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

NCT ID: NCT01379716

Last Updated: 2020-01-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-01-31
• Study Completion Date: 2013-06-30

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Interventions

skin biopsy

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.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 95 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

National Institutes of Health (NIH)

NIH

Sponsor Role: collaborator

Albany Medical College

OTHER

Sponsor Role: lead

Responsible Party

Charles Argoff

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

James P. Wymer, MD

Role: PRINCIPAL_INVESTIGATOR

Albany Medical College

Locations

Albany Medical College

Albany, New York, United States

Countries

United States

Other Identifiers

INT/AMC-001

Identifier Type: -

Identifier Source: org_study_id