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

NCT01379716 | Completed

• 1 other identifier: INT/AMC-001
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Postherpetic Neuralgia; Healthy Age/Gender Matched Volunteers

Outcome Measures

Primary Outcomes (1)

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

  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.

  One year

Interventions

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.

Eligibility Criteria

• Age: 50 Years - 95 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Albany Medical College: lead
• National Institutes of Health (NIH): collaborator

Study Sites (1)

Albany Medical College

Albany, New York, 12208, United States

Location

MeSH Terms

Conditions

Neuralgia, Postherpetic

Condition Hierarchy (Ancestors)

Neuralgia; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• James P. Wymer, MD

  Albany Medical College

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 22, 2011
• First Posted: June 23, 2011
• Study Start: January 1, 2011
• Primary Completion: January 1, 2013
• Study Completion: June 1, 2013
• Last Updated: January 9, 2020

Record last verified: 2020-01

Locations

US (1)