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

Surgical Site Infection Clinical Trial

Official title:

A Clinical Evaluation of the Contact Sensitizing Potential of Topically Applied ZuraPrep™ and ZuraPrep™ Without IPA in Healthy Adult Volunteers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02160587
• Other study ID #: 130821-303 (ZX-ZP-0018)
• Status: Completed
• Phase: Phase 1
• First received: June 5, 2014
• Last updated: March 11, 2015
• Start date: July 2014
• Est. completion date: October 2014

Study information

• Verified date: March 2015
• 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 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 208
• Est. completion date: October 2014
• Est. primary completion date: October 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
ChloraPrep will be compared to ZuraPrep with regard to skin sensitization and irritation.
• 0.9% Physiological Saline
0.9% Physiological Saline will be compared to ZuraPrep with regard to skin sensitization and irritation.

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

Locations

Country	Name	City	State
United States	BioScience Laboratories, Inc.	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	Skin sites evaluated and graded for irritancy or sensitization	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.	0-40 days post dose	Yes
Secondary	Statistics of irritation scores	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.	0-40 days post dose	Yes