Department of Dermatology, Sapienza University, Rome, Italy.
Scientific Department, Polichem SA, Lugano, Switzerland.
Clin Cosmet Investig Dermatol. 2014 May 27;7:185-90. doi: 10.2147/CCID.S61659. eCollection 2014.
Nail psoriasis occurs in up to 50% of patients affected by psoriasis, with a significant impact on quality of life that leads to a real clinical need for new therapeutic options.
To confirm whether the strengthening and hardening properties of the hydroxypropyl-chitosan (HPCH) nail lacquer could improve the structure of the nail plates on psoriatic nails.
A randomized, double-blind, placebo controlled, parallel-group trial was carried out to evaluate the efficacy and tolerability of a hydrosoluble nail lacquer containing HPCH, Equisetum arvense, and methylsulfonylmethane on nail psoriasis. The test product or a placebo was applied once daily for 24 weeks to all fingernails. Efficacy assessments were performed on the target fingernail by means of the modified Nail Psoriasis Severity Index score. A cut-off score of 4 was considered to define the clinical cure rate (ie, Cure ≤4, Failure >4).
After 24 weeks, the clinical cure rate showed the statistically significant superiority of the HPCH nail lacquer compared to placebo in both the intention-to-treat (Fisher's exact test, P=0.0445) and the per protocol population (Fisher's exact test, P=0.0437). This superiority was already present after 16 weeks of treatment. Moreover, the analysis of the modified Nail Psoriasis Severity Index-50 showed a statistically significant clinical improvement after 12 weeks of treatment in comparison to the results obtained after 8 weeks (Fisher's exact test, P<0.05).
The trial showed that HPCH nail lacquer could be a new, valid, effective, and safe option for decreasing the signs of nail dystrophy in psoriatic patients.
指甲银屑病发生于多达 50%的银屑病患者，对生活质量有重大影响，导致对新的治疗选择有实际的临床需求。
确认羟丙基壳聚糖（HPCH）指甲漆的强化和硬化特性是否可以改善银屑病指甲板的结构。
进行了一项随机、双盲、安慰剂对照、平行组试验，以评估含有 HPCH、问荆和甲磺酸的水溶性指甲漆在指甲银屑病中的疗效和耐受性。将测试产品或安慰剂每天应用于所有指甲一次，持续 24 周。通过改良指甲银屑病严重程度指数评分对目标指甲进行疗效评估。将 4 分的截止值定义为临床治愈率（即治愈≤4，失败>4）。
24 周后，在意向治疗人群（Fisher 确切检验，P=0.0445）和方案人群（Fisher 确切检验，P=0.0437）中，HPCH 指甲漆的临床治愈率均显示出与安慰剂相比具有统计学上的优越性。在治疗 16 周后就已经出现了这种优越性。此外，改良指甲银屑病严重程度指数-50 的分析显示，与治疗 8 周后的结果相比，治疗 12 周后临床改善具有统计学意义（Fisher 确切检验，P<0.05）。
该试验表明，HPCH 指甲漆可能是一种新的、有效的、安全的选择，可以减少银屑病患者指甲营养不良的迹象。
