Evaluate the Effect of Elimune Capsules



Status:Completed
Conditions:Psoriasis
Therapuetic Areas:Dermatology / Plastic Surgery
Healthy:No
Age Range:18 - Any
Updated:4/21/2016
Start Date:September 2014
End Date:February 2015

Use our guide to learn which trials are right for you!

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.

Inclusion Criteria:

1. Subject voluntarily agrees to participate in this study and signs an IRB-approved
informed consent prior to performing any of the screening procedures.

2. Males and females at least 18 years of age.

3. Except for plaque psoriasis with or without arthritis, subject is in generally good
health.

4. Subject exhibits acutely active at least moderate to severe plaque-type psoriasis (>
5% BSA) with or without arthritis.

5. 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.

6. Non-smokers (or other nicotine use) as determined by history (no nicotine use over
the past year).

7. Subject is willing and able to cooperate to the extent required by the protocol.

Exclusion Criteria:

1. Subject has known allergy or hypersensitivity to Vitamin D3, Folic Acid,
Nicotinamide, Eicosapentaenoic Acid, Doscosahexaenoic Acid, Quercetin, Curcumin,
Glycyrrhizin, and Hesperetin.

2. Subject has history of alcohol and/or illicit drug abuse.

3. Female subjects who are pregnant or breastfeeding.

4. History of use of any immunosuppressant products (e.g. Enbrel, Remicade, Humira)
within 12 months of Day 1.

5. Use of oral corticosteroids, methotrexate, cyclosporine, ultraviolet light, or
Soriatane for 90 Days prior to Day 1 and throughout the trial.

6. 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.

7. Use of an investigational drug within 90 days prior to Day 1.
We found this trial at
4
sites
Chicago, Illinois 60611
?
mi
from
Chicago, IL
Click here to add this to my saved trials
?
mi
from
Cleveland, OH
Click here to add this to my saved trials
Fair Lawn, New Jersey 07410
?
mi
from
Fair Lawn, NJ
Click here to add this to my saved trials
Lake Forest, Illinois 60045
?
mi
from
Lake Forest, IL
Click here to add this to my saved trials