A comparison of the efficacy, safety, and longevity of two different hyaluronic acid dermal fillers in the treatment of severe nasolabial folds: a multicenter, prospective, randomized, controlled, single-blind, within-subject study

Abstract

Background

Commercially available hyaluronic acid (HA)-based fillers have distinct physicochemical properties related to their specific manufacturing technology, including HA concentration, cross-linking percentage, and particle size. These factors may determine treatment effectiveness, safety, and longevity; however, this requires confirmation in the clinic.

Methods

To compare the efficacy, safety, and longevity of two distinct HA-based dermal fillers in the correction of severe nasolabial folds (NLFs), a 24 mg/mL smooth gel (Juvederm ULTRA PLUS™ [JUP]) and a 20 mg/mL particulate gel (Perlane^® [PER]) were injected in a total of 80 normal, healthy subjects using a split face design and were followed for 12 months in this prospective, randomized, controlled, multicenter study.

Results

Both fillers achieved a clinically relevant NLF correction (one point or more improvement, based on a validated NLF severity scale). However, JUP displayed greater longevity, with this correction maintained in a significantly larger percentage of NLFs after 6 months (physician’s evaluation) or 9 months (subject’s evaluation) and thereafter for the remainder of the study (70% vs 45%; P = 0.0002 and 62.5% vs 46.3%; P = 0.01 at month 12, based on physician and subject assessments, respectively). At month 12, 71.4% of the subjects nominated a preference for the NLF injected with JUP (P < 0.0001). Both treatments were well tolerated.

Conclusion

These results suggest that different physicochemical properties of HA-based fillers, associated with distinct manufacturing technologies, may influence treatment longevity in the correction of volume deficits. This may relate to a differential resistance to hyaluronidase and/or free radical degradation as previously documented in vitro.

Keywords:

• hyaluronic acid
• dermal fillers
• volume deficit
• nasolabial folds
• randomized
• controlled

Acknowledgments

The study was sponsored by Allergan Australia. The project management, monitoring, and data management were performed independently by Omnicare Clinical Research Pty Ltd, Macquarie Park, NSW, Australia. The statistical analysis for this study was conducted independently by John Wlodarczyk Consulting Services, New Lambton, NSW, Australia.

Disclosure

GG, PB, MR, and RR were paid investigators and were provided with product by Allergan for use in this study. GG has also been a paid investigator for studies conducted on behalf of Kythera, Galderma, and Peplin. He has also been a paid consultant to Allergan, Galderma, Valeant, Peplin, and Q-Med. RR has been a paid investigator for studies conducted on behalf of Peplin and has been a paid consultant to Allergan, Galderma, and Peplin. JR and MH are paid employees of Allergan.