Patient Comfort, Safety, and Effectiveness of Resilient Hyaluronic Acid Fillers Formulated With Different Local Anesthetics

Joely Kaufman-Janette, John H Joseph, Stephen H Dayan, Stacy Smith, Laura Eaton, Pauline Maffert, Joely Kaufman-Janette, John H Joseph, Stephen H Dayan, Stacy Smith, Laura Eaton, Pauline Maffert

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.

Trial registration: ClinicalTrials.gov NCT04069585.

Copyright © 2022 The Author(s). Published by Wolters Kluwer Health, Inc. on behalf of the American Society for Dermatologic Surgery, Inc.

Figures

Figure 1.
Figure 1.
Injection site pain during injection—primary outcome (box plot).
Figure 2.
Figure 2.
Assessment of the aesthetic improvement on photonumeric validated scales.

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