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Lin et al. Plast Aesthet Res 2019;6:16                                       Plastic and
               DOI: 10.20517/2347-9264.2019.23                                   Aesthetic Research




               Original Article                                                              Open Access


               Efficacy and safety of poly-D,L-lactic acid
               microspheres as subdermal fillers in animals


               Chuan-Yuan Lin , Jui-Yu Lin , Dae-Yeol Yang , Seong-Ho Lee , Jeoung-Yong Kim , Miyeon Kang 5
                                                                   3
                                                     2
                                                                                    4
                             1
                                       1
               1 Tobeauty Aesthetic Clinic, Taipei 10582, Taiwan.
               2 Department of Urology, Hallym University Dongtan Sacred Heart Hospital, Gyeonggi-do 18450, South Korea.
               3 Department of Urology, Hallym University Kangdong Sacred Heart Hospital, Seoul 05355, South Korea.
               4 Max Urology Clinic, Seoul 05051, South Korea.
               5 R&D center, Regen Biotech, Daejeon 34364, South Korea.
               Correspondence to: Dr. Jeoung-Yong Kim, Max Urology, Jeil B/D 201, Achasan-ro 390, Gwangjin-gu, Seoul 05051, South Korea.
               E-mail: aesthefill@aliyun.com


               How to cite this article: Lin CY, Lin JY, Yang DY, Lee SH, Kim JY, Kang M. Efficacy and safety of poly-D,L-lactic acid microspheres as
               subdermal fillers in animals. Plast Aesthet Res 2019;6:16. http://dx.doi.org/10.20517/2347-9264.2019.23

               Received: 17 Apr 2019    First Decision: 3 Jun 2019    Revised: 19 Jul 2019    Accepted: 20 Jul 2019     Published: 25 Jul 2019

               Science Editor: Raúl González-García    Copy Editor: Cai-Hong Wang    Production Editor: Tian Zhang



               Abstract

               Aim: This animal study aims to examine the efficacy and safety of poly-D,L-lactic acid (PDLLA) microspheres as
               subdermal fillers.


               Methods: Thirty 2-week-old male Sprague Dawley rats were used as test animals, and 0.5 mL filler solutions were injected
               into the subdermal tissues on their backs. Groups of five rats were randomly selected and sacrificed for examination on
               the 2nd, 4th, 8th, 12th, 16th, and 20th weeks after injection. Clinical and histological examinations were performed via
               the hematoxyline-eosin and immunohistochemical (IHC) staining of injected sites after collecting the injected masses.
               The body weights of the rats were measured, and the presence of filler substance in other organs was determined.

               Results: Injected volumes were stable from the 2nd to the 20th week after injection, and no abnormalities were observed
               around the injection sites. The injected substance did not migrate to the surrounding tissues. In IHC staining experiments,
               myofibroblasts were observed from the 2nd week, and collagen was detected from the 4th week. Myofibroblast was
               observed in the spaces between and inside the microspheres in the 8th week after injection, whereas type I collagen was
               found between and inside the microspheres at 8th and 12th weeks, respectively.

               Conclusion: The animal experiments confirm the efficacy and safety of injectable PDLLA as a subdermal filler.


                           © The Author(s) 2019. Open Access This article is licensed under a Creative Commons Attribution 4.0
                           International License (https://creativecommons.org/licenses/by/4.0/), which permits unrestricted use,
                sharing, adaptation, distribution and reproduction in any medium or format, for any purpose, even commercially, as long
                as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license,
                and indicate if changes were made.


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