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.
摘要：
光化性唇炎（AC）是一种嘴唇疾病，没有标准治疗。咪喹莫特（IMIQ）是一种治疗癌前病变的免疫调节剂；然而，其商业形式造成严重的不利影响。这项研究旨在评估含有0.05％纳米封装（NANO）咪喹莫特（IMIQ-0.05％-NANO）的壳聚糖水凝胶的IMQ释放及其在AC治疗中的功效。通过将壳聚糖掺入负载有IMQ的聚合物纳米胶囊（NCimiq）中来制备水凝胶，使用预制聚合物法的界面沉积法生产。使用自动化Franz细胞评估IMQ释放。一项三盲随机对照试验（49名受试者）比较了IMIQ-0.05％-NANO的疗效，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%组临床改善率明显较高(p<0.05);与其他组相比,IMIQ-5%组出现了更多的不良反应(92.3%的受试者)(p<0.05).总之,在研究的样本中，IMIQ-NANO-0.05％是治疗AC的安全有效选择。
