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

January 7, 2020 updated by: Charles Argoff, Albany Medical College

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • Albany, New York, United States, 12208
        • Albany Medical College

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 95 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
One year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Albany Medical College

Collaborators

National Institutes of Health (NIH)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2011

Primary Completion (Actual)

January 1, 2013

Study Completion (Actual)

June 1, 2013

Study Registration Dates

First Submitted

June 22, 2011

First Submitted That Met QC Criteria

June 22, 2011

First Posted (Estimate)

June 23, 2011

Study Record Updates

Last Update Posted (Actual)

January 9, 2020

Last Update Submitted That Met QC Criteria

January 7, 2020

Last Verified

January 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • INT/AMC-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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