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

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ClinicalTrials.gov Identifier: NCT01379716
Recruitment Status : Unknown
Verified December 2010 by Albany Medical College.
Recruitment status was:  Recruiting
First Posted : June 23, 2011
Last Update Posted : June 23, 2011
Sponsor:
Collaborator:
Information provided by:

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
Postherpetic Neuralgia Healthy Age/Gender Matched Volunteers Other: skin biopsy Phase 1

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated 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 : January 2011
Estimated Primary Completion Date : January 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Biopsy Shingles
U.S. FDA Resources

Arms and Interventions

Intervention Details:
    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.

Outcome Measures

Primary Outcome Measures :
  1. 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.


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 95 Years   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01379716


Contacts
Contact: Margaret Czerwinski, BSN, RN (518)262-0034 czerwim@mail.amc.edu
Contact: Katy Regan, BS (518)262-5938 regank@mail.amc.edu

Locations
United States, New York
Albany Medical College Recruiting
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
More Information

Responsible Party: Charles Argoff, MD, The Neurosciences Institute
ClinicalTrials.gov Identifier: NCT01379716     History of Changes
Other Study ID Numbers: INT/AMC-001
First Posted: June 23, 2011    Key Record Dates
Last Update Posted: June 23, 2011
Last Verified: December 2010

Additional relevant MeSH terms:
Neuralgia
Neuralgia, Postherpetic
Pain
Neurologic Manifestations
Nervous System Diseases
Peripheral Nervous System Diseases
Neuromuscular Diseases
Signs and Symptoms