NCT02160587

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

A Clinical Evaluation of the Contact Sensitizing Potential of Topically Applied ZuraPrep™ and ZuraPrep™ Without IPA in Healthy Adult Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 208 (actual)
• Sponsor: Zurex Pharma, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Detailed description

This study is designed to determine if the test product, ZuraPrep™ is a skin sensitizing agent when applied to human skin. The study, a modified Draize skin sensitization evaluation, will be conducted in three discrete phases: 1) induction, 2) rest, and 3) challenge. During the Induction Phase, skin sites are exposed to the test product repeatedly for 21 consecutive days. The Rest Phase, a 14-day period when no treatment is performed, serves to provide adequate time for the immune system to react to ZuraPrep™, given any of its components serve as antigens. During the Challenge Phase, the subjects' skin is re-exposed to the test product (ZuraPrep™) to determine if it is likely to be immunosensitizing.

Conditions

• Surgical Site Infection

Interventions

Type	Name	Description
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

Timeline

• Start date: 2014-07-01
• Primary completion: 2014-10-01
• Completion: 2014-10-01
• First posted: 2014-06-10
• Last updated: 2015-03-17

Locations

1 site across 1 country: United States