Pustulosis of Palms and Soles Clinical Trial
Official title:
Double-blind, Randomized, Right-left Study Comparing TEPSO® Socks With Standard Socks in Improving Palmoplantar Pustulosis
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 pustulosis present for at least one year.
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
- non-stick
- 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.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Outcomes Assessor), Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT00301002 -
Study to Evaluate the Efficacy of Alefacept to Treat Palmar Plantar Pustulosis
|
Phase 2 |