Open-Label, Post-Marketing Study to Evaluate the Performance and Safety of Calcium Hydroxylapatite With Integral Lidocaine to Correct Facial Volume Loss.

Background: Calcium hydroxylapatite (CaHA, Radiesse®) with integral 0.3% lidocaine (CaHA(+)) has recently been approved for use in aesthetic medicine. This study assessed the performance of CaHA(+) in subjects undergoing treatment for facial volume loss and evaluated subject and physician satisfaction. Methods: In a prospective, open-label, post-marketing study, 25 women seeking treatment for age-related facial volume loss received CaHA(+) injections in 1–3 facial areas including the cheeks, marionette lines, prejowl sulcus, and jawline. Subjects returned for follow-up at 14 and 120 days, with the option of touch-up injections at day 14 if required to achieve optimal correction. Filler performance was assessed using the Merz Aesthetics Scales (MAS) and subject satisfaction using the Global Impression of Change Scale (GICS). Physician satisfaction was assessed in terms of CaHA(+)-related properties (eg, ease of injection, distribution, positioning) and aesthetic outcomes. Adverse events were recorded. Results: Mean MAS scores at baseline were ~2 corresponding to moderate facial volume loss/sagging in the treated area. At day 14, the mean score had improved to ≤1.4 for all treated areas, indicating mild volume loss. At day 120, mean scores had further improved to ≤1.1. At both follow-up visits, mean GICS scores were ≥2 indicating facial appearance was ‘much improved’ compared with baseline. All subjects reported willingness to repeat treatment and recommend it to family/friends. Physician ratings were high for ease of CaHA(+) injection, distribution, positioning, sculpturing outcome, and effect on skin tension. Compared to CaHA without lidocaine, the physician rated CaHA(+) as better or similar in performance. Adverse events were mostly mild and expected with CaHA and filler injections in general. Conclusion: The well-established efficacy and safety profile of CaHA appears unchanged by the addition of integral lidocaine. CaHA(+) was effective for volume enhancement in a number of facial areas and associated with high subject and physician satisfaction. J Drugs Dermatol. 2019;18(1):86-91.