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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00186563
First Posted: September 16, 2005
Last Update Posted: June 19, 2013
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.
Information provided by (Responsible Party):
Martin Angst, Stanford University
  Purpose
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 Intervention
Skin Diseases Procedure: Micro-plasmapheresis

Study Type: Interventional
Study Design: 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 NLM:


Further study details as provided by Martin Angst, Stanford University:

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

Estimated Enrollment: 13
  Eligibility

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
Criteria

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.

  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT00186563


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

Responsible Party: Martin Angst, Professor of Anesthesia, Stanford University
ClinicalTrials.gov Identifier: NCT00186563     History of Changes
Other Study ID Numbers: 79723
First Submitted: September 14, 2005
First Posted: September 16, 2005
Last Update Posted: June 19, 2013
Last Verified: June 2013

Additional relevant MeSH terms:
Skin Diseases