A Phase 1 interventional study of Chloraprep and 0.9% Physiological Saline in Surgical Site Infection, sponsored by Zurex Pharma, Inc.. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-03-17.
Sponsored by Zurex Pharma, Inc. · Phase 1 and Interventional
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.
687 studies on the registry are indexed under Surgical Wound Infection; 142 are open to participants now.
This study's enrollment of 208 is close to the median of 200 across 526 interventional studies indexed under Surgical Wound Infection.
Browse Surgical Wound Infection studies →Zurex Pharma, Inc. is the lead sponsor of 9 studies on the registry; none are open to participants now.
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Exclusion Criteria:
Irritation scores of the following applied to test sites will be compared: ZuraPrep, ZuraPrep without IPA, ChloraPrep, and 0.9% Physiological Saline.
Drug: Chloraprep · Drug: 0.9% Physiological Saline · Other: ZuraPrep without IPA
ChloraPrep will be compared to ZuraPrep with regard to skin sensitization and irritation.
Also known as: Reference Product, 2% Chlorhexidine Gluconate and 70% IPA
0.9% Physiological Saline will be compared to ZuraPrep with regard to skin sensitization and irritation.
Also known as: Negative Control
ZuraPrep without IPA will be compared to ZuraPrep with regard to skin sensitization and irritation
Also known as: ZuraPrep without Isopropyl Alcohol (IPA)
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
This study is completed, as verified in Mar 2015. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Chlorhexidine/Ethyl Alcohol Mouthwash
Zurex Pharma, Inc.