A Study of Skin and Systemic Biomarkers In Patients With Active Cutaneous Lupus Erythematosus And… (NCT02034344) | Clinical Trial Compass
CompletedNot Applicable
A Study of Skin and Systemic Biomarkers In Patients With Active Cutaneous Lupus Erythematosus And In Healthy Volunteers
United States77 participantsStarted 2013-10
Plain-language summary
The purpose of this study is to obtain skin, blood, and urine samples from patients with active cutaneous lupus lesions and from healthy participants.
Who can participate
Age range18 Years – 70 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Have Discoid Lupus Erythematosus (DLE) or Subacute Cutaneous Lupus Erythematosus (SCLE) with or without a diagnosis of Systemic Lupus Erythematosus (SLE)
* Active DLE or active SCLE confirmed by histological analysis (for participants with DLE or SCLE without SLE)
* Confirmed diagnosis of SLE using American College of Rheumatology criteria and has current or historical positive antinuclear antibodies (ANA) or anti double-stranded deoxyribonucleic acid (anti-dsDNA) (for participants with DLE or SCLE with SLE)
* An active skin lesion that can be biopsied (for participants with lupus erythematosus)
Exclusion Criteria:
* Known or thought to have a diagnosis of drug-induced lupus
* An active skin disease that is not a manifestation of lupus erythematosus
* Has an acute cutaneous lupus erythematosus rash only
* If taking anti-malarial therapy has not been on a stable dose for at least 8 weeks before Day 1
* Participants treated with greater than 10mg/day of prednisone therapy or equivalent in the last 4 weeks prior to Day 1
* Positive serology for human immunodeficiency virus antibody, hepatitis B virus, or hepatitis C virus
What they're measuring
1
The concentration of individual serum biomarkers
Timeframe: Day 1 (for healthy participants); Day 1 and Day 84 (for participants with lupus erythematosus)