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 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.