Abstract
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 7 sites were randomized 1:1 to Belotero Intense (n = 50) or Belotero Intense Lidocaine (n = 48) (Anteis S.A., Plan-les-Ouates, Switzerland, a company of the Merz Aesthetics group), 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 < .0001), 83.5% for marionette lines (95% CI 75.5, 91.4; P < .0001), and 57.4% for lip volume (95% CI 46.2, 68.7; P = .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). The overall incidence of treatment-related treatment-emergent adverse events was 24.5% and was comparable across the 3 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.