Efficacy Study of TEPSO® Socks in Improving Palmoplantar Pustulosis

NCT ID: NCT01197989

Last Updated: 2012-09-25

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 17 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-03-31
• Study Completion Date: 2012-06-30

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.

Conditions

Pustulosis of Palms and Soles

Keywords

pustulosis; soles; teflon

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

TEPSO socks

This arm include all patients sides (left or right) treated with TEPSO socks.

Group Type: EXPERIMENTAL

TEPSO cloth

Intervention Type: DEVICE

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).

Standard socks

This arm include all patients sides (left or right) treated with standard cotton socks.

Group Type: PLACEBO_COMPARATOR

Standard cloth

Intervention Type: DEVICE

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).

Interventions

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).

Intervention Type: 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).

Intervention Type: DEVICE

Other Intervention Names

Teflon; cotton

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Lenzi Egisto S.P.A.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Luigi Naldi, dermatology

Role: STUDY_DIRECTOR

Centro Studi Gised

Locations

Department of Dermatology, "Tor Vergata" general hospital

Rome, Lazio, Italy

Department of Dermatology, Fondazione S.Raffaele del monte Tabor

Milan, Lombardy, Italy

Department of Dermatology, USL 4

Prato, Tuscany, Italy

Countries

Italy

References

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.

Reference Type: DERIVED

PMID: 24434748 (View on PubMed)

Other Identifiers

TEPSO2

Identifier Type: -

Identifier Source: org_study_id