NCT00929578

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Nov 2008

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2008

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

June 25, 2009

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 29, 2009

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2010

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2011

Completed
5.6 years until next milestone

Results Posted

Study results publicly available

August 2, 2016

Completed
Last Updated

March 31, 2017

Status Verified

March 1, 2017

Enrollment Period

2 years

First QC Date

June 25, 2009

Results QC Date

August 13, 2012

Last Update Submit

March 2, 2017

Conditions

Psoriasis

Keywords

PsoriasisT-lymphocytesFluphenazine

Outcome Measures

Primary Outcomes (1)

  • Change in Target Lesion Scoring Evaluated at Baseline and 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.

    4 weeks

Secondary Outcomes (3)

  • Change in the Target Lesion Visual Analog Scale (VAS) Score for Pruritus Evaluated at Baseline and 4 Weeks

    4 weeks

  • Safety Outcome Measures

    8 weeks

  • Fluphenazine Serum Levels Measured at Baseline, 2 Hours Post Dose and 1 Week Post Dose.

    1 week

Study Arms (2)

Placebo

PLACEBO COMPARATOR

The sterile placebo: Bacteriostatic Sodium Chloride for Injection.

Drug: Placebo

Fluphenazine

ACTIVE COMPARATOR

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

Interventions

FluphenazineDRUG

Intralesional injection of Fluphenazine

Also known as: FP-CL2
Fluphenazine
PlaceboDRUG

Intralesional injection of placebo

Also known as: Bacteriostatic Sodium Chloride
Placebo

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.)

You may not qualify if:

  • 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)
  • +24 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Tufts Medical Center, Department of Dermatology

Boston, Massachusetts, 02111, United States

Location

Robert Wood Johnson Medical School, Psoriasis Center of Excellence

New Brunswick, New Jersey, 08903, United States

Location

Related Publications (1)

  • 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: 11843209BACKGROUND

MeSH Terms

Conditions

Psoriasis

Interventions

Fluphenazine

Condition Hierarchy (Ancestors)

Skin Diseases, PapulosquamousSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

PhenothiazinesSulfur CompoundsOrganic ChemicalsHeterocyclic Compounds, 3-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Results Point of Contact

Title
Alice Gottlieb, MD PhD
Organization
Tufts Medical Center
agottlieb@tuftsmedicalcenter.org
617-636-7462

Study Officials

  • Alice B. Gottlieb, M.D., PhD.

    Tufts Medical Center, Department of Dermatology

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 25, 2009

First Posted

June 29, 2009

Study Start

November 1, 2008

Primary Completion

November 1, 2010

Study Completion

January 1, 2011

Last Updated

March 31, 2017

Results First Posted

August 2, 2016

Record last verified: 2017-03

Data Sharing

IPD Sharing
Will not share

Locations

US(2)