背景:用于增加软组织的可注射填充剂是美容医学领域中最受欢迎的程序之一,特别是在解决皮肤老化的临床迹象。在软组织填充物中,几十年来,非永久性填料已安全地用于许多医疗应用。
目的:本次上市后观察的目的,开放标签,不受控制,多中心,前瞻性研究(PMS)旨在评估可注射的基于聚L-乳酸的胶原刺激剂(Lanluma®,研究产品)。
方法:该分析基于从研究人员和参与者在第一次注射(T0,2022年9月)到之后9个月(T3,2023年6月)之间收集的临床结果数据(安全性和有效性)。
结果:总体而言,70名参与者进行了99次颈部治疗(31%),上臂(20%),手(17%),大腿(16%)和大腿(15%)。肿块(颈部,上臂,手)和结节(颈部,手,大腿)是研究者报告的最常见的不良事件(AE)。都是治疗相关的。没有人是认真的,严重的或致命的。治疗后未报告AE。研究人员和参与者都报告说,在九个月的随访期内,对五个身体部位的治疗有很高的满意度。
结论:这些积极的临床结果可以归因于最佳实践和建议的正确实施。和研究产品的流变特性。在25个月随访时,应根据研究的最终分析目标重新考虑9个月的随访分析。
BACKGROUND: Injectable fillers for soft tissue augmentation stand out as one of the most favored procedures in the field of aesthetic medicine, especially in addressing the clinical signs of skin aging. Among soft tissue fillers, non-permanent fillers have been safely used in numerous medical applications for several decades.
OBJECTIVE: The aim of this post-market observational, open-label, uncontrolled, multicentered, prospective study (PMS) was to evaluate the effects of an injectable poly-L-lactic acid-based collagen stimulator (Lanluma®, the study product).
METHODS: This analysis is based on the clinical outcomes data (safety and effectiveness) collected from investigators and participants between the first injection (T0, September 2022) and 9 months thereafter (T3, June 2023) in the treatment of five body-contouring areas.
RESULTS: Overall, 70 participants had 99 treatment sessions of the neck (31%), upper arm (20%), hand (17%), thigh (16%) and décolleté (15%). Lumps (neck, upper arm, hand) and nodules (neck, hand, thigh) were the most frequent adverse events (AEs) reported by investigators. All were treatment related. None were serious, severe or fatal. No AEs were reported following treatment of the décolleté. Both investigators and participants reported high levels of satisfaction during the nine-month follow-up period with the treatments in five body areas.
CONCLUSIONS: These positive clinical outcomes can be attributed to a proper implementation of best practices and recommendations, and the rheological properties of the study product. This 9-month follow-up analysis should be reconsidered in light of the study\'s objectives for the final analysis at the 25-month follow-up.