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

Surgical Site Infection Clinical Trial

Official title:

A 21-Day Evaluation of the Cumulative Irritation Potential of Topically Applied ZuraPrep™ and ZuraPrep™ Without IPA in Healthy Adult Volunteers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02160574
• Other study ID #: 130820-302 (ZX-ZP-0017)
• Status: Completed
• Phase: Phase 1
• First received: June 5, 2014
• Last updated: October 24, 2014
• Start date: June 2014
• Est. completion date: September 2014

Study information

• Verified date: October 2014
• Source: Zurex Pharma, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: September 2014
• Est. primary completion date: September 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Outcomes Assessor)

Related Conditions & MeSH terms

• Surgical Site Infection
• Surgical Wound Infection

Intervention

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

Locations

Country	Name	City	State
United States	BioScience Laboratories	Bozeman	Montana

Sponsors (1)

Lead Sponsor	Collaborator
Zurex Pharma, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	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	Yes