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 I

Further Study Details: 

Primary Outcomes: Quantitation of epidermal innervation
Expected Total Enrollment:  40

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.

Ages Eligible for Study:  18 Years   -   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.

Taiwan
      Departments of Neurology, National Taiwan University Hospital, Taipei,  Taiwan

Study chairs or principal investigators

Sung-Tsang Hsieh, MD, PhD,  Study Director,  Department of Neurology, National Taiwan University Hospital, 7 Chung-Shan S Rd., Taipei 100, Taiwan   

Study ID Numbers:  9261700704
Last Updated:  September 9, 2005
Record first received:  September 9, 2005
ClinicalTrials.gov Identifier:  NCT00155532
Health Authority: Taiwan: Department of Health
ClinicalTrials.gov processed this record on 2005-09-13