Trial | NCT02160574  Report issue

Title

Safety Study to Evaluate the Cumulative Irritation Potential of Topically Applied ZuraPrep™ and ZuraPrep™ Without IPA
A 21-Day Evaluation of the Cumulative Irritation Potential of Topically Applied ZuraPrep™ and ZuraPrep™ Without IPA in Healthy Adult Volunteers

  • Phase

    Phase 1

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    40
This is a safety study to determine the cumulative skin irritation potential of ZuraPrep™ and ZuraPrep™ without Isopropyl Alcohol after repetitive patch applications to skin of human subjects.
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.
Study Started
Jun 30
2014
Primary Completion
Sep 30
2014
Study Completion
Sep 30
2014
Last Update
Oct 27
2014
Estimate

Drug ChloraPrep

The degree of skin irritation caused by ChloraPrep will be graded and compared to ZuraPrep and ZuraPrep without IPA.

  • Other names: Reference Product, 2% Chlorhexidine Gluconate and 70% IPA

Drug 0.1% Sodium Lauryl Sulfate

The degree of skin irritation caused by 0.1% Sodium Lauryl Sulfate will be graded and compared to ZuraPrep and ZuraPrep without IPA.

  • Other names: Positive Control

Drug 0.9% Physiological Saline

The degree of skin irritation caused by 0.9% Physiological Saline will be graded and compared to ZuraPrep and ZuraPrep without IPA.

  • Other names: Negative Control

Other ZuraPrep without IPA

Results from exposure to ZuraPrep will be compared statistically those from exposure to ZuraPrep without IPA

  • Other names: ZuraPrep without Isopropol Alcohol (IPA)

ZuraPrep Active Comparator

ZuraPrep will be compared statistically to ZuraPrep without IPA and both to the Positive Control (0.1% Sodium Lauryl Sulfate). The degree of skin irritation caused by the Reference Product (ChloraPrep) and the Negative Control (0.9% Physiological Saline) will be graded.

Criteria 

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
No Results Posted