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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Martin Angst, Stanford University
ClinicalTrials.gov Identifier:
NCT00186563
First received: September 14, 2005
Last updated: June 18, 2013
Last verified: June 2013
  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-Blind
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 Stanford University:

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

Estimated Enrollment: 13
  Eligibility

Ages Eligible for Study:   21 Years to 60 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Martin Angst, Professor of Anesthesia, Stanford University
ClinicalTrials.gov Identifier: NCT00186563     History of Changes
Other Study ID Numbers: 79723
Study First Received: September 14, 2005
Last Updated: June 18, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Skin Diseases

ClinicalTrials.gov processed this record on April 16, 2014