Palmoplantar PsoriasisPhase 2NCT01197976
Efficacy Study of TEPSO® Socks in Improving Palmoplantar Psoriasis
A Phase 2 study testing TEPSO cloth and Standard cloth in people with Palmoplantar Psoriasis, run by Lenzi Egisto S.P.A. at 3 sites in Italy.
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 psoriasis present for at least one year. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Palmoplantar Psoriasis
- What is being tested?
- TEPSO cloth and Standard cloth
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 3 sitesItaly
- Study dates
- Mar 2010to Sep 2011
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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)
Trial locations and contacts
3 sites in 1 country.
Italy3 sites
Department of Dermatology, Fondazione S.Raffaele del monte Tabor
Milan, Lombardy, 20132
Department of Dermatology, USL 4
Prato, Tuscany, 59100
Department of Dermatology, "Tor Vergata" general hospital
Rome, Lazio, 00133
About this study
Official title: Double-blind, Randomized, Right-left Study Comparing TEPSO® Socks With Standard Socks in Improving Palmoplantar Psoriasis
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 psoriasis present for at least one year.
Read the 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.
- Conditions
- Palmoplantar Psoriasis
- Being tested
- TEPSO cloth, Standard cloth
- Keywords
- psoriasis, soles, teflon
- Medical subject headings
- Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TEPSO clothDevice
Also called Teflon
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 clothDevice
Also called cotton
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).
| Study group | Role | What they receive |
|---|---|---|
| TEPSO socks | Experimental | This arm include all patients sides (left or right) treated with TEPSO socks. Receives: Device: TEPSO cloth |
| Standard socks | Placebo comparator | This arm include all patients sides (left or right) treated with standard cotton socks. Receives: Device: Standard cloth |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage reduction of treated areas from baseline
Percentage reduction is based on standardized photos and computerized image evaluation
Measured: 4 weeks
Secondary outcomes (1)
Quality of life
Quality of life is assessed by patient with visual analogue scale (VAS).
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2010 (estimated)
- Study startMar 2010
- Primary completionSep 2011
- Study completionSep 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Palmoplantar PsoriasisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lenzi Egisto S.P.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Luigi Naldi, dermatology, Study director, Centro Studi Gised
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01197976
- Sponsor's protocol ID
- TEPSO1
- Status last verified
- Sep 2011
- First submitted
- 8 Sep 2010
- Last updated
- 27 Sep 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Double-blind, Randomized, Right-left Study Comparing TEPSO® Socks With Standard Socks in Improving Palmoplantar Psoriasis
- ClinicalTrials.gov ID
- NCT01197976
- Acronym / sponsor ID
- TEPSO1
- Conditions
- Palmoplantar Psoriasis
- Keywords
- psoriasis, soles, teflon
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Lenzi Egisto S.P.A.Industry (pharma, biotech, devices)
- Study start
- Mar 2010
- Primary completion
- Sep 2011 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 9 Sep 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 psoriasis present for at least one year.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TEPSO socks | Experimental | Device: TEPSO clothThis arm include all patients sides (left or right) treated with TEPSO socks. |
| Standard socks | Placebo comparator | Device: Standard clothThis arm include all patients sides (left or right) treated with standard cotton socks. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (3 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TEPSO clothAlso: TeflonTEPSO 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). | Device | TEPSO socks |
| Standard clothAlso: cottonStandard 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). | Device | Standard socks |
Primary outcome
Percentage reduction of treated areas from baseline
Time frame: 4 weeks
Percentage reduction is based on standardized photos and computerized image evaluation
1 secondary outcome
Quality of life
Time frame: 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Sep 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Luigi Naldi, dermatology study director
Centro Studi Gised
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing TEPSO cloth and Standard cloth in people with Palmoplantar Psoriasis, run by Lenzi Egisto S.P.A. at 3 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Sep 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage reduction of treated areas from baseline (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Sep 2011.