Fluphenazine Hydrochloride for Psoriasis (FP-CL2)
The objective of this study is to assess the safety and biologic activity of intralesional injection of fluphenazine in adult subjects with psoriasis.
|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|
- The following primary biologic activity outcome measure will be evaluated at 4 weeks: Improvement in target lesion scoring. [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
- The following secondary biologic activity outcome measure will be evaluated at 4 weeks: Improvement from baseline in the target lesion Visual Analog Scale (VAS) score for pruritus. [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
- Safety Outcome Measures: All adverse events will be recorded and monitored. [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]
- Fluphenazine serum levels to be measured at baseline, after 2 hours & after 1 week. [ Time Frame: 1 week ] [ Designated as safety issue: Yes ]
|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
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.
|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|