Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China.
Zhejiang Provincial People's Hospital, Hangzhou, China.
J Cosmet Dermatol. 2022 Jun;21(6):2387-2397. doi: 10.1111/jocd.14952. Epub 2022 May 9.
The therapeutic effects of hyaluronic acid dermal fillers to correct facial wrinkles and folds usually last up to 6-12 months. Few studies have evaluated their long-term safety.
To evaluate the long-term safety and biodegradability of two hyaluronic acid dermal fillers (YVOIRE classic s and YVOIRE volume s) for the correction of nasolabial folds (NLFs) in two prospective, observational studies.
Subjects scheduled to receive the injections of YVOIRE classic s (N = 503) or YVOIRE volume s (N = 503) at NLFs were followed up until complete clinical biodegradation, defined as a change in Wrinkle Severity Rating Scale (WSRS) score of ≥0 from baseline. The primary biodegradation endpoint was the proportion of subjects with complete clinical biodegradation during or after the 104-week post-treatment period.
Complete clinical biodegradation was observed in 93.5% [95% CI 91.0%-95.5%] of 494 assessable YVOIRE classic s recipients and 98.5% [95% CI 97.0%-99.4%] of 469 YVOIRE volume s recipients during the 104-week post-treatment period. In most subjects, complete clinical biodegradation was observed within 52 weeks of the last treatment. Treatment-related adverse events (AEs) (mostly mild local injection-site reactions) occurred within 52 weeks post-treatment, in 68.2% and 75.0% of YVOIRE classic s and YVOIRE volume s recipients, respectively. During the 12 to 18 months after YVOIRE volume s injection, 0.6% of subjects had treatment-related AEs (local injection-site reactions). No treatment-related AEs occurred 12 to 24 months after YVOIRE classic s injection.
YVOIRE classic s and YVOIRE volume s can be safely used to correct NLFs. Total clinical biodegradation tends to occur within 12 months of injection.
透明质酸真皮填充剂治疗面部皱纹和褶皱的疗效通常可持续 6-12 个月。很少有研究评估其长期安全性。
评估两种透明质酸真皮填充剂（YVOIRE classic 和 YVOIRE volume）用于纠正鼻唇沟皱纹的长期安全性和生物降解性，这两项研究均为前瞻性观察研究。
计划在鼻唇沟皱纹处注射 YVOIRE classic（N=503）或 YVOIRE volume（N=503）的受试者，随访至完全临床生物降解，定义为从基线起皱纹严重程度评分（WSRS）至少增加 0 分。主要生物降解终点是在治疗后 104 周期间或之后完全临床生物降解的受试者比例。
在可评估的 494 例 YVOIRE classic 接受者中，有 93.5%（95%CI 91.0%-95.5%）观察到完全临床生物降解，在 469 例 YVOIRE volume 接受者中，有 98.5%（95%CI 97.0%-99.4%）观察到完全临床生物降解，均发生在治疗后 104 周内。在大多数受试者中，在最后一次治疗后的 52 周内观察到完全临床生物降解。治疗相关不良事件（AE）（多为轻度局部注射部位反应）发生在治疗后 52 周内，YVOIRE classic 和 YVOIRE volume 接受者的发生率分别为 68.2%和 75.0%。在 YVOIRE volume 注射后 12 至 18 个月期间，有 0.6%的受试者出现治疗相关的 AE（局部注射部位反应）。在 YVOIRE classic 注射后 12 至 24 个月期间未发生与治疗相关的 AE。
YVOIRE classic 和 YVOIRE volume 可安全用于纠正鼻唇沟皱纹。总体临床生物降解倾向于在注射后 12 个月内发生。
