Statements in which the resource exists as a subject.
PredicateObject
rdf:type
lifeskim:mentions
pubmed:issue
6
pubmed:dateCreated
2010-6-1
pubmed:databankReference
pubmed:abstractText
Desensitization of nociceptive sensory nerve endings is the basis for the therapeutic use of capsaicin in neuropathic pain syndromes. This study evaluated the pharmacodynamic effects of a single 60-minute application of NGX-4010, a high-concentration (8% w/w) capsaicin patch, on both thighs of healthy volunteers. Epidermal nerve fiber (ENF) density and quantitative sensory testing (QST) using thermal, tactile, and sharp mechanical-pain (pinprick) stimuli were evaluated 1, 12 and 24 weeks after capsaicin exposure. After 1 week, there was about an 80% reduction of ENF density compared to unexposed sites. In addition, there was about an 8% increase in tactile thresholds compared to baseline and the proportion of stimuli reported as sharp mechanical pain decreased by about 15 percentage points. Twelve weeks after exposure to capsaicin, ENF regeneration was evident, but not complete, and sharp mechanical-pain sensation and tactile thresholds did not differ from unexposed sites. Nearly full (93%) ENF recovery was observed at 24 weeks. No statistically significant changes in heat- or cold-detection thresholds were observed at any time point. NGX-4010 was generally well tolerated. Transient, mild warming or burning sensations at the site of application were common adverse effects. PERSPECTIVE: This article evaluates the effect of a single 60-minute NGX-4010 application on ENF density and QST in healthy volunteers followed for 24 weeks. The results help predict the long-term safety of NGX-4010 applications in patients.
pubmed:language
eng
pubmed:journal
pubmed:citationSubset
IM
pubmed:chemical
pubmed:status
MEDLINE
pubmed:month
Jun
pubmed:issn
1528-8447
pubmed:author
pubmed:copyrightInfo
Copyright (c) 2010 American Pain Society. Published by Elsevier Inc. All rights reserved.
pubmed:issnType
Electronic
pubmed:volume
11
pubmed:owner
NLM
pubmed:authorsComplete
Y
pubmed:pagination
579-87
pubmed:meshHeading
pubmed-meshheading:20400377-Adolescent, pubmed-meshheading:20400377-Adult, pubmed-meshheading:20400377-Capsaicin, pubmed-meshheading:20400377-Cold Temperature, pubmed-meshheading:20400377-Epidermis, pubmed-meshheading:20400377-Female, pubmed-meshheading:20400377-Health Status, pubmed-meshheading:20400377-Hot Temperature, pubmed-meshheading:20400377-Humans, pubmed-meshheading:20400377-Male, pubmed-meshheading:20400377-Nerve Regeneration, pubmed-meshheading:20400377-Pain Threshold, pubmed-meshheading:20400377-Peripheral Nerves, pubmed-meshheading:20400377-Physical Stimulation, pubmed-meshheading:20400377-Sensory Receptor Cells, pubmed-meshheading:20400377-Sensory System Agents, pubmed-meshheading:20400377-Sensory Thresholds, pubmed-meshheading:20400377-Time Factors, pubmed-meshheading:20400377-Young Adult
pubmed:year
2010
pubmed:articleTitle
A randomized, controlled, open-label study of the long-term effects of NGX-4010, a high-concentration capsaicin patch, on epidermal nerve fiber density and sensory function in healthy volunteers.
pubmed:affiliation
Department of Neurology, University of Minnesota, Minneapolis, Minnesota 55455, USA. kenne001@umn.edu
pubmed:publicationType
Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't, Clinical Trial, Phase I