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

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.

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Key information

Conditions

Skin Diseases Skin and Connective Tissue Diseases

Age range

21 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Stanford University School of Medicine

Stanford, California, 94305, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Consumption of analgesic drugs. 3. Hypersensitivity to sunlight.

Treatment and study plan

Micro-plasmapheresis

Procedure

Primary outcomes

Cytokine-release profile in response to inflammation, noxious heat, and asministration of a COX-inhibitor

Sponsors and collaborators

Lead sponsor

Martin Angst

Other

Registry information

Official study title

Proof-of-concept Study for Bio-marker Assay Validation in Humans

Important dates

First posted: Sep 16, 2005
Registry last updated: Jun 19, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed