Fluphenazine Hydrochloride for Psoriasis

Psoriasis Clinical Trial

— FP-CL2  

Official title:

Ascending-Dose, Double-Blind, Placebo-Controlled, Study of Intralesional Fluphenazine Hydrochloride for Psoriasis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00929578
• Other study ID #: FP-CL2
• Status: Completed
• Phase: Phase 2
• First received: June 25, 2009
• Last updated: July 20, 2012
• Start date: November 2008
• Est. completion date: January 2011

Study information

• Verified date: July 2012
• Source: Tufts Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: January 2011
• Est. primary completion date: November 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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 TNF-alpha inhibitor within the past 3 months (12 weeks)

• Other systemic psoriasis therapies (e.g., methotrexate, cyclosporine, acitretin) or PUVA within the past 4 weeks

• UVB or topical therapy (other than 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 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, PABA or benzyl alcohol

• Clinically significant and uncontrolled cardiovascular disease

• 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Psoriasis

Intervention

Drug:
• Fluphenazine
Intralesional injection of Fluphenazine
• Placebo
Intralesional injection of placebo

Locations

Country	Name	City	State
United States	Tufts Medical Center, Department of Dermatology	Boston	Massachusetts
United States	Robert Wood Johnson Medical School, Psoriasis Center of Excellence	New Brunswick	New Jersey

Sponsors (2)

Lead Sponsor	Collaborator
Tufts Medical Center	Immune Control

Country where clinical trial is conducted

United States, 

References & Publications (1)

Gupta MA, Guptat AK. The use of antidepressant drugs in dermatology. J Eur Acad Dermatol Venereol. 2001 Nov;15(6):512-8. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The following primary biologic activity outcome measure will be evaluated at 4 weeks: Improvement in target lesion scoring.		4 weeks	No
Secondary	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.		4 weeks	No
Secondary	Safety Outcome Measures: All adverse events will be recorded and monitored.		8 weeks	Yes
Secondary	Fluphenazine serum levels to be measured at baseline, after 2 hours & after 1 week.		1 week	Yes

External Links

•   Tufts Medical Center, Department of Dermatology, Research