Aesthetic surgery journal · 2026
A Prospective, Multicenter, Evaluator-Blind, Randomized, Comparator-Controlled Study of Belotero Intense (+), a Hyaluronic Acid Filler With Lidocaine, for Lip Augmentation.
СтатьяРандомизированное исследованиеМногоцентровое исследованиеСравнительное исследованиеEquivalence TrialНазвание и аннотация: Перевод пока не подготовлен
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Moradi Amir, Gold Michael H, Hill David, Dersch Hanna, Radusky Ross, Schwab Ute
Аннотация
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.
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.