PMID- 36129233
OWN - NLM
STAT- MEDLINE
DCOM- 20221005
LR  - 20221222
IS  - 1524-4725 (Electronic)
IS  - 1076-0512 (Print)
IS  - 1076-0512 (Linking)
VI  - 48
IP  - 10
DP  - 2022 Oct 1
TI  - Patient Comfort, Safety, and Effectiveness of Resilient Hyaluronic Acid Fillers 
      Formulated With Different Local Anesthetics.
PG  - 1065-1070
LID - 10.1097/DSS.0000000000003541 [doi]
AB  - BACKGROUND: Maximizing patient comfort during hyaluronic acid gel injection is a 
      common concern that is usually addressed by selecting fillers with lidocaine. 
      OBJECTIVE: Two randomized, double-blinded, split-face trials aimed to demonstrate 
      noninferiority of specific hyaluronic acid fillers incorporating mepivacaine 
      (RHA-M) versus their lidocaine controls, at providing pain relief. METHODS: 
      Thirty subjects per trial received injections of RHA R -M versus RHA R , and 
      RHA4-M versus RHA4, respectively, in the perioral rhytids (PR) and nasolabial 
      folds (NLF). Pain was assessed on a visual analog scale; aesthetic effectiveness 
      was evaluated with validated scales, and safety was monitored based on common 
      treatment responses (CTRs) and adverse events (AEs). RESULTS: RHA-M fillers 
      proved as effective as their lidocaine counterparts at reducing pain 
      (noninferior, p < .0002 and p < .0001). Bilateral wrinkle improvement was 
      measured both in the PR (-1.5 +/- 0.6 points on each side) and in the NLF (-1.8 +/- 
      0.6 and -1.9 +/- 0.5 points) trials at one month, with virtually identical 
      responder rates (>/=96.7%). Common treatment responses and AEs were similar between 
      treated sides, and none was clinically significant. CONCLUSION: Resilient 
      hyaluronic acid fillers with either mepivacaine or lidocaine are equally 
      effective at reducing pain during treatment and equally performant and safe for 
      correction of dynamic facial wrinkles and folds.
CI  - Copyright (c) 2022 The Author(s). Published by Wolters Kluwer Health, Inc. on 
      behalf of the American Society for Dermatologic Surgery, Inc.
FAU - Kaufman-Janette, Joely
AU  - Kaufman-Janette J
AD  - Skin Research Institute, LLC, Coral Gables, Florida.
FAU - Joseph, John H
AU  - Joseph JH
AD  - Clinical Testing of Beverly Hills, Beverly Hills, California.
FAU - Dayan, Stephen H
AU  - Dayan SH
AD  - DeNova Research, Chigago, Illinois.
FAU - Smith, Stacy
AU  - Smith S
AD  - California Dermatology & Clinical Research Institute, Encinitas, California.
FAU - Eaton, Laura
AU  - Eaton L
AD  - UltaMed Corporation, Fort Lauderdale, Florida.
FAU - Maffert, Pauline
AU  - Maffert P
AD  - Clinical and Medical Affairs Department, Teoxane S.A., Geneva, Switzerland.
LA  - eng
SI  - ClinicalTrials.gov/NCT04069585
PT  - Journal Article
PT  - Randomized Controlled Trial
DEP - 20220713
PL  - United States
TA  - Dermatol Surg
JT  - Dermatologic surgery : official publication for American Society for Dermatologic 
      Surgery [et al.]
JID - 9504371
RN  - 0 (Anesthetics, Local)
RN  - 0 (Dermal Fillers)
RN  - 9004-61-9 (Hyaluronic Acid)
RN  - 98PI200987 (Lidocaine)
RN  - B6E06QE59J (Mepivacaine)
SB  - IM
MH  - Anesthetics, Local
MH  - *Cosmetic Techniques/adverse effects
MH  - *Dermal Fillers/adverse effects
MH  - Double-Blind Method
MH  - Humans
MH  - *Hyaluronic Acid/adverse effects
MH  - Lidocaine
MH  - Mepivacaine/adverse effects
MH  - Nasolabial Fold
MH  - Pain/prevention & control
MH  - Patient Comfort
MH  - Skin Aging
MH  - Treatment Outcome
PMC - PMC9521576
EDAT- 2022/09/22 06:00
MHDA- 2022/10/06 06:00
PMCR- 2022/09/29
CRDT- 2022/09/21 08:33
PHST- 2022/09/22 06:00 [pubmed]
PHST- 2022/10/06 06:00 [medline]
PHST- 2022/09/21 08:33 [entrez]
PHST- 2022/09/29 00:00 [pmc-release]
AID - 00042728-202210000-00010 [pii]
AID - ds-00852-2021 [pii]
AID - 10.1097/DSS.0000000000003541 [doi]
PST - ppublish
SO  - Dermatol Surg. 2022 Oct 1;48(10):1065-1070. doi: 10.1097/DSS.0000000000003541. 
      Epub 2022 Jul 13.