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Safety and Efficacy of Infliximab in Palmoplantar Psoriasis

NCT00629772 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2011-09-09

Study results available
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Summary

Palmoplantar psoriasis is a variant of psoriasis affecting palms and soles. It is one of the most debilitating variants of psoriasis which very often interferes with daily activities and with the ability to work. This type of psoriasis is very difficult to treat as topicals have difficulty penetrating the thick epidermis of palms and soles and are therefore not very effective. The response to standard agents (methotrexate, cyclosporine and acitretin) is also usually limited. A number of these patients have very severe hand and feet disease with mild to no involvement elsewhere on the body.

Given the efficacy of infliximab in psoriasis, the purpose of this study is to evaluate if infliximab is safe and if it will improve severity and quality of life in patients with palmoplantar psoriasis, a debilitating variant of psoriasis.

Conditions

  • Palmoplantar Psoriasis

Interventions

DRUG

Placebo

Patients receive placebo on weeks 0, 2 and 6. They receive infliximab 5mg/kg at weeks 14, 16 and 20.

DRUG

Infliximab

Patients in infliximab group receive infliximab 5mg/kg at weeks 0, 2, 6, 14 and 22. Patients in placebo then infliximab group receive placebo at weeks 0, 2, 6, then receive infliximab at weeks 14, 16 and 20.

Sponsors & Collaborators

  • Schering-Plough

    collaborator INDUSTRY

  • Innovaderm Research Inc.

    lead OTHER

Principal Investigators

  • Robert Bissonnette, MD · Innovaderm Research

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-03-31
Primary Completion
2009-02-28
Completion
2009-07-31

Countries

  • Canada

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00629772 on ClinicalTrials.gov