Clinical trial NCT01197989: Efficacy Study of TEPSO® Socks in Improving Palmoplantar Pustulosis
Official title: Double-blind, Randomized, Right-left Study Comparing TEPSO® Socks With Standard Socks in Improving Palmoplantar Pustulosis
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Pustulosis of Palms and Soles
Keywords: pustulosis
soles
teflon
Lead sponsor: Lenzi Egisto S.P.A.
Sponsor class: INDUSTRY
First posted: 2010-09-09
Enrollment: 17
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 pustulosis present for at least one year.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Palmoplantar pustulosis 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)

Primary outcomes:
measure: Percentage reduction of treated areas from baseline
timeFrame: 4 weeks
Secondary outcomes:
measure: Quality of life
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Rome
country: Italy
facility: Department of Dermatology, "Tor Vergata" general hospital
state: Lazio
city: Milan
country: Italy
facility: Department of Dermatology, Fondazione S.Raffaele del monte Tabor
state: Lombardy
city: Prato
country: Italy
facility: Department of Dermatology, USL 4
state: Toscana
Study officials:
affiliation: Centro Studi Gised
name: Luigi Naldi, dermatology
role: STUDY_DIRECTOR
References:
citation: Cazzaniga S, Lo Scocco G, Schincaglia E, Mercuri SR, Chimenti S, Saraceno R, Naldi L. Randomized, within-patient, clinical trial comparing fluorine-synthetic fiber socks with standard cotton socks in improving plantar pustulosis. Dermatology. 2014;228(2):166-71. doi: 10.1159/000357221. Epub 2014 Jan 9.