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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
Sponsor:
Information provided by (Responsible Party):
Elorac, Inc.

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 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

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 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.

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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Psoriasis

Arm Intervention/treatment
Experimental: Elimune capsules
Elimune capsules 2 capsules BID (four total capsules per day)
Dietary Supplement: Elimune Capsules
2 capsules BID for 28 days




Primary Outcome Measures :
  1. 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)


Secondary Outcome Measures :
  1. 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).

  2. 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).



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

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


Locations
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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
TKL Research
Fair Lawn, New Jersey, United States, 07410
United States, Ohio
University Hospitals Case Medical Center / Dept of Dermatology
Cleveland, Ohio, United States, 44106
Sponsors and Collaborators
Elorac, Inc.
Investigators
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Study Director: Scott B. Phillips, MD Elorac, Inc.

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Responsible Party: Elorac, Inc.
ClinicalTrials.gov Identifier: NCT02251678     History of Changes
Other Study ID Numbers: EL-1005-01-01
First Posted: September 29, 2014    Key Record Dates
Last Update Posted: December 8, 2015
Last Verified: February 2015
Keywords provided by Elorac, Inc.:
Plaque
Psoriasis
Biomarkers
CRP
αTNF
Interleuken
Additional relevant MeSH terms:
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Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases