Conditions: Psoriasis
Keywords: Psoriasis T-lymphocytes Fluphenazine
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 15
Healthy volunteers: no

Brief summary:
The objective of this study is to assess the safety and biologic activity of intralesional injection of fluphenazine in adult subjects with psoriasis.

Detailed description:
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.

Arms:
arm 1: The sterile placebo: Bacteriostatic Sodium Chloride for Injection. arm 2: 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.

Interventions: intervention 1: Fluphenazine intervention 2: Placebo
Intervention descriptions: intervention 1: Intralesional injection of Fluphenazine intervention 2: Intralesional injection of placebo

Protocol document: