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Safety Study to Evaluate the Cumulative Irritation Potential of Topically Applied ZuraPrep™ and ZuraPrep™ Without IPA

NCT02160574 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2014-10-27

No results posted yet for this study

Summary

This is a safety study to determine the cumulative skin irritation potential of ZuraPrep™ and ZuraPrep™ without Isopropyl Alcohol after repetitive patch applications to skin of human subjects.

Conditions

  • Surgical Site Infection

Interventions

DRUG

ChloraPrep

The degree of skin irritation caused by ChloraPrep will be graded and compared to ZuraPrep and ZuraPrep without IPA.

DRUG

0.1% Sodium Lauryl Sulfate

The degree of skin irritation caused by 0.1% Sodium Lauryl Sulfate will be graded and compared to ZuraPrep and ZuraPrep without IPA.

DRUG

0.9% Physiological Saline

The degree of skin irritation caused by 0.9% Physiological Saline will be graded and compared to ZuraPrep and ZuraPrep without IPA.

OTHER

ZuraPrep without IPA

Results from exposure to ZuraPrep will be compared statistically those from exposure to ZuraPrep without IPA

Sponsors & Collaborators

  • Zurex Pharma, Inc.

    lead INDUSTRY

Principal Investigators

  • Esther Campbell · BioScience Laboratories, Inc.

Study Design

Allocation
NA
Masking
DOUBLE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-06-30
Primary Completion
2014-09-30
Completion
2014-09-30

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 NCT02160574 on ClinicalTrials.gov