Allergic Reaction Clinical Trial
Official title:
A Safety Study to Assess the Allergy Potential of Omeza Collagen Matrix in Human Subjects Using the Skin Prick Method
Verified date | August 2020 |
Source | Omeza, LLC |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Single-center, monadic, one day study utilizing the skin prick method to assess the allergy potential of Omeza Collagen Matrix in Human Subjects
Status | Completed |
Enrollment | 25 |
Est. completion date | November 14, 2019 |
Est. primary completion date | November 14, 2019 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
United States | PCR Corp | Saint Petersburg | Florida |
Lead Sponsor | Collaborator |
---|---|
Omeza, LLC |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Allergic Reaction | Latent reaction to skin prick (safety assessment) | 60 minutes |
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