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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Masking
DOUBLE
Enrollment
208
ChloraPrep will be compared to ZuraPrep with regard to skin sensitization and irritation.
0.9% Physiological Saline will be compared to ZuraPrep with regard to skin sensitization and irritation.
ZuraPrep without IPA will be compared to ZuraPrep with regard to skin sensitization and irritation
BioScience Laboratories, Inc.
Bozeman, Montana, United States
Skin sites evaluated and graded for irritancy or sensitization
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.
Time frame: 0-40 days post dose
Statistics of irritation scores
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.
Time frame: 0-40 days post dose
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