Efficacy and Safety of New Hyaluronic Acid Filler for Nasolabial Fold Correction: A Double-Blind, Randomized Trial.
Summary
In a 24-week, double-blind, randomized split-face non-inferiority trial (n=74), the new monophasic HA filler CUREA was non-inferior to Juvederm for nasolabial fold correction, significantly improving WSRS scores. Safety and patient satisfaction were comparable, with only mild, transient local reactions.
Key Findings
- CUREA improved WSRS from 3.16 ± 0.84 to 2.59 ± 0.87 at 24 weeks (P<0.001).
- Non-inferiority to Juvederm was demonstrated in a double-blind, randomized, split-face design.
- Safety and satisfaction were similar to Juvederm with only mild, transient local reactions.
Clinical Implications
Clinicians can consider CUREA as an alternative to Juvederm for moderate-to-severe nasolabial folds, expecting similar efficacy, safety, and patient satisfaction over 6 months.
Why It Matters
Provides high-quality RCT evidence supporting a new HA filler as a viable alternative to a widely used comparator with similar safety and effectiveness over 24 weeks.
Limitations
- Single-center study with 24-week follow-up may limit generalizability and long-term conclusions
- Non-inferiority margin details beyond summary not provided in abstract
Future Directions
Conduct multicenter, longer-term RCTs including durability beyond 6–12 months, volumetric outcomes, and comparative cost-effectiveness across diverse skin types.
Study Information
- Study Type
- RCT
- Research Domain
- Treatment
- Evidence Level
- I - High-quality randomized, double-blind, split-face non-inferiority clinical trial
- Study Design
- OTHER