A Prospective, Multicenter, Evaluator-Blind, Randomized, Comparator-Controlled Study of Belotero Intense (+), a Hyaluronic Acid Filler With Lidocaine, for Lip Augmentation.
Amir Moradi, Michael H Gold, David Hill et al.
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In 30 seconds
This multicenter, evaluator-blind randomized comparator-controlled equivalence trial assessed Belotero Intense with lidocaine (BIL) for lip augmentation in patients with lip volume deficits, comparing it with Restylane Silk with lidocaine (RSL). At Week 8, 91.1% of BIL-treated patients (144/158; 95% CI, 85.6-95.1) met the Merz Lip Fullness Assessment Scale responder definition, exceeding the prespecified success criterion. The between-group difference in change from baseline was 0.1 (95% CI, 0.0-0.3), meeting the trial’s noninferiority criterion. No severe or serious related treatment-emergent adverse events were reported.
Key findings
- At Week 8, the BIL responder rate was 91.1% (144/158; 95% CI, 85.6-95.1), exceeding the prespecified 50% success criterion.
- The least squares mean difference versus RSL in change from baseline was 0.1 (95% CI, 0.0-0.3), meeting the prespecified noninferiority criterion.
- Among Week 8 responders, 70/137 (51.1%) maintained improvement through Week 48 in a post hoc analysis.
- No severe or serious related treatment-emergent adverse events or unexpected adverse events were reported.
Why it matters
The trial provides comparative evidence that BIL can improve assessed lip fullness and was noninferior to an FDA-approved comparator over the primary assessment period. The Week 48 responder analysis also offers information about persistence of improvement, although it was post hoc and applies only to initial responders. Reported safety findings are reassuring within the study’s follow-up.
What to keep in mind
The Week 48 maintenance result was a post hoc analysis among Week 8 responders; retreatment at Week 48 was offered only to BIL patients.