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

Albany Medical College

Status: Completed

Conditions: Postherpetic Neuralgia; Healthy Age/Gender Matched Volunteers

Treatments: Other: skin biopsy

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT01379716

INT/AMC-001

Details and patient eligibility

About

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.

Enrollment: 10 patients

Sex: Male

Ages: 50 to 95 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)