Systemic Lupus ErythematosusPhase 2NCT00004375
Ultraviolet Light Therapy for Systemic Lupus Erythematosus
A Phase 2 study testing ultraviolet A-1 light treatment in people with Systemic Lupus Erythematosus, run by National Center for Research Resources (NCRR) at 2 sites in United States.
Trial summary
OBJECTIVES: I. Evaluate the mechanisms of ultraviolet A-1 light therapy in patients with systemic lupus erythematosus and normal controls. Read more about this study
- Who is it for?
- Ages 15 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Systemic Lupus Erythematosus
- What is being tested?
- ultraviolet A-1 light treatment
- Type of treatment
- Surgery or procedure
- How many people
- 20 participants
- Where
- 2 sitesUnited States
- Study dates
- Sep 1991to not given
- Phase
- Phase 2
- 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 15 to 70 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
PROTOCOL ENTRY CRITERIA:
--Disease Characteristics--
Patients ages 15 to 70 with symptomatic systemic lupus erythematosus meeting American Rheumatism Association criteria and normal controls
--Prior/Concurrent Therapy--
No requirement for tetracycline or other photosensitizing drugs
Trial locations and contacts
2 sites in 1 country.
United States2 sites, 2 recruiting
- Recruiting
General Clinical Research Center and Charity Hospital (University of Louisiana)
New Orleans, Louisiana, 70112-2822
Hugh McGrath, Jr., 504-568-4630, hmcgra@lsuhsc.edu
- Recruiting
Alton Ochsner Medical Foundation Hospital
New Orleans, Louisiana, 70121
Jawed Alam, 504-842-3314
About this study
OBJECTIVES:
- Evaluate the mechanisms of ultraviolet A-1 light therapy in patients with systemic lupus erythematosus and normal controls.
Read the detailed description
PROTOCOL OUTLINE:
Treatment with ultraviolet A-1 light is administered 5 days a week for 6 weeks, at the lowest dose or frequency required to maintain a response. The dose and frequency are progressively decreased over the next 9 weeks.
- Conditions
- Systemic Lupus Erythematosus
- Being tested
- ultraviolet A-1 light treatment
- Keywords
- arthritis & connective tissue diseases, immunologic disorders and infectious disorders, rare disease, systemic lupus erythematosus
- Medical subject headings
- Lupus Erythematosus, Systemic, Arthritis, Connective Tissue Diseases, Immune System Diseases, Communicable Diseases, Rare Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ultraviolet A-1 light treatmentProcedure or surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 1999 (estimated)
- Study startSep 1991
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Systemic Lupus ErythematosusStudies of the same condition, open and under way.
- 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 2
- Primary purpose
- Treatment
- Enrolment
- 20 participants
Sponsor and investigators
- Lead sponsor
- National Center for Research Resources (NCRR)
- Sponsor type
- US National Institutes of Health
- Collaborators
- Louisiana State University Health Sciences Center in New Orleans
- Investigators
- Hugh McGrath, Jr., Study chair, Louisiana State University Health Sciences Center in New Orleans
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00004375
- Sponsor's protocol ID
- NCRR-M01RR05096-0002
- Other IDs
- LSUMC-1765, LSUMC-910067
- Status last verified
- Jan 2004
- First submitted
- 18 Oct 1999
- Last updated
- 24 Jun 2005
- Results posted
- No
Publications
McGrath H, Martinez-Osuna P, Lee FA. Ultraviolet-A1 (340-400 nm) irradiation therapy in systemic lupus erythematosus. Lupus. 1996 Aug;5(4):269-74. doi: 10.1177/096120339600500405.
PubMed 8869897
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultraviolet Light Therapy for Systemic Lupus Erythematosus
- ClinicalTrials.gov ID
- NCT00004375
- Acronym / sponsor ID
- NCRR-M01RR05096-0002
- Conditions
- Systemic Lupus Erythematosus
- Keywords
- arthritis & connective tissue diseases, immunologic disorders and infectious disorders, rare disease, systemic lupus erythematosus
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants
- Lead sponsor
- National Center for Research Resources (NCRR)US National Institutes of Health
- Collaborators
- Louisiana State University Health Sciences Center in New Orleans
- Study start
- Sep 1991
- First posted
- 19 Oct 1999 (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.
OBJECTIVES:
- Evaluate the mechanisms of ultraviolet A-1 light therapy in patients with systemic lupus erythematosus and normal controls.
Detailed description
PROTOCOL OUTLINE:
Treatment with ultraviolet A-1 light is administered 5 days a week for 6 weeks, at the lowest dose or frequency required to maintain a response. The dose and frequency are progressively decreased over the next 9 weeks.
Study design
- Primary purpose
- Treatment
Who may qualify
- Ages
- 15 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
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 |
|---|---|---|
| ultraviolet A-1 light treatment | Procedure or surgery | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2005.
- Background: PubMed 8869897McGrath H, Martinez-Osuna P, Lee FA. Ultraviolet-A1 (340-400 nm) irradiation therapy in systemic lupus erythematosus. Lupus. 1996 Aug;5(4):269-74. doi: 10.1177/096120339600500405.
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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.
General Clinical Research Center and Charity Hospital (University of Louisiana)
New Orleans, United States
Hugh McGrath, Jr. study chair
Louisiana State University Health Sciences Center in New Orleans
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ultraviolet A-1 light treatment in people with Systemic Lupus Erythematosus, run by National Center for Research Resources (NCRR) at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: status not confirmed, as of the sponsor's last update on 24 Jun 2005. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00004375, which also lists 1 linked publication.
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 24 Jun 2005.