Allergy Potential of Omeza Collagen Matrix in Human Subjects Using the Skin Prick Method

Inclusion criteria

• Healthy volunteers aged 18 years of age and older as demonstrated by selfreported medical history, concurrent medication, and a brief dermal skin assessment of the test sites;
• Fully informed of the risks of entering the study and willing to provide written informed consent and HIPAA authorization to disclose protected health information;
• Subject has normal healthy skin on the either volar forearm.

Exclusion criteria

Subjects must be excluded if any of the following conditions exist:

• Self-reported pregnant or nursing at the screening visit;
• Clinically significant skin disease which may contraindicate participation, including psoriasis, eczema, atopic dermatitis, and active cancer;
• History of drug abuse or current drug user;
• Treatment with antihistamine or steroid (any route) administered within the last 7 days;
• History of anaphylaxis to matrix ingredients (e.g. fish, palm oil, hemp oil, beeswax);
• Persistent severe/ unstable asthma;
• Subjects on beta blockers and/or ACE inhibitors;
• Medical condition which in the opinion of the Investigator would compromise the safety of the subject or confound study results (Subjects with the following conditions: chronic renal failure, CVA, cancer, spinal cord injury, diabetic neuropathy, recent anaphylaxis, limbs affected by lymphoedema, paralysis, or neurogenic abnormalities;
• Diabetic (type 1 or 2);
• Subjects taking the following: Antidepressants such as doxepin, other tricyclics, Phenothiazines, and tetracyclics within the last two weeks;
• Subjects taking OTC cold and flu remedies, "sinus" analgesics, antitussives, antiemetics, sedatives, relaxants, migraine prophylactics (cyproheptadine, pizotifen);
• Prolonged use of topical corticosteroids;
• Use of topical moisturizers on the volar forearms;
• Dermographism "writing on the skin" - common localized hive reaction, characterized by the abrupt onset of welts and hives where the skin is exposed to pressure, scratching, itching, or stroking;
• Investigator deems the subject an unsuitable candidate for this study.