The Comparative Efficacy and Safety of 250 μm versus 350 μm Long Microneedle Patch on Under-Eye Skin

Abstract

Background: Microneedle patch (MNP) technology is now applied for many purposes, including transdermal drug delivery and percutaneous collagen induction in the cosmetic and dermatology fields. Previous research showed that a MNP effectively improved skin appearance, while treatments using larger or deeper microneedles were not easily tolerated by human subjects. Few studies have compared MNP designs in humans. Study Objective: To compare novel MNP designs with high length and low density versus low length and high density for rejuvenating skin wrinkles under the eyes. Methods: This non-randomized split-face clinical trial was conducted as a double-blind study with 36 Thai female participants. Each participant was treated with two different MNP designs, one on each side of the face. The microneedle lengths were 250 μm with a density of 945 needles/cm2 on the left side of the face under the eye and 350 μm with a density of 482 needles/cm2 on the right side of the face under the eye. The treatments were applied for 12 weeks, with the assessment outcomes evaluated at the baseline and 2, 4, 6, 8, 10, and 12 weeks. Results: The application of these two novel MNP designs successfully rejuvenated under-eye wrinkles with low pain level scores. Increasing the length of the needle or having a 350 μm long MN can better reduce under-eye wrinkles without statistical significance. During the study period, there was an improvement in skin surface roughness in both groups accompanied by a consistent reduction in under-eye skin wrinkles, without statistically significant differences observed between the groups when using the Antera 3D system. However, the 350 μm long MN also slightly increased the pain compared to the shorter needles (250 μm long MN) with a higher density of needles. There were no side effects associated with the two designs. Conclusions: The two novel MNPs gave favorable results as a safe non-invasive treatment for the rejuvenation of skin wrinkles under the eyes. Increasing the number of needles and increasing the length of the needles were both effective in safely reducing under-eye wrinkles without any adverse effects. Additionally, participants could self-apply them at home and were highly satisfied. However, increasing the length of the needles may result in slightly more pain compared to increasing the number of needles.