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Completed

NCT Number: NCT01197976

Efficacy Study of TEPSO® Socks in Improving Palmoplantar Psoriasis

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Department of Dermatology, "Tor Vergata" general hospital, Rome, Lazio, Italy

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Palmoplantar psoriasis 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)

Exclusion criteria

  • 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)

Treatment and study plan

TEPSO cloth

Device

TEPSO stocks should be worn continuously for 4 weeks of the study and will be changed every 3 days without wearing again those already used (even after washing).

Other names: Teflon

Standard cloth

Device

Standard cotton stocks should be worn continuously for 4 weeks of the study and will be changed every 3 days without wearing again those already used (even after washing).

Other names: cotton

Primary outcomes

  1. Percentage reduction of treated areas from baseline

    Time frame: 4 weeks

    Percentage reduction is based on standardized photos and computerized image evaluation

Secondary outcomes

  1. Quality of life

    Time frame: 4 weeks

    Quality of life is assessed by patient with visual analogue scale (VAS).

Sponsors and collaborators

Lead sponsor

Lenzi Egisto S.P.A.

Industry

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Sep 9, 2010
Registry last updated
Sep 27, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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