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

Primary Purpose

Postherpetic Neuralgia, Healthy Age/Gender Matched Volunteers

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
skin biopsy
Sponsored by
Albany Medical College
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Postherpetic Neuralgia

Eligibility Criteria

50 Years - 95 Years (Adult, Older Adult)MaleAccepts 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

Sites / Locations

  • Albany Medical College

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
June 22, 2011
Last Updated
January 7, 2020
Sponsor
Albany Medical College
Collaborators
National Institutes of Health (NIH)
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1. Study Identification

Unique Protocol Identification Number
NCT01379716
Brief Title
Evaluation of Five Selected Markers in Skin Biopsies of Patients With Postherpetic Neuralgia and Healthy Controls
Acronym
STTR
Official Title
Immunolabeling Evaluation of Five Selected Markers in Skin Biopsies of Patients With Postherpetic Neuralgia (PHN) and Age and Gender-Matched Normal Controls
Study Type
Interventional

2. Study Status

Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
January 2011 (undefined)
Primary Completion Date
January 2013 (Actual)
Study Completion Date
June 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Albany Medical College
Collaborators
National Institutes of Health (NIH)

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postherpetic Neuralgia, Healthy Age/Gender Matched Volunteers

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Other
Intervention Name(s)
skin biopsy
Intervention Description
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.
Primary Outcome Measure Information:
Title
use of genetic data to enhance the search for targeted therapeutic approaches to chronic pain management
Description
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.
Time Frame
One year

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
95 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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: 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 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
James P. Wymer, MD
Organizational Affiliation
Albany Medical College
Official's Role
Principal Investigator
Facility Information:
Facility Name
Albany Medical College
City
Albany
State/Province
New York
ZIP/Postal Code
12208
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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