Twelve-Month Outcome of Nasolabial Fold Correction by a Novel Non-1,4-Butanediol Diglycidyl Ether, Click-Crosslinked,...

Hyaluronic acid (HA) products used for nasolabial fold (NLF) correction are typically crosslinked with 1,4-Butanediol diglycidyl ether (BDDE) and contain high HA concentrations and short HA chains. These characteristics may contribute to increased stiffness, enhanced immune reactivity, and less natural aesthetic outcomes. A novel HA material utilizing click-chemistry for crosslinking to preserve long-chain structure and afford low HA concentration and minimal modification was developed as a potential alternative.

The aim of this study was to evaluate the 12-month safety and clinical performance of a non-BDDE, click-chemistry crosslinked, long-chain HA compound (HLR-2, Hallura) for NLF correction.

Two prospective, open-label studies were conducted, one in Europe and the other in Israel. All subjects received HLR-2 injections and were followed for 12 months. Efficacy was assessed by the Wrinkle Severity Rating Scale, Global Aesthetic Improvement Scale, and patient satisfaction measures. Safety was monitored through reporting of adverse events (AE) and documentation of injection site reactions (ISR).

Sixty-two subjects (29 Israeli and 33 European) were included. Responder rates at 6 months were 90.7% and 86.4%, respectively, with improvements sustained throughout 12 months. Satisfaction levels remained high (≥ 94% at all time points). ISRs were mild and transient, with no serious or delayed-onset AEs, and favorable induction of collagen and elastin and enhanced tissue integration were documented.

HLR-2 demonstrated high efficacy, high patient satisfaction, and a favorable safety profile over 12 months. The product's distinctive composition and clinical performance support its use for aesthetic indications, with potential for broader therapeutic applications.