Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
21 participants
INTERVENTIONAL
2014-09-30
2015-02-28
Brief Summary
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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
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Conditions
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Study Design
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NA
SINGLE_GROUP
BASIC_SCIENCE
NONE
Study Groups
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Elimune capsules
Elimune capsules 2 capsules BID (four total capsules per day)
Elimune Capsules
2 capsules BID for 28 days
Interventions
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Elimune Capsules
2 capsules BID for 28 days
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
ALL
No
Sponsors
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Elorac, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Scott B. Phillips, MD
Role: STUDY_DIRECTOR
Elorac, Inc.
Locations
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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
Countries
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Other Identifiers
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EL-1005-01-01
Identifier Type: -
Identifier Source: org_study_id