Efficacy Study to Evaluate Antimicrobial Effectiveness of ZuraPrep™ (ZX-ZP-0035)

July 13, 2016 updated by: Zurex Pharma, Inc.

A Pilot Clinical Evaluation of the Antimicrobial Effectiveness of Topically Applied ZuraPrep™

The purpose of this pilot study is to evaluate antimicrobial properties of a single test product, a vehicle product and a reference product applied in two different areas when used as a patient preoperative skin preparation.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This is an open label pilot study to evaluate antimicrobial properties of a single test product, a vehicle product and a reference product applied bilaterally to the skin of the abdomen and the inguina. Testing will be performed according to FDA TFM for Effectiveness Testing of a Patient Preoperative Skin Preparation.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
64

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Montana
      • Bozeman, Montana, United States, 59718
        • BioSciences Laboratories, Inc.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Subjects may be of either sex, at least 18 years of age and of any race.
  • Subjects must be in good general health, as evidenced by the Subject Confidential Information and Acceptance Criteria
  • Subjects must read and sign an Informed Consent Form, Authorization to Use and Disclose Protected Health Information Form, and List of Restricted Products

Exclusion Criteria:

  • Exposure of test sites to antimicrobial agents, medicated soaps, medicated shampoos, or medicated lotions, use of biocide-treated pools or hot tubs, use of tanning beds, or sunbathing during the 14-day pre-test conditioning period or during the test period.
  • Use of topical or systemic antimicrobials, antibiotics, or steroids (other than hormones for contraception or post-menopausal indications), or any other product known to affect the normal microbial flora of the skin during the 14-day pre-test conditioning period or during the test period.
  • Exposure of the test sites to strong detergents, solvents, or other irritants during the 14-day pre-test conditioning period or during the test period.
  • Known allergies to vinyl, latex (rubber), alcohols, metals, inks, or tape adhesives, or to common antibacterial agents found in soaps, lotions, or ointments, particularly chlorhexidine gluconate (CHG), citric acid, methylene blue, methylparaben, propylparaben, or isopropyl alcohol.
  • A medical diagnosis of a physical condition, such as a current or recent severe illness, asthma, diabetes, hepatitis, an organ transplant, mitral valve prolapse, congenital heart disease, internal prostheses, or any immunocompromised conditions such as AIDS (or HIV positive).
  • Subjects must be unable to become pregnant, or willing to use an acceptable method of contraception to prevent pregnancy, if female of child-bearing potential.

Inability to become pregnant would include subjects who are:

  • Male
  • Females unable to become pregnant (i.e., postmenopausal for at least 1 year or surgically sterile due to hysterectomy, bilateral oophorectomy, uterine ablation, or bilateral tubal ligation)
  • Females of child-bearing potential but using acceptable methods of contraception, including one of the following methods that have been used for at least 2 weeks prior to Treatment Day Visit.

Acceptable methods of contraception include one of the following methods:

  • Systemic birth control (the same type of birth control for at least 3 months prior to entering the study and continuation of this type of birth control throughout the study)
  • Double barrier methods (condom with spermicide or diaphragm with spermicide)
  • IUD
  • Vasectomized partner; or

  • Abstinence from sexual intercourse

    • Any large tattoos, scars, active skin rashes, or breaks in the skin of the test sites.
    • Dermatoses, cuts, lesions, or other skin disorders on or around the test sites
    • A currently active skin disease or inflammatory skin condition (e.g., contact dermatitis) that, in the opinion of the Consulting Physician or Principal Investigator, would compromise subject safety or study integrity.
    • Showering, bathing, or swimming within the 72 hour period prior to Baseline Day, the first Test Day, and throughout the test period.
    • Participation in another clinical study in the past 30 days or current participation in another clinical study.
    • Any medical condition or use of any medications that, in the opinion of the Medical Expert/Consulting Physician or Principal Investigator, should preclude participation.
    • Unwillingness to fulfill the performance requirements of the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: ChloraPrep
Chlorhexidine gluconate (CHG) 2% / Isopropyl alcohol (IPA) 70%
Drug: Chloraprep
Apply topically.
Other Names:
  • CHG 2% / IPA 70%
  • 2% chlorhexidine gluconate / 70% Isopropyl alcohol
Experimental: ZuraPrep Config 1
Isopropyl alcohol (IPA) 70% Standard scrub time.
Drug: ZuraPrep
Apply topically.
Other Names:
  • Isopropyl alcohol 70%
Experimental: ZuraPrep Config 2
Isopropyl alcohol (IPA) 70% Half scrub time.
Drug: ZuraPrep
Apply topically.
Other Names:
  • Isopropyl alcohol 70%
Placebo Comparator: ZuraPrep Vehicle
ZuraPrep without IPA
Drug: ZuraPrep Vehicle
Apply topically.
Other Names:
  • ZuraPrep without IPA
  • ZuraPrep Placebo

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Calculations of mean log10 reductions from baseline populations
Time Frame: 0-24 hours post dose
Antimicrobial efficacy will be evaluated based upon calculation of mean log10 reductions from baseline populations by subtracting the log10 number of viable microorganisms recovered at each post-product application sample from the log10 number of viable microorganisms recovered in the baseline samples. The performance criteria are mean reductions in microbial flora of ≥2 log10 per square cm on skin of the abdomen and ≥3 log10 per square cm on skin of the inguen.
0-24 hours post dose

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Zurex Pharma, Inc.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Chris Beausoleil, BioScience Laboratories, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2014

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2014

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 1, 2014

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 18, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 19, 2014

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 20, 2014

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 18, 2016

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 13, 2016

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 131112-103 (ZX-ZP-0035)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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