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

NCT ID: NCT02160587

Last Updated: 2015-03-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 208 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-07-31
• Study Completion Date: 2014-10-31

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.

Conditions

Surgical Site Infection

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Blinding Strategy: DOUBLE

Study Groups

ZuraPrep

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

Group Type: ACTIVE_COMPARATOR

Chloraprep

Intervention Type: DRUG

ChloraPrep will be compared to ZuraPrep with regard to skin sensitization and irritation.

0.9% Physiological Saline

Intervention Type: DRUG

0.9% Physiological Saline will be compared to ZuraPrep with regard to skin sensitization and irritation.

ZuraPrep without IPA

Intervention Type: OTHER

ZuraPrep without IPA will be compared to ZuraPrep with regard to skin sensitization and irritation

Interventions

Chloraprep

ChloraPrep will be compared to ZuraPrep with regard to skin sensitization and irritation.

Intervention Type: DRUG

0.9% Physiological Saline

0.9% Physiological Saline will be compared to ZuraPrep with regard to skin sensitization and irritation.

Intervention Type: DRUG

ZuraPrep without IPA

ZuraPrep without IPA will be compared to ZuraPrep with regard to skin sensitization and irritation

Intervention Type: OTHER

Other Intervention Names

Reference Product; 2% Chlorhexidine Gluconate and 70% IPA; Negative Control; ZuraPrep without Isopropyl Alcohol (IPA)

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Zurex Pharma, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Maggie Butler, PhD

Role: PRINCIPAL_INVESTIGATOR

BioScience Laboratories, Inc.

Locations

BioScience Laboratories, Inc.

Bozeman, Montana, United States

Countries

United States

Other Identifiers

130821-303 (ZX-ZP-0018)

Identifier Type: -

Identifier Source: org_study_id