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.

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.