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

Not Applicable

Completed

• Conditions: Allergic Reaction
• Interventions: Device: Test Article; Other: Negative Control; Other: Positive Control

• Registration Number: NCT04510376
• Lead Sponsor: Omeza, LLC

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

Detailed Description

Not available

Study Timeline

• Study Start: 2019-11-14
• Primary Completion: 2019-11-14
• Study Completion: 2019-11-14
• Status Verified: 2020-08
• Study First Submitted: 2020-08-10
• Study First Submitted QC: 2020-08-10
• Last Update Submitted: 2020-08-10
• Study First Posted: 2020-08-12
• Last Update Posted: 2020-08-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Test article	Test Article	-
Aqueous Negative Control	Negative Control	-
Histamine Positive Skin Test Control	Positive Control	-

Primary Outcome Measures

Name	Time	Method
Allergic Reaction	20 minutes	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

Secondary Outcome Measures

Name	Time	Method
Allergic Reaction	60 minutes	Latent reaction to skin prick (safety assessment)

Trial Locations

Locations (1)

PCR Corp; 🇺🇸 Saint Petersburg, Florida, United States