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

Overview

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.

Full Title of Study: “A 21-Day Evaluation of the Cumulative Irritation Potential of Topically Applied ZuraPrep™ and ZuraPrep™ Without IPA in Healthy Adult Volunteers”

Study Type

  • Study Type: Interventional
  • Study Design
    • Intervention Model: Single Group Assignment
    • Masking: Double (Participant, Outcomes Assessor)
  • Study Primary Completion Date: September 2014

Detailed Description

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.

Interventions

  • Drug: ChloraPrep
    • The degree of skin irritation caused by ChloraPrep will be graded and compared to ZuraPrep and ZuraPrep without 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.
  • 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: ZuraPrep without IPA
    • Results from exposure to ZuraPrep will be compared statistically those from exposure to ZuraPrep without IPA

Arms, Groups and Cohorts

  • Active Comparator: ZuraPrep
    • 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.

Clinical Trial Outcome Measures

Primary Measures

  • Scoring Scale (0-7) for Visual Evaluation of Skin Condition
    • Time Frame: 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 Measures

  • Scoring Scale (0-7) for Visual Evaluation of Skin Condition
    • Time Frame: 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.

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Zurex Pharma, Inc.
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Esther Campbell, Principal Investigator, BioScience Laboratories, Inc.

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