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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2010 by Albany Medical College.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Information provided by:
Albany Medical College
ClinicalTrials.gov Identifier:
NCT01379716
First received: June 22, 2011
Last updated: NA
Last verified: December 2010
History: No changes posted

June 22, 2011
June 22, 2011
January 2011
January 2012   (final data collection date for primary outcome measure)
use of genetic data to enhance the search for targeted therapeutic approaches to chronic pain management [ Time Frame: One year ] [ Designated as safety issue: No ]
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.
Same as current
No Changes Posted
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Immunolabeling Evaluation of Five Selected Markers in Skin Biopsies of Patients With Postherpetic Neuralgia and Healthy Controls
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.

Not Provided
Interventional
Phase 1
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
  • Postherpetic Neuralgia
  • Healthy Age/Gender Matched Volunteers
Other: 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.
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
10
Not Provided
January 2012   (final data collection date for primary outcome measure)

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
Male
50 Years to 95 Years
Yes
Contact: Margaret Czerwinski, BSN, RN (518)262-0034 czerwim@mail.amc.edu
Contact: Katy Regan, BS (518)262-5938 regank@mail.amc.edu
United States
 
NCT01379716
INT/AMC-001
No
Charles Argoff, MD, The Neurosciences Institute
Albany Medical College
National Institutes of Health (NIH)
Principal Investigator: James P. Wymer, MD Albany Medical College
Albany Medical College
December 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP