Objective: The purpose of this study was to evaluate the efficacy and safety of an automated microneedling device (Exceed, Amiea Med, MT.DERM GmbH, Berlin, Germany) when used for the rejuvenation of facial skin, as well as to generate data for an FDA 510K submission for the device. Study design: This was an open-label, single-center study. Participants: Forty-eight subjects aged 35 to 75 years with signs of facial skin aging were recruited. After consenting and satisfying inclusion criteria, each subject underwent four microneedling sessions 30 days apart. Subjects were assessed at baseline and at 30, 60, 90, and 150 days after the first treatment. Measurements: Wrinkles were assessed using the Lemperle Grading Scale. Skin laxity and texture were assessed using a modified Alexiades-Armenakas Grading Scale. Digital fringe projection technology (PRIMOS) was used to determine skin topography of the periorbital and mesolabial areas. Results: Mean improvements in global wrinkle score (mean of nine facial area grades), skin laxity, and skin texture at Day 150, compared to baseline were 1.23 (99% confidence interval [CI]: 1.11, 1.34), 1.09 (99% CI: 0.93, 1.26), and 1.54 (99% CI: 1.33, 1.75), respectively. Statistically significant mean improvements in these three measures were also observed at Day 90. Improvements in wrinkle grading and skin texture were confirmed by the PRIMOS profilometry. The treatment was well tolerated with minimal pain, discomfort, and downtime. Side effects were minor and easily managed. Conclusion: This study demonstrates that four microneedling treatments of facial skin, spaced four weeks apart, significantly improve lines, wrinkles, skin laxity and skin texture, 90 and 150 days after the first treatment. The treatment was well tolerated with minimal pain, discomfort, and downtime. Side effects were minor and easily managed compared to other invasive technologies, such as laser ablation and radiofrequency.
Keywords: Microneedling, device; aging skin; effectiveness; laxity; minimally invasive; open-label; percutaneous collagen induction; safety; single-center; skin ageing; skin rejuvenation; texture; tissue remodeling; wrinkles.