Safety Study to Evaluate the Contact Sensitizing Potential of Topically Applied ZuraPrep™ and ZuraPrep™ Without IPA

Phase 1

Completed

• Conditions: Surgical Site Infection
• Interventions: Drug: Chloraprep; Drug: 0.9% Physiological Saline; Other: ZuraPrep without IPA

• Registration Number: NCT02160587
• Lead Sponsor: Zurex Pharma, Inc.

Brief Summary

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.

Detailed 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.

Study Timeline

• Study First Submitted: 2014-06-05
• Study First Submitted QC: 2014-06-06
• Study First Posted: 2014-06-10
• Study Start: 2014-07
• Primary Completion: 2014-10
• Study Completion: 2014-10
• Status Verified: 2015-03
• Last Update Submitted: 2015-03-11
• Last Update Posted: 2015-03-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 208

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
ZuraPrep	ZuraPrep without IPA	Irritation scores of the following applied to test sites will be compared: ZuraPrep, ZuraPrep without IPA, ChloraPrep, and 0.9% Physiological Saline.
ZuraPrep	0.9% Physiological Saline	Irritation scores of the following applied to test sites will be compared: ZuraPrep, ZuraPrep without IPA, ChloraPrep, and 0.9% Physiological Saline.
ZuraPrep	Chloraprep	Irritation scores of the following applied to test sites will be compared: ZuraPrep, ZuraPrep without IPA, ChloraPrep, and 0.9% Physiological Saline.

Primary Outcome Measures

Name	Time	Method
Skin sites evaluated and graded for irritancy or sensitization	0-40 days post dose	Only frank sensitization will be categorized, as a positive control (known sensitizing agent) is prohibitive due to ethical considerations/risk of life-time sensitization. Reactions observed will be assessed as to whether indicative of sensitization or of irritation.

Secondary Outcome Measures

Name	Time	Method
Statistics of irritation scores	0-40 days post dose	Irritation scores, relative to the Test Products, Reference Product, and the Negative Control applied to skin on each test day will be compared as well as the total cumulative irritation scores across all test days.

Trial Locations

Locations (1)

BioScience Laboratories, Inc.; 🇺🇸 Bozeman, Montana, United States