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

A Safety Study to Assess the Allergy Potential of Omeza Collagen Matrix in Human Subjects Using the Skin Prick Method

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

Study Overview

• Status: Completed
• Conditions: Allergic Reaction
• Intervention / Treatment: Device: Test Article; Other: Positive Control; Other: Negative Control

• Study Type: Interventional
• Enrollment (Actual): 25
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Saint Petersburg, Florida, United States, 33702
      • PCR Corp

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Test article	Device: Test Article; Omeza Collagen Matrix
Active Comparator: Histamine Positive Skin Test Control	Other: Positive Control; 1.0 mg/mL Histamine Base
Placebo Comparator: Aqueous Negative Control	Other: Negative Control; Aqueous Negative Control

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Allergic Reaction	Latent reaction to skin prick (safety assessment)	60 minutes

Collaborators and Investigators

• Sponsor: Omeza, LLC
• Investigators: Principal Investigator: Lynne Ellis, M.D., PCR Corp

Publications and helpful links

Helpful Links

• Allergy Diagnostic Testing: An Updated Practice Parameter

Study record dates

Study Major Dates

• Study Start (Actual): November 14, 2019
• Primary Completion (Actual): November 14, 2019
• Study Completion (Actual): November 14, 2019

Study Registration Dates

• First Submitted: August 10, 2020
• First Submitted That Met QC Criteria: August 10, 2020
• First Posted (Actual): August 12, 2020

Study Record Updates

• Last Update Posted (Actual): August 12, 2020
• Last Update Submitted That Met QC Criteria: August 10, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Hypersensitivity
• Other Study ID Numbers: OMZPRI1F

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No