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

NCT04510376 | Completed FDA Device

• 1 other identifier: OMZPRI1F
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Allergic Reaction

  60 minutes

Study Arms (3)

Test article

EXPERIMENTAL

Device: Test Article

Histamine Positive Skin Test Control

ACTIVE COMPARATOR

Other: Positive Control

Aqueous Negative Control

PLACEBO COMPARATOR

Other: Negative Control

Interventions

Test Article DEVICE

Omeza Collagen Matrix

Test article

Positive Control OTHER

1.0 mg/mL Histamine Base

Histamine Positive Skin Test Control

Negative Control OTHER

Aqueous Negative Control

Aqueous Negative Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;
• Fully informed of the risks of entering the study and willing to provide written informed consent and HIPAA authorization to disclose protected health information;
• Subject has normal healthy skin on the either volar forearm.

You may not qualify if:

• Subjects must be excluded if any of the following conditions exist:
• Self-reported pregnant or nursing at the screening visit;
• Clinically significant skin disease which may contraindicate participation, including psoriasis, eczema, atopic dermatitis, and active cancer;
• History of drug abuse or current drug user;
• Treatment with antihistamine or steroid (any route) administered within the last 7 days;
• History of anaphylaxis to matrix ingredients (e.g. fish, palm oil, hemp oil, beeswax);
• Persistent severe/ unstable asthma;
• Subjects on beta blockers and/or ACE inhibitors;
• 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;
• Diabetic (type 1 or 2);
• Subjects taking the following: Antidepressants such as doxepin, other tricyclics, Phenothiazines, and tetracyclics within the last two weeks;
• Subjects taking OTC cold and flu remedies, "sinus" analgesics, antitussives, antiemetics, sedatives, relaxants, migraine prophylactics (cyproheptadine, pizotifen);
• Prolonged use of topical corticosteroids;
• Use of topical moisturizers on the volar forearms;
• 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;

Sponsors & Collaborators

• Omeza, LLC: lead

Study Sites (1)

PCR Corp

St. Petersburg, Florida, 33702, United States

Location

Related Links

• Allergy Diagnostic Testing: An Updated Practice Parameter

MeSH Terms

Conditions

Hypersensitivity

Condition Hierarchy (Ancestors)

Immune System Diseases

Study Officials

• Lynne Ellis, M.D.

  PCR Corp

  PRINCIPAL INVESTIGATOR

• Lori Decaro

  PCR Corp

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 10, 2020
• First Posted: August 12, 2020
• Study Start: November 14, 2019
• Primary Completion: November 14, 2019
• Study Completion: November 14, 2019
• Last Updated: August 12, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)