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

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04510376
• Other study ID #: OMZPRI1F
• Status: Completed
• Phase: N/A
• Start date: November 14, 2019
• Est. completion date: November 14, 2019

Study information

• Verified date: August 2020
• Source: Omeza, LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• 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.

Related Conditions & MeSH terms

• Allergic Reaction
• Hypersensitivity

Intervention

Device:
• Test Article
Omeza Collagen Matrix

Other:
• Positive Control
1.0 mg/mL Histamine Base
• Negative Control
Aqueous Negative Control

Locations

Country	Name	City	State
United States	PCR Corp	Saint Petersburg	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Omeza, LLC

Country where clinical trial is conducted

United States, 

Outcome

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

External Links

•   Allergy Diagnostic Testing: An Updated Practice Parameter