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

Zurex Pharma

Status and phase: Completed; Phase 1

Conditions: Surgical Site Infection

Treatments: Drug: 0.1% Sodium Lauryl Sulfate; Drug: ChloraPrep; Other: ZuraPrep without IPA; Drug: 0.9% Physiological Saline

Study type: Interventional

Funder types: Industry

Identifiers

NCT02160574

130820-302 (ZX-ZP-0017)

Details and patient eligibility

About

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 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.

Enrollment: 40 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

40 participants in 1 patient group

ZuraPrep

Active Comparator group

Description:

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.

Treatment:

Drug: 0.9% Physiological Saline

Other: ZuraPrep without IPA

Drug: ChloraPrep

Drug: 0.1% Sodium Lauryl Sulfate