blind Randomized, Controlled Study of a Volumizing Hyaluronic Acid Filler for Midface Volume Deficit: Patient-Reported Outcomes at 2 Years.

Few J, Cox SE, Paradkar-Mitragotri D, Murphy DK - Aesthet Surg J (2015)

Diagram showing the midface treatment areas.
© Copyright Policy - creative-commons
Related In: Results  -  Collection

License
Show All Figures
getmorefigures.php?uid=PMC4482214&req=5

SJV050F1: Diagram showing the midface treatment areas.
Mentions: Patients were randomized to 20 mg/mL Juvéderm Voluma XC (n = 235) or to a no-treatment control (n = 47). A no-treatment control was chosen because there were no products approved by the US FDA for an age-related MVD-treatment indication that could serve as an injection control. As each subsequent patient qualified for study entry, the investigator contacted Allergan for treatment assignment based on a previously generated randomization schedule. Control patients received treatment after month 6 (ie, after the primary study endpoint evaluation). Initial treatment was followed by an optional touch-up 1 month later if optimal cheek augmentation was not achieved based on investigator and patient assessment. Areas of treatment included the zygomaticomalar region, the anteromedial cheek, and the submalar region (Figure 1).20,21 The study protocol was registered at www.clinicaltrials.gov (NCT00978042) and was approved by applicable institutional review boards (ie, Quorum Review IRB, Seattle, WA; Saint Louis University, St. Louis, MO; The University of Texas Southwestern Medical Center at Dallas IRB, Dallas, TX). All patients provided written informed consent prior to any study-related procedures.Figure 1.

Bottom Line: The effectiveness of Juvéderm Voluma XC was examined from the patient perspective.Increased satisfaction with outer and lower cheek areas and cheek-bone projection and clinically significant improvements in LAFM were noted through month 24.Juvéderm Voluma XC for age-related MVD is effective and well-tolerated from the patient perspective, with results lasting up to 2 years. 4 Therapeutic.

View Article: PubMed Central - PubMed

Affiliation: Dr Few is Clinical Professor of Surgery, Division of Plastic Surgery, University of Chicago Pritzker School of Medicine, Chicago, Illinois. Dr Cox is Assistant Clinical Professor, University of North Carolina, Chapel Hill, North Carolina; and is Supervising Physician, Dermatology Program, Duke University, Durham, North Carolina. Dr Paradkar-Mitragotri was the Manager of Biostatistics at the time of this study and is a former employee of Allergan, Inc., Irvine, California, and Ms Murphy is the Director of Clinical Development Submissions at Allergan, Inc., Irvine, California.

No MeSH data available.


Related in: MedlinePlus