The purpose of this study is to determine the short and long term safety and effectiveness of ustekinumab in subjects with moderate to severe chronic palmar plantar psoriasis.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
26
Dosing will consist of a 45mg subcutaneous injection for patients weighing less than 100 kg and a 90 mg subcutaneous injection for patients whose weight is greater than 100 kg. Dosing will begin on week 0 followed by subsequent dosing on week 4 and week 16.
Tufts Medical Center
Boston, Massachusetts, United States
Percentage of Patients Achieving a Palmar/Plantar PGA Score of 0 or 1 at Week 16.
Time frame: 16 weeks
PGA Score Over Time From Baseline to Week 24
Measurement of subject's palmar and plantar psoriasis severity as measured by the Physician's Global Assessment (PGA) scale, which rates the severity of psoriasis using the measures of erythema, scaling and induration. Scores are from 0 to 4, in 1 unit increments. A score of 4 is very severe, and a score of 0 is clear.
Time frame: Baseline, 24 weeks
Pustule Count (if Present at Baseline) From Baseline to Week 24
Number of pustules present in each subject
Time frame: Baseline, 24 weeks
Fissure Count (if Present at Baseline) From Baseline to Week 24
Number of discrete fissures on the hands and feet of each subject.
Time frame: Baseline, 24 weeks
Pruritus Visual Analog Scale From Baseline to Week 24
Patient's score on the questionnaire of "how itchy are you", as measured in mm from the left end of scale. Maximum score is 100, minimum score is 0. 100 indicates maximum itch (worse outcome), 0 indicates minimum itch (better outcome).
Time frame: Baseline, 24 weeks
Pain Visual Analog Scale From Baseline to Week 24
Patient's score on the questionnaire of "how much pain are you experiencing from your disease of your hands and feet", as measured in mm from the left end of scale. Maximum score is 100, minimum score is 0. Visual Analog Scale (VAS). 100 indicates maximum pain (worse outcome), 0 indicates minimum pain (better outcome).
Time frame: Baseline, 24 weeks
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Safety Outcome Measures
All adverse events (AE's) will be recorded and monitored. At each of the study visits, patients will be questioned about the occurrence of new AE's since the last visit, or the outcome of any AE's that were reported at previous visits. Upon study completion of the first 10 subjects the principal investigator will review all adverse events to check for trends.
Time frame: 24 weeks