Calcium Hydroxyapatite Filler With Integral Lidocaine CaHA (+) for Soft Tissue Augmentation: Results from an...

Facial volume loss is a common concern in aging populations, prompting interest in soft tissue augmentation. Calcium hydroxyapatite (CaHA) has been widely used for its ability to restore volume and enhance skin texture. Prior research has shown that CaHA can improve facial contours and reduce the appearance of wrinkles. However, the integration of lidocaine into CaHA formulations remains a relatively new area of investigation. This gap motivated the present study to evaluate a CaHA product with lidocaine in real-world clinical settings. Established knowledge includes the biocompatibility and structural benefits of CaHA, but the addition of lidocaine introduces new variables. No prior work had resolved the long-term effectiveness of CaHA with lidocaine in treating nasolabial folds and marionette lines. The study aimed to bridge this gap by assessing both safety and aesthetic outcomes over an extended period.

The primary aim of this study was to evaluate the safety and effectiveness of a calcium hydroxyapatite filler with integrated lidocaine in treating facial volume deficits. The specific problem addressed was the need for a product that could provide immediate pain relief during injection while maintaining long-term aesthetic improvements. The motivation stemmed from the desire to enhance patient comfort and satisfaction in soft tissue augmentation procedures. The study focused on nasolabial folds, marionette lines, and cheek volume loss, which are common targets for cosmetic interventions. By incorporating lidocaine, the product aimed to reduce injection discomfort, a known limitation of traditional CaHA fillers. The study sought to confirm whether CaHA with lidocaine could achieve significant aesthetic improvements while maintaining a favorable safety profile. The holistic treatment approach considered multiple facial regions to reflect real-world clinical practice. The ultimate goal was to provide evidence supporting the use of this product in routine aesthetic procedures.

The study employed an open-label, multicenter design to assess the product’s performance in real-world clinical settings. A total of 207 subjects with moderate to severe facial volume loss were enrolled. The subjects received injections of CaHA with lidocaine in targeted facial regions. Effectiveness was measured using the Merz Aesthetics Scales (MAS), investigator- and subject-assessed Global Aesthetic Improvement Scales (iGAIS/sGAIS), and FACE-Q questionnaires. Responder rates were defined as subjects showing at least a one-point improvement on the MAS. Safety assessments included tracking of adverse events and injection site reactions. The primary endpoint was evaluated 12 weeks after the last injection. Follow-up assessments were conducted at 18 months to determine the durability of results. The study design allowed for a comprehensive evaluation of both short- and long-term outcomes.

The study reported high responder rates across all treated areas, with 93.6% for nasolabial folds, 88.7% for marionette lines, and 81.9% for cheeks at 12 weeks post-treatment. These values were statistically significant above the pre-defined 60% threshold (P<0.0001). Investigator-assessed GAIS showed a peak improvement rate of 98.0% at week 4, while subject-assessed GAIS reached 93.5% at 12 weeks. After 18 months, 52.5% of subjects still reported perceived improvement via sGAIS. FACE-Q scores indicated high levels of patient satisfaction with the treatment. Adverse events were primarily mild to moderate and transient, with no serious complications reported. The lidocaine component provided immediate pain relief during injections, enhancing patient comfort. The results suggest that the product maintains effectiveness for up to 18 months following the last injection.

The study concluded that CaHA with lidocaine demonstrated safety and effectiveness in treating nasolabial folds, marionette lines, and cheek volume loss. The authors noted that the product achieved statistically significant improvements in aesthetic outcomes, as measured by MAS, iGAIS, and sGAIS. The high responder rates and sustained improvement over 18 months support the product’s use in real-life clinical settings. The transient nature of adverse events and the presence of lidocaine for pain relief further reinforce its safety profile. The authors propose that this formulation offers a viable option for soft tissue augmentation in facial rejuvenation. The study did not suggest any new mechanisms or generalizations beyond the observed outcomes. The findings align with the product’s intended use and clinical expectations. The authors emphasize the importance of continued monitoring for long-term safety and effectiveness.