Efficacy Study of TEPSO® Socks in Improving Palmoplantar Pustulosis
|Pustulosis of Palms and Soles||Device: TEPSO cloth Device: Standard cloth||Phase 2|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (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 Pustulosis|
- Percentage reduction of treated areas from baseline [ Time Frame: 4 weeks ]Percentage reduction is based on standardized photos and computerized image evaluation
- Quality of life [ Time Frame: 4 weeks ]Quality of life is assessed by patient with visual analogue scale (VAS)
|Study Start Date:||March 2010|
|Study Completion Date:||June 2012|
|Primary Completion Date:||June 2012 (Final data collection date for primary outcome measure)|
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
The clinical manifestations of palmoplantar pustulosis 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
- Complete biocompatibility and chemical inertness
We can therefore speculate that in palmoplantar pustulosis 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 pustulosis 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 pustular lesions of feet in order to include areas that are comparable and relevant from a functional point of view.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01197989
|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|