Safety Study to Evaluate the Contact Sensitizing Potential of Topically Applied ZuraPrep™ and ZuraPrep™ Without IPA
This trial is active, not recruiting.
|Condition||surgical site infection|
|Treatments||chloraprep, 0.9% physiological saline, zuraprep without ipa|
|Sponsor||Zurex Pharma, Inc.|
|Start date||July 2014|
|End date||October 2014|
|Trial size||200 participants|
|Trial identifier||NCT02160587, 130821-303 (ZX-ZP-0018)|
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.
|Endpoint classification||safety study|
|Intervention model||single group assignment|
|Masking||double blind (subject, outcomes assessor)|
Skin sites evaluated and graded for irritancy or sensitization
time frame: 0-40 days post dose
Statistics of irritation scores
time frame: 0-40 days post dose
Male or female participants at least 18 years old.
- 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
- 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
|Official title||A Clinical Evaluation of the Contact Sensitizing Potential of Topically Applied ZuraPrep™ and ZuraPrep™ Without IPA in Healthy Adult Volunteers|
|Principal investigator||Maggie Butler, PhD|
|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.|
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