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

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT01379716
• Date of registration: 22/06/2011
• Primary sponsor: Albany Medical College
• Public title: Immunolabeling Evaluation of Five Selected Markers in Skin Biopsies of Patients With Postherpetic Neuralgia and Healthy Controls STTR
• Scientific title: Immunolabeling Evaluation of Five Selected Markers in Skin Biopsies of Patients With Postherpetic Neuralgia (PHN) and Age and Gender-Matched Normal Controls
• Date of first enrolment: January 2011
• Target sample size: 10
• Recruitment status: Recruiting
• URL: http://clinicaltrials.gov/show/NCT01379716
• Study type: Interventional
• Study design: Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Countries of recruitment

United States

Contacts

• Name: Margaret Czerwinski, BSN, RN

• Name: James P. Wymer, MD
• Affiliation: Albany Medical College

Key inclusion & exclusion 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



Age minimum: 50 Years
Age maximum: 95 Years
Gender: Male

Health Condition(s) or Problem(s) studied

Healthy Age/Gender Matched Volunteers

Postherpetic Neuralgia

Intervention(s)

Other: skin biopsy

Primary Outcome(s)

use of genetic data to enhance the search for targeted therapeutic approaches to chronic pain management [Time Frame: One year]

Secondary ID(s)

INT/AMC-001

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

National Institutes of Health (NIH)