Juvéderm Volbella in the perioral area: a 12-month prospective, multicenter, open-label study

véderm Volbella in the perioral area: a 12-month prospective, multicenter, open-label study Original Research (2040) Total Article Views Authors: Eccleston D, Murphy DK Published Date October 2012 Volume 2012:5 Pages 167 - 172 DOI: http://dx.doi.org/10.2147/CCID.S35800 Received: 18 August 2012 Accepted: 26 September 2012 Published: 26 October 2012 David Eccleston,1 Diane K Murphy2 1Private Practice, Birmingham, UK; 2Allergan, Santa Barbara, CA, USA Background: Hyaluronic acid dermal fillers are frequently used for lip augmentation, and a new filler has been developed with characteristics especially suited for the lips. Methods: Four European sites treated 60 subjects with Juvéderm Volbella injectable gel in the perioral area, and subjects returned to the clinic at 1, 3, 6, 9, and 12 months for follow-up. The primary effectiveness endpoint established a priori was a Month 3 responder rate on the 4-point Lip Fullness Scale (LFS) of ≥40% and statistically > 0%, where responders improved ≥ 1 point from baseline on the investigator's assessment of LFS. At follow-up, subjects assessed lip fullness goal achievement, the look and feel of their lips, and their satisfaction with the effects of treatment. Results: The Month 3 LFS responder rate was 93.2% (P < 0.0001), so the primary endpoint was met, and clinical effectiveness was demonstrated. The responder rate over time showed that 78.0% of subjects still had improved lip fullness at Month 9 and 48.3% at Month 12. After treatment 98.3% of subjects reported that their lip fullness goal had been achieved, and this was maintained at 86.4% at Month 9 and 56.9% at Month 12. At Month 1, 81.0% of subjects reported that their lips felt smooth, and 91.4% reported that their lips looked natural (scores of 7–10 on an 11-point scale, where 0 was an unfavorable outcome and 10 was a favorable outcome). Similarly, 96.6% of subjects reported being satisfied (scores between 7 and 10 on an 11-point scale where 0 = very dissatisfied, 10 = very satisfied) at Month 1, and by Month 12 more than 80% of subjects were still satisfied. There were no severe adverse events related to treatment. Conclusion: Juvéderm Volbella injectable gel is well tolerated and has been demonstrated to provide a smooth and natural improvement in lip fullness that lasts for up to 1 year.