Efficacy Study of TEPSO® Socks in Improving Palmoplantar Psoriasis
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Palmoplantar Psoriasis |
Device: TEPSO cloth Device: Standard cloth |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Double-blind, Randomized, Right-left Study Comparing TEPSO® Socks With Standard Socks in Improving Palmoplantar Psoriasis |
- Percentage reduction of treated areas from baseline [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]Percentage reduction is based on standardized photos and computerized image evaluation
- Quality of life [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]Quality of life is assessed by patient with visual analogue scale (VAS).
| Enrollment: | 20 |
| Study Start Date: | March 2010 |
| Study Completion Date: | September 2011 |
| Primary Completion Date: | September 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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
|
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.
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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| 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 | |
| Study Director: | Luigi Naldi, dermatology | Centro Studi Gised |
More Information
No publications provided
| Responsible Party: | Lenzi Egisto S.P.A. |
| ClinicalTrials.gov Identifier: | NCT01197976 History of Changes |
| Other Study ID Numbers: | TEPSO1 |
| Study First Received: | September 8, 2010 |
| Last Updated: | September 26, 2011 |
| Health Authority: | Italy: Ethics Committee Italy: National Monitoring Centre for Clinical Trials - Ministry of Health |
Keywords provided by Lenzi Egisto S.P.A.:
|
psoriasis soles teflon |
Additional relevant MeSH terms:
|
Psoriasis Skin Diseases, Papulosquamous Skin Diseases |
ClinicalTrials.gov processed this record on May 22, 2013