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

NCT02160574 | Completed Phase 1

• 1 other identifier: 130820-302 (ZX-ZP-0017)
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Surgical Site Infection

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Scoring Scale (0-7) for Visual Evaluation of Skin Condition

  0-21 days post dose

Study Arms (1)

ZuraPrep

ACTIVE COMPARATOR

ZuraPrep will be compared statistically to ZuraPrep without IPA and both to the Positive Control (0.1% Sodium Lauryl Sulfate). The degree of skin irritation caused by the Reference Product (ChloraPrep) and the Negative Control (0.9% Physiological Saline) will be graded.

Drug: ChloraPrep; Drug: 0.1% Sodium Lauryl Sulfate; Drug: 0.9% Physiological Saline; Other: ZuraPrep without IPA

Interventions

ChloraPrep DRUG

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

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

ZuraPrep

0.1% Sodium Lauryl Sulfate DRUG

The degree of skin irritation caused by 0.1% Sodium Lauryl Sulfate will be graded and compared to ZuraPrep and ZuraPrep without IPA.

Also known as: Positive Control

ZuraPrep

0.9% Physiological Saline DRUG

The degree of skin irritation caused by 0.9% Physiological Saline will be graded and compared to ZuraPrep and ZuraPrep without IPA.

Also known as: Negative Control

ZuraPrep

ZuraPrep without IPA OTHER

Results from exposure to ZuraPrep will be compared statistically those from exposure to ZuraPrep without IPA

Also known as: ZuraPrep without Isopropol 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

Bozeman, Montana, 59718, United States

Location

MeSH Terms

Conditions

Surgical Wound Infection

Interventions

chlorhexidine gluconate; Sodium Dodecyl Sulfate; citrate, isopropyl alcohol, methylene blue, parabens drug combination; Ethanol

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Dodecanol; Fatty Alcohols; Alcohols; Organic Chemicals; Alkanesulfonates; Alkanesulfonic Acids; Sulfonic Acids; Sulfur Acids; Sulfur Compounds; Lipids

Study Officials

• Esther Campbell

  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: June 1, 2014
• Primary Completion: September 1, 2014
• Study Completion: September 1, 2014
• Last Updated: October 27, 2014

Record last verified: 2014-10

Locations

US (1)