Evaluation of Five Selected Markers in Skin Biopsies of Patients With Postherpetic Neuralgia and Healthy Controls

Postherpetic Neuralgia is a painful nerve condition that can occur when nerve fibers are damaged following an outbreak of shingles.

The purpose of this study is to identify and study abnormalities in the nerves and cells in the of patients with postherpetic Neuralgia (PHN) and characterize changes that could be responsible for causing nerve pain. This data will be compared to the tissue of healthy volunteers. Our goal is that this information will lead to the development of better treatment options for people with painful nerve conditions.

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Key information

Conditions

Postherpetic Neuralgia Healthy Age/Gender Matched Volunteers Nervous System Diseases Neuralgia Neuralgia, Postherpetic Neurologic Manifestations Neuromuscular Diseases Pain Pathological Conditions, Signs and Symptoms Peripheral Nervous System Diseases Signs and Symptoms

Age range

50 year–95 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Albany Medical College

Albany, New York, 12208, United States

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

Group 1: 5 Caucasian males >50 years of age with PHN of greater than 6 months duration since rash healed and clinically meaningful pain (Visual Analog Scale (VAS) >40mm at Baseline) Group 2: 5 Caucasian males >50 years of age, non-diabetic with no nervous system disease (healthy control groups)

Exclusion criteria

History of clinically significant liver disease, serious peripheral vascular disease, a blood clotting disorder, or any other medical condition felt to be exclusionary by the investigator
Allergy to lidocaine
Unwillingness to sign informed consent or any other reasons for which the investigator feels the subject cannot complete the study
History of slow-healing diabetic foot ulcers
HgA1c >11% within the last three months
Active cancer within the previous two years, except treated basal cell carcinoma of the skin
Co-morbidities that can produce neuropathy
Subjects taking sodium channel blockers within one week of study treatment and throughout the study
Subjects taking any other experimental drugs within 30 days prior to enrollment
Application of lidocaine patch to either foot or to PHN site within two weeks of enrollment

Treatment and study plan

Skin biopsy

Other

Using a punch biopsy, the study doctor will take a small sample of skin (3mm diameter) from a pre-defined site of the subject. For PHN patients, 4 biopsies will be obtained: 2 in an area of PHN and 2 in a contralateral control site. Biopsy sites for each PHN control subject will be matched anatomically to the corresponding PHN patient with two biopsies each from symmetrical sites in a left and right dermatome. One biopsy from each site in each subject will be fixed in a left and right dermatome. One biopsy from each site in each subject will fixed yb immersion in 4% paraformaldehyde for immunocytochemical analysis, and the second biopsy form each site will be flash frozen for assessments of mRNA expression.

Primary outcomes

use of genetic data to enhance the search for targeted therapeutic approaches to chronic pain management

Time frame: One year

The skin biopsies will be used to identify the site of expression of selected makers in skin, including nerve fibers and skin substructures in patients with PHN and age and gender-atched normal controls.

Sponsors and collaborators

Lead sponsor

Albany Medical College

Other

Collaborators

National Institutes of Health (NIH)

Registry information

Official study title

Immunolabeling Evaluation of Five Selected Markers in Skin Biopsies of Patients With Postherpetic Neuralgia (PHN) and Age and Gender-Matched Normal Controls

Acronym: STTR

Important dates

Study start: 2011
Primary completion: 2013
Study completion: 2013
First posted: Jun 23, 2011
Registry last updated: Jan 9, 2020

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.

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