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临床试验/NCT01197989
NCT01197989终止2 期

Double-blind, Randomized, Right-left Study Comparing TEPSO® Socks With Standard Socks in Improving Palmoplantar Pustulosis

Lenzi Egisto S.P.A.6 个研究点 分布在 1 个国家目标入组 17 人开始时间: 2010年3月1日最近更新:
适应症
干预措施

试验速览

阶段
2 期
状态
终止
发起方
入组人数
17
试验地点
6
主要终点
Percentage reduction of treated areas from baseline

研究概览

简要总结

The purpose of this study is to evaluate the efficacy of a special sock, manufactured using TEPSO®, compared to a normal cotton sock in the prognosis of symmetrical palmoplantar pustulosis present for at least one year.

详细描述

The clinical manifestations of palmoplantar pustulosis have an important impact on well being and quality of life. The manifestation of the disease is often exacerbated by factors such as significant physical and mechanical stress resulting from repeated and prolonged pressure over the affected areas and by everyday clothing. These problems have led the textile industry Lenzi Egisto S.p.A. to conduct some preliminary analyses to find a fabric that meets the specific needs of psoriatic patients in relation to everyday clothing. This preliminary study led to the creation of a particular fabric, TEPSO®, with features specific to the identified needs. This material consists essentially of PTFE (commercially known as Teflon®) and thus presents interesting characteristics that make it suitable for creating garments for patients with psoriasis:

  • Excellent flow properties and low surface friction
  • non-stick
  • Complete biocompatibility and chemical inertness

We can therefore speculate that in palmoplantar pustulosis high smoothness of the fabric and low coefficient of friction may translate into less discomfort felt by patients during normal physical activities, and into improved clinical course of the disease. In the end, it is expected that reduced mechanical compression and friction, would result into partial or complete clinical remission within a few weeks of use.

Therefore we propose to conduct a randomized controlled, double-blind, left-right clinical trial to assess the hypothesis that in palmoplantar pustulosis the use of TEPSO® could induce an improvement of disease and overall quality of life. To better assess the effects of treatment, the use of clothing in the study will be limited to symmetrical pustular lesions of feet in order to include areas that are comparable and relevant from a functional point of view.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Triple (Participant, Care Provider, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Palmoplantar pustulosis present for at least one year
  • Symmetrical foot lesions with at least 5% of the skin surface involvement
  • Difference less than or equal to 10% extension of lesions on both sides of the body
  • Suspension for over 3 months from start of the study of any systemic drugs for psoriasis, immunosuppressive treatments (cyclosporine, systemic steroids), psoralen plus ultraviolet A irradiation (PUVA) or ultraviolet B phototherapy (UVB)

排除标准

  • Nonsymmetrical foot lesions or less than 5% of the skin surface involvement
  • Difference of more than 10% extension of lesions on both sides of the body
  • Patients who have performed, within 3 months before inclusion in the study, treatments with systemic drugs for psoriasis, immunosuppressive treatments (cyclosporine, systemic steroids), psoralen plus ultraviolet A irradiation (PUVA) or ultraviolet B phototherapy (UVB)

研究组 & 干预措施

TEPSO socks

Experimental

This arm include all patients sides (left or right) treated with TEPSO socks.

干预措施: TEPSO cloth (Device)

Standard socks

Placebo Comparator

This arm include all patients sides (left or right) treated with standard cotton socks.

干预措施: Standard cloth (Device)

结局指标

主要结局

Percentage reduction of treated areas from baseline

时间窗: 4 weeks

Percentage reduction is based on standardized photos and computerized image evaluation

次要结局

  • Quality of life(4 weeks)

研究者

发起方
Lenzi Egisto S.P.A.
申办方类型
Industry
责任方
Sponsor

研究点 (6)

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