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Completed

NCT Number: NCT00155532

Skin Denervation in Systemic Lupus Erythematosus

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

Completed

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Departments of Neurology, National Taiwan University Hospital

Taipei, Taiwan

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

3 mm-punch biopsies of the skin

Procedure

Primary outcomes

  1. Quantitation of epidermal innervation

Sponsors and collaborators

Lead sponsor

National Taiwan University Hospital

Other

Registry information

Important dates

Study start
2002
Study completion
2004
First posted
Sep 12, 2005
Registry last updated
Sep 12, 2005

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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