Fluphenazine Decanoate for Psoriasis

NCT00356200 | Terminated Phase 2 Results

• 1 other identifier: FP-CL1
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

We are doing this research study to evaluate the effectiveness and safety of fluphenazine decanoate when injected with a needle into psoriasis lesions in adults. Fluphenazine decanoate is FDA (U.S. Food and Drug Administration) approved for use in people who have schizophrenia and psychotic symptoms. Fluphenazine decanoate is not approved by the FDA for use in psoriasis. Fluphenazine decanoate slows T cell growth in cells in laboratory test tubes. Its usefulness and safety in people with psoriasis will be investigated in this study.

Conditions

Psoriasis

Outcome Measures

Primary Outcomes (1)

• Change in Target Lesion Score at Week 4 Compared to Baseline

  Change in score from 0-14 of target lesion disease activity based on scaling, erythema, and induration as determined by a physician assessor at week 4 compared to baseline (with 0 being no disease activity and 14 being maximum disease activity).

  Baseline to week 4

Secondary Outcomes (1)

• Change in Target Lesion Pruritus Visual Analog Scale (VAS) at Week 4 Compared to Baseline.

  Baseline to week 4

Study Arms (2)

Fluphenazine treated

EXPERIMENTAL

Treated with fluphenazine

Drug: Fluphenazine Decanoate

Placebo

PLACEBO COMPARATOR

Treated with Placebo

Drug: Placebo

Interventions

Fluphenazine Decanoate DRUG

Fluphenazine decanoate marketed by APP Pharmaceuticals (25 mg/mL, 5 mL vial) was used in this study. This was an ascending dose study with the first cohort of 5 subjects dosed at 10 µg/mL, followed by 5 subject dosed in the second cohort at 100 µg/mL. Note: "APP Pharmaceuticals" is the name of the pharmaceutical company; APP is not an acronym.

Fluphenazine treated

Placebo DRUG

The sterile placebo (sesame oil with 1.2% (w/v) benzyl alcohol) was prepared at the University of Iowa, Division of Pharmaceutical Services, a FDA registered pharmaceutical manufacturing facility.

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults 18 to 65 years of age with psoriasis, in general good health
• Must have symmetric target lesions approximately 2-4 cm in diameter on each side of the body (e.g., thighs) with baseline target lesion score of 6 or higher (scale of 0-12) for each target
• Women of childbearing potential must agree to use two forms of contraception for the duration of the study

You may not qualify if:

• 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 PUVA (psoralen plus ultraviolet A) 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)
• Receipt of an investigational agent within the past 4 weeks
• Systemic corticosteroid therapy
• Inability to understand consent or comply with protocol
• Pregnancy, lactation, or unwillingness to use adequate birth control during the study
• Impaired hepatic function
• Known Human immunodeficiency virus (HIV)/acquired immune deficiency syndrome (AIDS), hepatitis B/C
• Blood dyscrasia
• Epilepsy
• Tardive dyskinesia
• Excessive alcohol consumption
• Current use of selective serotonin reuptake inhibitors (SSRI), tricyclic, or norephinephrine reuptake inhibitor antidepressants or use within 6 weeks of beginning the study

Sponsors & Collaborators

• Tufts Medical Center: lead
• Immune Control: collaborator

Study Sites (1)

Tufts-New England Medical Center

Boston, Massachusetts, 02111, United States

Location

Related Publications (4)

• Tutrone WD, Kagen MH, Barbagallo J, Weinberg JM. Biologic therapy for psoriasis: a brief history, II. Cutis. 2001 Dec;68(6):367-72.

  PMID: 11775769 BACKGROUND

• Kipnis CD, Myers WA, Opeola M, Gottlieb AB. Biologic treatments for psoriasis. J Am Acad Dermatol. 2005 Apr;52(4):671-82. doi: 10.1016/j.jaad.2004.12.032. No abstract available.

  PMID: 15793519 BACKGROUND

• Gupta MA, Gupta AK. Psychiatric and psychological co-morbidity in patients with dermatologic disorders: epidemiology and management. Am J Clin Dermatol. 2003;4(12):833-42. doi: 10.2165/00128071-200304120-00003.

  PMID: 14640776 BACKGROUND

• Gupta MA, Guptat AK. The use of antidepressant drugs in dermatology. J Eur Acad Dermatol Venereol. 2001 Nov;15(6):512-8. doi: 10.1046/j.1468-3083.2001.00278.x.

  PMID: 11843209 BACKGROUND

MeSH Terms

Conditions

Psoriasis

Interventions

fluphenazine depot

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Results Point of Contact

• Title: Alice B Gottlieb, MD, PhD
• Organization: Tufts Medical Center

agottlieb@tuftsmedicalcenter.org

617 636 4802

Study Officials

• Alice B Gottlieb, MD, PhD

  Tufts Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: July 24, 2006
• First Posted: July 25, 2006
• Study Start: July 1, 2006
• Primary Completion: December 1, 2007
• Study Completion: September 1, 2008
• Last Updated: December 22, 2010
• Results First Posted: December 22, 2010

Record last verified: 2010-12

Locations

US (1)