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

Study Overview
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Brief Summary
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Single-center, monadic, one day study utilizing the skin prick method to assess the allergy potential of Omeza Collagen Matrix in Human Subjects

Official Title
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A Safety Study to Assess the Allergy Potential of Omeza Collagen Matrix in Human Subjects Using the Skin Prick Method

Conditions
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Allergic Reaction

Intervention / Treatment
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* Device: Test Article
* Other: Positive Control
* Other: Negative Control


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Test article<br> | Device: Test Article<br>* Omeza Collagen Matrix<br>|
| Active Comparator: Histamine Positive Skin Test Control<br> | Other: Positive Control<br>* 1.0 mg/mL Histamine Base<br>|
| Placebo Comparator: Aqueous Negative Control<br> | Other: Negative Control<br>* Aqueous Negative Control<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Allergic Reaction | Response of at least 3-mm diameter (with equivalent erythema) more than negative control is required as proof of presence of cutaneous allergen specific IgE | 20 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Allergic Reaction | Latent reaction to skin prick (safety assessment) | 60 minutes |