Randomized, Patient/Evaluator-Blinded, Intraindividual Comparison Study to Evaluate the Efficacy and Safety of a Novel Hyaluronic Acid Dermal Filler in the Treatment of Nasolabial Folds.

BACKGROUND: Comparative research on the characteristics of filler products is limited, especially in the preclinical analysis of hyaluronic acid (HA) fillers.

OBJECTIVE: This study was performed to compare the preclinical characteristics, clinical efficacy, and safety of a new HA filler, IDHF-001, with Restylane SubQ in the treatment of nasolabial folds (NLFs).

METHODS: Viscoelasticity and injection force were evaluated. Ninety-one subjects were enrolled in this randomized, patient/evaluator-blind, intraindividual clinical study. Each subject was randomized to receive injections of IDHF-001 or Restylane SubQ in their left or right NLF. At 4, 8, 16, 24, 36, and 48 weeks, all participants were evaluated through Wrinkle Severity Rating Scale (WSRS).

RESULTS: The IDHF-001 showed higher viscosity (1,271 Pa·s), lower elastic modulus (G'; 611 Pa), and lower injection force (8.89 N) than Restylane SubQ (464.6 Pa·s; 674.8 Pa; 19.14 N). No significant difference in WSRS was detected between IDHF-001 side and Restylane SubQ side at 24 weeks (mean improvement in WSRS from baseline at Week 24-IDHF-001: 1.85 ± 0.61, Restylane SubQ: 1.88 ± 0.61). The noninferiority was sustained until Week 48.

CONCLUSION: The novel HA filler IDHF-001 shows suitable characteristics and tolerability, widening the selection possibilities for clinicians and patients in the treatment of NLFs.