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.
A total of 24 patients with non-pustular palmoplantar psoriasis affecting at least 10% of the combined palms and soles area and with a modified palmoplantar pustulosis area severity index (m-PPPASI) 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 (physician's global assessment PGA), percentage of palms and soles area affected by psoriasis (palmoplantar surface area - PPSA) as well as m-PPPASI (modified palmoplantar pustulosis area and severity index). Quality of life will be evaluated at every visit by performing the dermatology life quality index 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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
24
Patients receive placebo on weeks 0, 2 and 6. They receive infliximab 5mg/kg at weeks 14, 16 and 20.
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.
The Guenther Dermatology Research Center
London, Ontario, Canada
Lynderm Research Inc.
Markham, Ontario, Canada
Innovaderm Research Laval
Laval, Quebec, Canada
Innovaderm Research
Montreal, Quebec, Canada
Centre de recherche dermatologique du Québec Métropolitain
Québec, Quebec, Canada
75% Improvement in Modified Palmoplantar Pustulosis Area and Severity Index (m-PPPASI) From Day 0
Efficacy by comparing the number of patients reaching a 75% improvement in m-PPPASI (m-PPPASI 75) m-PPPASI = (E + I + D)Area X 0.2 (R palm) + (E + I + D) Area X 0.2 (L palm) + (E + I + D) Area X 0.3 (R sole) + (E + I + D) Area X 0.3 (L sole). Erythema, induration and desquamation are evaluated on a scale of 0 to 4 while area is evaluated on a scale of 0 to 6. The m-PPPASI score can vary from 0 (absence of disease) to 72 (most severe palmoplantar psoriasis possible).
Time frame: 14 weeks
Number of Adverse Events at Week 14
Safety of infliximab administered for 14 weeks in patients who received by comparing adverse events
Time frame: 14 weeks
Mean Dermatology Life Quality Index (DLQI) at Week 14
Impact on quality of life with the Dermatology Life Quality Index (DLQI) The aim of the questionnaire is to measure how much a patient's skin problem has affected their life over the previous week. * 0-1 = no effect at all on patient's life * 2-5 = small effect on patient's life * 6-10 = moderate effect on patient's life * 11-20 = very large effect on patient's life * 21-30 = extremely large effect on patient's life
Time frame: 14 weeks
Mean Percent Palmoplantar Psoriasis Surface Area (PPSA) at Week 14
Efficacy by comparing the mean percent PPSA. The surface affected by psoriasis on palms and soles is estimated on the day of the visit as a percentage of the total surface of palms and soles affected by psoriasis. Each palm represents 20% and each sole 30%. As a rule of thumb half a palm equals 10% of the total surface area of palm and soles. A sole completely covered with psoriasis would have a PPSA of 30% (if the other sole and the palms are unaffected) while a palm completely covered with psoriasis would have a PPSA of 20% (if the other palm and the soles are unaffected).
Time frame: 14 weeks
Mean Physician's Global Assessment (PGA) at Week 14
Efficacy by comparing the mean Physician's Global Assessment(PGA). * 0 = clear. * 1 = almost clear. * 2 = Mild. * 3 = Moderate. * 4 = Severe. * 5 = Very severe.
Time frame: 14 weeks
Mean Percent Improvement in Modified Palmoplantar Pustulosis Area and Severity Index (m-PPPASI) at Week 26
Efficacy of infliximab administered for 22 weeks in patients who received infliximab at Day 0 by evaluating the improvement over time in modified m-PPPASI from Day 0 to Week 26. m-PPPASI = (E + I + D)Area X 0.2 (R palm) + (E + I + D) Area X 0.2 (L palm) + (E + I + D) Area X 0.3 (R sole) + (E + I + D) Area X 0.3 (L sole). Erythema, induration and desquamation are evaluated on a scale of 0 to 4 while area is evaluated on a scale of 0 to 6. The m-PPPASI score can vary from 0 (absence of disease) to 72 (most severe palmoplantar psoriasis possible).
Time frame: Baseline, 26 weeks
Mean Percent Improvement in Dermatology Life Quality Index (DLQI) at Week 26
Efficacy of infliximab administered for 22 weeks in patients who received infliximab at Day 0 by evaluating the improvement over time in dermatology life quality index (DLQI) from Day 0 to Week 26. Impact on quality of life with the DLQI. The aim of the questionnaire is to measure how much a patient's skin problem has affected their life over the previous week. * 0-1 = no effect at all on patient's life * 2-5 = small effect on patient's life * 6-10 = moderate effect on patient's life * 11-20 = very large effect on patient's life * 21-30 = extremely large effect on patient's life
Time frame: Baseline, 26 weeks
Mean Percent Improvement in Physician's Global Assessment (PGA) at Week 26
Efficacy of infliximab administered for 22 weeks in patients who received infliximab at Day 0 by evaluating the improvement over time in Physician's Global Assessment (PGA) from Day 0 to Week 26. * 0 = clear * 1 = almost clear * 2 = Mild * 3 = Moderate * 4 = Severe * 5 = Very severe
Time frame: Baseline, 26 weeks
Mean Percent Improvement in Palmoplantar Psoriasis Surface Area (PPSA) at Week 26
Efficacy of infliximab administered for 22 weeks in patients who received infliximab at Day 0 by evaluating the improvement over time in percent PPSA from Day 0 to Week 26. The surface affected by psoriasis on palms and soles is estimated on the day of the visit as a percentage of the total surface of palms and soles affected by psoriasis. Each palm represents 20% and each sole 30%. As a rule of thumb half a palm equals 10% of the total surface area of palm and soles.
Time frame: Baseline, 26 weeks
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