NCT00026741

Brief Summary

This study will examine the production of proteins called chemokines in inflammatory skin reactions. It is thought that chemokines attract or recruit white blood cells from the blood stream into the skin when there is a skin injury or infection, causing inflammation. This study will examine chemokine production in induced inflammatory reactions to try to gain a better understanding of how white blood cells are attracted to inflamed areas of the body. Healthy normal volunteers between 33 and 60 years old may be eligible for this study if they 1) have no history of chronic skin disease; 2) are not allergic to eggs; and 3) do not tend to form large irregular scars after trauma to the skin from, for example, cuts, scratches and surgical incisions. Candidates will be asked a short series of questions and have a limited skin examination. Participants will have 10 ml (2 tablespoons) of blood drawn from an arm vein at the start and end of the 5-day study and undergo the following procedures:

  1. 1.Day 1 - Participants receive an injection in the right upper arm of mumps antigen (a protein commonly used to tests for immunization against mumps) and an injection of "vehicle" (saline plus the preservatives thimerosal, glycine and formaldehyde) in the left upper arm.
  2. 2.Day 3 - Participants who develop a swelling from the mumps antigen larger than 5 mm wide will receive another injection of antigen in the right arm and another injection of vehicle in the left arm. Those whose swelling is not greater than 5 mm will be excluded from the study at this point.
  3. 3.Day 5 - All four injection sites, plus another site on the left upper arm will be biopsied. For this procedure the five injection areas are numbed with a local anesthetic. A punch biopsy instrument that resembles a small cookie cutter (about one-third the diameter of a dime) is inserted about one-fifth of an inch deep into the skin and the tissue is removed. Two stitches are used to close the wound. Antibiotic and bandages are applied for 5 days. Nine days after the biopsy the participant returns to NIH for removal of the stitches.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
10

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Mar 2001

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

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

March 1, 2001

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

November 14, 2001

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 15, 2001

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2002

Completed
Last Updated

March 4, 2008

Status Verified

January 1, 2002

First QC Date

November 14, 2001

Last Update Submit

March 3, 2008

Conditions

Keywords

CytokineInflammationLymphocyteT CellMigrationHealthy VolunteerSkin Biopsy

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Male or Female Age: 33-60 years. No ingestion of aspirin, ibuprofen, corticosteroids, COX-2 inhibitor such as Rofecoxib, or other non-steroidal anti-inflammatory agents within 7 days of start of protocol. No history of psoriasis or other chronic skin disease. No known underlying chronic disease for which volunteer takes systemic medications. Immunocompromised individuals are not eligible. Patients with an allergy to eggs and/or thimerosal are not eligible. Individuals with a history or physical evidence of keloid or hypertrophic scarring resulting from skin trauma are not eligible. Patients with a history of HIV, HTLV-1, or other immunodeficiency syndrome are not eligible.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

National Cancer Institute (NCI)

Bethesda, Maryland, 20892, United States

Location

Related Publications (3)

  • Fitzhugh DJ, Naik S, Caughman SW, Hwang ST. Cutting edge: C-C chemokine receptor 6 is essential for arrest of a subset of memory T cells on activated dermal microvascular endothelial cells under physiologic flow conditions in vitro. J Immunol. 2000 Dec 15;165(12):6677-81. doi: 10.4049/jimmunol.165.12.6677.

    PMID: 11120783BACKGROUND
  • Feng Y, Broder CC, Kennedy PE, Berger EA. HIV-1 entry cofactor: functional cDNA cloning of a seven-transmembrane, G protein-coupled receptor. Science. 1996 May 10;272(5263):872-7. doi: 10.1126/science.272.5263.872.

    PMID: 8629022BACKGROUND
  • Ebnet K, Vestweber D. Molecular mechanisms that control leukocyte extravasation: the selectins and the chemokines. Histochem Cell Biol. 1999 Jul;112(1):1-23. doi: 10.1007/s004180050387.

    PMID: 10461808BACKGROUND

MeSH Terms

Conditions

PsoriasisInflammation

Condition Hierarchy (Ancestors)

Skin Diseases, PapulosquamousSkin DiseasesSkin and Connective Tissue DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Sponsor Type
NIH

Study Record Dates

First Submitted

November 14, 2001

First Posted

November 15, 2001

Study Start

March 1, 2001

Study Completion

January 1, 2002

Last Updated

March 4, 2008

Record last verified: 2002-01

Locations