Efficacy Study of TEPSO® Socks in Improving Palmoplantar Pustulosis

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01197989
• Other study ID #: TEPSO2
• Status: Terminated
• Phase: Phase 2
• First received: September 8, 2010
• Last updated: September 24, 2012
• Start date: March 2010
• Est. completion date: June 2012

Study information

• Verified date: September 2012
• Source: Lenzi Egisto S.P.A.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics CommitteeItaly: National Monitoring Centre for Clinical Trials - Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 17
• Est. completion date: June 2012
• Est. primary completion date: June 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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)

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Psoriasis
• Pustulosis of Palms and Soles

Intervention

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).
• 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).

Locations

Country	Name	City	State
Italy	Department of Dermatology, Fondazione S.Raffaele del monte Tabor	Milan	Lombardy
Italy	Department of Dermatology, USL 4	Prato	Toscana
Italy	Department of Dermatology, "Tor Vergata" general hospital	Rome	Lazio

Sponsors (1)

Lead Sponsor	Collaborator
Lenzi Egisto S.P.A.

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage reduction of treated areas from baseline	Percentage reduction is based on standardized photos and computerized image evaluation	4 weeks	No
Secondary	Quality of life	Quality of life is assessed by patient with visual analogue scale (VAS)	4 weeks	No