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分次射频治疗和减轻痤疮瘢痕的安全性与有效性:一项前瞻性研究。

Safety and efficacy of fractional radiofrequency for the treatment and reduction of acne scarring: A prospective study.

作者信息

Eubanks Stephen W, Solomon James A

机构信息

Ameriderm Research, Leavitt Medical Associates of Florida, Port Orange, Florida, USA.

College of Medicine, University of Central Florida, Orlando, Florida, USA.

出版信息

Lasers Surg Med. 2022 Jan;54(1):74-81. doi: 10.1002/lsm.23453. Epub 2021 Aug 19.

Abstract

OBJECTIVES

Skin rejuvenation with radiofrequency has been a widely used treatment modality for the safe and efficient remodeling of the dermis and revision of textural irregularities, achieved with minimal downtime. The efficacy of fractional radiofrequency (FRF) specifically for acne scarring has not been widely established. The objective of this clinical trial was to establish the efficacy and safety of FRF for moderate to severe acne scarring in a wide range of Fitzpatrick skin types using two different applicator tips to deliver energy to the skin (80-pin of up to 124 mJ/pin and 160-pin of up to 62 mJ/pin).

METHODS

Enrolled subjects received a series of three FRF treatments to the full face, each 4 weeks apart. A visual analog scale was utilized to assess pain of the treatment. Subject satisfaction questionnaires were completed at follow-up visits at 6 and 12 weeks post final treatment. Photographs were graded for change by three blinded evaluators using the Global Aesthetic Improvement Scale (GAIS).

RESULTS

Image sets of 23 enrolled subjects were assessed by blinded evaluation, showing a statistically significant improvement (p = 0.009) from the baseline visit to the 12-week follow-up on the GAIS for acne scarring. Subject satisfaction was high with subjects giving an average satisfaction score of 3.27 ("satisfied") out of 4. Pain was "mild" as treatments were rated an average of 2.15 on a 10-point visual analog scale. The GAIS score of the 80-pin tip improved patients' acne scars treated with that applicator by 1.06 points and 0.85 for the 160-pin tip. Ninety-five percent (95.5%) of subjects reported either a mild, moderate, or significant improvement to their treatment area. Ninety-one percent of subjects reported that they would recommend the treatment to a friend.

CONCLUSION

FRF produced a statistically significant improvement in acne scarring when assessed by independent blinded evaluators. No serious adverse events resulted from treatment by either applicator tip. Treatment pain was low and tolerable among subjects of all Fitzpatrick skin types. Subjects had high levels of satisfaction with the results.

摘要

目的

射频皮肤年轻化已成为一种广泛应用的治疗方式,用于真皮层的安全有效重塑以及改善质地不规则问题,且停机时间最短。专门用于痤疮疤痕的分次射频(FRF)的疗效尚未得到广泛证实。本临床试验的目的是使用两种不同的施术头向皮肤输送能量(80针的高达124 mJ/针和160针的高达62 mJ/针),确定FRF对广泛的菲茨帕特里克皮肤类型中重度痤疮疤痕的疗效和安全性。

方法

入选受试者全脸接受一系列三次FRF治疗,每次间隔4周。使用视觉模拟量表评估治疗疼痛程度。在最后一次治疗后6周和12周的随访中完成受试者满意度问卷调查。由三名盲法评估者使用全球美学改善量表(GAIS)对照片变化进行评分。

结果

对23名入选受试者的图像集进行盲法评估,结果显示从基线访视到12周随访时,痤疮疤痕的GAIS评分有统计学显著改善(p = 0.009)。受试者满意度较高,平均满意度评分为4分中的3.27分(“满意”)。疼痛为“轻度”,因为治疗在10分视觉模拟量表上的平均评分为2.15分。80针施术头的GAIS评分使使用该施术头治疗的患者痤疮疤痕改善了1.06分,160针施术头为0.85分。95.5%的受试者报告其治疗区域有轻度、中度或显著改善。91%的受试者报告他们会向朋友推荐该治疗。

结论

经独立盲法评估者评估,FRF在痤疮疤痕治疗方面产生了统计学显著改善。两种施术头治疗均未导致严重不良事件。所有菲茨帕特里克皮肤类型的受试者治疗疼痛程度低且可耐受。受试者对结果满意度较高。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/f6c5/9291574/fc061b72f41d/LSM-54-74-g005.jpg

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