PDF(Pubmed)
Abstract：
BACKGROUND: Anti-aging products are widely used, but the desire for safe and more efficient anti-aging products continues to increase. Dissolving microneedle patches (MNPs) have provided a more efficient transdermal drug delivery solution. MNP is a promising candidate for developing better anti-aging products.
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.
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.
摘要：
背景：抗衰老产品被广泛使用，但对安全和更有效的抗衰老产品的需求不断增加。溶解微针贴剂(MNP)提供了更有效的经皮药物递送溶液。MNP是开发更好的抗衰老产品的有希望的候选人。
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。
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。
