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

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.

• ChloraPrep (Drug), also known as Reference Product, 2% Chlorhexidine Gluconate and 70% IPA: The degree of skin irritation caused by ChloraPrep will be graded and compared to ZuraPrep and ZuraPrep without IPA.
• 0.1% Sodium Lauryl Sulfate (Drug), also known as Positive Control: The degree of skin irritation caused by 0.1% Sodium Lauryl Sulfate will be graded and compared to ZuraPrep and ZuraPrep without IPA.
• 0.9% Physiological Saline (Drug), also known as Negative Control: The degree of skin irritation caused by 0.9% Physiological Saline will be graded and compared to ZuraPrep and ZuraPrep without IPA.
• ZuraPrep without IPA (Other), also known as ZuraPrep without Isopropol Alcohol (IPA): Results from exposure to ZuraPrep will be compared statistically those from exposure to ZuraPrep without IPA

Primary outcomes

• Scoring Scale (0-7) for Visual Evaluation of Skin Condition [0-21 days post dose]: Results from skin scores of ZuraPrep and ZuraPrep without IPA will be compared statistically, and both will be compared to the Positive Control (0.1% Sodium Lauryl Sulfate).

Secondary outcomes

• Scoring Scale (0-7) for Visual Evaluation of Skin Condition [0-21 days post dose]: The degree of skin irritation caused by the Reference Product (ChloraPrep) and the Negative Control (0.9% Physiological Saline) will be graded.

Sex: All, ages: 18 Years to any, accepts healthy volunteers

Inclusion Criteria:

* Subjects may be of either sex, at least 18 years of age and of any race
* Subjects must be free of tattoos, sunburn, dermatoses, cuts, lesions or other disorders of the skin of the back.
* Subjects must be in good general health

Exclusion Criteria:

* Known allergies to latex, metals, tape and/or adhesives, soap, citric acid, methylene blue, methylparaben, propylparaben, chlorhexidine gluconate, isopropyl alcohol, and sodium lauryl sulfate.
* Exposure of the back region to antimicrobial agents, medicated soaps, medicated shampoos, medicated lotions, strong detergents, sun-tanning, use of tanning beds, or swimming or soaking in pools or hot tubs, in the 7 days prior to, or during the 3-week test period.
* Use of topical or systemic corticosteroid, antihistamine, or anti-inflammatory medications in the 7 days prior to, or during the 3-week test period.
* Current or recent severe illness such as asthma, diabetes, hepatitis, organ transplant, mitral valve prolapse, congenital heart disease, internal prostheses, or any immunocompromised condition such as AIDS or HIV positive.
* Pregnancy, plans to become pregnant, breast-feeding
* Any active skin rash or breaks in the skin of the back
* Any sunburn or tattoos on the skin of the back
* Current active skin disease or inflammatory skin condition including contact dermatitis
* Participation in a clinical study in the past 7 days or current participation in another clinical study
* Any medical condition or use of any medications that, in the opinion of the Principal Investigator, would preclude participation
* Unwillingness to fulfill the performance requirements of the study

• Esther Campbell, Principal investigator, BioScience Laboratories, Inc.