Skin Denervation in Systemic Lupus Erythematosus
Primary Purpose
Systemic Lupus Erythematosus
Status
Completed
Phase
Phase 1
Locations
Taiwan
Study Type
Interventional
Intervention
3 mm-punch biopsies of the skin
Sponsored by
About this trial
This is an interventional diagnostic trial for Systemic Lupus Erythematosus focused on measuring Peripheral neuropathy;systemic lupus erythematosus
Eligibility Criteria
Inclusion Criteria: Diagnosis of systemic lupus erythematosus based on the consensus criteria Exclusion Criteria: Conditions known to be associated with peripheral neuropathy, such as diabetes, uremia, alcoholism, and the administration of potentially neurotoxic agents, such as alkylating agents, methotrexate, cyclosporine, and antibiotics.
Sites / Locations
- Departments of Neurology, National Taiwan University Hospital
Outcomes
Primary Outcome Measures
Quantitation of epidermal innervation
Secondary Outcome Measures
Full Information
NCT ID
NCT00155532
First Posted
September 9, 2005
Last Updated
September 9, 2005
Sponsor
National Taiwan University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT00155532
Brief Title
Skin Denervation in Systemic Lupus Erythematosus
Study Type
Interventional
2. Study Status
Record Verification Date
June 2005
Overall Recruitment Status
Completed
Study Start Date
April 2002 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
March 2004 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
National Taiwan University Hospital
4. Oversight
5. Study Description
Brief Summary
To address the issues of skin denervation and its clinical and pathological correlations in systemic lupus erythematosus
Detailed Description
To address the issues of skin denervation and its clinical and pathological correlations in lupus, we will study a systemic lupus erythematosus (SLE) cohort by evaluating the extent of cutaneous innervation. Patients are recruited from the rheumatologic clinic, and various neuropsychiatric syndromes are diagnosed based on clinical judgement following detailed history taking and neurological examinations. Skin biopsy with PGP 9.5 immunohistochemistry will be performed following established procedures after informed consent is obtained, and punches of 3 mm in diameter will be taken from the lateral side of the distal leg, 10 cm above the lateral malleolus. Intraepidermal nerve fibre densities will be compared with results of immunological, pathological, psychophysical, and electrophysical studies to understand the pathogenesis of peripheral neuropathy in SLE.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Systemic Lupus Erythematosus
Keywords
Peripheral neuropathy;systemic lupus erythematosus
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
40 (false)
8. Arms, Groups, and Interventions
Intervention Type
Procedure
Intervention Name(s)
3 mm-punch biopsies of the skin
Primary Outcome Measure Information:
Title
Quantitation of epidermal innervation
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Eligibility Criteria
Inclusion Criteria:
Diagnosis of systemic lupus erythematosus based on the consensus criteria
Exclusion Criteria:
Conditions known to be associated with peripheral neuropathy, such as diabetes, uremia, alcoholism, and the administration of potentially neurotoxic agents, such as alkylating agents, methotrexate, cyclosporine, and antibiotics.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sung-Tsang Hsieh, MD, PhD
Organizational Affiliation
Department of Neurology, National Taiwan University Hospital, 7 Chung-Shan S Rd., Taipei 100, Taiwan
Official's Role
Study Director
Facility Information:
Facility Name
Departments of Neurology, National Taiwan University Hospital
City
Taipei
Country
Taiwan
12. IPD Sharing Statement
Learn more about this trial
Skin Denervation in Systemic Lupus Erythematosus
We'll reach out to this number within 24 hrs