PMID- 35357748 OWN - NLM STAT- MEDLINE DCOM- 20220622 LR - 20220622 IS - 1473-2165 (Electronic) IS - 1473-2130 (Linking) VI - 21 IP - 6 DP - 2022 Jun TI - Evaluation of the long-term safety and biodegradability of hyaluronic acid dermal fillers (YVOIRE((R)) ) for the correction of nasolabial folds: Two multicenter, prospective, observational cohort studies. PG - 2387-2397 LID - 10.1111/jocd.14952 [doi] AB - BACKGROUND: 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. AIMS: To evaluate the long-term safety and biodegradability of two hyaluronic acid dermal fillers (YVOIRE((R)) classic s and YVOIRE((R)) volume s) for the correction of nasolabial folds (NLFs) in two prospective, observational studies. METHODS: Subjects scheduled to receive the injections of YVOIRE((R)) classic s (N = 503) or YVOIRE((R)) 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. RESULTS: Complete clinical biodegradation was observed in 93.5% [95% CI 91.0%-95.5%] of 494 assessable YVOIRE((R)) classic s recipients and 98.5% [95% CI 97.0%-99.4%] of 469 YVOIRE((R)) 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((R)) classic s and YVOIRE((R)) volume s recipients, respectively. During the 12 to 18 months after YVOIRE((R)) 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((R)) classic s injection. CONCLUSIONS: YVOIRE((R)) classic s and YVOIRE((R)) volume s can be safely used to correct NLFs. Total clinical biodegradation tends to occur within 12 months of injection. CI - (c) 2022 Wiley Periodicals LLC. FAU - Xie, Yun AU - Xie Y AD - Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China. FAU - Wu, Sufan AU - Wu S AD - Zhejiang Provincial People's Hospital, Hangzhou, China. FAU - Li, Shirong AU - Li S AD - Southwest Hospital, Third Military Medical University, Chongqing, China. FAU - Li, Qingfeng AU - Li Q AD - Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China. FAU - Zhao, Hongyi AU - Zhao H AD - Beijing Hospital, Ministry of Health, Beijing, China. LA - eng GR - LG Chem, Ltd./ PT - Journal Article PT - Multicenter Study PT - Observational Study DEP - 20220509 PL - England TA - J Cosmet Dermatol JT - Journal of cosmetic dermatology JID - 101130964 RN - 0 (Dermal Fillers) RN - 9004-61-9 (Hyaluronic Acid) SB - IM MH - *Cosmetic Techniques/adverse effects MH - *Dermal Fillers MH - Humans MH - Hyaluronic Acid MH - Injection Site Reaction/etiology MH - Nasolabial Fold MH - Prospective Studies MH - *Skin Aging MH - Treatment Outcome OTO - NOTNLM OT - YVOIRE(R) classic s OT - YVOIRE(R) volume s OT - biodegradability OT - hyaluronic acid OT - nasolabial folds OT - safety EDAT- 2022/04/01 06:00 MHDA- 2022/06/23 06:00 CRDT- 2022/03/31 12:07 PHST- 2022/02/20 00:00 [revised] PHST- 2021/06/26 00:00 [received] PHST- 2022/03/28 00:00 [accepted] PHST- 2022/04/01 06:00 [pubmed] PHST- 2022/06/23 06:00 [medline] PHST- 2022/03/31 12:07 [entrez] AID - 10.1111/jocd.14952 [doi] PST - ppublish SO - J Cosmet Dermatol. 2022 Jun;21(6):2387-2397. doi: 10.1111/jocd.14952. Epub 2022 May 9.