Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 4:51 PM
Ignite Modification Date:
2025-12-24 @ 4:51 PM
NCT ID:
NCT01597050
Eligibility Criteria:
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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT01597050
Study Brief:
Protocol Section:
NCT01597050