Fluphenazine Hydrochloride for Psoriasis (FP-CL2)
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|ClinicalTrials.gov Identifier: NCT00929578|
Recruitment Status : Completed
First Posted : June 29, 2009
Results First Posted : August 2, 2016
Last Update Posted : March 31, 2017
|Condition or disease||Intervention/treatment||Phase|
|Psoriasis||Drug: Fluphenazine Drug: Placebo||Phase 2|
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 (Clinical Trial)|
|Actual Enrollment :||15 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Official Title:||Ascending-Dose, Double-Blind, Placebo-Controlled, Study of Intralesional Fluphenazine Hydrochloride for Psoriasis|
|Study Start Date :||November 2008|
|Actual Primary Completion Date :||November 2010|
|Actual Study Completion Date :||January 2011|
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
- Change in Target Lesion Scoring Evaluated at Baseline and 4 Weeks [ Time Frame: 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.
- Change in the Target Lesion Visual Analog Scale (VAS) Score for Pruritus Evaluated at Baseline and 4 Weeks [ Time Frame: 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.
- Safety Outcome Measures [ Time Frame: 8 weeks ]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 ]Number of participants with fluphenazine serum levels > 0.200ng/ml, at baseline, 2 hours post dose and 1 week post dose.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|