Efficacy Study of TEPSO® Socks in Improving Palmoplantar Psoriasis

September 26, 2011 updated by: Lenzi Egisto S.P.A.

Double-blind, Randomized, Right-left Study Comparing TEPSO® Socks With Standard 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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 Type

Interventional

Enrollment (Actual)

20

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
    • Lazio
      • Rome, Lazio, Italy, 00133
        • Department of Dermatology, "Tor Vergata" general hospital
    • Lombardy
      • Milan, Lombardy, Italy, 20132
        • Department of Dermatology, Fondazione S.Raffaele del monte Tabor
    • Toscana
      • Prato, Toscana, Italy, 59100
        • Department of Dermatology, USL 4

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 63 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: TEPSO socks
This arm include all patients sides (left or right) treated with TEPSO socks.
Device: TEPSO cloth
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
Placebo Comparator: Standard socks
This arm include all patients sides (left or right) treated with standard cotton socks.
Device: Standard cloth
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage reduction of treated areas from baseline
Time Frame: 4 weeks
Percentage reduction is based on standardized photos and computerized image evaluation
4 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality of life
Time Frame: 4 weeks
Quality of life is assessed by patient with visual analogue scale (VAS).
4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Lenzi Egisto S.P.A.

Investigators

  • Study Director: Luigi Naldi, dermatology, Centro Studi Gised

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2010

Primary Completion (Actual)

September 1, 2011

Study Completion (Actual)

September 1, 2011

Study Registration Dates

First Submitted

September 8, 2010

First Submitted That Met QC Criteria

September 8, 2010

First Posted (Estimate)

September 9, 2010

Study Record Updates

Last Update Posted (Estimate)

September 27, 2011

Last Update Submitted That Met QC Criteria

September 26, 2011

Last Verified

September 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TEPSO1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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