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聚甲基丙烯酸甲酯胶原蛋白凝胶可注射真皮填充剂用于全颜面萎缩性痤疮瘢痕矫正。

Polymethylmethacrylate Collagen Gel-Injectable Dermal Filler for Full Face Atrophic Acne Scar Correction.

机构信息

Clinic Testing of Beverly Hills, Beverly Hills, California.

AVAMD, Santa Monica and Beverly Hills, California.

出版信息

Dermatol Surg. 2019 Dec;45(12):1558-1566. doi: 10.1097/DSS.0000000000001863.

Abstract

BACKGROUND/OBJECTIVES: This trial evaluated the effectiveness and safety of Bellafill for full-face acne scar treatment.

PATIENTS AND METHODS

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.

RESULTS

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.

CONCLUSION

Polymethylmethacrylate is effective for treating full-face acne scarring. Clinicaltrials.gov #NCT02642627.

摘要

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。

患者和方法

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。

结果

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。

结论

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。

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