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Safety Study to Evaluate the Contact Sensitizing Potential of Topically Applied ZuraPrep™ and ZuraPrep™ Without IPA

NCT02160587 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 208

Last updated 2015-03-17

No results posted yet for this study

Summary

This is a safety study to determine the skin sensitization potential of ZuraPrep™ and ZuraPrep™ without isopropyl alcohol (IPA) after repetitive patch applications to skin of human subjects. Indications of both sensitization and skin irritation will be evaluated.

Conditions

  • Surgical Site Infection

Interventions

DRUG

Chloraprep

ChloraPrep will be compared to ZuraPrep with regard to skin sensitization and irritation.

DRUG

0.9% Physiological Saline

0.9% Physiological Saline will be compared to ZuraPrep with regard to skin sensitization and irritation.

OTHER

ZuraPrep without IPA

ZuraPrep without IPA will be compared to ZuraPrep with regard to skin sensitization and irritation

Sponsors & Collaborators

  • Zurex Pharma, Inc.

    lead INDUSTRY

Principal Investigators

  • Maggie Butler, PhD · 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
2014-07-31
Primary Completion
2014-10-31
Completion
2014-10-31

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 NCT02160587 on ClinicalTrials.gov