Clinical trial NCT03782103
Conditions: Surgical Skin Preparation
Sponsor: Zurex Pharma, Inc.
Start date: 2019-01-25; Completion date: 2019-09-26
Enrollment: 156 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The objective of the study is to demonstrate the antimicrobial efficacy of the Zurex Preoperative Prep (ZuraPrep - clear) on skin flora of the abdomen and inguinal regions of human subjects.

Detailed description:
The primary objective of this study is to measure the antimicrobial effectiveness of a single investigational test article, ZuraPrep™ as specified by the Healthcare Antiseptics, Topical Antimicrobial Drug Products Final Rule of December 20, 2017. The treatments will be ZuraPrep™ as the investigational test article, ChloraPrep® as an active control, and ZuraPrep™ Vehicle as a negative control. For efficacy at 30 seconds post-prep, the test article should be superior to the negative control using a margin of 1.2 log10 CFU/cm2 and non-inferior to the active control using a margin of 0.5 log10 CFU/cm2.

Arms: arm 1: Isopropyl alcohol (IPA) 70% arm 2: Chlorhexidine gluconate (CHG) 2% / Isopropyl alcohol (IPA) 70% arm 3: Zurex Prep without IPA
Interventions: intervention 1: ZuraPrep Clear Solution intervention 2: ChloraPrep intervention 3: ZuraPrep Vehicle
Intervention descriptions: intervention 1: Apply topically. intervention 2: Apply topically. intervention 3: Apply topically.

Protocol documents:
Prot_SAP_000.pdf: 
Study Number and Title: 
Zurex Pharma, Inc. Project No. ZX-ZP-0092 
Microbac Project No. 865-107 
 
Pivotal Clinical Evaluation of the Antimicrobial 
Effectiveness of Topically Applied ZuraPrep™ 
 
 
NCT:  
 
 
 
      03782103 
 
 
 
 
 
Date:  
 
 
 
      December 4, 2018 
 
 
 
 
       
 
 
 


Confidentiality Statement 
This document contains the confidential information of Zurex Pharma, Inc., and Microbac Laboratories, Inc. 
(Microbac). It is intended solely for the guidance of the clinical investigation. This protocol may not be 
disclosed to parties not associated with the clinical investigation or used for any purpose without the prior 
written consent of Zurex Pharma, Inc., and/or Microbac. 
 
Microbac Laboratories, Inc.  
105 Carpenter Drive | Sterling, VA 20164 | 703.925.0100 p | 703.925.9366 f | www.microbac.com 
 
 
 
  
Microbac Clinical Protocol 
Study Number and Title: 
Zurex Pharma, Inc. Project No. ZX-ZP-0092 
Microbac Project No. 865-107 
 
Pivotal 
Clinical 
Evaluation 
of 
the 
Antimicrobial 
Effectiveness of Topically Applied ZuraPrep™ 
 
 
Investigational Test Article: 
ZuraPrep™ 
 
Reference Control Article: 
ChloraPrep® 
 
Negative Control Article: 
ZuraPrep™ 
  
Principal Investigator: 
M. Hamid Bashir, MD, CCRP 
 
 
Sub-Investigator: 
Angela L. Hollingsworth 
 
 
Qualified Physician / Sub-Investigator: 
Rajeev Khanna, MD 
 
  
 
Research Facility: 
Microbac Laboratories, Inc. 
105 Carpenter Drive 
Sterling, Virginia 20164 
Telephone: 703-925-0100 
 
IRB: 
MicroBioTest Internal IRB 
 
 
Sponsor: 
Zurex Pharma, Inc. 
2113 Eagle Drive 
Middleton, WI 53562 
Date: 
December 4, 2018 
 


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TITLE PAGE (continued) 
Zurex Pharma, Inc.  
Sponsor Representative: 
  
  
 
 
 
 
 
5
 
 
Study Monitor 
 
 
 
 
 
 
  
 
 
 
  
Statistical Consultant: 
 
 
 
 
 
 
 
 




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Table of Contents 
 
 
 
