Back to resultsA Human In-vivo Model for the Detection of Inflammatory and Nociceptive Biomarkers
Primary Purpose
Skin Diseases
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Micro-plasmapheresis
Sponsored by
About this trial
This is an interventional diagnostic trial for Skin Diseases
Eligibility 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.
Sites / Locations
- Stanford University School of Medicine
Outcomes
Primary Outcome Measures
Cytokine-release profile in response to inflammation, noxious heat, and asministration of a COX-inhibitor
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00186563
Brief Title
A Human In-vivo Model for the Detection of Inflammatory and Nociceptive Biomarkers
Official Title
Proof-of-concept Study for Bio-marker Assay Validation in Humans
Study Type
Interventional
2. Study Status
Record Verification Date
June 2013
Overall Recruitment Status
Completed
Study Start Date
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Primary Completion Date
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Study Completion Date
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3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Martin Angst
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Skin Diseases
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Double
Allocation
Randomized
Enrollment
13 (false)
8. Arms, Groups, and Interventions
Intervention Type
Procedure
Intervention Name(s)
Micro-plasmapheresis
Primary Outcome Measure Information:
Title
Cytokine-release profile in response to inflammation, noxious heat, and asministration of a COX-inhibitor
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Martin S Angst
Organizational Affiliation
Stanford University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stanford University School of Medicine
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States
12. IPD Sharing Statement
Learn more about this trial
A Human In-vivo Model for the Detection of Inflammatory and Nociceptive Biomarkers
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