Postherpetic NeuralgiaSTTRNCT01379716
Evaluation of Five Selected Markers in Skin Biopsies of Patients With Postherpetic Neuralgia and Healthy Controls
A study testing skin biopsy in people with Postherpetic Neuralgia and Healthy Age/Gender Matched Volunteers, run by Albany Medical College at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 50 to 95 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Postherpetic Neuralgia, Healthy Age/Gender Matched Volunteers
- What is being tested?
- skin biopsy
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2011to Jun 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 95 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
- Allergy to lidocaine
- Unwillingness to sign informed consent or any other reasons for which the investigator feels the subject cannot complete the study
- History of slow-healing diabetic foot ulcers
- HgA1c >11% within the last three months
- Active cancer within the previous two years, except treated basal cell carcinoma of the skin
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- Co-morbidities that can produce neuropathy
- Subjects taking sodium channel blockers within one week of study treatment and throughout the study
- Subjects taking any other experimental drugs within 30 days prior to enrollment
- Application of lidocaine patch to either foot or to PHN site within two weeks of enrollment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Being tested
- skin biopsy
- Medical subject headings
- Neuralgia, Postherpetic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
skin biopsyOther
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2011 (estimated)
- Study startJan 2011
- Primary completionJan 2013
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postherpetic NeuralgiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Albany Medical College
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Responsible party
- Principal investigator, Charles Argoff, Albany Medical College
- Investigators
- James P. Wymer, MD, Principal investigator, Albany Medical College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01379716
- Sponsor's protocol ID
- INT/AMC-001
- Acronym
- STTR
- Status last verified
- Jan 2020
- First submitted
- 22 Jun 2011
- Last updated
- 9 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immunolabeling Evaluation of Five Selected Markers in Skin Biopsies of Patients With Postherpetic Neuralgia (PHN) and Age and Gender-Matched Normal Controls
- ClinicalTrials.gov ID
- NCT01379716
- Acronym / sponsor ID
- STTR / INT/AMC-001
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Albany Medical CollegeUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Study start
- Jan 2011
- Primary completion
- Jan 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 23 Jun 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 50 to 95 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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)
Key exclusion criteria (10 listed)
- 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
- Allergy to lidocaine
- Unwillingness to sign informed consent or any other reasons for which the investigator feels the subject cannot complete the study
- History of slow-healing diabetic foot ulcers
- HgA1c >11% within the last three months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| skin biopsyUsing 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. | Other | – |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2020.
Related trials for Postherpetic Neuralgia
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Obesity and Obesity-Related Factors and Risk of Herpes Zoster (Shingles) and Postherpetic Neuralgia
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The Analgesic Efficacy and Safety of Venlafaxine for Prevention of Postherpetic Neuralgia in Patients With Acute Herpes Zoster
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
James P. Wymer, MD principal investigator
Albany Medical College
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing skin biopsy in people with Postherpetic Neuralgia and Healthy Age/Gender Matched Volunteers, run by Albany Medical College at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
use of genetic data to enhance the search for targeted therapeutic approaches to chronic pain management (time frame: One year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jan 2020.