1. 
BACKGROUND INFORMATION ..................................................................................... 5 
2. 
STUDY OBJECTIVES AND PURPOSE .......................................................................... 6 
3. 
STUDY DESIGN ............................................................................................................. 7 
4. 
SUBJECT SELECTION ................................................................................................. 16 
5. 
STUDY TREATMENT ................................................................................................... 18 
6. 
ASSESSMENT OF EFFICACY...................................................................................... 25 
7. 
ASSESSMENT OF SAFETY ......................................................................................... 26 
8. 
STATISTICS.................................................................................................................. 29 
9. 
MONITORING ............................................................................................................... 31 
10. 
QUALITY CONTROL AND QUALITY ASSURANCE ..................................................... 32 
11. 
ETHICS ......................................................................................................................... 32 
12. 
DATA HANDLING AND RECORD KEEPING ................................................................ 32 
13. 
REFERENCES .............................................................................................................. 34 
14. 
APPENDICES ............................................................................................................... 35 
 
 
 


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1. 
Background Information 
1.1 
Name, Description and Intended Use of the Test and Control Articles 
(Treatments) 
The single investigational test article, ZuraPrep™ 
 
 is being evaluated for efficacy as a 
preoperative skin preparation solution by demonstrating its immediate and persistent 
antimicrobial properties. Testing will be performed based upon procedures outlined in 
the FDA Safety and Effectiveness of Health Care Antiseptics; Topical Antimicrobial 
Drug Products for Over-the-Counter Human Use, Final Rule (Federal Register Volume 
82, Number 243, Wednesday, December 20, 2017) and ASTM E1173 – 15 Evaluation 
of Preoperative, Precatheterization, or Preinjection Skin Preparations. 
 
 
 
 
ZuraPrep™
 Solution Vehicle, 
 will be evaluated as a negative 
control (ZuraPrep™ 
 
ChloraPrep® 
 will be evaluated as an active control (reference 
control). 
1.2 
Risk/Benefit Summary 
There are minimal anticipated adverse health risks for the participants of this study. 
Considerable safety and efficacy data are available for the active ingredient in the test 
and control formulations as described in the investigator brochure (IB). 
1.3 
Treatment Application Configurations 
This study treatment will be conducted using ZuraPrep™ 
 
, ZuraPrep™ 
 Vehicle, 
 and ChloraPrep®, 
. The product (including packaging) will be weighed pre-application 
and post-application. 
The treatments will be applied topically to intact skin of the abdomen and groin regions 
of each subject. The treatments will be applied per the Treatment Application 
Instructions (Appendix 14.7). 
1.4 
Good Clinical Practice and Regulatory Requirements 
This study will be conducted in compliance with this protocol, Good Clinical Practice 
(GCP) including 45 CFR 160 and 164 (Authorization for Use/Disclosure of Protected 
Health Information (PHI), 21 CFR 50 (Protection of Human Subjects), 56 (Institutional 
Review Boards), 330 (Over-The-Counter Human Drugs which are generally 
recognized as safe and effective and not misbranded) and Tentative Final Monograph 
for Health Care Antiseptic Drug Products (TFM), International Conference on 


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Harmonisation ICH Harmonised Tripartite Guideline E6: Good Clinical Practice, the 
Standard Operating Procedures of Microbac, the study protocol and any protocol 
amendments. 
1.5 
Study Population 
Healthy male and female volunteers, 18 years of age or older, with no dermatological 
conditions or known history of sensitivity to natural rubber latex, adhesive skin 
products (e.g., Band-Aids, medical tapes), isopropyl alcohol or chlorhexidine 
gluconate will be enrolled into this study. For this trial, a sufficient number of volunteers 
will be recruited in the screening phase such that a total of at least 72 abdominal 
(sebaceous poor) regions and 72 groin (sebaceous rich) regions are evaluable at the 
completion of the study for each treatment. Subjects must satisfy all Screening Day 
and Treatment Day Inclusion/Exclusion Criteria prior to screening sample collection 
and Treatment Day procedures.  
The right and left sides of both the abdomen and the groin must meet the minimum 
Screening Day baseline values stated in the Inclusion Criteria (Section 4.1) to qualify 
for the study. 
At least 108 human subjects will be employed utilizing bilateral applications assuring 
that the treatments will be evaluated on the sites as described in the following table: 
Table 1.5:  Minimum number of readings per anatomical site (abdomen and groin), per treatment, 
per sampling interval (30 seconds and 6 hours post-application) 
Treatment 
Number of Abdomen 
Evaluations 
Number of Groin 
Evaluations 
ZuraPrep™ 
 
