- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01197976
Efficacy Study of TEPSO® Socks in Improving Palmoplantar Psoriasis
Double-blind, Randomized, Right-left Study Comparing TEPSO® Socks With Standard Socks in Improving Palmoplantar Psoriasis
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The clinical manifestations of palmoplantar psoriasis 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 psoriasis 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 psoriasis 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 psoriatic lesions of feets in order to include areas that are comparable and relevant from a functional point of view.
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
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Lazio
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Rome, Lazio, Italy, 00133
- Department of Dermatology, "Tor Vergata" general hospital
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Lombardy
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Milan, Lombardy, Italy, 20132
- Department of Dermatology, Fondazione S.Raffaele del monte Tabor
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Toscana
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Prato, Toscana, Italy, 59100
- Department of Dermatology, USL 4
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Palmoplantar psoriasis 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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: TEPSO socks
This arm include all patients sides (left or right) treated with TEPSO socks.
|
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 Names:
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Placebo Comparator: Standard socks
This arm include all patients sides (left or right) treated with standard cotton socks.
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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 Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percentage reduction of treated areas from baseline
Time Frame: 4 weeks
|
Percentage reduction is based on standardized photos and computerized image evaluation
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4 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Quality of life
Time Frame: 4 weeks
|
Quality of life is assessed by patient with visual analogue scale (VAS).
|
4 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Luigi Naldi, dermatology, Centro Studi Gised
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- TEPSO1
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Palmoplantar Psoriasis
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Medical University of ViennaUnknownPustular Palmoplantar PsoriasisAustria
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AbbVieCompleted
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Boehringer IngelheimCompletedPalmoplantar Pustulosis (PPP)United Kingdom, Korea, Republic of, United States, Canada, Belgium, Australia, Taiwan, Japan, France, Germany, Russian Federation, Hungary, Netherlands, Czechia, Poland
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Innovaderm Research Inc.Schering-PloughCompleted
-
Bristol-Myers SquibbRecruitingPalmoplantar Psoriasis | Genital PsoriasisUnited States, Germany, Spain, Italy, Poland, Argentina, Canada
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Icahn School of Medicine at Mount SinaiBausch Health Americas, Inc.CompletedPlaque Psoriasis | Palmoplantar PsoriasisUnited States
-
Novartis PharmaceuticalsCompletedPalmoplantar Pustular PsoriasisGermany, Belgium, Austria, Italy, Spain, France, Sweden, United Kingdom, Russian Federation, Poland
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Peking University Third HospitalUnknownPalmoplantar Pustulosis | Generalized Pustular Psoriasis
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Janssen Pharmaceutical K.K.Active, not recruiting
Clinical Trials on TEPSO cloth
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Lenzi Egisto S.P.A.TerminatedPustulosis of Palms and SolesItaly
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American University of Beirut Medical CenterRecruitingDevelopment, Infant | Development, Child | Behavior, InfantLebanon
-
Chang Gung Memorial HospitalRecruiting
-
Icahn School of Medicine at Mount SinaiCompletedEndometritis | Surgical Site Infections | Infection; Cesarean Section | Chlorhexidine Gluconate Cloths | Infectious MorbidityUnited States
-
Chang Gung Memorial HospitalRecruiting
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University of OxfordKing's College London; University of NottinghamCompletedImpact of Masks on Oxygen LevelsUnited Kingdom
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The Cleveland ClinicCompletedCOVID-19United States
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Vanderbilt UniversityTerminatedWound InfectionUnited States
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Bandim Health ProjectUniversity of Southern Denmark; Engineers without Borders, Denmark (https:/...Active, not recruitingCOVID-19 | Respiratory IllnessGuinea-Bissau
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Assistance Publique - Hôpitaux de ParisFédération Française de Cardiologie; BioSerenityCompletedCancer | Cardiovascular Abnormalities | Immune DefectFrance