Calcium hydroxylapatite (CaHA) soft tissue augmentation was a line filling, skin tightening, lifting, contouring, and volumizing technique. The study was designed to confirm the product’s safety and efficacy with lidocaine (CaHA (+)) in the holistic treatment of nasolabial folds (NLFs), marionette lines, and cheeks. This study gave 207 people with moderate to severe facial volume deficits CaHA(+). Merz Aesthetics Scales® (MAS), investigator- and subject-assessed Global Aesthetic Improvement Scales (iGAIS/sGAIS), and FACE-QTM questionnaires were used to assess effectiveness. Responder rates were defined as MAS improvement based on blinded ratings, and safety was determined through adverse event reporting. The primary endpoint was assessed 12 weeks after the last injection. Responder rates in the NLFs, marionette lines, and cheeks were 93.6%, 88.7%, and 81.9% and were statistically significant above the pre-defined 60% threshold (P<0.0001). GAIS was consistent and showed high improvement rates throughout the study, with peak values of 98.0% on iGAIS at week 4 and 93.5% on sGAIS 12 weeks after the last injection. Most subjects (52.5%) perceived improvement via sGAIS after 18 months. Furthermore, total FACE-Q scores indicated that subjects were very satisfied with the treatment. All treatment-related adverse events were transient, with injection-site reactions ranging from mild to moderate. CaHA (+) was effective in treating NLFs, marionette lines, and cheek volume loss in real-life conditions for up to 18 months.
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