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.

IF 5.2 Q1 DERMATOLOGY Psoriasis (Auckland, N.Z.) Pub Date : 2017-06-15 eCollection Date: 2017-01-01 DOI:10.2147/PTT.S130295
Ulrich R Hengge, Kristina Röschmann, Henning Candler
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引用次数: 4

Abstract

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.

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单中心、非介入性临床试验,评估基于二甲二酮的医疗器械在银屑病或头皮癣患者局部应用后促进鳞片去除的安全性、有效性和耐受性。
简介:银屑病是一种常见的炎症性皮肤病,在西方国家约占人口的2%-3%。银屑病皮损的脱屑是银屑病患者最严重的症状。与传统的含有水杨酸或尿素的角化治疗概念相反,基于二甲基苯胺的医疗设备(Loyon®)以物理方式去除鳞片,而不会产生任何药理作用。目的:评价基于二甲二酮的医疗器械在现实条件下用于牛皮癣/头皮癣患者去鳞的疗效和耐受性。方法:选取40例银屑病患者,每日1次,连续治疗7 d。临床评估牛皮癣区域严重程度指数评分(牛皮癣公司)和牛皮癣头皮严重程度指数评分(牛皮癣头皮癣)在基线,治疗3天和7天后进行和评估。对头皮或身体的两个目标病变分别以5分制计算基线评分和发红评分。结果:治疗后主要疗效变量评分有统计学意义的降低,银屑病患者治疗7天后评分相对降低36.8%。头皮癣患者治疗成功的比例为76.8%,头皮癣患者治疗成功的时间为4.14天,公司型牛皮癣患者治疗成功的时间为4.33天。结论:本试验表明,基于二美二酮的医疗器械是一种安全、耐受性好、实用、高效的角化化合物,可以很好地实施并推荐用于银屑病的标准治疗。
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