Efficacy and safety of a 0.05 % nanoencapsulated imiquimod hydrogel for the treatment of actinic cheilitis: Drug release analysis and clinical study

IF 4.2 2区 医学 Q2 MEDICINE, RESEARCH & EXPERIMENTAL Nanomedicine : nanotechnology, biology, and medicine Pub Date : 2024-08-14 DOI:10.1016/j.nano.2024.102779
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Abstract

Actinic cheilitis (AC) is a lip disorder, with no standard treatment. Imiquimod (IMIQ) is an immunomodulator that treat precancerous lesions; however, its commercial form causes severe adverse effects. This study aimed to assess IMQ release from a chitosan hydrogel containing 0.05 % nanoencapsulated (NANO) imiquimod (IMIQ-0.05 %-NANO) and its efficacy in AC treatment. The hydrogels were prepared by incorporating chitosan into polymeric nanocapsules (NCimiq) loaded with IMQ, produced using the interfacial deposition of preformed polymer method. IMQ release was evaluated using automated Franz Cells. A triple-blind randomized controlled trial (49 subjects) compared the efficacy of: IMIQ-0.05 %-NANO, 5 % free imiquimod (IMIQ-5 %), 0.05 % free imiquimod (IMIQ-0.05 %), and placebo hydrogel. The IMIQ-NANO-0.05 % and IMIQ-5 % groups exhibited significantly higher rates of clinical improvement (p < 0.05); however, the IMIQ-5 % group experienced more adverse effects (92.3 % of subjects) compared to other groups (p < 0.05). In conclusion, in the studied sample, IMIQ-NANO-0.05 % was a safe and effective option to treat AC.

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0.05 % 纳米包封咪喹莫特水凝胶治疗光化性咽颊炎的有效性和安全性:药物释放分析与临床研究。
光化性唇炎(AC)是一种唇部疾病,目前尚无标准治疗方法。咪喹莫特(IMIQ)是一种免疫调节剂,可治疗癌前病变;然而,其商业形式会导致严重的不良反应。本研究旨在评估含有 0.05 % 纳米胶囊化(NANO)咪喹莫特(IMIQ-0.05 %-NANO)的壳聚糖水凝胶中 IMQ 的释放情况及其在 AC 治疗中的疗效。水凝胶的制备方法是将壳聚糖加入装有 IMQ 的聚合物纳米胶囊(NCimiq)中,纳米胶囊是采用预成型聚合物界面沉积法生产的。使用自动弗朗兹细胞对 IMQ 的释放进行了评估。一项三盲随机对照试验(49 名受试者)比较了以下药物的疗效:IMIQ-0.05 %-NANO、5 % 游离咪喹莫特(IMIQ-5 %)、0.05 % 游离咪喹莫特(IMIQ-0.05 %)和安慰剂水凝胶。IMIQ-NANO-0.05 % 和 IMIQ-5 % 组的临床改善率明显更高(p
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来源期刊
CiteScore
11.10
自引率
0.00%
发文量
133
审稿时长
42 days
期刊介绍: The mission of Nanomedicine: Nanotechnology, Biology, and Medicine (Nanomedicine: NBM) is to promote the emerging interdisciplinary field of nanomedicine. Nanomedicine: NBM is an international, peer-reviewed journal presenting novel, significant, and interdisciplinary theoretical and experimental results related to nanoscience and nanotechnology in the life and health sciences. Content includes basic, translational, and clinical research addressing diagnosis, treatment, monitoring, prediction, and prevention of diseases.
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