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| Sponsor: | Innovaderm Research Inc. |
|---|---|
| Collaborator: |
Schering-Plough |
| Information provided by: | Innovaderm Research Inc. |
| ClinicalTrials.gov Identifier: | NCT00629772 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Palmoplantar Psoriasis |
Drug: Placebo Drug: Infliximab |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | A Double-Blind Study on the Safety and Efficacy of Infliximab in Palmoplantar Psoriasis |
| Enrollment: | 24 |
| Study Start Date: | March 2007 |
| Study Completion Date: | July 2009 |
| Primary Completion Date: | February 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1: Placebo Comparator
Patients randomized to initiate the study with placebo infusion
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Drug: Placebo
Patients receive placebo on weeks 0, 2 and 6. They receive infliximab 5mg/kg at weeks 14, 16 and 20 and placebo again at week 22.
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2: Active Comparator
Patients randomized to initiate the study with infliximab infusion.
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Drug: Infliximab
Patients receive infliximab 5mg/kg on weeks 0, 2, 6 and 14. They receive placebo at weeks 16 and 20 and infliximab again at week 22.
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A total of 24 patients with non-pustular palmoplantar psoriasis affecting at least 10% of the combined palms and soles area and with a palmoplantar psoriasis area severity index (PPASI) of at least 8 will be recruited. Patients will be randomized (1:1) to receive either infliximab 5 mg/kg or placebo (normal saline) on weeks 0, 2 and 6. Patients assigned to placebo during the first 3 infusions will receive infliximab 5 mg/kg at weeks 14, 16 and 20 and placebo again at week 22 while patients who were assigned to receive infliximab during the first 3 infusions will receive infliximab at week 14 and placebo at week 16 and week 20 as well as infliximab for the last infusion at week 22. The primary endpoint will be at week 14. Patients will come back to the clinic at week 26 for a final efficacy and safety assessment.
Efficacy will be evaluated by assessing psoriasis plaque severity on palms and soles, percentage of palms and soles area affected by psoriasis as well as PPASI. Quality of life will be evaluated at every visit by performing the DLQI. Safety will be evaluated by repeating chemistry and haematology laboratories at regular visits as well as by physical examinations and assessment of adverse events.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Canada | |
| Centre de recherche dermatologique du Québec Métropolitain | |
| Quebec, Canada, G1V 4X7 | |
| Canada, Ontario | |
| The Guenther Dermatology Research Center | |
| London, Ontario, Canada, N6A 3H7 | |
| Lynderm Research Inc. | |
| Markham, Ontario, Canada, L3P 1A8 | |
| Canada, Quebec | |
| Innovaderm Research | |
| Montreal, Quebec, Canada, H2K 4L5 | |
| Innovaderm Research Laval | |
| Laval, Quebec, Canada, H7S 2C6 | |
| Principal Investigator: | Robert Bissonnette, MD | Innovaderm Research |
More Information
| Responsible Party: | Innovaderm Research Inc ( Robert Bissonnette ) |
| Study ID Numbers: | Inno-6003, P-05121 |
| Study First Received: | February 27, 2008 |
| Last Updated: | July 30, 2009 |
| ClinicalTrials.gov Identifier: | NCT00629772 History of Changes |
| Health Authority: | Canada: Health Canada |
|
Palmoplantar psoriasis Infliximab |
|
Anti-Inflammatory Agents Skin Diseases Infliximab Psoriasis Therapeutic Uses |
Gastrointestinal Agents Antirheumatic Agents Dermatologic Agents Skin Diseases, Papulosquamous Pharmacologic Actions |