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

NCT ID: NCT04510376

Last Updated: 2020-08-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-11-14
• Study Completion Date: 2019-11-14

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

Conditions

Allergic Reaction

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Test article

Group Type: EXPERIMENTAL

Test Article

Intervention Type: DEVICE

Omeza Collagen Matrix

Histamine Positive Skin Test Control

Group Type: ACTIVE_COMPARATOR

Positive Control

Intervention Type: OTHER

1.0 mg/mL Histamine Base

Aqueous Negative Control

Group Type: PLACEBO_COMPARATOR

Negative Control

Intervention Type: OTHER

Aqueous Negative Control

Interventions

Test Article

Omeza Collagen Matrix

Intervention Type: DEVICE

Positive Control

1.0 mg/mL Histamine Base

Intervention Type: OTHER

Negative Control

Aqueous Negative Control

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Omeza, LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Lynne Ellis, M.D.

Role: PRINCIPAL_INVESTIGATOR

PCR Corp

Lori Decaro

Role: STUDY_DIRECTOR

PCR Corp

Locations

PCR Corp

St. Petersburg, Florida, United States

Countries

United States

Related Links

https://www.aaaai.org/Aaaai/media/MediaLibrary/PDF%20Documents/Practice%20and%20Parameters/allergydiagnostictesting.pdf

Allergy Diagnostic Testing: An Updated Practice Parameter

Other Identifiers

OMZPRI1F

Identifier Type: -

Identifier Source: org_study_id