Evaluate the Effect of Elimune Capsules

Completed · Phase 1

Conditions studied: Plaque Psoriasis

In brief

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).

Key facts

Study ID

NCT02251678

Run by

Elorac, Inc.

People needed

21

Starts

2014-09-01

Expected to finish

2015-02-01

Last updated by the study team

2015-12-08

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Subject voluntarily agrees to participate in this study and signs an IRB-approved informed consent prior to performing any of the screening procedures.
• Males and females at least 18 years of age.
• Except for plaque psoriasis with or without arthritis, subject is in generally good health.
• Subject exhibits acutely active at least moderate to severe plaque-type psoriasis (> 5% BSA) with or without arthritis.
• Non-pregnant, non-lactating females of childbearing potential who agree to use medically acceptable forms of birth control (abstinence, hormonal contraceptives, diaphragm with spermicide, condom with spermicide, or intrauterine device) throughout the study or females of non-childbearing potential (surgically sterile [hysterectomy or bilateral tubal ligation] or post-menopausal ≥ 1 year). A negative urine pregnancy test must be confirmed at screening for all female subjects who are not surgically sterile.
• Non-smokers (or other nicotine use) as determined by history (no nicotine use over the past year).
• Subject is willing and able to cooperate to the extent required by the protocol.

You may not qualify if…

• Subject has known allergy or hypersensitivity to Vitamin D3, Folic Acid, Nicotinamide, Eicosapentaenoic Acid, Doscosahexaenoic Acid, Quercetin, Curcumin, Glycyrrhizin, and Hesperetin.
• Subject has history of alcohol and/or illicit drug abuse.
• Female subjects who are pregnant or breastfeeding.
• History of use of any immunosuppressant products (e.g. Enbrel, Remicade, Humira) within 12 months of Day 1.
• Use of oral corticosteroids, methotrexate, cyclosporine, ultraviolet light, or Soriatane for 90 Days prior to Day 1 and throughout the trial.
• Use of over the counter (OTC) medications (including vitamins), prescription medications, or herbal remedies that have not been stable for 30 days prior to Day 1 or will not be stable throughout the study.
• Use of an investigational drug within 90 days prior to Day 1.

Where it is running

• NMFF Dermatology Clinic — Chicago, Illinois, United States
• NM Lake Forest Hospital/ Women's Center — Lake Forest, Illinois, United States
• TKL Research — Fair Lawn, New Jersey, United States
• University Hospitals Case Medical Center / Dept of Dermatology — Cleveland, Ohio, United States

Full record on ClinicalTrials.gov

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