Fluphenazine Hydrochloride for Psoriasis (FP-CL2)
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00929578 |
Recruitment Status :
Completed
First Posted : June 29, 2009
Results First Posted : August 2, 2016
Last Update Posted : March 31, 2017
|
- Study Details
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Psoriasis | Drug: Fluphenazine Drug: Placebo | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 15 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Triple (Participant, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
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 |

Arm | Intervention/treatment |
---|---|
Placebo Comparator: Placebo
The sterile placebo: Bacteriostatic Sodium Chloride for Injection.
|
Drug: Placebo
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.
|
Drug: Fluphenazine
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.

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years to 65 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Adults 18 to 65 years of age with psoriasis, in general good health as determined by the Principal Investigator based upon the results of medical history, laboratory profile, and physical examination
- Must have symmetric target lesions 2-4 cm in diameter on each side of the body (e.g., thighs) with baseline Target Lesion Score (TLS) of 6 or higher (scale of 0-12) for each target
-
Women are eligible to participate in the study if they meet one of the following criteria:
- Women who are postmenopausal (for at least one year), sterile, or hysterectomized
-
Women of childbearing potential must undergo monthly pregnancy testing during the study and agree to use two of the following methods of contraception throughout the study and for 60 days after the last dose of study drug:
- Oral contraceptives
- Transdermal contraceptives
- Injectable or implantable methods
- Intrauterine devices
- Barrier methods (diaphragm with spermicide, condom with spermicide)
(Abstinence and Tubal Ligation are also considered a form of Birth control.)
Exclusion Criteria:
- Patient is not asymptomatic and has major ailments on screening exam.
- Infliximab (Remicade®) or alefacept (Amevive®) within the past 6 months (24 weeks)
- Etanercept (Enbrel®), efalizumab (Raptiva™), adalimumab (Humira®) or other tumor necrosis factor (TNF)-alpha inhibitor within the past 3 months (12 weeks)
- Other systemic psoriasis therapies (e.g., methotrexate, cyclosporine, acitretin) or oral psoralen with ultraviolet A (PUVA) within the past 4 weeks
- ultraviolet B (UVB) or topical therapy (other than over-the-counter (OTC) moisturizers and shampoos) within the past 2 weeks (including topical corticosteroids, vitamin A and D analogues) with the exception of betamethasone valerate lotion (0.01%) for treatment of scalp lesions, and triamcinolone cream (0.1%) for lesions at least 3 inches away from the target lesions
- Receipt of an investigation agent within the past 4 weeks
- Systemic corticosteroid therapy
- Inability to understand consent or comply with protocol (patients will be asked if they understand or have any questions)
- Pregnancy, lactation, or unwillingness to use adequate birth control during the study
- Impaired hepatic function
- Known HIV/AIDS, hepatitis B/C
- Blood dyscrasia
- Epilepsy
- Tardive dyskinesia
- Excessive alcohol consumption (drinking more than two drinks per day on average for men or more than one drink per day on average for women)
- Use of phenothiazine antipsychotics or anticholinergics
- Current use of selective serotonin reuptake inhibitor (SSRI), tricyclic, or norepinephrine reuptake inhibitor antidepressants or use within 6 weeks of beginning the study
- Concurrent use of anti-seizure drugs, with the exception of gabapentin for treatment of neuropathy
- Known allergy to fluphenazine or other phenothiazines, sesame oil or sesame seeds
- Known allergy to parabens, para-aminobenzoate (PABA) or benzyl alcohol
- Clinically significant and uncontrolled cardiovascular disease
- corrected QT interval (QTc) > 450 msec, or evidence of a clinically significant dysrhythmia on ECG
- Operator of heavy machinery
- Pheochromocytoma
- Clinically significant mitral valve disease
- History of breast cancer
- History of seizure disorder
- Occupational exposure to organophosphate insecticides
- Parkinson's disease and other related movement disorders
-
Screening Lab abnormalities including:
- Serum Asparate transaminase (AST) or Alanine transaminase (ALT) > 2.5 upper limits of normal
- Creatinine ≥ 1.6 mg/dL
- Bilirubin ≥ 1.5 mg/dL
- White blood cell (WBC) count < 3 x 10^9 /L
- Platelets < 100 x 10^9/L
- Hemoglobin < 10 g/dL in females or < 12g/dL in males
- Glucose ≥ 200 mg/dL
- Fasting blood sugar ≥ 126 mg/dL
- Concurrent use of drugs listed in Appendix E of protocol

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 |
Publications:
Responsible Party: | Tufts Medical Center |
ClinicalTrials.gov Identifier: | NCT00929578 |
Other Study ID Numbers: |
FP-CL2 |
First Posted: | June 29, 2009 Key Record Dates |
Results First Posted: | August 2, 2016 |
Last Update Posted: | March 31, 2017 |
Last Verified: | March 2017 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Psoriasis T-lymphocytes Fluphenazine |
Psoriasis Skin Diseases, Papulosquamous Skin Diseases Fluphenazine Fluphenazine depot Fluphenazine enanthate Antipsychotic Agents Tranquilizing Agents |
Central Nervous System Depressants Physiological Effects of Drugs Psychotropic Drugs Dopamine Antagonists Dopamine Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action |