Allergic Reaction
Conditions
Brief summary
Single-center, monadic, one day study utilizing the skin prick method to assess the allergy potential of Omeza Collagen Matrix in Human Subjects
Interventions
DEVICETest Article
Omeza Collagen Matrix
OTHERPositive Control
1.0 mg/mL Histamine Base
OTHERNegative Control
Aqueous Negative Control
Sponsors
Omeza, LLC
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
1. 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; 2. Fully informed of the risks of entering the study and willing to provide written informed consent and HIPAA authorization to disclose protected health information; 3. Subject has normal healthy skin on the either volar forearm.
Exclusion criteria
Subjects must be excluded if any of the following conditions exist: 1. Self-reported pregnant or nursing at the screening visit; 2. Clinically significant skin disease which may contraindicate participation, including psoriasis, eczema, atopic dermatitis, and active cancer; 3. History of drug abuse or current drug user; 4. Treatment with antihistamine or steroid (any route) administered within the last 7 days; 5. History of anaphylaxis to matrix ingredients (e.g. fish, palm oil, hemp oil, beeswax); 6. Persistent severe/ unstable asthma; 7. Subjects on beta blockers and/or ACE inhibitors; 8. 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; 9. Diabetic (type 1 or 2); 10. Subjects taking the following: Antidepressants such as doxepin, other tricyclics, Phenothiazines, and tetracyclics within the last two weeks; 11. Subjects taking OTC cold and flu remedies, sinus analgesics, antitussives, antiemetics, sedatives, relaxants, migraine prophylactics (cyproheptadine, pizotifen); 12. Prolonged use of topical corticosteroids; 13. Use of topical moisturizers on the volar forearms; 14. 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; 15. Investigator deems the subject an unsuitable candidate for this study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Allergic Reaction | 20 minutes | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Allergic Reaction | 60 minutes | Latent reaction to skin prick (safety assessment) |
Countries
United States
Outcome results
None listed