Optimization of Clinical Trial Design in Cutaneous Lupus

In the past, clinical trials on cutaneous lupus erythematosus (CLE) have not used patient-reported outcome measures to evaluate treatment efficacy; however, recent studies with small numbers of patients with CLE have compared questionnaires before and after treatment. Overall, there is little data available on changes in patient-reported outcome measures in patients with CLE on treatments. Establishing changes in patient-reported outcome measure scores will provide benchmarks for treatment efficacy endpoints in CLE clinical trials. Patients with CLE who are 18 years old and over and with demonstrable lesions will be recruited. Subjects' medical history, current therapies/medications, results of patient and physician questionnaires and other information obtained from subjects' medical records will be evaluated. Photographs of lesional and non-lesional skin will be take at all visits. The photographs will be de-identified and they will not include identifiable features (tattoo markings, etc.). De-identified clinical data (age, gender, medications, skin classification, scoring by the CLASI clinical tool, etc.) will be collected with the photographs. For the optional sub-study, the biological samples (blood/biopsy) may be stored for unspecified, exploratory biomarker analysis, including genetic analysis. A unique identification number will be assigned to each subject, and his/her questionnaire data. These numbers will be used throughout all data analysis and presentation of results.