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

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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.

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