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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 October 2017 |
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Main ID: |
NCT01597050 |
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Date of registration:
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09/05/2012 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Safety and Efficacy of Topical R333 in Patients With Discoid Lupus Erythematosus (DLE) and Systemic Lupus Erythematosus (SLE) Lesions
SKINDLE |
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Scientific title:
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A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Study to Evaluate the Efficacy and Safety of R333 6% Ointment Administered Topically to Discoid Lupus Erythematosus (DLE) and Systemic Lupus Erythematosus (SLE) Patients With Active Cutaneous Discoid Lesions |
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Date of first enrolment:
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August 2012 |
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Target sample size:
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54 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT01597050 |
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Study type:
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Interventional |
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Study design:
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Phase:
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Phase 2
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Countries of recruitment
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Canada
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United States
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Contacts
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Name:
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Daniel Magilavy, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Rigel Pharmaceuticals, Inc. |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Diagnosis of SLE or DLE (DLE confirmed histologically prior to randomization).
- 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:
- Congenital or acquired immunodeficiency including: HIV infection, agammaglobulinemias,
T cell deficiencies or HTLV-1 infection at any time prior to the study.
- 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.
Age minimum:
18 Years
Age maximum:
75 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Lupus Erythematosus, Systemic
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Lupus Erythematosus, Discoid
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Intervention(s)
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Drug: R932333
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Drug: Placebo
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Primary Outcome(s)
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Decrease in the Total Combined Erythema and Scaling Score (Minimum of 0 and Maximum of 65) of All Treated Lesions.
[Time Frame: Up to Week 4]
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Secondary ID(s)
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C-932333-002
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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