Clinical Safety and Efficacy Evaluation of a Dissolving Microneedle Patch Having Dual Anti-Wrinkle Effects With Safe and Long-Term Activities

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.Conclusion: 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.