Aesthetic surgery journal
A Prospective, Multicenter, Evaluator-Blind, Randomized, Comparator-Controlled Study of Belotero Intense (+), a Hyaluronic Acid Filler With Lidocaine, for Lip Augmentation
By Moradi A, Gold MH, Hill D and 3 others.
Abstract
Background
Lip augmentation with hyaluronic acid (HA)-based dermal fillers is commonly performed to enhance lip volume, shape, and symmetry.
Objectives
The aim of this study was to establish the safety and effectiveness of Belotero Intense with lidocaine (BIL), a cohesive polydensified matrix HA filler, for lip augmentation, and demonstrate its noninferiority to Restylane Silk with lidocaine (RSL), a US FDA-approved HA filler.
Methods
Patients with a Merz Lip Fullness Assessment Scale (MLFAS) rating of very thin, thin, or medium on upper and lower lips (Fitzpatrick skin type [FST] I-IV) or at least one lip (FST V or VI) were randomized 3:1 to receive BIL or RSL at baseline. Touch-up treatment was allowed at Week 4; retreatment at Week 48 was offered to BIL patients only. Primary effectiveness was assessed by a blinded evaluator using the MLFAS, and adverse events (AEs) were recorded up to 60 weeks.