Abstract

Background: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.Methods: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.Results: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.Conclusions: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.

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