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Skin Denervation in Systemic Lupus Erythematosus

This study has been completed.
Sponsor:
Information provided by:
National Taiwan University Hospital
ClinicalTrials.gov Identifier:
NCT00155532
First received: September 9, 2005
Last updated: NA
Last verified: June 2005
History: No changes posted
  Purpose

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


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

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic

Resource links provided by NLM:

MedlinePlus related topics: Lupus
U.S. FDA Resources

Further study details as provided by National Taiwan University Hospital:

Primary Outcome Measures:
  • Quantitation of epidermal innervation

Estimated Enrollment: 40
Study Start Date: April 2002
Estimated Study Completion Date: March 2004
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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00155532     History of Changes
Other Study ID Numbers: 9261700704
Study First Received: September 9, 2005
Last Updated: September 9, 2005
Health Authority: Taiwan: Department of Health

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

ClinicalTrials.gov processed this record on May 23, 2013