Overview

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

Status:
Completed
Trial end date:
2014-09-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 1
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
Zurex Pharma, Inc.
Treatments:
Chlorhexidine
Chlorhexidine gluconate
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