Clinical Safety and Efficacy Evaluation of a Dissolving Microneedle Patch Having Dual Anti-Wrinkle Effects With Safe and Long-Term Activities
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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 pro- vided a more efficient transdermal drug deliver y 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 cor- neum. 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 elas- ticity and lifting, and no adverse effects. Conclusion: The present study demonstrated that the fabricated DA-MNP exhibited fast act- ing on deep wrinkles and enhanced anti-aging efficacy, with no skin safety concern. Thus, this DA-MNP may ser ve as a new transdermal deliver y solution for skin wrinkling and aging.
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 pro- vided a more efficient transdermal drug deliver y 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 cor- neum. 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 elas- ticity and lifting, and no adverse effects. Conclusion: The present study demonstrated that the fabricated DA-MNP exhibited fast act- ing on deep wrinkles and enhanced anti-aging efficacy, with no skin safety concern. Thus, this DA-MNP may ser ve as a new transdermal deliver y solution for skin wrinkling and aging.
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