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Negative Control

Test Article (Omeza Collagen Matrix) for Erythema

N/A
Waitlist Available
Led By Lynne Ellis, MD
Research Sponsored by Omeza, LLC
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24, 48, 72, and 96 hours
Awards & highlights

Study 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.

Eligible Conditions
  • Erythema
  • Sensitization

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24, 48, 72, and 96 hours
This trial's timeline: 3 weeks for screening, Varies for treatment, and 24, 48, 72, and 96 hours for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Evidence of Erythema During the Challenge Phase for Omeza Collagen Matrix
Secondary outcome measures
Adverse Events Deemed Related to the Test Product or the Study

Trial Design

2Treatment groups
Experimental Treatment
Group I: Test Article (Omeza Collagen Matrix)Experimental Treatment1 Intervention
Repetitive and continuous patch applications of the test article to the same test sites on the back approximately 48 hours on weekdays and for approximately 72-hour periods over weekends over 3 weeks, for a total of 9 induction applications. During a subsequent challenge phase 10-17 days after the induction phase, the test article and negative control will be applied for 48 hours. Each subject will receive both the test article and negative control at the same time.
Group II: Negative Control (0.9% aqueous sodium chloride)Experimental Treatment1 Intervention
Repetitive and continuous patch applications of the negative control to the same test sites on the back approximately 48 hours on weekdays and for approximately 72-hour periods over weekends over 3 weeks, for a total of 9 induction applications. During a subsequent challenge phase 10-17 days after the induction phase, the test article and negative control will be applied for 48 hours. Each subject will receive both the test article and negative control at the same time.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Test Article
2019
N/A
~110

Find a Location

Who is running the clinical trial?

Omeza, LLCLead Sponsor
6 Previous Clinical Trials
360 Total Patients Enrolled
1 Trials studying Erythema
22 Patients Enrolled for Erythema
Lori DeCaroStudy DirectorPCR Corp
Lynne Ellis, MDPrincipal InvestigatorPCR Corp

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Irritation Potential of Omeza Collagen Matrix Using Modified HRIPT
2019. "Irritation Potential of Omeza Collagen Matrix Using Modified HRIPT". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04510675.
~11 spots leftby May 2025
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