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

Postherpetic Neuralgia Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01379716
• Other study ID #: INT/AMC-001
• Status: Completed
• Phase: N/A
• Start date: January 2011
• Est. completion date: June 2013

Study information

• Verified date: January 2020
• Source: Albany Medical College
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: June 2013
• Est. primary completion date: January 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 50 Years to 95 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy Age/Gender Matched Volunteers
• Neuralgia
• Neuralgia, Postherpetic
• Postherpetic Neuralgia

Intervention

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.

Locations

Country	Name	City	State
United States	Albany Medical College	Albany	New York

Sponsors (2)

Lead Sponsor	Collaborator
Albany Medical College	National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	One year