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

NCT04510376 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2020-08-12

No results posted yet for this study

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

Interventions

DEVICE

Test Article

Omeza Collagen Matrix

OTHER

Positive Control

1.0 mg/mL Histamine Base

OTHER

Negative Control

Aqueous Negative Control

Sponsors & Collaborators

  • Omeza, LLC

    lead INDUSTRY

Principal Investigators

  • Lynne Ellis, M.D. · PCR Corp

  • Lori Decaro · PCR Corp

Study Design

Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-11-14
Primary Completion
2019-11-14
Completion
2019-11-14
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04510376 on ClinicalTrials.gov