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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00186563
Enrollment
13
Registered
2005-09-16
Start date
Unknown
Completion date
Unknown
Last updated
2013-06-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Skin Diseases

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.

Interventions

PROCEDUREMicro-plasmapheresis

Sponsors

Martin Angst
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
DIAGNOSTIC
Masking
DOUBLE

Eligibility

Sex/Gender
ALL
Age
21 Years to 60 Years
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.

Design outcomes

Primary

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026