Clinical safety and efficacy evaluation of a dissolving microneedle patch having dual anti-wrinkle effects with safe and long-term activities
Open accessAbstract
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.
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Previous randomized controlled trials and meta-analyses have reported improvements in skin elasticity following oral or topical interventions, including collagen peptides and other bioactive compounds.
“Although previous randomized controlled trials and meta-analyses have reported improvements in skin elasticity following oral or topical interventions, including collagen peptides and other bioactive compounds [43,44,45,46,47,48]”
From A Randomized, Double-Blind, Placebo-Controlled Trial Assessing the Effects of Oral Centella asiatica Extract on Skin Aging-Related Parameters in Middle-Aged Korean Women. (2026) · cites this paper as [46]
The Results (page not provided) report improved skin elasticity after application of a microneedle patch containing bioactive ingredients. The study does not report an oral collagen-peptide intervention or a meta-analysis, and the Methods passage does not establish that participants were randomized. Elasticity improved within the patch group but was not significantly different from placebo. (LLM, conf=0.85)
Experimental — accuracy not yet measuredRecent randomized controlled trials evaluating oral or topical bioactive compounds-including collagen peptides and other nutraceutical ingredients-have demonstrated improvements in wrinkle-related parameters assessed using validated quantitative techniques.
“Consistent with this, recent randomized controlled trials evaluating oral or topical bioactive compounds—including collagen peptides and other nutraceutical ingredients—have demonstrated improvements in wrinkle-related parameters assessed using validated quantitative techniques [43,44,45,46,47,48].”
From A Randomized, Double-Blind, Placebo-Controlled Trial Assessing the Effects of Oral Centella asiatica Extract on Skin Aging-Related Parameters in Middle-Aged Korean Women. (2026) · cites this paper as [46]
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Experimental — accuracy not yet measuredThe direction of change observed in the present study (increased skin hydration following supplementation) is generally consistent with previous reports.
“Although the direction of change observed in the present study (i.e., increased skin hydration following supplementation) is generally consistent with previous reports [43,44,45,46,47,48]”
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References 23 · Cited by 19
- Authors
- Shin, J. Y., Han, D., Yoon, K. Y., Jeong, D. H., & Park, Y. I.
- Affiliations
- Catholic University of Korea (KR)
- Raphas Co., Ltd., Seoul, Korea.
- Corresponding author
- Park, Yong Il
- Venue
- Annals of Dermatology
- Publisher
- XMLink
- Published
- 2024
- Volume
- 36
- Issue
- 4
- Pages
- 215
- ISSN
- 1013-9087 (ISSN-L)
- 2005-3894
- PMC
- PMC11291098
- OpenAlex
- W4395055511
- Cited by
- 19
- References
- 23
- Citations by year
- 2026: 10 · 2025: 7 · 2024: 2
- FWCI
- 3.31
- Type
- journal article
- Language
- en
- Open access
- diamond
- doi.org
- Licence
- Locations
- Annals of Dermatology (publishedVersion, cc-by-nc)
- PubMed Central (publishedVersion, cc-by-nc)
- PubMed (publishedVersion)
- Topics
- Life Sciences › Pharmacology, Toxicology and Pharmaceutics › Pharmaceutical Science › Advancements in Transdermal Drug Delivery
- Health Sciences › Medicine › Dermatology › Dermatologic Treatments and Research
- Health Sciences › Medicine › Dermatology › Skin Protection and Aging
- Keywords
- dissolving microneedle patch, anti-aging skin care, hyaluronic acid, transdermal drug delivery, transepidermal water loss, skin elasticity, stratum corneum penetration, ocular drug delivery
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