NCT02251678

Evaluate the Effect of Elimune Capsules

Open-Label Study to Evaluate the Effect of Elimune Capsules on Biomarkers in Patients With Plaque Psoriasis

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 21 (actual)
• Sponsor: Elorac, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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).

Detailed description

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.

Conditions

• Plaque Psoriasis

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Elimune Capsules	2 capsules BID for 28 days

Timeline

• Start date: 2014-09-01
• Primary completion: 2015-02-01
• Completion: 2015-02-01
• First posted: 2014-09-29
• Last updated: 2015-12-08

Locations

4 sites across 1 country: United States