A multicenter, randomized, double-blind, comparative study of a multiphasic hyaluronic acid filler and existing hyaluronic acid fillers for temporary restoration of the midface volume of Asian individuals.

Autor: Yi CC; Department of Plastic and Reconstructive Surgery, Pusan National University, School of Medicine, Busan, Republic of Korea; Biomedical Research Institute, Pusan National University Hospital, Busan, Republic of Korea., Hahn HM; Department of Plastic and Reconstructive Surgery, Ajou University School of Medicine, Suwon, Gyeonggi, Republic of Korea., Lim H; Department of Plastic and Reconstructive Surgery, Ajou University School of Medicine, Suwon, Gyeonggi, Republic of Korea., Kim YJ; Department of Plastic and Reconstructive Surgery, Sanggye Paik Hospital, School of Medicine, Inje University, Seoul, Republic of Korea., Choi YW; Department of Plastic and Reconstructive Surgery, Sanggye Paik Hospital, School of Medicine, Inje University, Seoul, Republic of Korea., Kim JH; Department of Plastic and Reconstructive Surgery, Pusan National University, School of Medicine, Busan, Republic of Korea; Biomedical Research Institute, Pusan National University Hospital, Busan, Republic of Korea. Electronic address: medic144@hanmail.net.
Jazyk: angličtina
Zdroj: Journal of plastic, reconstructive & aesthetic surgery : JPRAS [J Plast Reconstr Aesthet Surg] 2023 Jul; Vol. 82, pp. 92-102. Date of Electronic Publication: 2023 Mar 31.
DOI: 10.1016/j.bjps.2023.01.049
Abstrakt: Background: Giselleligne is the world's first multiphasic gel product that evenly surrounds particles. In the current study, Giselleligne was compared with other existing fillers to evaluate their clinical use, safety, and ability to improve midface volume deficits of Asian individuals.
Methods: A comparative experiment was conducted to gain an understanding of the physical properties of Giselleligne, which is a multilayered hyaluronic acid filler, and to compare its properties with those of existing hyaluronic acid fillers. The primary outcome of this study was a Midface Volume Deficit Scale (MFVDS) score improvement at 24 weeks after the procedure. The secondary outcomes were as follows: MFVDS score improvement after the procedure; MFVDS score changes after the procedure; Global Esthetic Improvement Scale (GAIS) scores as evaluated by the operator after the procedure; the operator's satisfaction with the product; evaluation of the GAIS scores by the patient after the procedure; and pain level of the patient on the day of the procedure.
Results: Giselleligne exhibited properties that are expected to result in significantly superior clinical outcomes compared to existing products. Giselleligne was superior not only to the existing products but also in terms of global esthetic improvement, effect duration, and operator satisfaction. Furthermore, Giselleligne was found significantly safer than the existing products.
Conclusion: Giselleligne is a safer, more user-friendly, and more effective alternative to existing products for improving the midfacial volume.
Competing Interests: Declaration of Competing Interest None.
(Copyright © 2023 British Association of Plastic, Reconstructive and Aesthetic Surgeons. Published by Elsevier Ltd. All rights reserved.)
Databáze: MEDLINE