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

NCT02160587 | Completed Phase 1

• 1 other identifier: 130821-303 (ZX-ZP-0018)
• Study Type: interventional
• Target: 208
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Surgical Site Infection

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Statistics of irritation scores

  0-40 days post dose

Study Arms (1)

ZuraPrep

ACTIVE COMPARATOR

Irritation scores of the following applied to test sites will be compared: ZuraPrep, ZuraPrep without IPA, ChloraPrep, and 0.9% Physiological Saline.

Drug: Chloraprep; Drug: 0.9% Physiological Saline; Other: ZuraPrep without IPA

Interventions

Chloraprep DRUG

ChloraPrep will be compared to ZuraPrep with regard to skin sensitization and irritation.

Also known as: Reference Product, 2% Chlorhexidine Gluconate and 70% IPA

ZuraPrep

0.9% Physiological Saline DRUG

0.9% Physiological Saline will be compared to ZuraPrep with regard to skin sensitization and irritation.

Also known as: Negative Control

ZuraPrep

ZuraPrep without IPA OTHER

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

Also known as: ZuraPrep without Isopropyl Alcohol (IPA)

ZuraPrep

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Zurex Pharma, Inc.: lead

Study Sites (1)

BioScience Laboratories, Inc.

Bozeman, Montana, 59718, United States

Location

MeSH Terms

Conditions

Surgical Wound Infection

Interventions

chlorhexidine gluconate; citrate, isopropyl alcohol, methylene blue, parabens drug combination; 2-Propanol

Condition Hierarchy (Ancestors)

Wound Infection; Infections; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Propanols; Alcohols; Organic Chemicals

Study Officials

• Maggie Butler, PhD

  BioScience Laboratories, Inc.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 5, 2014
• First Posted: June 10, 2014
• Study Start: July 1, 2014
• Primary Completion: October 1, 2014
• Study Completion: October 1, 2014
• Last Updated: March 17, 2015

Record last verified: 2015-03

Locations

US (1)