Clinic Testing of Beverly Hills, Beverly Hills, California.
AVAMD, Santa Monica and Beverly Hills, California.
Dermatol Surg. 2019 Dec;45(12):1558-1566. doi: 10.1097/DSS.0000000000001863.
BACKGROUND/OBJECTIVES: This trial evaluated the effectiveness and safety of Bellafill for full-face acne scar treatment.
In this open-label, nonrandomized, multicenter pilot study investigating the use of polymethylmethacrylate for full-face atrophic acne scar correction, 42 adult subjects with a mean age of 43 years were treated and assessed for safety and effectiveness at Months 4 and 7. There were no hypersensitivity reactions to pretreatment skin testing or during scar treatments.
At 4 and 7 months after initial treatment, 92% and 95% of subjects, respectively, were responders with ≥1-point improvement on the 5-point Acne Scar Assessment Scale. Subjects reported very high levels of improvement on the Global Aesthetic Improvement Scale (GAIS), with 95% of subjects reporting "improved or better" at 4 months and 90% at 7 months. The outcome of the physician GAIS was also high with 92% of patients classified as "improved or better" at 4 months and 97% at 7 months. There were only 2 device-related adverse events, both mild events related to Bellafill skin test (bruising, ecchymosis). There were no serious adverse events in response to the treatment product in this short-term follow-up study.
Polymethylmethacrylate is effective for treating full-face acne scarring. Clinicaltrials.gov #NCT02642627.
背景/目的：本试验评估了 Bellafill 治疗全面部痤疮瘢痕的有效性和安全性。
在这项开放性、非随机、多中心的初步研究中，我们使用聚甲基丙烯酸甲酯治疗全颜面萎缩性痤疮瘢痕矫正，共有 42 名年龄平均为 43 岁的成年患者接受了治疗，并在第 4 个月和第 7 个月时进行了安全性和有效性评估。在进行预处理皮肤测试或瘢痕治疗期间，均未出现过敏反应。
初次治疗后 4 个月和 7 个月时，分别有 92%和 95%的患者在 5 分痤疮瘢痕评估量表上改善≥1 分，为应答者。患者在全球美学改善量表（GAIS）上报告了非常高的改善水平，95%的患者在第 4 个月报告“改善或更好”，90%的患者在第 7 个月报告“改善或更好”。医生 GAIS 的结果也很高，92%的患者在第 4 个月和 97%的患者在第 7 个月被归类为“改善或更好”。只有 2 例与器械相关的不良事件，均为与 Bellafill 皮肤试验相关的轻度事件（瘀斑、瘀点）。在这项短期随访研究中，没有与治疗产品相关的严重不良事件。
聚甲基丙烯酸甲酯治疗全面部痤疮瘢痕有效。临床试验.gov #NCT02642627。
