Hyaluronic Acid Filler CPM-V ± Lidocaine for Chin Augmentation: A Randomized, Multicenter, Open-Label Post-Market Follow-Up Study

Tatjana Pavicic,1 Martina Kerscher,2 Sonja Sattler,3,4 Welf Prager,5 Ulrich Kühne,6 Ernst Magnus Noah,7 Eva Kristina Bee,8 Rodrigo da Mota,9 Michael Sebastian,10 Peter Arne Gerber,11,12 YingJu Tseng,13 Christian Carreon,14 Tanja C Fischer15 1Private Practice for Dermatology & Aesthetics Dr. Tatjana Pavicic, Munich, Germany; 2Division of Cosmetic Sciences, Institute of Biochemistry and Molecular Biology, Universität Hamburg, Hamburg, Germany; 3Rosenpark Klinik GmbH, Darmstadt, Germany; 4Rosenpark Research GmbH, Darmstadt, Germany; 5Derma Science GmbH Hamburg, Studienzentrum, Hamburg, Germany; 6Hautmedizin Bad Soden, Bad Soden, Germany; 7Noahklinik GmbH, Kassel, Germany; 8Practice for Aesthetic Dermatology, Drensteinfurt, Germany; 9Privatpraxis Dr. Hilton & Partner, Düsseldorf, Germany; 10Dermatologie Mahlow, Studienzentrum, Mahlow, Germany; 11Dermatologie am Luegplatz, Düsseldorf, Germany; 12Department of Dermatology, Medical Faculty and University Hospital Düsseldorf, Heinrich-Heine-University, Düsseldorf, Germany; 13Biostatistics, Merz Aesthetics GmbH, Frankfurt, Germany; 14Clinical Development, Merz Aesthetics GmbH, Frankfurt, Germany; 15Haut- und Lasercentrum Potsdam-Berlin, Potsdam, GermanyCorrespondence: Tatjana Pavicic, Private Practice for Dermatology & Aesthetics Dr. Tatjana Pavicic, Maximilianstr. 36, Munich, 80539, Germany, Tel +49 89 55293445, Email [email protected]: This post-marketing study evaluated the clinical performance and safety of Belotero® Volume (CPM-V) and Belotero® Volume Lidocaine (CPM-V+) for chin augmentation in a real-world setting.Methods: This prospective, open-label, randomized study was carried out in Germany. Participants seeking chin augmentation received treatment with CPM-V (n=58) or CPM-V+ (n=63), with an optional touch-up 4 weeks after. The primary effectiveness endpoint was change in chin volume (mL) from baseline to 12 weeks after the last injection (Week 12 or Week 16 for participants with touch-up treatment), measured by validated 3D facial imaging. Secondary endpoints included the change from baseline in the glabella-subnasale-pogonion (G-Sn-Pg) angle (°), the investigator- and participant-assessed Global Aesthetic Improvement Scales (iGAIS/pGAIS) scores, the investigator-assessed Merz Aesthetics Scale (MAS) for chin projection, and participant satisfaction with treatment evaluated by FACE-Q – Satisfaction with Chin. Safety was assessed through adverse event reporting.Results: From baseline to Week 12/16, chin volume increased by a mean (standard deviation [SD]) of 2.5 (0.2) mL (95% confidence interval 2.1, 2.9; p< 0.0001) and mean (SD) G-Sn-Pg angle increased by 1.9° (1.7°). At Week 12/16, almost all participants experienced ≥ 1 point improvements from baseline in MAS for chin projection (91.4%), iGAIS (100%), and pGAIS (99.1%). The mean (SD) Rasch-transformed score FACE-Q – Satisfaction with Chin was 66.6 (18.7) at Week 12/16. Thirty participants (24.8%) reported treatment-related adverse events; incidence was similar between treatment groups and the majority of events were mild to moderate in intensity and transient in nature.Conclusion: CPM-V and CPM-V+ were effective for chin augmentation in aesthetic clinical practice. No new safety concerns were identified.Keywords: hyaluronic acid filler, dermal filler, chin augmentation, HA, Belotero volume, CPM-V