NCT02160574

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

A 21-Day Evaluation of the Cumulative Irritation Potential of Topically Applied ZuraPrep™ and ZuraPrep™ Without IPA in Healthy Adult Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Zurex Pharma, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Detailed description

This cumulative irritation evaluation is designed to determine the skin irritation potential of ZuraPrep™ and ZuraPrep™ without Isopropyl Alcohol (IPA) after repetitive patch application to skin of healthy human subjects.

Conditions

• Surgical Site Infection

Interventions

Type	Name	Description
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

Timeline

• Start date: 2014-06-01
• Primary completion: 2014-09-01
• Completion: 2014-09-01
• First posted: 2014-06-10
• Last updated: 2014-10-27

Locations

1 site across 1 country: United States