Gfrerer Lisa, Kilmer Suzanne L, Waibel Jill S, Geronemus Roy G, Biesman Brian S
Division of Plastic and Reconstructive Surgery, Massachusetts General Hospital, Harvard Medical School, Boston, Mass.
Laser and Skin Surgery Center of Northern California, Sacramento, Calif.
Plast Reconstr Surg Glob Open. 2022 Oct 17;10(10):e4547. doi: 10.1097/GOX.0000000000004547. eCollection 2022 Oct.
Micro-coring technology (MCT) removes cores of skin without formation of scars, thereby tightening skin and reducing skin wrinkling. The purpose of this study was to evaluate the safety and efficacy of MCT with the dermal micro-coring device for the treatment of facial wrinkles.
This prospective, multicenter clinical trial included fifty-one subjects who underwent MCT treatments of the mid to lower face. The primary study endpoint was change in the Lemperle Wrinkle Severity Scale. Secondary study endpoints were change in Global Aesthetic Improvement Scale (GAIS), participant satisfaction, and evaluation of treatment outcome by an independent review panel. All study endpoints were evaluated at 1, 7, 30, 60, and 150 or 180 days after treatment. Procedure bleeding, pain, and early healing profile were also captured.
The mean Lemperle Wrinkle Severity Scale change was 1.3 grades. Improvement in the GAIS was reported for 89.7% (87/97) of treated sites, and average improvement of GAIS was 1.5. Participants reported satisfaction with 85.6% of treatment sites. The independent review panel correctly identified 84.2% of the post-treatment photographs as post-treatment. Procedure bleeding and pain was mild with good healing responses and patient-reported average down time of 3 days.
The results of this study demonstrate the safety and efficacy of MCT with the dermal micro-coring device for the treatment of moderate to severe facial wrinkles. MCT led to significant improvement of facial wrinkles with high patient satisfaction and fast recovery time and should be considered in patients who are seeking minimally invasive treatment for wrinkles of the face.
微取芯技术(MCT)可去除皮肤芯而不形成疤痕,从而紧致皮肤并减少皮肤皱纹。本研究的目的是评估使用真皮微取芯装置的MCT治疗面部皱纹的安全性和有效性。
这项前瞻性、多中心临床试验纳入了51名接受中下面部MCT治疗的受试者。主要研究终点是Lemperle皱纹严重程度量表的变化。次要研究终点是全球美学改善量表(GAIS)的变化、参与者满意度以及独立评审小组对治疗结果的评估。所有研究终点均在治疗后1、7、30、60和150或180天进行评估。还记录了手术出血、疼痛和早期愈合情况。
Lemperle皱纹严重程度量表的平均变化为1.3级。89.7%(87/97)的治疗部位报告了GAIS的改善,GAIS的平均改善为1.5。参与者对85.6%的治疗部位表示满意。独立评审小组正确识别出84.2%的治疗后照片为治疗后照片。手术出血和疼痛较轻,愈合反应良好,患者报告的平均停机时间为3天。
本研究结果证明了使用真皮微取芯装置的MCT治疗中度至重度面部皱纹的安全性和有效性。MCT可显著改善面部皱纹,患者满意度高,恢复时间快,对于寻求面部皱纹微创治疗的患者应予以考虑。