A Phase 1 interventional study of Elimune Capsules in Plaque Psoriasis, sponsored by Elorac, Inc.. Completed at 4 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-12-08.
Sponsored by Elorac, Inc. · Phase 1, Interventional, and Basic science
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.
1,899 studies on the registry are indexed under Psoriasis; 233 are open to participants now.
This study's enrollment of 21 is below the median of 70 across 1,447 interventional studies indexed under Psoriasis.
Browse Psoriasis studies →Elorac, Inc. is the lead sponsor of 3 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Elimune capsules 2 capsules BID (four total capsules per day)
Dietary Supplement: Elimune Capsules
2 capsules BID for 28 days
Individual subject serum levels of biomarkers
C-reactive protein (CRP), Tumor Necrosis Factor (αTNF), Interleuken-2 (IL-2), Interleuken-6 (IL-6), and Interleuken-12 (IL-12)
Time frame: 28 Days
Physician's Evaluation of Plaque Severity
Change in Physician's Evaluation of Plaque Severity from Baseline Period to Day 7 and the last day (Day 28).
Time frame: 28 Days
Physician's Evaluation of Arthritis Severity
Change in Physician's Evaluation of Arthritis Severity from Baseline Period to Day 7 and the last day (Day 28).
Time frame: 28 Days
This study is completed, as verified in Feb 2015. You cannot join it, but the record below documents what was studied.
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