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

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.

Study Overview

• Status: Completed
• Conditions: Surgical Site Infection
• Intervention / Treatment: Drug: ChloraPrep; Drug: 0.1% Sodium Lauryl Sulfate; Drug: 0.9% Physiological Saline; Other: ZuraPrep without IPA

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.

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Montana
    • Bozeman, Montana, United States, 59718
      • BioScience Laboratories

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: Double

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

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.

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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Scoring Scale (0-7) for Visual Evaluation of Skin Condition	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).	0-21 days post dose

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Zurex Pharma, Inc.
• Investigators: Principal Investigator: Esther Campbell, BioScience Laboratories, Inc.

Study record dates

Study Major Dates

• Study Start: June 1, 2014
• Primary Completion (Actual): September 1, 2014
• Study Completion (Actual): September 1, 2014

Study Registration Dates

• First Submitted: June 5, 2014
• First Submitted That Met QC Criteria: June 6, 2014
• First Posted (Estimate): June 10, 2014

Study Record Updates

• Last Update Posted (Estimate): October 27, 2014
• Last Update Submitted That Met QC Criteria: October 24, 2014
• Last Verified: October 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Postoperative Complications; Wound Infection; Surgical Wound Infection; Anti-Infective Agents, Local; Anti-Infective Agents; Dermatologic Agents; Disinfectants; Chlorhexidine; Chlorhexidine gluconate
• Other Study ID Numbers: 130820-302 (ZX-ZP-0017)