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首页> 外文期刊>Psoriasis: Targets and Therapy >Single-center, noninterventional clinical trial to assess the safety, efficacy, and tolerability of a dimeticone-based medical device in facilitating the removal of scales after topical application in patients with psoriasis corporis or psoriasis capitis
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Single-center, noninterventional clinical trial to assess the safety, efficacy, and tolerability of a dimeticone-based medical device in facilitating the removal of scales after topical application in patients with psoriasis corporis or psoriasis capitis

机译：一项单中心，非介入性临床试验，旨在评估基于二甲双胍的医疗器械在局部应用银屑病或牛皮癣性头皮炎患者后促进清除水垢的安全性，有效性和耐受性

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Introduction: Psoriasis is a frequent inflammatory skin disease affecting ~2%–3% of the population in western countries. Scaling of the psoriatic lesions is the most impairing symptom in patients with psoriasis. In contrast to conventional keratolytic treatment concepts containing salicylic acid or urea, a dimeticone-based medical device (Loyon?) removes scales in a physical way without any pharmacological effect. Objective: To assess the efficacy and tolerability of a dimeticone-based medical device in removal of scales in patients with psoriasis corporis/capitis under real-life conditions. Methods: Forty patients with psoriasis capitis or corporis were included and received once-daily treatments for 7 days. Clinical assessment of the psoriasis area severity index score (psoriasis corporis) and the psoriasis scalp severity index score (psoriasis capitis) was performed and evaluated at baseline, after 3 and 7 days of treatment. Baseline scaling scores and redness scores were calculated for two target lesions of the scalp or the body on a 5-point scale each. Results: For the primary efficacy variable scaling score, a statistically significant decrease was observed after treatment, with a relative reduction in scaling of 36.8% after 7 days of treatment within patients affected by psoriasis capitis. Treatment success was achieved in 76.8% of patients with psoriasis capitis, and time to treatment success was evaluated to be 4.14 days for these patients and 4.33 days for patients suffering from psoriasis corporis. Conclusion: In conclusion, this trial demonstrated that the dimeticone-based medical device is a safe, well-tolerated, practicable, and efficient keratolytic compound, which can be well implemented in and recommended for standard therapy of psoriasis.
机译：简介：牛皮癣是一种常见的炎症性皮肤病，在西方国家影响约2％–3％的人口。银屑病皮损的扩大是牛皮癣患者中最受损的症状。与传统的包含水杨酸或尿素的角质溶解治疗概念相反，基于二甲硅油的医疗器械（Loyon ？）可以物理方式去除水垢，而没有任何药理作用。目的：评估在现实生活条件下，以二甲双胍为基础的医疗器械在去除银屑病/毛细血管炎患者鳞片中的功效和耐受性。方法：纳入40例牛皮癣性头炎或体炎患者，每天接受一次治疗，为期7天。在治疗的第3天和第7天，对银屑病区域严重程度指数评分（corporiasis corporis）和牛皮癣头皮严重程度指数评分（牛皮癣capitis）进行了临床评估，并在基线进行了评估。针对头皮或身体的两个目标病变分别以5分制计算基线缩放分数和发红分数。结果：对于主要功效变量评分，治疗后第7天观察到统计学上显着降低，在受牛皮癣性头炎影响的患者中，治疗7天后评分相对降低36.8％。在牛皮癣性头皮炎患者中，有76.8％的患者获得了治疗成功，并且这些患者的治疗成功时间分别为4.14天和corporaria corporis患者为4.33天。结论：总而言之，该试验证明基于二甲双胍的医疗器械是一种安全，耐受性强，实用且有效的溶角蛋白化合物，可在牛皮癣的标准疗法中很好地实施并推荐使用。

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