Fluphenazine Hydrochloride for Psoriasis (FP-CL2)
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Ascending-Dose, Double-Blind, Placebo-Controlled, Study of Intralesional Fluphenazine Hydrochloride for Psoriasis|
- Change in Target Lesion Scoring Evaluated at Baseline and 4 Weeks [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]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.
- Change in the Target Lesion Visual Analog Scale (VAS) Score for Pruritus Evaluated at Baseline and 4 Weeks [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]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.
- Safety Outcome Measures [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]adverse events will be recorded and monitored. Adverse events will be noted in a separate chart.
- Fluphenazine Serum Levels Measured at Baseline, 2 Hours Post Dose and 1 Week Post Dose. [ Time Frame: 1 week ] [ Designated as safety issue: Yes ]Number of participants with fluphenazine serum levels > 0.200ng/ml, at baseline, 2 hours post dose and 1 week post dose.
|Study Start Date:||November 2008|
|Study Completion Date:||January 2011|
|Primary Completion Date:||November 2010 (Final data collection date for primary outcome measure)|
Placebo Comparator: Placebo
The sterile placebo: Bacteriostatic Sodium Chloride for Injection.
Intralesional injection of placebo
Other Name: Bacteriostatic Sodium Chloride
Active Comparator: Fluphenazine
This will be an ascending dose study with the first cohort of 5 subjects dosed at 100 µg/mL, followed by cohorts at 500 and 2500 µg/mL. Dosing will be on Days 0, 7 and 14 and will consist of 5, or 10, 100 µL injections into the psoriatic lesion. The number of injections will depend on the lesion size. As this is a vehicle controlled study, subjects will receive intralesional injections of both drug and placebo, each into a separate target plaque, in a randomized fashion.
Intralesional injection of Fluphenazine
Other Name: FP-CL2
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00929578
|United States, Massachusetts|
|Tufts Medical Center, Department of Dermatology|
|Boston, Massachusetts, United States, 02111|
|United States, New Jersey|
|Robert Wood Johnson Medical School, Psoriasis Center of Excellence|
|New Brunswick, New Jersey, United States, 08903|
|Principal Investigator:||Alice B. Gottlieb, M.D., PhD.||Tufts Medical Center, Department of Dermatology|