Format

Send to

Choose Destination
Aesthet Surg J. 2015 Jul;35(5):589-99. doi: 10.1093/asj/sjv050. Epub 2015 May 11.

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

Author information

1
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.

Abstract

BACKGROUND:

Juvéderm Voluma XC is a volumizing hyaluronic acid filler used for correction of age-related midface volume deficit (MVD).

OBJECTIVES:

The effectiveness of Juvéderm Voluma XC was examined from the patient perspective.

METHODS:

Patients with moderate to severe age-related MVD (N = 235) received Juvéderm Voluma XC. At quarterly follow-up visits for 2 years, patients rated treatment outcomes on the Global Aesthetic Improvement Scale (GAIS), overall satisfaction with facial appearance, satisfaction with midfacial regions, achievement of treatment goal, Look and Feel of the Midface (LAFM), and Self-Perception of Age (SPA). Patients recorded treatment-site responses in 30-day diaries.

RESULTS:

At 6 months and 2 years after treatment, 92.8% and 79.0% of patients, respectively, rated their cheek volume as improved/much improved on the GAIS. Improvement in satisfaction with facial appearance was noted by 89.8% of patients at 6 months and 75.8% at 2 years. Increased satisfaction with outer and lower cheek areas and cheek-bone projection and clinically significant improvements in LAFM were noted through month 24. Treatment goals were achieved by 67.8% of patients at 6 months and 49.0% at 2 years. Patients reported looking, on average, 5 years younger at 6 months and 3 years younger at 2 years. The most common treatment site responses were tenderness, swelling, firmness, and lumps/bumps; most were mild to moderate in severity and lasted ≤2 weeks.

CONCLUSIONS:

Juvéderm Voluma XC for age-related MVD is effective and well-tolerated from the patient perspective, with results lasting up to 2 years.

LEVEL OF EVIDENCE:

4 Therapeutic.

TRIAL REGISTRATION:

ClinicalTrials.gov NCT00978042.

PMID:
25964628
PMCID:
PMC4482214
DOI:
10.1093/asj/sjv050
[Indexed for MEDLINE]
Free PMC Article

Supplemental Content

Full text links

Icon for Silverchair Information Systems Icon for PubMed Central
Loading ...
Support Center