Evaluation of the long‐term safety and biodegradability of hyaluronic acid dermal fillers (YVOIRE^®) for the correction of nasolabial folds: Two multicenter, prospective, observational cohort studies

Abstract

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® classic s and YVOIRE® volume s) for the correction of nasolabial folds (NLFs) in two prospective, observational studies. Methods 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. Results 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. Conclusions 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.

Efficacy of a New Hyaluronic Acid Dermal Filler on Nasolabial Folds Correction: A Prospective, Comparative, Double-Blinded Clinical Trial

“…The complications resulting from dermal filler injections have been suggested to be directly related to the injection site technique rather than the type of HA filler. 13,14 In this study, EST LF was compared with RES L , which is a well-established option for antiwrinkle treatment and has been used in various trials as a reference treatment to investigate the clinical efficacy of other HA-based fillers. [15][16][17][18][19] RES L and EST LF present several similarities in terms of composition, biocompatibility, and indication.…”

“…The complications resulting from dermal filler injections have been suggested to be directly related to the injection site technique rather than the type of HA filler. 13 , 14 …”

One-Year Safety Evaluation of New Hyaluronic Acid Fillers (YYS Series): A Prospective, Multicenter, Observational Study

“…10 Furthermore, a previous study that evaluated the biodegradation of YVOIRE (YV) classics and YV volumes, previous fillers manufactured by LG Chem, Ltd., showed that total clinical biodegradation had generally occurred before 52 weeks. 7 In this study, 3 types of filler with different filler rheologies were used. The filler selection must be tailored to various mechanical dynamics in each part of the face.…”

“… 10 Furthermore, a previous study that evaluated the biodegradation of YVOIRE (YV) classics and YV volumes, previous fillers manufactured by LG Chem, Ltd., showed that total clinical biodegradation had generally occurred before 52 weeks. 7 …”

“…The physicochemical properties of the filler possibly influence the adverse events, especially delayed-onset inflammatory reactions. 7 Theoretically, hyaluronic acid–based fillers are likely immunologically inert, given their lack of protein epitopes. 8 , 9 However, evidence indicates that hyaluronic acid fragments can be substrates for cell trafficking and can activate macrophages, dendritic cells, and T cells.…”