Lip and Perioral Enhancement: A 12-Month Prospective, Randomized, Controlled Study

December 2015 | Volume 14 | Issue 12 | Original Article | 1444 | Copyright © 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

Abstract

BACKGROUND: Juvéderm® Volbella® with Lidocaine is a hyaluronic acid filler suited for lip enhancement.
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.

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INTRODUCTION

Hyaluronic acid dermal fillers are commonly used for lip augmentation to enhance appearance and to restore fullness and definition lost due to hypoplasia or aging.1,2 Treatment with temporary hyaluronic acid fillers restores the natural contour of the lip region, enhances overall lip fullness and the vermilion border, and minimizes perioral lines and oral commissures.3-6 Juvéderm® Volbella® with Lidocaine (Allergan, Inc, Irvine CA) is a dermal filler that uses the Vycross® (Allergan, Inc) technology platform. By combining low– and high–molecular-weight hyaluronic acid with a novel crosslinking process, the technology allows increased crosslinking efficiency and results in a tightly crosslinked hyaluronic acid network that increases product duration of action and produces a moldable, higher-viscosity gel with greater lift capacity. The inclusion of a small quantity of non-crosslinked hyaluronic acid reduces extrusion force and allows injection through a 30-gauge half-inch needle. The addition of lidocaine makes the injection process more comfortable and reduces the need for conventional anesthesia.2,7

This study evaluated the safety and effectiveness of Juvéderm Volbella with Lidocaine for lip volume enhancement compared with Restylane-L® (non-animal stabilized hyaluronic acid with lidocaine; Medicis Aesthetics, Scottsdale, AZ), another lidocaine- containing hyaluronic acid dermal filler approved for lip augmentation. Results of the 3-month primary endpoint were published recently8; this report presents results from the entire 12-month follow-up, including duration of effectiveness and safety and effectiveness of repeat treatment.

METHODS

Study Design

This prospective, randomized, 2-arm, active-controlled study (NCT01579305) was conducted from April 2012 through January

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