Evaluate the Effect of Elimune Capsules
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|ClinicalTrials.gov Identifier: NCT02251678|
Recruitment Status : Completed
First Posted : September 29, 2014
Last Update Posted : December 8, 2015
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).
|Condition or disease||Intervention/treatment||Phase|
|Plaque Psoriasis||Dietary Supplement: Elimune Capsules||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||21 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Basic Science|
|Official Title:||Open-Label Study to Evaluate the Effect of Elimune Capsules on Biomarkers in Patients With Plaque Psoriasis|
|Study Start Date :||September 2014|
|Actual Primary Completion Date :||February 2015|
|Actual Study Completion Date :||February 2015|
Experimental: Elimune capsules
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 [ Time Frame: 28 Days ]C-reactive protein (CRP), Tumor Necrosis Factor (αTNF), Interleuken-2 (IL-2), Interleuken-6 (IL-6), and Interleuken-12 (IL-12)
- Physician's Evaluation of Plaque Severity [ Time Frame: 28 Days ]Change in Physician's Evaluation of Plaque Severity from Baseline Period to Day 7 and the last day (Day 28).
- Physician's Evaluation of Arthritis Severity [ Time Frame: 28 Days ]Change in Physician's Evaluation of Arthritis Severity from Baseline Period to Day 7 and the last day (Day 28).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02251678
|United States, Illinois|
|NMFF Dermatology Clinic|
|Chicago, Illinois, United States, 60611|
|NM Lake Forest Hospital/ Women's Center|
|Lake Forest, Illinois, United States, 60045|
|United States, New Jersey|
|Fair Lawn, New Jersey, United States, 07410|
|United States, Ohio|
|University Hospitals Case Medical Center / Dept of Dermatology|
|Cleveland, Ohio, United States, 44106|
|Study Director:||Scott B. Phillips, MD||Elorac, Inc.|