Systemic Lupus ErythematosusPhase 1NCT00155532
Skin Denervation in Systemic Lupus Erythematosus
A Phase 1 study testing 3 mm-punch biopsies of the skin in people with Systemic Lupus Erythematosus, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
To address the issues of skin denervation and its clinical and pathological correlations in systemic lupus erythematosus Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Systemic Lupus Erythematosus
- What is being tested?
- 3 mm-punch biopsies of the skin
- Type of treatment
- Surgery or procedure
- How many people
- 40 participants
- Where
- 1 siteTaiwan
- Study dates
- Apr 2002to Mar 2004
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Adult, Older adult
Who may be able to join
- Diagnosis of systemic lupus erythematosus based on the consensus criteria
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site
Departments of Neurology, National Taiwan University Hospital
Taipei
About this study
To address the issues of skin denervation and its clinical and pathological correlations in systemic lupus erythematosus
Read the 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.
- Conditions
- Systemic Lupus Erythematosus
- Being tested
- 3 mm-punch biopsies of the skin
- Keywords
- Peripheral neuropathy;systemic lupus erythematosus
- Medical subject headings
- Lupus Erythematosus, Systemic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3 mm-punch biopsies of the skinProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Quantitation of epidermal innervation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2005 (estimated)
- Study startApr 2002
- Study completionMar 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Systemic Lupus ErythematosusStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Sung-Tsang Hsieh, MD, PhD, Study director, Department of Neurology, National Taiwan University Hospital, 7 Chung-Shan S Rd., Taipei 100, Taiwan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00155532
- Sponsor's protocol ID
- 9261700704
- Status last verified
- Jun 2005
- First submitted
- 9 Sep 2005
- Last updated
- 12 Sep 2005
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Skin Denervation in Systemic Lupus Erythematosus
- ClinicalTrials.gov ID
- NCT00155532
- Acronym / sponsor ID
- 9261700704
- Conditions
- Systemic Lupus Erythematosus
- Keywords
- Peripheral neuropathy;systemic lupus erythematosus
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- Apr 2002
- Study completion
- Mar 2004
- First posted
- 12 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To address the issues of skin denervation and its clinical and pathological correlations in systemic lupus erythematosus
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 design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Diagnosis of systemic lupus erythematosus based on the consensus criteria
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 3 mm-punch biopsies of the skin | Procedure or surgery | – |
Primary outcome
Quantitation of epidermal innervation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Sep 2005.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sung-Tsang Hsieh, MD, PhD study director
Department of Neurology, National Taiwan University Hospital, 7 Chung-Shan S Rd., Taipei 100, Taiwan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing 3 mm-punch biopsies of the skin in people with Systemic Lupus Erythematosus, run by National Taiwan University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Sep 2005. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quantitation of epidermal innervation. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Sep 2005.