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
1 other identifier
interventional
20
1 country
3
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 psoriasis present for at least one year.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Mar 2010
Shorter than P25 for phase_2
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2010
CompletedFirst Submitted
Initial submission to the registry
September 8, 2010
CompletedFirst Posted
Study publicly available on registry
September 9, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2011
CompletedSeptember 27, 2011
September 1, 2011
1.5 years
September 8, 2010
September 26, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percentage reduction of treated areas from baseline
Percentage reduction is based on standardized photos and computerized image evaluation
4 weeks
Secondary Outcomes (1)
Quality of life
4 weeks
Study Arms (2)
TEPSO socks
EXPERIMENTALThis arm include all patients sides (left or right) treated with TEPSO socks.
Standard socks
PLACEBO COMPARATORThis arm include all patients sides (left or right) treated with standard cotton socks.
Interventions
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 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).
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
Department of Dermatology, "Tor Vergata" general hospital
Rome, Lazio, 00133, Italy
Department of Dermatology, Fondazione S.Raffaele del monte Tabor
Milan, Lombardy, 20132, Italy
Department of Dermatology, USL 4
Prato, Tuscany, 59100, Italy
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Luigi Naldi, dermatology
Centro Studi Gised
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 8, 2010
First Posted
September 9, 2010
Study Start
March 1, 2010
Primary Completion
September 1, 2011
Study Completion
September 1, 2011
Last Updated
September 27, 2011
Record last verified: 2011-09