A Prospective, Multicenter, Evaluator-Blind, Randomized, Comparator-Controlled Study of Belotero Intense (+), a Hyaluronic Acid Filler With Lidocaine, for Lip Augmentation.

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.

RESULTS

Belotero Intense with lidocaine achieved a Week 8 MLFAS-responder rate of 91.1% (144/158; 95% CI, 85.6-95.1), with the lower limit of the CI exceeding the prespecified 50% success criterion. The least squares mean difference in change from baseline vs RSL was 0.1 (95% CI, 0.0-0.3), meeting the prespecified noninferiority criterion (ie, lower CI limit >-0.5). Among Week 8 responders, 70/137 (51.1%) maintained improvement through Week 48 (post hoc analysis). No severe or serious related treatment-emergent AEs or unexpected AEs were reported.

CONCLUSIONS

Belotero Intense with lidocaine is a safe and effective treatment for lip augmentation in patients with upper and/or lower lip volume deficits.