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.
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.
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.