Skin Denervation in Systemic Lupus Erythematosus

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-04-30

Study Completion Date

2004-03-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Systemic Lupus Erythematosus

Keywords

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Peripheral neuropathy;systemic lupus erythematosus

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Interventions

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3 mm-punch biopsies of the skin

Intervention Type PROCEDURE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

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Sung-Tsang Hsieh, MD, PhD

Role: STUDY_DIRECTOR

Department of Neurology, National Taiwan University Hospital, 7 Chung-Shan S Rd., Taipei 100, Taiwan

Locations

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Departments of Neurology, National Taiwan University Hospital

Taipei, , Taiwan

Site Status

Countries

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Taiwan

Other Identifiers

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9261700704

Identifier Type: -

Identifier Source: org_study_id