Lip and Perioral Enhancement: A 12-Month Prospective, Randomized, Controlled Study
December 2015 | Volume 14 | Issue 12 | Original Article | 1444 | Copyright © December 2015
Hervé Raspaldo MD,a Jonquille Chantrey MD,b Lakhdar Belhaouari MD,c David Eccleston MD,d Roy Saleh MD,e Raj Acquilla MD,f and Diane K. Murphy MBAg
aCannes Private Clinic, Cannes, France
bJonquille Chantrey – Expert Aesthetics, Cheshire, United Kingdom
cCentre de Chirurgie Esthetique, Toulouse, France
dMediZen Ltd, Sutton Coldfield, United Kingdom
eSaleh Aesthetic Clinic, Cheadle, United Kingdom
fCheshire Cosmetic Ltd, Cheshire, United Kingdom
gAllergan, Inc., Irvine, CA
OBJECTIVE: Evaluate the safety and effectiveness of Juvéderm Volbella with Lidocaine versus non-animal stabilized hyaluronic acid with lidocaine (Restylane-L®).
METHODS: This study randomized 280 subjects desiring lip enhancement to Juvéderm Volbella with Lidocaine or Restylane-L. Investigators rated outcomes using Allergan’s Lip Fullness Scale (LFS), Perioral Lines Severity Scale, and Oral Commissures Severity Scale. Independent central reviewers (ICRs) assessed 3-dimensional photographs using these scales. Noninferiority of Juvéderm Volbella with Lidocaine to Restylane-L was based on ICR assessment of LFS responders (≥1-point improvement from baseline) at month 3. Subjects were evaluated up to 12 months and after repeat treatment.
RESULTS: Juvéderm Volbella with Lidocaine was noninferior to Restylane-L at 3 months. Investigator assessments showed significant improvements in lip fullness (P≤.03), perioral lines (P≤.04), and oral commissures (P≤.03) with Juvéderm Volbella with Lidocaine versus Restylane-L at months 6 to 12. There was less acute swelling and fewer severe injection site responses with Juvéderm Volbella with Lidocaine. Safety and effectiveness of repeat treatment with Juvéderm Volbella with Lidocaine was comparable to initial treatment, regardless of initial filler.
CONCLUSIONS: Juvéderm Volbella with Lidocaine is safe and effective for lip and perioral enhancement, with effectiveness lasting up to 12 months.
J Drugs Dermatol. 2015;14(12):1444-1452.