Ultraviolet Light Therapy for Systemic Lupus Erythematosus | NCT00004375

Studies
Ultraviolet Light Therapy for Systemic Lupus Erythematosus

NCT00004375

Sponsor

National Center for Research Resources (NCRR)

Status

Unknown status

Last Update Posted

Jun 24, 2005Estimated

Enrollment

Phase

Phase 2

Conditions

Systemic Lupus Erythematosus

Interventions

ultraviolet A-1 light treatment

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2004

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 1991

Primary Completion Date

Not provided

Completion Date

Not provided

First Submitted Date

Oct 18, 1999

First Submission Date that Met QC Criteria

Oct 18, 1999

First Posted Date

Oct 19, 1999Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 23, 2005

Last Update Posted Date

Jun 24, 2005Estimated

Name	Class
Louisiana State University Health Sciences Center in New Orleans	OTHER

Description Module

Brief Summary

OBJECTIVES:

I. 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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

Name	Type	Description	Arm Group Labels	Other Names
ultraviolet A-1 light treatment	Procedure

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

15 Years

Maximum Age

70 Years

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Hugh McGrath, Jr.	Louisiana State University Health Sciences Center in New Orleans	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
General Clinical Research Center and Charity Hospital (University of Louisiana)	Recruiting	New Orleans	Louisiana	70112-2822	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
8869897	Background	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.

ID	Term
D008180	Lupus Erythematosus, Systemic
D001168	Arthritis
D003240	Connective Tissue Diseases
D007154	Immune System Diseases
D003141	Communicable Diseases
D035583	Rare Diseases

ID	Term
D017437	Skin and Connective Tissue Diseases
D001327	Autoimmune Diseases
D007592	Joint Diseases
D009140	Musculoskeletal Diseases

ID	Type	Description	Link
LSUMC-1765
LSUMC-910067