Aesthet Surg J. 2024 Oct 15;44(11):1218-1226. doi: 10.1093/asj/sjae133.
Hyaluronic acid dermal fillers are used for multiple indications, including wrinkle correction and restoration of volume/fullness.
The aim of this study was to compare the efficacy and safety of 2 hyaluronic acid products for correcting moderate to severe nasolabial folds (NLFs).
A prospective, randomized, double-blind, split-face study was undertaken. The subjects' left and right NLFs were randomly allocated for treatment with DKL23 or Juvéderm Volift. Follow-up was conducted at 1, 3, 6, and 9 months. The changes from baseline on the Wrinkle Severity Rating Scale and the Global Aesthetics Improvement Scale were evaluated. Posttreatment adverse events (AEs) were recorded.
Forty-eight women (median age, 57.0 years) with Type I to VI skin were enrolled. Both treatments showed statistically significant improvement (P < .0001) in NLFs according to the Wrinkle Severity Rating Scale score from baseline to each of the time points assessed. The improvement in NLFs was maintained until the end of the study (9 months). Furthermore, the change from baseline to each of the time points assessed was similar between DKL23 and Juvéderm Volift. Investigator- and subject-rated Global Aesthetics Improvement Scale scores showed similar rates of improvement (indicated by the sum of responses of improved, much improved, or very much improved) between the 2 products. The AEs reported in the study were in line with previous and expected experience after injection of hyaluronic acid dermal fillers. The types of AEs, their rates, intensity, and duration were comparable between the 2 products.
DKL23 improved NLF severity from baseline and for up to 9 months, and the results were comparable to the improvement shown by Juvéderm Volift. Treatment was safe and well tolerated.
透明质酸皮肤填充剂用于多种适应症,包括皱纹矫正和体积/丰满度的恢复。
本研究旨在比较两种透明质酸产品治疗中度至重度鼻唇沟(NLFs)的疗效和安全性。
进行了一项前瞻性、随机、双盲、分割面研究。将受试者的左右 NLF 随机分配接受 DKL23 或 Juvéderm Volift 治疗。在 1、3、6 和 9 个月时进行随访。评估皱纹严重程度评分量表和整体美学改善量表的基线变化。记录治疗后的不良事件(AE)。
48 名女性(中位数年龄为 57.0 岁),皮肤类型为 I 至 VI 型,入组。根据 Wrinkle Severity Rating Scale 评分,两种治疗方法均显示 NLF 显著改善(P <.0001),从基线到每个评估时间点均有统计学意义。NLF 的改善一直持续到研究结束(9 个月)。此外,DKL23 和 Juvéderm Volift 之间从基线到每个评估时间点的变化相似。研究者和受试者评估的整体美学改善量表评分显示,两种产品的改善率相似(由改善、明显改善或非常明显改善的综合反应表示)。研究中报告的 AE 与之前和预期的注射透明质酸皮肤填充剂后的经验相符。两种产品的 AE 类型、发生率、强度和持续时间相当。
DKL23 从基线开始改善 NLF 的严重程度,最长可达 9 个月,其效果与 Juvéderm Volift 相似。治疗安全且耐受良好。