Open-Label, Post-Marketing Study to Evaluate the Performance and Safety of Calcium Hydroxylapatite With Integral Lidocaine to Correct Facial Volume Loss
Muti, G.F..
Journal of Drugs in Dermatology Jdd 18(1): 86-91
2019
ISSN/ISBN: 1545-9616 PMID: 30681803 Document Number: 17696
Background: Calcium hydroxylapatite (CaHA, Radiesse9 with integral 0.3% lidocaine (CaHA(+1) 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 followup 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 51.4 for all treated areas, indicating mild volume loss. At day 120, mean scores had further improved to At both follow-up visits, mean GICS scores were 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.
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