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

• Published in: Journal of cosmetic dermatology Vol. 21; no. 6; pp. 2387 - 2397
• Main Authors: Xie, Yun, Wu, Sufan, Li, Shirong, Li, Qingfeng, Zhao, Hongyi
• Format: Journal Article
• Language: English
• Published: England 01.06.2022
• Subjects: biodegradability; hyaluronic acid; nasolabial folds; safety; YVOIRE® classic s; YVOIRE® volume s; YVOIRE® classic s; nasolabial folds; YVOIRE® volume s; Biodegradability; safety; hyaluronic acid
• ISSN: 1473-2130; 1473-2165; 1473-2165
• DOI: 10.1111/jocd.14952

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.