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
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.


CONCLUSIONS
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.
Dermatology Research Institute LLC, Coral Gables, Florida 33146, USA. dermbrandt@aol.com
Fredric
F
Brandt
David
D
Bank
Sharon L
SL
Cross
Robert
R
Weiss
D000779:Anesthetics, Local / Q000008:administration & dosage; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D004338:Drug Combinations; D005145:Face; D005260:Female; D005500:Follow-Up Studies; D005782:Gels / Q000008:administration & dosage*; D006801:Humans; D006820:Hyaluronic Acid / Q000008:administration & dosage*; D007271:Injections, Intradermal; D008012:Lidocaine / Q000008:administration & dosage*; D008297:Male; D008875:Middle Aged; D010146:Pain / Q000175:diagnosis / Q000517:prevention & control*; D010147:Pain Measurement; D015361:Rhytidoplasty / Q000379:methods*; D015595:Skin Aging / Q000187:drug effects; D016896:Treatment Outcome; D055675:Viscosupplements / Q000008:administration & dosage
D000779:Anesthetics, Local; D004338:Drug Combinations; D005782:Gels; D055675:Viscosupplements; D006820:Hyaluronic Acid; D008012:Lidocaine