A Retrospective Analysis of Safety in Participants Treated with a Hybrid Hyaluronic Acid and Calcium Hydroxyapatite Filler.
| Autor: | Braz A; From the Clínica André Braz, Rio de Janeiro, Brazil., Colucci L; Clínica Colucci, Belo Horizonte, Brazil., Macedo de Oliveira L; Clínica Luciana Macedo, São Paulo, Brazil., Monteiro G; Clínica Grasiela Monteiro, Caxias do Sul, Brazil., Ormiga P; Clínica Patricia Ormiga, Rio de Janeiro, Brazil., Wanick F; Fabiana Wanick Clínica de Dermatologia, Niterói, Brazil., Cazerta C; Allergan Aesthetics, an AbbVie Company, São Paulo, Brazil., Kerson G; Allergan Aesthetics, an AbbVie Company, Marlow, UK., Musumeci M; Allergan Aesthetics, an AbbVie Company, Marlow, UK., Silberberg M; Allergan Aesthetics, an AbbVie Company, Marlow, UK. |
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| Jazyk: | angličtina |
| Zdroj: | Plastic and reconstructive surgery. Global open [Plast Reconstr Surg Glob Open] 2024 Feb 12; Vol. 12 (2), pp. e5622. Date of Electronic Publication: 2024 Feb 12 (Print Publication: 2024). |
| DOI: | 10.1097/GOX.0000000000005622 |
| Abstrakt: | Background: Limited long-term safety data are published on HA/CaHA/L, a hybrid dermal filler combining hyaluronic acid (HA), calcium hydroxyapatite (CaHA), and lidocaine (L). Methods: This retrospective multicenter study assessed treatment-emergent adverse events (TEAEs) in adults treated with HA/CaHA/L. The full analysis set (FAS) included eligible consented adults ( N = 403); the long-term safety analysis (LTSA) set included FAS participants with greater than or equal to 12-months HA/CaHA/L exposure ( n = 243). Results: Participants were majority female (94.0%), with Fitzpatrick skin phototypes II/III (80.1%) and a mean age of 50.1 years. Most participants (86.4%) received one HA/CaHA/L treatment. The median time between participants' first HA/CaHA/L treatment and chart review was 15.4 months. Participants received a mean of 2.2 mL (0.5-8.9 mL) filler per treatment. Treated areas were predominantly malar (71.2%) and mandible (69.7%) regions. Most participants (95.0%) had one or more aesthetic treatments other than HA/CaHA/L [eg, other dermal fillers (84.1%), botulinum toxin (63.3%)]. Nineteen (4.7%) FAS participants had 20 documented TEAEs; most (3.5%, n = 14 participants) were mild in severity. Twelve TEAEs in 11 participants (2.7%) were related to HA/CaHA/L: induration (three, 0.7%), edema (3, 0.7%), and implant site nodules (five, 1.2%), which were noninflammatory and likely related to product placement. Among the LTSA, 15 (6.2%) participants had 16 documented TEAEs (six edema, five implant site nodules, one inflammation, three skin induration, one hypersensitivity); most were mild in severity. Nine TEAEs in eight participants (3.3%) were HA/CaHA/L-related. No treatment-emergent serious AEs were reported. Conclusion: The data from this noninterventional retrospective study support the favorable longer term (>12 month) safety profile of HA/CaHA/L. Competing Interests: Braz is an investigator and advisory board member for Allergan Aesthetics, an AbbVie company. Colucci is an investigator, speaker, and consultant for Allergan Aesthetics, an AbbVie company. Macedo de Oliveira, Monteiro, Ormiga, and Wanick are investigators, speakers, and advisory board members for Allergan Aesthetics, an AbbVie company. Cazerta, Kerson, Musumeci, and Silberberg are full-time employees of AbbVie Inc and may own AbbVie stock. Allergan Aesthetics, an AbbVie Company, funded this study and participated in the study design, research, analysis, data collection, interpretation of data, reviewing, and approval of the publication. All authors had access to relevant data and participated in the drafting, review, and approval of this publication. No honoraria or payments were made for authorship. Medical writing support was provided by Sarah J. Cross, PhD, of AbbVie Inc. and editorial support was provided by Angela T. Hadsell of AbbVie Inc.; both were funded by AbbVie Inc. (Copyright © 2024 The Authors. Published by Wolters Kluwer Health, Inc. on behalf of The American Society of Plastic Surgeons.) |
| Databáze: | MEDLINE |
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