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Irritation Potential of Omeza Collagen Matrix Using Modified HRIPT

NCT04510675 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 58

Last updated 2023-05-17

Study results available
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Summary

The primary objective of this study was to assess the sensitization potential of Omeza Collagen Matrix compared to that of a negative control based on a Modified Human Repeat Insult Patch Test.

Conditions

  • Erythema
  • Sensitisation

Interventions

DEVICE

Test Article

Omeza Collagen Matrix

OTHER

Negative Control

Occlusive Patch of 0.9% sodium chloride, NaCl

Sponsors & Collaborators

  • Omeza, LLC

    lead INDUSTRY

Principal Investigators

  • Lynne Ellis, MD · PCR Corp

  • Lori DeCaro · PCR Corp

Study Design

Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-12-02
Primary Completion
2020-01-11
Completion
2020-01-11
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 NCT04510675 on ClinicalTrials.gov