 
72  
72  
ChloraPrep® 
  
(active control) 
72  
72  
ZuraPrep™ 
 Vehicle,  
 (negative control) 
72  
72  
 
 
 
2. 
Study Objectives and Purpose 
The primary objective of this study is to measure the antimicrobial effectiveness of a single 
investigational test article, ZuraPrep™ 
 as specified by the 
Healthcare Antiseptics, Topical Antimicrobial Drug Products Final Rule of December 20, 
2017. The treatments will be ZuraPrep™ 
 as the 
investigational test article, ChloraPrep® 
as an active control, 
and ZuraPrep™ 
 Vehicle 
 as a negative control. For 
efficacy at 30 seconds post-prep, the test article should be superior to the negative control 
using a margin of 1.2 log10 CFU/cm2 and non-inferior to the active control using a margin of 
0.5 log10 CFU/cm2.  
The secondary objective of this study is to show persistent effect as defined in the Health 
Care Antiseptics, Topical Antimicrobial Drug Products Final Rule of December 20, 2017, 


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(Final Rule). Due to the normal variability associated with this biological system, the test 
article is considered to have persistent effect if the percentage of body sites with log10 
CFU/cm2 values less than or equal to baseline for the 6-hour sample is between 95 to 100%. 
3. 
Study Design 
3.1 
Study Type 
This is a randomized, paired-comparisons design where each subject receives two of 
the planned treatments. 
Table 3.1:  Treatments, Anatomical Sites of Evaluation, Application and Dry Times and Coverage 
Areas (See Appendix 14.7 for detailed application instructions) 
Treatment 
(Quantity/Volume) 
Body Site 
Application 
Time 
Dry Time 
Area of 
Coverage 
ZuraPrep™ 
 
 
 
Abdomen 
(sebaceous poor) 
30 seconds 
3 minutes 
5” x 5” 
Groin 
(sebaceous rich) 
2 minutes 
3 minutes 
1.5” x 5” 
ChloraPrep® 
 
 
(active control) 
Abdomen 
(sebaceous poor) 
30 seconds 
3 minutes 
5” x 5” 
Groin 
(sebaceous rich) 
2 minutes 
3 minutes 
1.5” x 5” 
ZuraPrep™ 
 
Vehicle, 
 
(negative control) 
Abdomen 
(sebaceous poor) 
30seconds 
3 minutes 
5” x 5” 
Groin 
(sebaceous rich) 
2 minutes 
3 minutes 
1.5” x 5” 
 
3.2 
Primary Endpoint/Analysis 
The primary analysis for the study utilizes the standards of the Health Care Antiseptics, 
Topical Antimicrobial Drug Products Final Rule of December 20, 2017. The primary 
efficacy criteria will be assessed based on log10 CFU/cm2 values at 30 seconds for 
immediate effect and at 6 hours for persistent effect. 
Product effectiveness will be measured using superiority and non-inferiority estimates 
for the 30-second sample time calculated using average treatment effects (ATEs). 
ATEs will be estimated from a linear regression of the 30 second post-treatment 
bacterial counts (log10 scale) on the additive effect of a treatment indicator and the 
baseline or pre-treatment measurements (log10 scale). To show effectiveness the test 
product will be (1) non-inferior to ChloraPrep®
 with a 0.5 margin (upper bound 
of 95% confidence interval of the ATE of the test product versus active control value < 
0.5) and (2) superior to the ZuraPrep 
 Vehicle (negative control) by a margin of 
1.2 (lower bound of the 95% confidence interval of the ATE of the test product versus 


