Clinical trial NCT04510376: Allergy Potential of Omeza Collagen Matrix in Human Subjects Using the Skin Prick Method
Official title: A Safety Study to Assess the Allergy Potential of Omeza Collagen Matrix in Human Subjects Using the Skin Prick Method
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Allergic Reaction
Lead sponsor: Omeza, LLC
Sponsor class: INDUSTRY
First posted: 2020-08-12
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

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 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.

Primary outcomes:
measure: Allergic Reaction
timeFrame: 20 minutes
Secondary outcomes:
measure: Allergic Reaction
timeFrame: 60 minutes
Other outcomes:
Locations:
city: Saint Petersburg
country: United States
facility: PCR Corp
state: Florida
Study officials:
affiliation: PCR Corp
name: Lynne Ellis, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: PCR Corp
name: Lori Decaro
role: STUDY_DIRECTOR
References: