A prospective, split-face, randomized, comparative study of safety and 12-month longevity of three formulations of hyaluronic acid dermal filler for treatment of nasolabial folds

Dermatol Surg. 2012 Jul;38(7 Pt 2):1143-50. doi: 10.1111/j.1524-4725.2012.02468.x.

Abstract

Background: Data regarding several hyaluronic acids (HAs) used identically for facial tissue augmentation have heretofore been unavailable.

Objectives: This prospective, split-face, randomized, two-armed study sought to determine the long-term safety and effectiveness of three HAs (HA-1 (Belotero Basic/Balance), HA-2 (Restylane), and HA-3 (Juvéderm Ultra 3/Juvéderm Ultra Plus XC) in the treatment of nasolabial folds (NLFs).

Methods: Twenty participants in Arm A received HA-1 in one NLF and HA-2 in the other. In Arm B, 20 participants received HA-1 in one NLF and HA-3 in the other. Injection was at visit 2, with follow-up visits at 1, 6, 9, and 12 months. Mean volume of HA was slightly <1.5 mL/NLF.

Results: Adverse events were unremarkable across all HAs, with injection site erythema being the most frequent adverse event. Mean pretreatment NLF severity rating for both arms was 2.3; at 12 months, mean posttreatment severity rating was 1.5 for HA-1/HA-2 and 1.6 for HA-1/HA-3. Although not statistically significant, participants tended to show a preference for HA-1.

Conclusion: All three HAs provided essentially equivalent results, except for 4-week evenness results, which favored HA-1. Injection volumes of the three HAs were also similar.

Publication types

  • Comparative Study
  • Randomized Controlled Trial

MeSH terms

  • Cosmetic Techniques*
  • Humans
  • Hyaluronic Acid / administration & dosage
  • Hyaluronic Acid / analogs & derivatives
  • Hyaluronic Acid / therapeutic use*
  • Injections, Intradermal
  • Nasolabial Fold / surgery*
  • Prospective Studies
  • Treatment Outcome

Substances

  • Juvederm Ultra
  • Hyaluronic Acid
  • Restylane