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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT01317017
Other study ID # MLO-0717
Secondary ID
Status Terminated
Phase Phase 0
First received March 10, 2011
Last updated March 4, 2013
Start date July 2010
Est. completion date May 2011

Study information

Verified date March 2013
Source Rockefeller University
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Terminated
Enrollment 2
Est. completion date May 2011
Est. primary completion date May 2011
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
United States Rockefeller University New York New York

Sponsors (1)

Lead Sponsor Collaborator
Rockefeller University

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Function of dendritic cells from IFNg-injected skin To perform an assay using dendritic cells from the biopsy as stimulator cells and T cells as responders. 6 months No
Secondary Flow cytometry analysis of circulating leukocyte populations Surface phenotype and intracellular cytokine staining will be performed to determine if a single dose of IFNg alters circulating leukocyte phenotype. 9 months No
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