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Patient Comfort, Safety, and Effectiveness of Resilient Hyaluronic Acid Fillers Formulated With Different Local Anesthetics.
Kaufman-Janette, Joely; Joseph, John H; Dayan, Stephen H; Smith, Stacy; Eaton, Laura; Maffert, Pauline.
Afiliação
  • Kaufman-Janette J; Skin Research Institute, LLC, Coral Gables, Florida.
  • Joseph JH; Clinical Testing of Beverly Hills, Beverly Hills, California.
  • Dayan SH; DeNova Research, Chigago, Illinois.
  • Smith S; California Dermatology & Clinical Research Institute, Encinitas, California.
  • Eaton L; UltaMed Corporation, Fort Lauderdale, Florida.
  • Maffert P; Clinical and Medical Affairs Department, Teoxane S.A., Geneva, Switzerland.
Dermatol Surg ; 48(10): 1065-1070, 2022 10 01.
Article em En | MEDLINE | ID: mdl-36129233
ABSTRACT

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.
Assuntos

Texto completo: 1 Base de dados: MEDLINE Assunto principal: Técnicas Cosméticas / Preenchedores Dérmicos / Ácido Hialurônico Tipo de estudo: Clinical_trials Limite: Humans Idioma: En Ano de publicação: 2022 Tipo de documento: Article

Texto completo: 1 Base de dados: MEDLINE Assunto principal: Técnicas Cosméticas / Preenchedores Dérmicos / Ácido Hialurônico Tipo de estudo: Clinical_trials Limite: Humans Idioma: En Ano de publicação: 2022 Tipo de documento: Article