BACKGROUND There are several approaches to reducing injection-related pain associated with hyaluronic acid (HA) dermal fillers, each with advantages and disadvantages. OBJECTIVE To compare the pain relief and safety of small-gel particle HA plus 0.3% lidocaine hydrochloride (SGP-HA 1 L) with that of SGP-HA without lidocaine during correction of nasolabial folds (NLFs) and to assess filler safety in different skin types.
METHODS AND MATERIALS We conducted a randomized, double-blind, split-face study of SGP-HA and SGP-HA 1 L in 60 subjects undergoing NLF correction. Subjects evaluated pain on a 100-mm visual analog scale (VAS). The primary end point was to demonstrate that more than 50% of subjects experienced pain relief with SGP-HA 1 L, defined as a VAS within-subject difference of at least 10 mm at injection. RESULTS At the end of injection, 71.7% (95% confidence interval = 58.6-82.5) of subjects reported a difference in pain of 10 mm or more on the VAS; the mean within-subject VAS difference was 30 mm. The safety profile of SGP-HA 1 L was similar to that of SGP-HA. SGP-HA and SGP-HA 1 L were observed to be safe in all Fitzpatrick skin types. CONCLUSION The addition of lidocaine substantially reduces the pain of SGP-HA injection in most patients without altering safety. SGP-HA and SGP-HA 1 L injections were safe in all skin types.