The objective of this study is to assess the safety and biologic activity of intralesional injection of fluphenazine in adult subjects with psoriasis.
This is a double-blind, placebo-controlled, bilateral, ascending dose study. In vitro, fluphenazine has been shown to suppress growth of proliferating T-lymphocytes. Fluphenazine would be expected to also suppress growth of proliferating T-lymphocytes in psoriatic plaques.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
15
Intralesional injection of Fluphenazine
Intralesional injection of placebo
Tufts Medical Center, Department of Dermatology
Boston, Massachusetts, United States
Robert Wood Johnson Medical School, Psoriasis Center of Excellence
New Brunswick, New Jersey, United States
Change in Target Lesion Scoring Evaluated at Baseline and 4 Weeks
Actual change in target lesion score comparing 4 week score with baseline score. Improvement is positive, worsening is negative. Target lesions scores range from 0 (no disease) to 12 (severe disease), and are scored based on the sum of erythema (0-4), induration (0-4) and scale (0-4) scores.
Time frame: 4 weeks
Change in the Target Lesion Visual Analog Scale (VAS) Score for Pruritus Evaluated at Baseline and 4 Weeks
Visual Analog Scale (VAS) score for pruritus. Subjective measurement of pruritus on an analog scale with a single mark denoting self-perceived pruritus: Minimum 0mm for no itch, Maximum 100mm for worst itch imaginable. Scores are measured in millimeters. This secondary outcome is a percentage improvement from baseline score for pruritus. Improvement is negative, worsening is positive.
Time frame: 4 weeks
Safety Outcome Measures
adverse events will be recorded and monitored. Adverse events will be noted in a separate chart.
Time frame: 8 weeks
Fluphenazine Serum Levels Measured at Baseline, 2 Hours Post Dose and 1 Week Post Dose.
Number of participants with fluphenazine serum levels \> 0.200ng/ml, at baseline, 2 hours post dose and 1 week post dose.
Time frame: 1 week
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