product- or injection-related serious AEs. The most commonly reported product- or injection-related AEs were implant site reactions, mass, pain, and nodules, which were mostly mild or moderate in intensity and resolved during the study. Post-hoc analyses revealed a relationship between total injected volume (initial and touch-up) and product-related AEs, including mass and nodules, with a higher AE frequency with volumes above 2.8 mL (Table 3). The GCRS results tended to be similar for both subgroups (Table 3) indicating that both higher and lower volumes (less than/equal to median and greater than median) achieved optimal aesthetic results. However, overall, these findings suggest that a smaller total injection volume may be preferable, to reduce the risk of developing nodules or mass. Smaller volumes of product per injection point have previously been reported to minimize the risk of serious AEs.6 Overall, the safety profile for HASHA appears to be generally comparable with that reported for other HA fillers injected in the chin area.7,8 Other pivotal studies have reported injection site mass/nodule rates of 21.8%/1.7% for VYC-25L8 and 60.2% ("lumps/bumps") for VYC-20L,7 while our study reported mass/nodule rates of 5.5%/3.9% for HASHA.
The patient perspective is important in aesthetic treatments, particularly as appearance can impact the perception of attractiveness and potentially psychological well-being.1,2 Subject satisfaction rates in the HASHA group remained high throughout the present study (Figure 3). At month 12, most subjects (82 to 87%) remained satisfied/very satisfied with the shape, projection, and profile of their chin, as well as their overall appearance. Most subjects still felt after 12 months that the treatment results looked natural (95%), and made them feel more attractive (72%) and better about themselves (77%).
CONCLUSION
The results of this study showed that HASHA is safe and effective for chin augmentation and improvement of chin retrusion, with high aesthetic improvements and high subject satisfaction lasting through 12 months. The study findings support HASHA as a safe option for patients with mild to moderate chin retrusion (by GCRS) looking for a minimally invasive and reversible treatment option for chin augmentation.
DISCLOSURES
Andreas Nikolis is a paid consultant, speaker, and clinical trial investigator for Galderma, Allergan, Prollenium, and Merz. Vince Bertucci is a paid consultant, speaker, and/or clinical trial investigator for Galderma, Allergan Aesthetics, an AbbVie Company, Clarion, Cutera, Merz, Prollenium, Revance and Teoxane. Shannon Humphrey is a speaker, consultant, and/or investigator for Galderma, Merz, Revance, and Allergan Aesthetics, an AbbVie company. Jason K Rivers is an advisory board member, speakers' bureau member, and investigator for AbbVie/Allergan; advisory board member and paid consultant for Bausch Health; Investigator for Galderma; advisory board member, speakers' bureau member, paid consultant, and investigator for Leo Pharma; investigator for Medytox; consultant for MetaOptima Technology Inc; investigator for Pfizer; investigator for SaNOtize; founder, stockholder of Riversol Skin Care Solutions Inc. Nowell Solish is a clinical trial investigator for Galderma. Andrei Metelitsa is a paid consultant, speaker, and clinical trial investigator for Galderma and Allergan. Nathan Rosen is a clinical trial investigator for Galderma. Kristy Bailey is a clinical trial investigator for Galderma. William McGillivray is a clinical trial investigator for Galderma. Annika Rugheimer, Felipe Weinberg, Torun Bromee, and Inna Prygova are employees of Galderma.
Galderma (Uppsala, Sweden) and Galderma R&D, LLC (Dallas, Texas, USA) sponsored and assumed overall responsibility for this study. Scientific writing assistance in the preparation of this article was provided by Zenith Healthcare Communications Ltd (Cheshire, UK), funded by Galderma.
ACKNOWLEDGMENT
The authors would like to thank all study participants, investigators, and site staff who contributed to this clinical investigation, and acknowledge the scientific writing assistance provided by Vanessa Cobb (Zenith Healthcare Communications Ltd, Cheshire, UK).
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AUTHOR CORRESPONDENCE
Andreas Nikolis MD PhD anikolis@vicpark. com
