Effectiveness and Safety of Belotero Intense ± Lidocaine for the Correction of Nasolabial Folds, Marionette Lines, and Lip Volume Enhancement: A Randomized Post-market Clinical Follow-up Study

Background Although hyaluronic acid-based dermal fillers are widely used, real-world effectiveness and safety data remain limited. Objectives To confirm the effectiveness and safety of Belotero Intense and Belotero Intense Lidocaine (cohesive polydensified matrix hyaluronic acid fillers) in a real-world setting. Methods In this multicenter, randomized, rater-blind, uncontrolled, post-market clinical study, 98 participants from seven sites were randomized 1:1 to Belotero Intense (n=50) or Belotero Intense Lidocaine (n=48), administered to 2–3 facial areas (nasolabial folds, marionette lines, and upper/lower lips including lip border), with optional touch-up at Week 4. Primary effectiveness endpoints were responder rate (defined as ≥1 point improvement compared with baseline on both sides of the treated area or both lips) at 12 weeks after last injection on the Merz Aesthetics® Scales. Results The responder rate was 85.5% for nasolabial folds (95% confidence interval [CI] 78.4, 92.6; p<0.0001), 83.5% for marionette lines (95% CI 75.5, 91.4; p<0.0001), and 57.4% for lip volume (95% CI 46.2, 68.7; p=0.0967). Post hoc analyses using a revised definition of response for the lips (≥1 point improvement in at least one lip) demonstrated a clinical meaningful improvement (85.1% responder rate; 95% CI 77.0, 93.2). Overall incidence of treatment-related treatment-emergent adverse events was 24.5% and was comparable across the three treatment areas. Conclusions Under real-world conditions, this study demonstrated that Belotero Intense and Belotero Intense Lidocaine were effective and well tolerated in the correction of nasolabial folds, marionette lines and lip volume.