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Fluphenazine Decanoate for Psoriasis

NCT00356200 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2010-12-22

Study results available
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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

Interventions

DRUG

Fluphenazine Decanoate

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.

DRUG

Placebo

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.

Sponsors & Collaborators

  • Immune Control

    collaborator INDUSTRY

  • Tufts Medical Center

    lead OTHER

Principal Investigators

  • Alice B Gottlieb, MD, PhD · Tufts Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-07-31
Primary Completion
2007-12-31
Completion
2008-09-30

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00356200 on ClinicalTrials.gov