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

Not Applicable

Completed

• Conditions: Healthy Age/Gender Matched Volunteers; Postherpetic Neuralgia

• Registration Number: NCT01379716
• Lead Sponsor: Albany Medical College

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-01
• Study First Submitted: 2011-06-22
• Study First Submitted QC: 2011-06-22
• Study First Posted: 2011-06-23
• Primary Completion: 2013-01
• Study Completion: 2013-06
• Status Verified: 2020-01
• Last Update Submitted: 2020-01-07
• Last Update Posted: 2020-01-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 10

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

1. 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
2. Allergy to lidocaine
3. Unwillingness to sign informed consent or any other reasons for which the investigator feels the subject cannot complete the study
4. History of slow-healing diabetic foot ulcers
5. HgA1c >11% within the last three months
6. Active cancer within the previous two years, except treated basal cell carcinoma of the skin
7. Co-morbidities that can produce neuropathy
8. Subjects taking sodium channel blockers within one week of study treatment and throughout the study
9. Subjects taking any other experimental drugs within 30 days prior to enrollment
10. Application of lidocaine patch to either foot or to PHN site within two weeks of enrollment

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
use of genetic data to enhance the search for targeted therapeutic approaches to chronic pain management	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.

Trial Locations

Locations (1)

Albany Medical College; 🇺🇸 Albany, New York, United States