Efficacy Study of TEPSO® Socks in Improving Palmoplantar Pustulosis

This study has been terminated.
(Unable to recruit suitable subjects within a reasonable time period.)
Sponsor:
Information provided by (Responsible Party):
Lenzi Egisto S.P.A.
ClinicalTrials.gov Identifier:
NCT01197989
First received: September 8, 2010
Last updated: September 24, 2012
Last verified: September 2012
  Purpose

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.


Condition Intervention Phase
Pustulosis of Palms and Soles
Device: TEPSO cloth
Device: Standard cloth
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Double-blind, Randomized, Right-left Study Comparing TEPSO® Socks With Standard Socks in Improving Palmoplantar Pustulosis

Further study details as provided by Lenzi Egisto S.P.A.:

Primary Outcome Measures:
  • Percentage reduction of treated areas from baseline [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    Percentage reduction is based on standardized photos and computerized image evaluation


Secondary Outcome Measures:
  • Quality of life [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    Quality of life is assessed by patient with visual analogue scale (VAS)


Enrollment: 17
Study Start Date: March 2010
Study Completion Date: June 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01197989

Locations
Italy
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
Sponsors and Collaborators
Lenzi Egisto S.P.A.
Investigators
Study Director: Luigi Naldi, dermatology Centro Studi Gised
  More Information

No publications provided by Lenzi Egisto S.P.A.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Lenzi Egisto S.P.A.
ClinicalTrials.gov Identifier: NCT01197989     History of Changes
Other Study ID Numbers: TEPSO2
Study First Received: September 8, 2010
Last Updated: September 24, 2012
Health Authority: Italy: Ethics Committee
Italy: National Monitoring Centre for Clinical Trials - Ministry of Health

Keywords provided by Lenzi Egisto S.P.A.:
pustulosis
soles
teflon

Additional relevant MeSH terms:
Psoriasis
Skin Diseases
Skin Diseases, Papulosquamous

ClinicalTrials.gov processed this record on October 21, 2014