Title: Randomized, Double-Blind, Split-Face Study of Small-Gel-Particle Hyaluronic Acid with and without Lidocaine During Correction of Nasolabial Folds
Abstract: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 re...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+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+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+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+L was similar to that of SGP-HA. SGP-HA and SGP-HA+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+L injections were safe in all skin types. The writing of this manuscript was funded by Medicis Aesthetics, Inc. (Scottsdale, AZ). Dr. Weiss, Dr. Bank, and Dr. Brandt have received research grants and served as investigators for Medicis. Dr. Bank and Dr. Brandt also serve as consultants for Medicis, and Dr. Brandt is a speaker for Medicis. Dr. Brandt is a consultant and investigator for Allergan, Inc. (Irvine, CA) and is principal investigator at the Dermatology Research Institute (Coral Gables, FL). Dr. Weiss is principal investigator at the Maryland Laser, Skin & Vein Institute (Hunt Valley, MD).Read More
Publication Year: 2010
Publication Date: 2010-04-20
Language: en
Type: article
Indexed In: ['crossref']
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Cited By Count: 19
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