Lip and Perioral Enhancement: A 12-Month Prospective, Randomized, Controlled Study

Injectable hyaluronic acid fillers are widely used in cosmetic procedures to enhance lip volume and reduce perioral lines. Prior research has shown that these fillers can provide temporary improvements in lip fullness and facial contour. However, the comparative effectiveness and safety of different hyaluronic acid formulations remain unclear. No prior work had resolved whether Juvéderm Volbella with Lidocaine offers equivalent or superior outcomes compared to Restylane-L. This uncertainty motivated a randomized controlled trial to evaluate non-animal stabilized hyaluronic acid fillers in lip augmentation. Existing studies often focus on short-term effects, but long-term data beyond 6 months are limited. The need for evidence on sustained outcomes and repeat treatment safety remains unmet. This study aimed to address these gaps by following subjects for up to 12 months. The results could clarify the role of specific hyaluronic acid formulations in lip and perioral enhancement.

The aim of this clinical trial was to assess the safety and effectiveness of Juvéderm Volbella with Lidocaine compared to Restylane-L in lip and perioral enhancement. The study sought to determine whether Juvéderm Volbella with Lidocaine is noninferior to Restylane-L in improving lip fullness and reducing perioral lines. Researchers focused on evaluating outcomes over a 12-month period, including repeat treatment effects. The study's design allowed for investigator and independent central reviewer assessments of lip volume and perioral line severity. The primary endpoint was noninferiority in lip fullness improvement at 3 months. Secondary endpoints included sustained improvements at 6 and 12 months. The study also aimed to compare adverse effects between the two fillers. This trial provided data to guide clinical decisions on filler selection for long-term aesthetic outcomes.

The study enrolled 280 subjects seeking lip enhancement and randomly assigned them to receive either Juvéderm Volbella with Lidocaine or Restylane-L. Investigators used Allergan's Lip Fullness Scale (LFS), Perioral Lines Severity Scale, and Oral Commissures Severity Scale to rate outcomes. Independent central reviewers (ICRs) assessed 3D photographs using the same scales. Noninferiority was determined based on ICR assessments of LFS responders at 3 months. Subjects were followed for up to 12 months and evaluated after repeat treatments. Data collection included assessments of swelling, injection site responses, and long-term effectiveness. Statistical analysis compared improvement scores between the two groups at 3, 6, and 12 months. The study design ensured blinded assessments and standardized outcome measures.

Juvéderm Volbella with Lidocaine was noninferior to Restylane-L at 3 months in improving lip fullness. Investigator assessments showed significant improvements in lip fullness (P ≤ .03) at 6 to 12 months with Juvéderm Volbella with Lidocaine. Perioral lines and oral commissures also improved significantly (P ≤ .04 and P ≤ .03, respectively) in the Juvéderm group. Independent central reviewers confirmed these findings using 3D photographic analysis. Subjects treated with Juvéderm Volbella with Lidocaine experienced less acute swelling compared to those with Restylane-L. Fewer severe injection site responses were reported in the Juvéderm group. Repeat treatment with Juvéderm Volbella with Lidocaine showed comparable safety and effectiveness to initial treatment. The study demonstrated sustained effectiveness up to 12 months after the initial injection.

The authors concluded that Juvéderm Volbella with Lidocaine is noninferior to Restylane-L in improving lip fullness at 3 months. They proposed that Juvéderm Volbella with Lidocaine provides significant and sustained improvements in lip volume and perioral lines up to 12 months. The study found that Juvéderm Volbella with Lidocaine is associated with less acute swelling and fewer severe injection site responses. The authors suggested that repeat treatments with Juvéderm Volbella with Lidocaine maintain effectiveness and safety comparable to initial treatments. These findings support the use of Juvéderm Volbella with Lidocaine for lip and perioral enhancement. The study did not suggest that Juvéderm Volbella with Lidocaine is superior to Restylane-L in all outcomes. The authors emphasized the importance of long-term follow-up in assessing filler effectiveness. The results may inform clinical decisions regarding filler selection for lip augmentation.