A Non-drug Study Profiling Cutaneous Lupus (NCT01923415) | Clinical Trial Compass
CompletedNot Applicable
A Non-drug Study Profiling Cutaneous Lupus
United States, Poland29 participantsStarted 2013-04
Plain-language summary
The purpose of this study is to characterize the clinical and molecular profiles of patients with cutaneous lupus.
Who can participate
Age range18 Years – 70 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* have active DLE or active SCLE confirmed by histological analysis
* have a confirmed diagnosis of SLE with SLE Disease Activity Index (SLEDAI) of \>6 and current or historical positive ANA or anti-dsDNA
* have an active skin lesion that can be biopsied
* if using hydroxychloroquine or chloroquine, must be on stable doses for at least 2 months prior to screening.
Exclusion Criteria:
* have an active skin disease other than CLE
* have any known malignancy within the previous 5 years (with the exception of a non-melanoma skin cancer that has been treated with no evidence of recurrence)
* have used a topical corticosteroid on active lesion
* have donated blood (volume \>=500 mL) within 56 days prior to screening
* has been treated with drugs that are associated with CLE induction within 2 months prior to the screening
* have been treated with \>10 mg/day prednisone therapy or equivalent in the last 4 weeks prior to screening.