Clear Dermatology and Aesthetic Center, North Scottsdale, Arizona, USA.
Asyst Medical, LLC, Ogunquit, Maine, USA.
Lasers Surg Med. 2022 Dec;54(10):1251-1260. doi: 10.1002/lsm.23596. Epub 2022 Sep 7.
Fibrosis, including hypertrophic scar formation, is a pathological condition characterized by excessive production and accumulation of collagen, and loss of tissue architecture, in response to wound healing. Alterations in the extracellular matrix (ECM) biomechanical properties may be important in modulating myofibroblasts and fibrosis formation. The acoustic subcision device uses rapid acoustic pulse technology to noninvasively improve the appearance of hypertrophic scars through both microdisruption of scar tissue matrix and downregulation of fibrotic fibroblasts leading to scar remodeling. The objective of this single-site proof-of-concept IRB-approved human clinical study was to evaluate the efficacy of acoustic subcision device for the improvement in the appearance of hypertrophic scars.
Eleven hypertrophic scars in 10 participants were treated with a single 6-minute acoustic subcision application without anesthesia. Posttreatment adverse events (AEs) and tolerability were recorded. At 12 and 89 weeks posttreatment, scar heights and volumes were measured, and participant satisfaction questionnaires were completed. Finally, at the last visit the scar appearance was assessed by the Principal Investigator (PI) using the Mecott Modified Scar Scale (MMSS).
Immediately following the acoustic subcision treatment, only mild, moderate erythema or pinpoint bleeding were noted. The treatment sessions were considered tolerable by all participants with an average pain score of 2.2 (on a 0-10 pain score with 10 being the worse possible pain). The 12- and 89-week assessments demonstrated mean height reductions of 46.3% and 56.8%, respectively from baseline. The differences in scar height were statistically significant (p < 0.01). The 12- and 89-week assessments demonstrated a mean volume reduction of 63.2% and 58.1% respectively from baseline. The differences in the scar volume were statistically significant (p < 0.001). The PI graded an average improvement of 33.7% in scar appearance using the MMSS, a statistically significant change (p < 0.001). Finally, >90% of participants reported satisfaction with the improvement in their scar.
This proof-of-concept study showed that a single noninvasive acoustic subcision treatment session can safely provide statistically significant improvement in the appearance of hypertrophic scars with minimal treatment pain and meaningful participant satisfaction. More work is needed on a larger number of scars to verify this finding. Further improvement in appearance is expected with multiple acoustic subcision treatments and/or treatments in combination with currently available options. Additional trials to verify this are planned.
纤维化，包括肥厚性瘢痕形成，是一种病理状态，其特征是在创伤愈合过程中，胶原蛋白过度产生和积累，以及组织结构丧失。细胞外基质（ECM）生物力学特性的改变可能在调节肌成纤维细胞和纤维化形成方面很重要。声波微扰设备利用快速声波脉冲技术，通过微破坏瘢痕组织基质和下调纤维化成纤维细胞来改善瘢痕外观，从而非侵入性地改善肥厚性瘢痕的外观。这项单中心、经机构审查委员会批准的人体临床研究的目的是评估声波微扰设备改善肥厚性瘢痕外观的疗效。
10 名参与者的 11 处肥厚性瘢痕接受了单次 6 分钟的声波微扰治疗，无需麻醉。记录治疗后不良事件（AE）和耐受性。治疗后 12 周和 89 周时，测量瘢痕高度和体积，并完成参与者满意度问卷。最后，在最后一次就诊时，由主要研究者（PI）使用 Mecott 改良瘢痕量表（MMSS）评估瘢痕外观。
在进行声波微扰治疗后，仅观察到轻度、中度红斑或针尖样出血。所有参与者均认为治疗过程可耐受，平均疼痛评分为 2.2（疼痛评分 0-10 分，10 分为最严重疼痛）。12 周和 89 周的评估显示，与基线相比，瘢痕高度分别平均降低了 46.3%和 56.8%。瘢痕高度的差异具有统计学意义（p<0.01）。12 周和 89 周的评估显示，与基线相比，瘢痕体积分别平均减少了 63.2%和 58.1%。瘢痕体积的差异具有统计学意义（p<0.001）。PI 使用 MMSS 平均评定瘢痕外观改善 33.7%，具有统计学意义（p<0.001）。最后，>90%的参与者报告对瘢痕改善感到满意。
这项概念验证研究表明，单次非侵入性声波微扰治疗可安全地显著改善肥厚性瘢痕的外观，治疗疼痛最小，患者满意度高。需要更多的研究来验证这一发现。随着更多次的声波微扰治疗和/或与现有治疗方法联合治疗，预计外观会进一步改善。计划进行更多的试验来验证这一点。
