A Human In-vivo Model for the Detection of Inflammatory and Nociceptive Biomarkers

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00186563
Recruitment Status : Completed
First Posted : September 16, 2005
Last Update Posted : June 19, 2013
Information provided by (Responsible Party):
Martin Angst, Stanford University

Brief Summary:
This study aims to establish a novel approach assisting the rational development of analgesic and anti-inflammatory drugs. In a first step we will test in healthy human volunteers whether proteins mediating inflammation and pain can be detected in an experimentally induced inflammatory skin lesion. Fluids that will be used to detect such proteins will be collected from the inflamed skin site via small porous catheters. We wish to establish the expression pattern of different proteins and correlate it with various tests assessing pain.

Condition or disease Intervention/treatment Phase
Skin Diseases Procedure: Micro-plasmapheresis Not Applicable

Study Type : Interventional  (Clinical Trial)
Enrollment : 13 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double
Primary Purpose: Diagnostic
Official Title: Proof-of-concept Study for Bio-marker Assay Validation in Humans

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Skin Conditions
U.S. FDA Resources

Primary Outcome Measures :
  1. Cytokine-release profile in response to inflammation, noxious heat, and asministration of a COX-inhibitor

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:1. Age between 21-60. 2. Skin type II or III according to the classification of Fitzpatrick (II: fair skin, always burns, sometimes tans, III: medium skin, sometimes burns, always tans).
 Exclusion Criteria:1. History of a significant systemic disease, a dermatological disease, bleeding disorder, or chronic pain.

2. Consumption of analgesic drugs. 3. Hypersensitivity to sunlight.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00186563

United States, California
Stanford University School of Medicine
Stanford, California, United States, 94305
Sponsors and Collaborators
Martin Angst
Principal Investigator: Martin S Angst Stanford University

Responsible Party: Martin Angst, Professor of Anesthesia, Stanford University Identifier: NCT00186563     History of Changes
Other Study ID Numbers: 79723
First Posted: September 16, 2005    Key Record Dates
Last Update Posted: June 19, 2013
Last Verified: June 2013

Additional relevant MeSH terms:
Skin Diseases