Efficacy Study of TEPSO® Socks in Improving Palmoplantar Psoriasis

• ClinicalTrials.gov Identifier: NCT01197976
• Recruitment Status: Completed
• First Posted: September 9, 2010
• Last Update Posted: September 27, 2011
• Sponsor: Lenzi Egisto S.P.A.
• Information provided by (Responsible Party): Lenzi Egisto S.P.A.

Study Description

Brief 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.

Condition or disease	Intervention/treatment	Phase
Palmoplantar Psoriasis	Device: TEPSO cloth; Device: Standard cloth	Phase 2

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 20 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Care Provider, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Double-blind, Randomized, Right-left Study Comparing TEPSO® Socks With Standard Socks in Improving Palmoplantar Psoriasis
• Study Start Date: March 2010
• Actual Primary Completion Date: September 2011
• Actual Study Completion Date: September 2011

Arms and Interventions

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 Name: 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 Name: cotton

Outcome Measures

Primary Outcome Measures :

1. Percentage reduction of treated areas from baseline [ Time Frame: 4 weeks ]
   Percentage reduction is based on standardized photos and computerized image evaluation

Secondary Outcome Measures :

1. Quality of life [ Time Frame: 4 weeks ]
   Quality of life is assessed by patient with visual analogue scale (VAS).

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 65 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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)

Contacts and Locations

Locations

Italy

Department of Dermatology, "Tor Vergata" general hospital

Rome, Lazio, Italy, 00133

Department of Dermatology, Fondazione S.Raffaele del monte Tabor

Milan, Lombardy, Italy, 20132

Department of Dermatology, USL 4

Prato, Toscana, Italy, 59100

Sponsors and Collaborators

Lenzi Egisto S.P.A.

Investigators

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

More Information

• Responsible Party: Lenzi Egisto S.P.A.
• ClinicalTrials.gov Identifier: NCT01197976 History of Changes
• Other Study ID Numbers: TEPSO1
• First Posted: September 9, 2010
• Last Update Posted: September 27, 2011
• Last Verified: September 2011

Keywords provided by Lenzi Egisto S.P.A.:

psoriasis; soles; teflon

Additional relevant MeSH terms:

Psoriasis; Skin Diseases, Papulosquamous; Skin Diseases