Status:
COMPLETED
Allergy Potential of Omeza Collagen Matrix in Human Subjects Using the Skin Prick Method
Lead Sponsor:
Omeza, LLC
Conditions:
Allergic Reaction
Eligibility:
All Genders
18+ years
Phase:
NA
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
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 14 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 14 2019
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT04510376
Start Date
November 14 2019
End Date
November 14 2019
Last Update
August 12 2020
Active Locations (1)
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1
PCR Corp
St. Petersburg, Florida, United States, 33702