Additional Use of Hyaluronic Acid-Based Dissolving Microneedle Patches to Treat Psoriatic Plaques: A Randomized Controlled Trial.

Annals of dermatology Pub Date : 2025-04-01 DOI:10.5021/ad.24.024

Hyun Jeong Ju, Ji Yoon Kim, Do Hyeon Jeong, Moon-Su Lee, Gyong Moon Kim, Jung Min Bae, Ji Hae Lee

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Abstract

Background: Despite advances in systemic targeted therapies, topical agents remain the primary treatment for localized psoriasis. However, their therapeutic effects are often delayed and unsatisfactory. The dissolving microneedle (DMN) patch, a novel transdermal drug delivery system, enhances the absorption of topical agents through micro-channels.

Objective: To evaluate the efficacy of DMN patches in enhancing drug delivery and improving clinical outcomes in psoriatic plaques.

Methods: A prospective, randomized, split-body study was conducted to verify the efficacy of additional use of DMN patches after topical agent application in psoriasis treatment. Patients with mild psoriasis were enrolled and 6 paired lesions per patient were randomized into 3 groups: ointment-only, ointment-with-no needle patch, and ointment-with-DMN patch. Lesions were treated with a topical agent (betamethasone and calcipotriol) once daily for 2 weeks. Modified psoriasis area and severity index (mPASI) scores were measured weekly. In vitro and ex vivo experiments were performed to confirm micro-channel formation, microneedle dissolution, and drug penetration enhancement.

Results: A total of 132 paired lesions from 22 patients were analyzed. The ointment-with-DMN patch group showed significantly improved mPASI scores (80.4%±20.5%; 5.42→1.06) compared to the ointment-with-no needle patch (64.6%±33.0%; 4.94→1.68) (p<0.05) and ointment-only groups (55.5%±31.4%; 5.00→2.15) (p<0.001). In vitro studies demonstrated 2.1-fold enhanced drug delivery with DMN patches, while ex vivo histological analysis confirmed micro-channel formation. No adverse events, including infection or psoriasis exacerbation, were observed.

Conclusion: The DMN patch is an effective adjunctive tool that enhances transdermal drug delivery and improves therapeutic outcomes in psoriatic plaques, particularly those refractory to topical agents.

Trial registration: ClinicalTrials.gov Identifier: NCT02955576.

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额外使用透明质酸溶解微针贴片治疗银屑病斑块：一项随机对照试验。

背景：尽管全身靶向治疗取得了进展，局部药物仍然是局部银屑病的主要治疗方法。然而，它们的治疗效果往往延迟和不令人满意。溶解性微针（DMN）贴剂是一种新型的经皮给药系统，通过微通道增强局部药物的吸收。目的：评价DMN贴片促进银屑病斑块药物传递和改善临床预后的疗效。方法：采用前瞻性、随机、分体研究，验证外用药物治疗银屑病后再加用DMN贴片的疗效。纳入轻度牛皮癣患者，每位患者6个配对病灶随机分为3组：仅软膏、软膏不带针贴和软膏带dmn贴。病灶用局部药物（倍他米松和钙化三醇）治疗，每天1次，持续2周。每周测量改良牛皮癣面积和严重程度指数（mPASI）评分。体外和离体实验证实了微通道的形成、微针的溶解和药物渗透的增强。结果：共分析了22例患者的132对病变。dmn贴片软膏组mPASI评分显著提高(80.4%±20.5%；5.42→1.06)与无针贴膏组比较(64.6%±33.0%；体外研究表明，DMN贴片的给药能力提高了2.1倍，而离体组织学分析证实了微通道的形成。没有观察到不良事件，包括感染或牛皮癣恶化。结论：DMN贴片是一种有效的辅助工具，可以增强经皮给药，改善银屑病斑块的治疗效果，特别是对局部药物难治的银屑病斑块。试验注册：ClinicalTrials.gov标识符：NCT02955576。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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Annals of dermatology

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