J Drugs Dermatol. 2021 May 1;20(5):529-533. doi: 10.36849/JDD.5380.
Poly-l-lactic acid (PLLA) is an injectable volumizer with biostimulatory properties used for volumetric structural rejuvenation in patients with facial fat volume loss but has increasingly been utilized for off-face applications.
The objectives of this randomized, double-blind, placebo-controlled single center study was to assess the safety and effectiveness of PLLA for the treatment of lower extremity cellulite in adult women.
31 healthy women were enrolled in the study. Eligible subjects received 3 treatments every 4 weeks with either PLLA (treatment group) or saline (control group) injections combined with subcision, into each of the glutes or thighs. Follow-up visits were at 1, 3, and 6 months after treatment. Assessments included live ratings, rating of standardized pictures by a blinded evaluator, patient questionnaires, safety, and tolerability ratings.
At the 3 and 6-month follow-up, there was a statistically significant change in the global aesthetic improvement scale (GAIS) compared to baseline as assessed by blinded investigators. Significant improvements were shown in the cellulite severity scale (CSS) as well as in the subject satisfaction questionnaires. Treatments were found to be tolerable, and no severe treatment-related adverse events occurred.
Repeated PLLA treatments combined with subcision are effective and safe in improving the appearance of cellulite. J Drugs Dermatol. 20(5): doi:10.36849/JDD.5380.
聚左旋乳酸(PLLA)是一种具有生物刺激特性的可注射体积增大剂,用于治疗面部脂肪容量丢失的患者的体积结构年轻化,但越来越多地用于非面部应用。
本随机、双盲、安慰剂对照的单中心研究的目的是评估 PLLA 治疗成年女性下肢脂肪团的安全性和有效性。
31 名健康女性入组本研究。合格的受试者每 4 周接受 3 次治疗,接受 PLLA(治疗组)或生理盐水(对照组)注射联合皮下分离术,分别注射至臀部或大腿。治疗后 1、3 和 6 个月进行随访。评估包括现场评分、由盲法评估者评估的标准化图片评分、患者问卷调查、安全性和耐受性评分。
在 3 个月和 6 个月的随访中,与基线相比,盲法评估者评估的全球美学改善量表(GAIS)有统计学意义的变化。在脂肪团严重程度量表(CSS)以及患者满意度问卷中也显示出显著改善。治疗被认为是可耐受的,没有发生严重的与治疗相关的不良事件。
重复 PLLA 治疗联合皮下分离术可有效、安全地改善脂肪团的外观。J 皮肤病学杂志。20(5):doi:10.36849/JDD.5380.