Pilot Clinical Evaluation to Characterize in Vivo Effects of Topically Applied ZuraPrep & ZuraPrep Vehicle

NCT ID: NCT02578771

Last Updated: 2017-07-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 123 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-10-31
• Study Completion Date: 2016-01-31

Brief Summary

ZuraPrep is being evaluated for efficacy as a preoperative skin preparation solution to demonstrate its immediate and persistent antimicrobial properties. At least 72 subjects will be randomized utilizing bilateral applications on abdomen and groin. ZuraPrep active product and reference positive control will be compared; ZuraPrep non-active and negative control will be compared. Each subject will receive two of the planned treatments, one on the left side of body and one of the right. Study duration for subjects - 3 to 4 weeks.

Detailed Description

The single investigational test article, ZuraPrep solution is being evaluated for efficacy as a preoperative skin preparation solution to demonstrate its immediate and persistent antimicrobial properties. At least 72 subjects will be randomized utilizing bilateral applications on abdomen and groin.

The primary objective of this study is to characterize the in vivo effects of the ZuraPrep test article compared to the positive reference control ChloraPrep, as well as to evaluate the ZuraPrep test vehicle to the negative control, Saline, using the newly proposed sampling intervals.

This is a randomized, paired-comparisons design where each subject will receive two of the planned treatments, one on the left side of body and one on the right. Treatments will be evaluated at 30 seconds, 10 minutes and 6 hour sampling intervals compared to baseline. Status will be calculated separately for the abdomen and groin for each side of the body.

Study duration for subjects - 3 to 4 weeks.

Conditions

Surgical Site Infection

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: DOUBLE

Study Groups

ZuraPrep with 70% Isopropyl alcohol

Test Article ZuraPrep with 70% isopropyl alcohol (IPA) will be compared with reference positive control Chloraprep

Group Type: EXPERIMENTAL

ZuraPrep with 70% IPA

Intervention Type: DRUG

Apply topically

ChloraPrep CHG/IPA Teal Tint

Intervention Type: DRUG

Apply topically

ZuraPrep without 70% IPA

Vehicle test article ZuraPrep without isopropyl alcohol will be compared with normal saline

Group Type: EXPERIMENTAL

ZuraPrep without 70% IPA

Intervention Type: DRUG

Apply topically. 0% IPA

Normal Saline

Intervention Type: OTHER

Apply topically

ChloraPrep Teal Tint

Test Article ZuraPrep with 70% isopropyl alcohol will be compared with reference positive control ChloraPrep \[Chlorhexidine gluconate(CHG)/IPA\] Teal Tint

Group Type: ACTIVE_COMPARATOR

ZuraPrep with 70% IPA

Intervention Type: DRUG

Apply topically

ChloraPrep CHG/IPA Teal Tint

Intervention Type: DRUG

Apply topically

Normal Saline 0.85%

Vehicle test article ZuraPrep without isopropyl alcohol will be compared with normal saline 0.85%

Group Type: PLACEBO_COMPARATOR

ZuraPrep without 70% IPA

Intervention Type: DRUG

Apply topically. 0% IPA

Normal Saline

Intervention Type: OTHER

Apply topically

Interventions

ZuraPrep with 70% IPA

Apply topically

Intervention Type: DRUG

ZuraPrep without 70% IPA

Apply topically. 0% IPA

Intervention Type: DRUG

ChloraPrep CHG/IPA Teal Tint

Apply topically

Intervention Type: DRUG

Normal Saline

Apply topically

Intervention Type: OTHER

Other Intervention Names

70% IPA; ZuraPrep Vehicle; CHG 2% / IPA 70%; 0.85% Sodium Chloride (NaCl)

Eligibility Criteria

Inclusion Criteria

• Healthy male and female volunteers, 18 years of age or older.
• Are in good general health.
• Have skin within 6 inches of the test sites that is free of tattoos, dermatoses, abrasions, cuts, lesions or other skin disorders.
• Cooperative and willing to follow Subject Instructions.
• Cooperative and willing to sign Consent Form and HIPAA Authorization Form.
• Have acceptable Screening Day baseline counts (CFU/cm2).

Exclusion Criteria

• Topical or systemic antimicrobial exposure within 14 days prior to Screening Day. Restrictions include, but are not limited to antimicrobial soaps, antiperspirants/deodorants, shampoos, lotions, perfumes, after shaves, colognes, and topical or systemic antibiotics.
• Swimming in chemically treated pools or bathing in hot tubs, spas and whirlpools within 14 days prior to Screening Day.
• Use of tanning beds, hot waxes, or depilatories, including shaving (in the applicable test areas) within 14 days prior to Screening Day.
• Contact with solvents, acids, bases, fabric softener-treated clothing or other household chemicals in the applicable test areas within 14 days prior to Screening Day.
• Subjects who have a history of sensitivity to natural rubber latex, adhesive skin products (e.g., Band-Aids, medical tapes), isopropyl alcohol, citric acid, methylene blue, methylparaben, propylparaben, or chlorhexidine gluconate products.
• Subjects who have a history of skin allergies.
• Subjects who have a history of skin cancer within 6 inches of the applicable test areas.
• Subjects who are pregnant, attempting pregnancy or nursing. For all females of child-bearing potential (<60 years of age), a urine pregnancy test will be performed prior to treatment on Treatment Day.
• Subjects who have showered or bathed within 72 hours of the Screening Day or Treatment Day (sponge baths may be taken, however, the lower abdomen and upper thigh region must be avoided).
• Subjects who receive an irritation score of 1 for any individual skin condition prior to Screening Day baseline or Treatment Day baseline sample collection.
• Participation in another clinical trial in the 30 days prior to Test Day of this study (treatment with test materials in this study), or be currently enrolled in another clinical trial, or has previously participated in this study.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Zurex Pharma, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

M. Hamid Barshir, MD

Role: PRINCIPAL_INVESTIGATOR

MicroBioTest

Locations

MicroBioTest

Sterling, Virginia, United States

Countries

United States

Other Identifiers

ZX-ZP-0068 (MBT#865-104)

Identifier Type: -

Identifier Source: org_study_id