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Cell Responses to IFN-gamma

This study has been terminated.
(Unable to isolate sufficient cells from the skin biopsy to perform study experiments.)
Sponsor:
Information provided by (Responsible Party):
Rockefeller University
ClinicalTrials.gov Identifier:
NCT01317017
First received: March 10, 2011
Last updated: March 4, 2013
Last verified: March 2013
  Purpose

IFN-gamma is a central player in the development of psoriasis lesions, which can be involved a variety of cellular processes in the skin. Dendritic cells are important cells in driving inflammation in psoriasis through the induction of T cells that produce IL-17 in psoriasis. Injecting IFN-g into the skin can increase the numbers of T cells and also inflammatory DCs that produce cytokines involved in IL-17 production. Thus, the investigators hypothesize that the dendritic cells present in the skin after IFN-g injection polarize IL-17-producing T cells.


Condition Intervention Phase
Plaque Psoriasis
Drug: Actimmune
Phase 0

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: Cellular Responses To Intradermal-Gamma (IFN-gamma) in Normal and Psoriatic Patients

Resource links provided by NLM:


Further study details as provided by Rockefeller University:

Primary Outcome Measures:
  • Function of dendritic cells from IFNg-injected skin [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    To perform an assay using dendritic cells from the biopsy as stimulator cells and T cells as responders.


Secondary Outcome Measures:
  • Flow cytometry analysis of circulating leukocyte populations [ Time Frame: 9 months ] [ Designated as safety issue: No ]
    Surface phenotype and intracellular cytokine staining will be performed to determine if a single dose of IFNg alters circulating leukocyte phenotype.


Enrollment: 2
Study Start Date: July 2010
Study Completion Date: May 2011
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Actimmune
    • All subjects will receive one intradermal injections of 0.25ml of IFN-g (Actimmune TM 100 micrograms/0.5ml), in normal appearing skin of both normal volunteers and psoriasis patients.
    • Blood will be taken at baseline and day 1. A skin biopsy (6mm punch) will be taken at the injection site 24 hours later.
    • Patients will return at one to two weeks for suture removal.
    • Clinical assessments done at every visit.
    • Patients will also be evaluated at each visit for any adverse events.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Signed informed consent
  • Normal volunteers with no evidence of skin disease OR diagnosis of plaque type psoriasis for at least 6 months
  • 18 years of age or greater
  • For women of childbearing potential or in men whose partners may become pregnant, willingness to use an acceptable method of contraception to prevent pregnancy for the duration of the study. Acceptable methods of contraception include use of a condom; abstinence; use by sexual partner of oral implantable or injectable contraceptives, IUD, female condom, diaphragm with spermicide, cervical cap; or a sterile sexual partner

Exclusion Criteria:

  • Guttate, erythrodermic, or pustular psoriasis as sole or predominant form of psoriasis
  • Clinically significant psoriasis flare during screening or on the first treatment day
  • Hypersensitivity to IFN-g or E. coli derivatives
  • Pre-existing, uncontrolled myelosuppression, cardiac disease, seizure disorders, compromised central nervous system function or multiple sclerosis
  • History of malignancy, clinically significant renal insufficiency, poorly controlled medical conditions that would increase the risks
  • Presence of malignancy within the past 5 years, including lymphoproliferative disorders. Subjects with a history of fully resolved basal cell or squamous cell skin cancer may be enrolled.
  • Pregnancy or lactation. As the risk of IFN-g in pregnancy is unknown, pregnant women will be excluded from the study.
  • Any medical condition that, in the judgment of the investigator, would jeopardize the subject's safety following exposure to study drug
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01317017

Locations
United States, New York
Rockefeller University
New York, New York, United States, 10065
Sponsors and Collaborators
Rockefeller University
Investigators
Principal Investigator: Michelle Lowes, MD The Rockefeller University
  More Information

No publications provided

Responsible Party: Rockefeller University
ClinicalTrials.gov Identifier: NCT01317017     History of Changes
Other Study ID Numbers: MLO-0717
Study First Received: March 10, 2011
Last Updated: March 4, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Rockefeller University:
Psoriasis

Additional relevant MeSH terms:
Psoriasis
Skin Diseases
Skin Diseases, Papulosquamous

ClinicalTrials.gov processed this record on November 25, 2014