This trial is active, not recruiting.

Condition surgical site infection
Treatments chloraprep, 0.9% physiological saline, zuraprep without ipa
Phase phase 1
Sponsor Zurex Pharma, Inc.
Start date July 2014
End date October 2014
Trial size 200 participants
Trial identifier NCT02160587, 130821-303 (ZX-ZP-0018)


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Endpoint classification safety study
Intervention model single group assignment
Masking double blind (subject, outcomes assessor)
(Active Comparator)
Irritation scores of the following applied to test sites will be compared: ZuraPrep, ZuraPrep without IPA, ChloraPrep, and 0.9% Physiological Saline.
chloraprep Reference Product
ChloraPrep will be compared to ZuraPrep with regard to skin sensitization and irritation.
0.9% physiological saline Negative Control
0.9% Physiological Saline will be compared to ZuraPrep with regard to skin sensitization and irritation.
zuraprep without ipa ZuraPrep without Isopropyl Alcohol (IPA)
ZuraPrep without IPA will be compared to ZuraPrep with regard to skin sensitization and irritation

Primary Outcomes

Skin sites evaluated and graded for irritancy or sensitization
time frame: 0-40 days post dose

Secondary Outcomes

Statistics of irritation scores
time frame: 0-40 days post dose

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title A Clinical Evaluation of the Contact Sensitizing Potential of Topically Applied ZuraPrep™ and ZuraPrep™ Without IPA in Healthy Adult Volunteers
Principal investigator Maggie Butler, PhD
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.
Trial information was received from ClinicalTrials.gov and was last updated in October 2014.
Information provided to ClinicalTrials.gov by Zurex Pharma, Inc..