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the vehicle value > 1.2). Superiority and non-inferiority will be calculated separately for 
each body area (abdomen and groin). 
A site is considered evaluable for efficacy (part of the per-protocol data set) if the 
criteria in the following table are met: 
Table 3.2:  Minimum and Maximum Treatment Day Baseline Values per Anatomical Site 
Anatomical Site 
Minimum and Maximum  
Treatment Day Baseline* 
Abdomen 
1.0 x 103 – 3.2 x 105 CFU/cm2  
(3.0 Log10 – 5.5 Log10) 
Groin 
1.0 x 105 – 3.2 x 107 CFU/cm2  
(5.0 Log10 – 7.5 Log10) 
*Note: For the Screening Day baseline, the maximum upper limit does not apply. Only the 
minimum criteria must be met. 
3.2.1 
Secondary Endpoints/Analysis 
Persistence or long-term efficacy is defined in the Final Rule as having the 6 
hour post-treatment log10 CFU/cm2 values lower than or equal to the baseline 
log10 CFU/cm2 values for 100 percent of the subjects in each indication and 
body area. Due to the normal variability associated with this biological 
system, the test article is considered to have persistent effect if the 
percentage of body sites with log10 CFU/cm2 values less than or equal to 
baseline for the 6-hour sample is between 95 to 100%. All subjects that do 
not achieve the 6-hour efficacy goal will be documented and discussed.  This 
only applies to ZuraPrep™ 
 for the purpose of determining 
efficacy but the same calculation will be performed for ChloraPrep® 
 for 
information purposes only. 
3.2.2 
Study Validity 
There are no study validity criteria. All calculations performed for ZuraPrep™ 
 will be performed for ChloraPrep® 
, but for informational 
purposes only. 
3.3 
Randomization and Blinding 
Subjects will be randomized before treatment, after screening eligibility is determined. 
Subjects will be randomized to treatment using the following block design: 
Treatment Balance 
Each subject will receive two different treatments, one on the right side of the body 
and one on the left. 
The treatment assignments will be balanced such that the number of readings per 
anatomical site matches the calculated requirements. 


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Left/Right Balance 
The application will be randomized so that each treatment is used on an equal 
number of left and right sides of the body. 
Site and Sample Time Balance 
Within each anatomical site, sample order with respect to sampling area number 
will be balanced with respect to treatments. 
The randomization plan is based on the estimated population size 
 
 
 
Subjects will be randomized to treatments in blocks 
of 12, randomly ordered within the block. Sample order will be randomized separately 
in blocks of 24 based on the 24 possible sample orders; 12 of the sample orders will 
be matched to the 12 treatment assignments in such a way to balance treatment with 
respect to sample order. Additional details on the randomization will be found in the 
randomization document. 
The Investigator is responsible for ensuring that the randomization is followed. A basic 
outline of a randomization schedule for the abdominal and groin sites is provided in 
Appendix 14.4. The final randomization schedule will be prepared before the initial 
treatment. The test and control articles will be labeled with the appropriate codes as 
designated by the study randomization.  
Subjects will be identified by their initials, a Screening ID Number, and a Subject 
Number. Subject Numbers will not be assigned until a subject has passed the 
screening criteria, including baseline bacterial counts (at least 1.0 x 105 CFU/cm2 in 
the groin and at least 1.0 x 103 CFU/cm2 on the abdomen). Subjects whose abdominal 
and groin regions qualify will be assigned the Subject Number on Treatment Day. 
Therefore, each of the participating treated subjects will be assigned two identification 
numbers: Screening Identification Number and a Subject Number. 
• 
Screening subjects will be assigned numbers ranging from 9001 to 9999. 
• 
Subjects to be treated (including treatment day baseline collection) will be 
assigned sequential numbers ranging from 1001 up to the total number of test 
subjects treated.  
The study materials will not be blinded from the Investigator or other study staff 
performing the study material application or bacterial sample collections. The staff 
member(s) performing bacterial enumeration will be blinded from the identification of 
treatment assignment. The study staff performing the bacterial enumeration will not be 
involved in the study material application or the collection of samples. The Raw Data 
Capture form sections will be maintained separately (from the pages which include 
study treatment identifications) during the conduct phase of the study. The study staff 
performing the bacterial enumeration will record counts directly onto the Raw Data 
Capture forms without accessing the subject study documentation folder containing 
the other source document pages. The Raw Data Capture forms will be compiled with 


