Plaque Psoriasis Clinical Trial
Official title:
Open-Label Study to Evaluate the Effect of Elimune Capsules on Biomarkers in Patients With Plaque Psoriasis
Elorac, Inc. is evaluating the effect of Elimune™ capsules on biomarkers C-reactive protein
(CRP), Tumor Necrosis Factor (αTNF), Interleuken-2 (IL-2), Interleuken-6 (IL-6),
Interleuken-12 (IL-12) in subjects with plaque psoriasis with or without arthritis.
Psoriasis is a chronic inflammatory skin disease with polygenic predisposition combined with
triggering factors such as trauma, inflammation or medication.
Elimune™ is a uniquely formulated prescription dietary supplement for oral administration.
Each capsule contains a proprietary blend of natural ingredients, Vitamin D3, Folic Acid,
Nicotinamide, Eicosapentaenoic Acid, Doscosahexaenoic Acid, Quercetin, Curcumin,
Glycyrrhizin, and Hesperetin, which share anti-inflammatory activities including the ability
to inhibit tumor necrosis factor-α (TNF-α).
This is an open-label study consisting of a 1 day Screening Period and a 28 day Treatment Period. During the Screening Period subjects will sign informed consent and eligibility will be determined by reviewing inclusion/exclusion criteria including history of plaque psoriasis. Demographics, medical history, medication history, height and weight will be recorded. A blood sample for pre-dose biomarker analysis will be collected. Subjects will take two Elimune capsules twice daily from Day 1 to Day 28. On Day 7 and Day 28 subjects will return to the site and provide a blood sample for biomarker analysis. Adverse events and concomitant medications will be recorded throughout the study. A Physician's Evaluation of Plaque Severity and Physician's Evaluation of Arthritis Severity will be performed on Day 1, Day 7, and Day 28. ;
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science
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