A multi-center, double-blind, randomized controlled study of the safety and effectiveness of Juvéderm injectable gel with and without lidocaine.
BACKGROUND
Pain is a common patient complaint during dermal filler injections. The primary objective of this study was to compare a new formulation of Juvéderm((R)) injectable gel with lidocaine (denoted as JUV + L) to commercially-available Juvéderm((R)) injectable gel without lidocaine (denoted as JUV) with respect to procedural pain scores in subjects desiring nasolabial fold (NLF) correction.


METHODS
Subjects received randomized treatment with the lidocaine filler in one NLF and the filler without lidocaine in the other NLF. Investigators determined the appropriate formulation (Ultra or Ultra Plus) and volume of material to inject but were blinded as to which syringe contained lidocaine. Subjects rated procedural pain (pain during injection) using an 11-point scale within 30 min after receiving treatment in both NLFs and compared procedural pain between right and left NLFs using a 5-point scale. NLF severity was rated by both subjects and investigators before and 2 weeks after treatment.


RESULTS
The mean difference on the procedural pain scale was 3.4 (P < 0.0001), and 93% of subjects found JUV + L to be less or slightly less painful than JUV. Improvement in NLF severity was comparable for both products. Common treatment site reactions (CTRs) of pain and tenderness were considerably less frequent for JUV + L than JUV while all other CTRs showed no statistically significant differences.


CONCLUSIONS
The dermal filler formulated with lidocaine is effective in reducing procedural pain during correction of facial wrinkles and folds while maintaining a similar safety and effectiveness profile to the filler without lidocaine.
Weinkle
Susan H
SH
Bank
David E
DE
Boyd
Charles M
CM
Gold
Michael H
MH
Thomas
Jane A
JA
Murphy
Diane K
DK
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000779:Anesthetics, Local / Q000008:administration & dosage; D004311:Double-Blind Method; D005260:Female; D007839:Functional Laterality; D005782:Gels / Q000008:administration & dosage / Q000494:pharmacology*; D006801:Humans; D006820:Hyaluronic Acid / Q000008:administration & dosage / Q000009:adverse effects / Q000494:pharmacology; D008012:Lidocaine / Q000008:administration & dosage / Q000009:adverse effects / Q000494:pharmacology*; D008297:Male; D008875:Middle Aged; D010146:Pain / Q000139:chemically induced / Q000517:prevention & control; D010147:Pain Measurement; D012449:Safety; D015595:Skin Aging / Q000187:drug effects*
D000779:Anesthetics, Local; D005782:Gels; C526061:Juvederm Ultra; C526062:Juvederm Ultra Plus; D006820:Hyaluronic Acid; D008012:Lidocaine