Evaluate the Effect of Elimune Capsules

NCT02251678 | Completed Phase 1

• 1 other identifier: EL-1005-01-01
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 4

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).

Conditions

Plaque Psoriasis

Keywords

Plaque; Psoriasis; Biomarkers; CRP; αTNF; Interleuken

Outcome Measures

Primary Outcomes (1)

• Individual subject serum levels of biomarkers

  C-reactive protein (CRP), Tumor Necrosis Factor (αTNF), Interleuken-2 (IL-2), Interleuken-6 (IL-6), and Interleuken-12 (IL-12)

  28 Days

Secondary Outcomes (2)

• Physician's Evaluation of Plaque Severity

  28 Days

• Physician's Evaluation of Arthritis Severity

  28 Days

Study Arms (1)

Elimune capsules

EXPERIMENTAL

Elimune capsules 2 capsules BID (four total capsules per day)

Dietary Supplement: Elimune Capsules

Interventions

Elimune Capsules DIETARY_SUPPLEMENT

2 capsules BID for 28 days

Elimune capsules

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Elorac, Inc.: lead

Study Sites (4)

NMFF Dermatology Clinic

Chicago, Illinois, 60611, United States

Location

NM Lake Forest Hospital/ Women's Center

Lake Forest, Illinois, 60045, United States

Location

TKL Research

Fair Lawn, New Jersey, 07410, United States

Location

University Hospitals Case Medical Center / Dept of Dermatology

Cleveland, Ohio, 44106, United States

Location

MeSH Terms

Conditions

Plaque, Amyloid; Psoriasis

Condition Hierarchy (Ancestors)

Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Scott B. Phillips, MD

  Elorac, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 25, 2014
• First Posted: September 29, 2014
• Study Start: September 1, 2014
• Primary Completion: February 1, 2015
• Study Completion: February 1, 2015
• Last Updated: December 8, 2015

Record last verified: 2015-02

Locations

US (4)