Efficacy and Safety of a Proposed Hyaluronic Acid (Lunaphil Ultra) Compared to the Reference Product (Juvéderm Ultra 4) for the Management of Moderate or Severe Nasolabial Folds: A Randomized, Double-Masked, Within-Subject, Equivalency-Controlled Trial.

Summary

In a randomized, double-masked, within-subject equivalence trial with 24-week follow-up, Lunaphil Ultra achieved WSRS improvements indistinguishable from Juvéderm Ultra 4 (mean change −0.80 vs −0.81; P > .99), with similar touch-up rates and acceptable safety. Results support clinical equivalence in treating moderate-to-severe nasolabial folds.

Key Findings

• Mean WSRS improvement at Week 24 was −0.80 (Lunaphil Ultra) vs −0.81 (Juvéderm Ultra 4), P > .99, meeting the ±0.17 equivalence margin.
• Touch-up injections were comparable: 71.15% (Lunaphil Ultra) vs 66.35% (Juvéderm), P = .33.
• Safety profile was acceptable in the studied population with double-masked within-subject design reducing intersubject variability.

Clinical Implications

Lunaphil Ultra can be considered an equivalent alternative to Juvéderm Ultra 4 for nasolabial folds over 24 weeks; clinicians may select based on cost, availability, and patient preference while monitoring long-term outcomes.

Limitations

• Sample size not reported in the abstract; power and subgroup analyses are unclear
• Follow-up limited to 24 weeks; long-term durability and rare adverse events not assessed

Future Directions

Report full sample size/power, extend follow-up to 12–18 months, and include diverse populations to assess generalizability and long-term safety/efficacy.