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

利多卡因 皱纹 医学 透明质酸 甲哌卡因 可视模拟标度 不利影响 随机对照试验 透明质酸酶 麻醉 外科 内科学 化学 解剖 老年学 生物化学
作者
Joely Kaufman‐Janette,John Joseph,Stephen H. Dayan,Stacy Smith,Laura Eaton,Pauline Maffert
出处
期刊:Dermatologic Surgery [Lippincott Williams & Wilkins]
卷期号:48 (10): 1065-1070
标识
DOI:10.1097/dss.0000000000003541
摘要

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.

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