Status:
COMPLETED
Evaluate the Effect of Elimune Capsules
Lead Sponsor:
Elorac, Inc.
Conditions:
Plaque Psoriasis
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief 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 s...
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 ...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
September 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2015
Estimated Enrollment :
21 Patients enrolled
Trial Details
Trial ID
NCT02251678
Start Date
September 1 2014
End Date
February 1 2015
Last Update
December 8 2015
Active Locations (4)
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1
NMFF Dermatology Clinic
Chicago, Illinois, United States, 60611
2
NM Lake Forest Hospital/ Women's Center
Lake Forest, Illinois, United States, 60045
3
TKL Research
Fair Lawn, New Jersey, United States, 07410
4
University Hospitals Case Medical Center / Dept of Dermatology
Cleveland, Ohio, United States, 44106