Department of Dermatology, College of Medicine, Chung-Ang University, Seoul, Republic of Korea.
Department of Dermatology, College of Medicine, Chung-Ang University Gwangmyeong Hospital, Gwangmyeong-si, Republic of Korea.
Dermatol Surg. 2024 Aug 1;50(8):731-738. doi: 10.1097/DSS.0000000000004190. Epub 2024 May 2.
With the continuous increasing availability of new filler products, each hyaluronic acid filler brand has distinctive pharmacokinetics, which may be associated with different complications. Therefore, the long-term safety of new generations of fillers should be evaluated.
This prospective, multicenter, observational, postmarketing study ( ClinicalTrials.gov identifier: NCT04738019) aimed to investigate the incidence of delayed-onset nodules and adverse reactions after the injection of new hyaluronic acid fillers (YYS series) into the facial skin.
Subjects scheduled to receive an injection YYS series filler were followed up for 52 weeks. The authors aimed to determine the incidence of a self-reported delayed-onset nodule-a visible or palpable nodule or mass at the injection site that was detected beyond the 14th day following the injection-during the 1-year follow-up period.
Among the 1,022 subjects who received an injection of the YYS series, the incidences of delayed-onset nodules were 0% for YYS 360, YYS 540, and YYS 720. A 0.21% incidence (1 delayed hypersensitivity reaction) of a delayed-onset adverse reaction was noted for YYS 720, although none were reported for YYS 360 and YYS 540.
In this study, a notably low frequency of adverse reactions associated with the YYS series was observed.
随着新型填充剂产品的不断增加，每种透明质酸填充剂品牌都具有独特的药代动力学特征，这可能与不同的并发症有关。因此，应该评估新一代填充剂的长期安全性。
本前瞻性、多中心、观察性、上市后研究（ClinicalTrials.gov 标识符：NCT04738019）旨在调查新型透明质酸填充剂（YYS 系列）注射后面部皮肤迟发性结节和不良反应的发生率。
计划接受 YYS 系列填充剂注射的受试者随访 52 周。作者旨在确定在 1 年随访期间，自我报告的迟发性结节（注射后 14 天以上发现的注射部位可见或可触及的结节或肿块）的发生率。
在接受 YYS 系列注射的 1022 名受试者中，YYS 360、YYS 540 和 YYS 720 的迟发性结节发生率均为 0%。YYS 720 迟发性不良反应的发生率为 0.21%（1 例迟发性过敏反应），而 YYS 360 和 YYS 540 均未报告。
在这项研究中，观察到 YYS 系列与不良反应相关的频率明显较低。
