Efficacy Study of TEPSO® Socks in Improving Palmoplantar Pustulosis

NCT01197989 | Terminated Phase 2

• 1 other identifier: TEPSO2
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 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 pustulosis present for at least one year.

Conditions

Pustulosis of Palms and Soles

Keywords

pustulosis; soles; teflon

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

EXPERIMENTAL

This arm include all patients sides (left or right) treated with TEPSO socks.

Device: TEPSO cloth

Standard socks

PLACEBO COMPARATOR

This arm include all patients sides (left or right) treated with standard cotton socks.

Device: Standard cloth

Interventions

TEPSO cloth DEVICE

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).

Also known as: Teflon

TEPSO socks

Standard cloth DEVICE

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).

Also known as: cotton

Standard socks

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

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

Sponsors & Collaborators

• Lenzi Egisto S.P.A.: lead

Study Sites (3)

Department of Dermatology, "Tor Vergata" general hospital

Rome, Lazio, 00133, Italy

Location

Department of Dermatology, Fondazione S.Raffaele del monte Tabor

Milan, Lombardy, 20132, Italy

Location

Department of Dermatology, USL 4

Prato, Tuscany, 59100, Italy

Location

Related Publications (1)

• Cazzaniga S, Lo Scocco G, Schincaglia E, Mercuri SR, Chimenti S, Saraceno R, Naldi L. Randomized, within-patient, clinical trial comparing fluorine-synthetic fiber socks with standard cotton socks in improving plantar pustulosis. Dermatology. 2014;228(2):166-71. doi: 10.1159/000357221. Epub 2014 Jan 9.

  PMID: 24434748 DERIVED

MeSH Terms

Conditions

Psoriasis

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Luigi Naldi, dermatology

  Centro Studi Gised

  STUDY DIRECTOR

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: June 1, 2012
• Study Completion: June 1, 2012
• Last Updated: September 25, 2012

Record last verified: 2012-09

Locations

IT (3)