Safety and Effectiveness of a Novel Hyaluronic Acid Gel for Lip Augmentation

January 2022 | Volume 21 | Issue 1 | 13 | Copyright © January 2022


Published online December 30, 2021

Jeffery Adelglass MDa, Javier Alonso-Llamazares MD PhDb, Jeremy Fenton MDc, Michael H. Gold MDd, Joel Schlessinger MDe, Stacy R. Smith MDf

aSkintastic, Plano, TX
bInternational Dermatology Research, Inc. Miami, FL
cSchweiger Dermatology, PLLC New York, NY
dTennessee Clinical Research Center, Nashville, TN
eSkin Specialists, PC, Omaha, NE
fCalifornia Dermatology & Clinical Research Institute Encinitas, CA

Abstract
Objective: To compare the safety and efficacy of a novel hyaluronic acid injectable gel with 0.3% lidocaine (test device) with that of a commercially available injectable hyaluronic acid gel with 0.3% lidocaine (comparator) for lip augmentation.
Methods: Eligible patients (n = 158) with an overall score of very thin (n = 0) or thin (n = 1) on a 5-point Lip Fullness Grading Scale (LFGS) participated in the double-blind, randomized, multicenter study. Efficacy was assessed periodically over 6 months on a per protocol (PP) population (definitive) and a modified intent-to-treat (mITT) population (supportive).
Results: In the PP population, the mean change from baseline (day 56) in LFGS score was 1.52 for the test device and 1.53 for the comparator. This 56-day change was the primary efficacy endpoint. The 95% confidence interval (CI) limits for the mean difference in scores (test device minus comparator) were -0.33 and 0.31. In the mITT population, the corresponding 95% CI limits were -0.26 and 0.31. In both populations, the lower limits, -0.33 and -0.26, were higher than the prespecified -0.50, indicating that the test device was non-inferior to comparator. The adverse event profile was similar between the treatment groups. Ninety-three percent of patients treated with test device considered themselves improved, much improved, or very much improved at day 168 compared to 82% of those treated with comparator. The corresponding investigator improvement ratings were 100% and 76%, respectively.
Conclusion: For lip augmentation, the efficacy and safety of the test device is non-inferior to comparator.

J Drugs Dermatol. 2022;21(1):13-20 doi:10.36849/JDD.6548

INTRODUCTION

Full lips are associated with a youthful appearance, while thinning of the visible red lip indicates natural aging. Lip augmentation is a procedure designed to increase vermilion height, create pout (effacement), soften perioral lines and wrinkles, add volume, and reduce excess visible dentition, all to improve the dimensional relationship of the lips to the face. Injectable hyaluronic acid (HA) gel fillers are well-established for augmenting lips and correcting perioral rhytids.1,2

The objective of the present study was to compare the safety and efficacy profile of a novel HA injectable gel with 0.3% lidocaine (test device) with that of a commercially available injectable HA gel with 0.3% lidocaine (comparator) for lip augmentation. The test device consists of small, spherical, and uniform particles designed to facilitate optimal integration in the treated area, slow and predictable breakdown, and ease of injection.3 The comparator is commercially available for (1) submucosal implantation with lip augmentation and (2) dermal implantation with correction of perioral rhytids in adults over the age of 21 years.

MATERIALS AND METHODS

Study Design
Qualified patients enrolled in the double-blind, randomized, controlled, multicenter, 6-month study of patients seeking lip augmentation. Patients were randomized 1:1 to treatment with either test device (Revanesse® Lips+, Prollenium Medical Technologies, Inc., Aurora, ON, Canada) or comparator (Restylane Silk, Galderma Laboratories, L.P., Fort Worth, TX). The test device is a clear, colorless gel in 1.0 mL pre-filled syringes with 25 mg/mL of stabilized HA and lidocaine 0.3% w/w. Comparator is a clear, colorless gel in 1.0 mL pre-filled syringes formulated to a concentration of 20 mg/mL of stabilized HA and lidocaine 0.3% w/w. The treating investigator was unblinded and the evaluating investigator was blinded to treatments administered.