The well-established efficacy and safety profile of calcium hydroxylapatite (CaHA) appears to be unchanged with the addition of integral lidocaine (CaHA+), with the injection of CaHA+ proven effective for the treatment of age-related volume loss in a number of different facial areas. Use of CaHA+ is associated with high levels of participant and physician satisfaction, according to the results of a prospective, open-label, postmarketing study conducted at the Plastic Surgery Department of the Istituto Dermatologico Europeo in Milan, Italy, and published in the Journal of Drugs in Dermatology.
A total of 25 women who were seeking treatment of age-related loss of facial volume were treated with CaHA+ injections in 1 to 3 different facial areas, including the cheeks, marionette lines, jawline, and prejowl sulcus. The participants returned for follow-up at 14 days and at 120 days, with the option of receiving touch-up injections at day 14, if needed, to achieve optimal results. All the 25 eligible women were aged 30 years or older (mean age, 52.3 years).
Filler performance was evaluated with use of the Merz Aesthetics Scales (MAS). Participant satisfaction was assessed with use of the Global Impression of Change Scale. Physician satisfaction was evaluated with respect to CaHA+-related properties, including ease of injection, positioning, and distribution, along with aesthetic outcomes. All adverse events were recorded.
At baseline, mean MAS scores were ~2, which correlated with moderate loss of facial volume/sagging in the treated area or areas. At day 14, the mean MAS score had improved to 1.4 or less for all treated areas, which was indicative of mild volume loss. At day 120, the mean MAS score had improved to <1.1.
At both follow-up visits, mean Global Impression of Change Scale scores were 2 or less, implying that the participant’s facial appearance was “much improved” compared with baseline. All the participants reported a willingness to repeat the treatment and to recommend the treatment to family/friends.
The physician ratings were high with respect to ease of use of CaHA+ injection, positioning, distribution, effect on skin tension, and sculpturing outcome. Physicians rated CaHA+ as better or similar in performance to CaHA without lidocaine. Adverse events were mostly mild and expected with the use of CaHA and with filler injections in general.
The investigators concluded that the results of the current study were consistent with the established efficacy and safety profile of CaHA without integral lidocaine. Use of this formulation was associated with high levels of both participant and physician satisfaction.
Muti GF. Open-label, post-marketing study to evaluate the performance and safety of calcium hydroxylapatite with integral lidocaine to correct facial volume loss. J Drugs Dermatol. 2019;18(1):86-91.