Efficacy Study of TEPSO® Socks in Improving Palmoplantar Psoriasis

Palmoplantar Psoriasis Clinical Trial

Official title: Double-blind, Randomized, Right-left Study Comparing TEPSO® Socks With Standard Socks in Improving Palmoplantar Psoriasis

Status Completed

Clinical Trial Summary

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 psoriasis present for at least one year.

Clinical Trial Description

The clinical manifestations of palmoplantar psoriasis 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 psoriasis 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 psoriasis 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 psoriatic lesions of feets in order to include areas that are comparable and relevant from a functional point of view. ;

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Palmoplantar Psoriasis
• Psoriasis

• NCT number: NCT01197976
• Study type: Interventional
• Source: Lenzi Egisto S.P.A.
• Status: Completed
• Phase: Phase 2
• Start date: March 2010
• Completion date: September 2011