背景:在评估美容产品的安全性和有效性的临床研究中,有色人种(POC)的代表性往往不足,包括透明质酸(HA)填充剂,迄今为止,POC的临床数据有限。
目的:评估新型动态HA填充剂(RHA®,Revance,纳什维尔TN)用于治疗POC与非POC中至重度鼻唇沟(NLF)。
方法:事后亚组分析比较了使用RHA2,RHA3或RHA4治疗的POC与非POC受试者的疗效和安全性。在两个临床试验中,合并的每个方案人群(N=217)中的中重度鼻唇沟。根据Fitzpatrick皮肤类型(FST)[高FST(IV-VI)与低FST(I-III)]和受试者报告的种族(非白人与白人),在6、9、12和15个月时对评估的人群进行分类。
结果:与非POC相比,POC在皱纹严重程度方面始终表现出更大的改善和更高的应答率,在几个测量时间点达到统计显著性。POC和非POC的全球美学改善得分(GAIS)和受试者满意度相似,并且在整个研究过程中一直很高。高FST与低FST相比,治疗相关的不良事件发生率通常较低,没有报告的瘢痕疙瘩病例。
结论:动态填充剂的RHA系列具有良好的耐受性,可有效纠正POC中至重度鼻唇沟褶皱,可以放心地用于这一重要且不断增长的患者人群。
BACKGROUND: People of color (POC) are often underrepresented in clinical studies evaluating the safety and effectiveness of aesthetic products, including hyaluronic acid (HA) fillers, for which there is to date limited clinical data in POC.
OBJECTIVE: The aim of this study was to assess the safety and effectiveness of a new line of dynamic resilient HA fillers (RHA; Revance, Nashville, TN) for treating moderate-to-severe nasolabial folds (NLFs) in POC vs non-POC.
METHODS: Post hoc subgroup analyses compared the efficacy and safety of POC vs non-POC subjects treated with RHA2, RHA3, or RHA4 for correction of moderate-to-severe NLFs in the pooled per-protocol population (N = 217) in 2 clinical trials. Evaluated population cohorts were classified by Fitzpatrick skin type (FST) (high FST [IV-VI] vs low FST [I-III]) and by subject-reported race (non-White vs White) relative to baseline at 6, 9, 12, and 15 months.
RESULTS: POC consistently showed greater improvement in wrinkle severity and higher responder rates compared with non-POC, which reached statistical significance at several measured time points. Global Aesthetic Improvement Scale scores and subject satisfaction ratings were similar for POC and non-POC and remained high throughout the course of the study. Treatment-related adverse event rates were generally lower for high FSTs vs low FSTs, with no reported cases of keloidal scarring.
CONCLUSIONS: The RHA line of dynamic fillers is well tolerated and effective for the correction of moderate-to-severe NLFs in POC and can be confidently used in this important and growing patient population.See the abstract translated into Hindi, Portuguese, Korean, German, Italian, Arabic, Chinese, and Taiwanese online here: https://doi.org/10.1093/asj/sjad251.
METHODS: