Safety and Efficacy of Topical R333 in Patients With Discoid Lupus Erythematosus (DLE) and Systemic Lupus Erythematosus (SLE) Lesions
NCT ID: NCT01597050
Last Updated: 2016-07-14
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
54 participants
INTERVENTIONAL
2012-08-31
2013-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Drug: R932333
R333 6% (60 mg/g), bid
R932333
R393233 6% (60 mg/g), bid
Placebo
Placebo, bid
Placebo
Placebo, bid
Interventions
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R932333
R393233 6% (60 mg/g), bid
Placebo
Placebo, bid
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* At least 2 active discoid lesions secondary to SLE or DLE prior to study entry, each with a minimum Erythema Rating Score of ≥ 2. At least 1 of the active discoid lesions must have been present (by history) for ≥ 3 weeks prior to screening.
* Patients who are taking azathioprine, hydroxychloroquine, chloroquine, quinacrine, methotrexate, and/ or oral glucocorticoids, must be receiving a stable daily dose ≥ 4 weeks prior to randomization and must remain on the same dose throughout the study. Azathioprine, hydroxychloroquine, chloroquine, quinacrine, or methotrexate must be initiated ≥ 8 weeks prior to randomization.
Exclusion Criteria
* Lymphoproliferative disease or previous total lymphoid irradiation.
* Uncontrolled or poorly controlled hypertension.
* History of psoriasis, eczema, or relevant atopy.
* Exposure to excessive or chronic UV radiation (e.g., tanning beds, sunbathing, solarium, phototherapy) within 2 weeks prior to randomization or during the study period.
18 Years
75 Years
ALL
No
Sponsors
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Rigel Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Daniel Magilavy, MD
Role: STUDY_DIRECTOR
Rigel Pharmaceuticals,Inc.
Locations
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Wallace Rheumatic Study Center
Los Angeles, California, United States
Stanford Dermatology
Redwood City, California, United States
Memorial Medical Group Clinical Research Institute
South Bend, Indiana, United States
North Shore Long Island Health System
Lake Success, New York, United States
Columbia University Medical Center
New York, New York, United States
Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States
Oklahoma Medical Research Foundation
Oklahoma City, Oklahoma, United States
University of Pennsylvania-Dermatology Research Office
Philadelphia, Pennsylvania, United States
Metroplex Clinical Research Center
Dallas, Texas, United States
University of Texas Medical School at Houston
Houston, Texas, United States
University of Utah Department of Dermatology
Salt Lake City, Utah, United States
Virginia Clinical Research, Inc
Norfolk, Virginia, United States
University of British Columbia, Vancouver Dermatology Clinical Trials Unit
Vancouver, British Columbia, Canada
Dermadvances Research
Winnipeg, Manitoba, Canada
Lynderm Research, Inc
Markham, Ontario, Canada
Countries
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References
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Hannon CW, McCourt C, Lima HC, Chen S, Bennett C. Interventions for cutaneous disease in systemic lupus erythematosus. Cochrane Database Syst Rev. 2021 Mar 9;3(3):CD007478. doi: 10.1002/14651858.CD007478.pub2.
Other Identifiers
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C-932333-002
Identifier Type: -
Identifier Source: org_study_id
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