OBJECTIVE: To develop a more efficient anti-aging MNP product, we fabricated a dual anti-wrinkle microneedle patch (named DA-MNP) using droplet extension (DEN®) technology and evaluated its skin puncture ability, safety, and efficacy through clinical studies.
METHODS: A DA-MNP comprising hyaluronic acid (HA) polymer backbone, acetyl octapeptide-3, and L-ascorbic acid 2-glucoside and sodium cyclic lysophosphatidic acid was fabricated using DEN® technology. Placebo MNPs comprising only HA were also fabricated. Twenty-four healthy subjects were enrolled in this comparative clinical study. The DA-MNP or placebo MNP was separately applied to the left and right eyes of subjects for overnight. Assessments, including wrinkle improvement, trans-epidermal water loss (TEWL), eye lifting and adverse effects were evaluated at each scheduled visit day for 28 days.
RESULTS: The DA-MNP showed mechanical strength enough for puncturing the stratum corneum. Compared to placebo MNP group, the DA-MNP treated group showed an effective eye wrinkles improvement and better anti-aging of skin, with reduced TEWL, enhanced skin elasticity and lifting, and no adverse effects.
CONCLUSIONS: The present study demonstrated that the fabricated DA-MNP exhibited fast acting on deep wrinkles and enhanced anti-aging efficacy, with no skin safety concern. Thus, this DA-MNP may serve as a new transdermal delivery solution for skin wrinkling and aging.
目标:为了开发更有效的抗衰老MNP产品,我们使用液滴延伸(DEN®)技术制造了双抗皱微针贴片(名为DA-MNP),并评估了其皮肤穿刺能力,安全,通过临床研究和疗效。
方法:包含透明质酸(HA)聚合物骨架的DA-MNP,使用DEN®技术制备乙酰八肽-3和L-抗坏血酸2-葡糖苷和环状溶血磷脂酸钠。还制造了仅包含HA的安慰剂MNP。24名健康受试者参加了这项比较临床研究。将DA-MNP或安慰剂MNP分别施用于受试者的左眼和右眼过夜。评估,包括改善皱纹,经表皮失水(TEWL),在28天的每个预定访视日评估了提眼力和不良反应.
结果:DA-MNP显示出足以刺穿角质层的机械强度。与安慰剂MNP组相比,DA-MNP治疗组显示出有效的眼部皱纹改善和更好的皮肤老化,TEWL降低,增强皮肤弹性和提升,没有不良影响。
结论:本研究表明,制造的DA-MNP对深层皱纹表现出快速作用,并增强了抗衰老功效,没有皮肤安全问题。因此,这种DA-MNP可以作为一种新的皮肤皱纹和老化的透皮给药方案。