A Lidocaine-Containing Formulation of Large-Gel Particle Hyaluronic Acid Alleviates Pain

BACKGROUND Effective pain management is an important component of aesthetic procedures. OBJECTIVE To compare the pain relief and safety of large-gel particle hyaluronic acid (HA) plus 0.3% lidocaine (LGP-HA+L) with that of LGP-HA without lidocaine during correction of nasolabial folds (NLFs) and to assess filler safety in different skin types. METHODS AND MATERIALS Sixty subjects were enrolled in a randomized, double-blind, split-face study of LGP-HA and LGP-HA+L for NLF correction. Subjects assessed pain on a 100-mm visual analog scale (VAS). The primary objective was to demonstrate that more than 50% of subjects experienced pain relief with LGP-HA+L, defined as a within-subject VAS difference of at least 10 mm at the end of injection. RESULTS LGP-HA+L resulted in pain relief in 57 (95.0%, 95% confidence interval=86.1-99.0) subjects at the end of injection. The mean within-subject VAS difference was 34.4 mm. Injection-related adverse events occurred at similar frequencies with both products. Slightly higher adverse event rates were observed with Fitzpatrick skin type IV for both compounds. The safety profiles of LGP-HA and LGP-HA+L were similar to each other in all skin types. CONCLUSION The addition of lidocaine substantially reduces the pain of LGP-HA injection without altering safety. LGP-HA and LGP-HA+L were generally well tolerated in all Fitzpatrick skin types. Medicis Aesthetics, Inc. (Scottsdale, AZ) sponsored the study and funded the writing of this manuscript. Drs. Brandt, Weiss, and Bank have received research grants and served as investigators and consultants for Medicis. Dr. Brandt serves as a speaker for Medicis and is a consultant and investigator for Allergan Inc. (Irvine, CA) and principal investigator at the Dermatology Research Institute (Coral Gables, FL). Dr. Cross received compensation from Premier Healthcare Resource Inc. (Morristown, NJ) for her contributions to the writing and editing of this manuscript.