ClinicalTrials.gov
ClinicalTrials.gov Menu

Skin Denervation in Systemic Lupus Erythematosus

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00155532
Recruitment Status : Completed
First Posted : September 12, 2005
Last Update Posted : September 12, 2005
Sponsor:
Information provided by:
National Taiwan University Hospital

Brief Summary:
To address the issues of skin denervation and its clinical and pathological correlations in systemic lupus erythematosus

Condition or disease Intervention/treatment Phase
Systemic Lupus Erythematosus Procedure: 3 mm-punch biopsies of the skin Phase 1

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.

Study Type : Interventional  (Clinical Trial)
Enrollment : 40 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Study Start Date : April 2002
Study Completion Date : March 2004

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lupus
U.S. FDA Resources




Primary Outcome Measures :
  1. Quantitation of epidermal innervation


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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.

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): NCT00155532


Locations
Taiwan
Departments of Neurology, National Taiwan University Hospital
Taipei, Taiwan
Sponsors and Collaborators
National Taiwan University Hospital
Investigators
Study Director: Sung-Tsang Hsieh, MD, PhD Department of Neurology, National Taiwan University Hospital, 7 Chung-Shan S Rd., Taipei 100, Taiwan

ClinicalTrials.gov Identifier: NCT00155532     History of Changes
Other Study ID Numbers: 9261700704
First Posted: September 12, 2005    Key Record Dates
Last Update Posted: September 12, 2005
Last Verified: June 2005

Keywords provided by National Taiwan University Hospital:
Peripheral neuropathy;systemic lupus erythematosus

Additional relevant MeSH terms:
Lupus Erythematosus, Systemic
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases