Safety Study to Evaluate the Contact Sensitizing Potential of Topically Applied ZuraPrep™ and ZuraPrep™ Without IPA
|ClinicalTrials.gov Identifier: NCT02160587|
Recruitment Status : Completed
First Posted : June 10, 2014
Last Update Posted : March 17, 2015
|Condition or disease||Intervention/treatment||Phase|
|Surgical Site Infection||Drug: Chloraprep Drug: 0.9% Physiological Saline Other: ZuraPrep without IPA||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||208 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||Double (Participant, Outcomes Assessor)|
|Official Title:||A Clinical Evaluation of the Contact Sensitizing Potential of Topically Applied ZuraPrep™ and ZuraPrep™ Without IPA in Healthy Adult Volunteers|
|Study Start Date :||July 2014|
|Actual Primary Completion Date :||October 2014|
|Actual Study Completion Date :||October 2014|
Active Comparator: ZuraPrep
Irritation scores of the following applied to test sites will be compared: ZuraPrep, ZuraPrep without IPA, ChloraPrep, and 0.9% Physiological Saline.
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 Name: Negative Control
Other: ZuraPrep without IPA
ZuraPrep without IPA will be compared to ZuraPrep with regard to skin sensitization and irritation
Other Name: ZuraPrep without Isopropyl Alcohol (IPA)
- Skin sites evaluated and graded for irritancy or sensitization [ Time Frame: 0-40 days post dose ]Only frank sensitization will be categorized, as a positive control (known sensitizing agent) is prohibitive due to ethical considerations/risk of life-time sensitization. Reactions observed will be assessed as to whether indicative of sensitization or of irritation.
- Statistics of irritation scores [ Time Frame: 0-40 days post dose ]Irritation scores, relative to the Test Products, Reference Product, and the Negative Control applied to skin on each test day will be compared as well as the total cumulative irritation scores across all test days.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02160587
|United States, Montana|
|BioScience Laboratories, Inc.|
|Bozeman, Montana, United States, 59718|
|Principal Investigator:||Maggie Butler, PhD||BioScience Laboratories, Inc.|