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

Sponsor
Albany Medical College (Other)
Overall Status
Completed
CT.gov ID
NCT01379716
Collaborator
National Institutes of Health (NIH) (NIH)
10
Enrollment
1
Location
29
Duration (Months)
0.3
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Other: skin biopsy
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
10 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
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 Start Date :
Jan 1, 2011
Actual Primary Completion Date :
Jan 1, 2013
Actual Study Completion Date :
Jun 1, 2013

Outcome Measures

Primary Outcome Measures

  1. 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
50 Years to 95 Years
Sexes Eligible for Study:
Male
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Albany Medical College Albany New York United States 12208

Sponsors and Collaborators

  • Albany Medical College
  • National Institutes of Health (NIH)

Investigators

  • Principal Investigator: James P. Wymer, MD, Albany Medical College

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Charles Argoff, Principal Investigator, Albany Medical College
ClinicalTrials.gov Identifier:
NCT01379716
Other Study ID Numbers:
  • INT/AMC-001
First Posted:
Jun 23, 2011
Last Update Posted:
Jan 9, 2020
Last Verified:
Jan 1, 2020
Additional relevant MeSH terms:
Neuralgia
Neuralgia, Postherpetic

Study Results

No Results Posted as of Jan 9, 2020