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the entire subject source record after all data recording has been completed. The data 
capture forms will serve as the source document. 
Data will first be recorded onto the data capture forms, followed by entry into the 
electronic Case Report Form (eCRF). Wherever the data are entered first is 
considered the source document. 
3.4 
Study Materials  
The materials identified in Table 3.4 will be used in the study. Specific product 
identification codes and lot numbers will also be included on the form titled 
“Confirmation of Release and Receipt of Study Materials” (Appendix 14.8) at the time 
the clinical supplies are shipped to the study site.  
Table 3.4:  Study Materials 
Study Arm 
Name 
Description 
Lot No. 
Exp. 
Test Article 
ZuraPrep™ 
 
  
  
  
 
 
 
 
 
 
 
 
 
 
 
  
 
 
Reference 
Control Article 
(Active Control) 
ChloraPrep® 
  
  
2% Chlorhexidine Gluconate (w/v) and 70% 
isopropyl alcohol (v/v)  
8218679 07/31/21 
Negative 
Control Article 
ZuraPrep™ 
 
 Vehicle,  
 
ZuraPrep™ 
 Vehicle 
 
 
 
 
 
 
 
 
 
 
  
 
  
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 Zurex 
 
 
 
  
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 


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3.4.1 
Study Materials Labeling 
Zurex Pharma, Inc. will label, package and ship the study materials required 
for ZuraPrep™ 
 and the negative control 
(ZuraPrep™ 
 
Vehicle 
 
) to the 
research facility. 
 
 
 
 
 
 
e 
 
 
 
 
 
 


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3.4.2 
Study Supplies Provided by Sponsor 
• 
Test article treatment materials and negative control treatment materials. 
3.4.3 
Study Supplies Provided by Study Site 
• 
Reference Control Article 
• 
Treatment Material Disposition forms 
• 
Product Washout Kits (toiletry items to be used by subjects during study) 
• 
Consent / Authorization forms, IRB-approved 
• 
Case Report Forms 
• 
Sampling Solution, sterile 
  
 
 
• 
Butterfield’s sterile Phosphate Buffered Water containing neutralizers, 
 
• 
High-purity deionized water, sterile 
• 
Trypticase Soy Agar (TSA) 
• 
Trypticase Soy Agar containing 0.5% Tween 80 and 0.07% lecithin 
(TSA+N) 
• 
Transfer pipettes, polyethylene, sterile 
• 
Serological pipettes 
, sterile, 
 
l 
• 
Pipetting device, calibrated to accurately dispense 5.0 mL 
• 
Tubes with sealable caps, polypropylene or glass, sterile 
• 
Petri dishes, 100 mm, sterile 


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• 
Gloves, sterile 
• 
Gauze, sterile (2” x 2”) 
• 
Marking templates, 5” x 5” & 1.5” x 5”, sterile (for marking test sites) 
• 
Non-toxic marking pen (Sharpie or equivalent) 
• 
Rubber policemen, sterile 
• 
Scrub cups 
 
 
 
• 
Timers or stopwatches 
• 
Pipette Aid or similar apparatus 
• 
Vortex mixer 
• 
Surgical Clipper & clipper blades 
• 
Water bath (45° ± 2°C) 
• 
Incubator (30° ± 2°C) 
• 
Disposable underwear for subjects 
• 
Tryptic Soy Broth (for the Neutralization Validation Procedure only – See 
Appendix 14.10) (TSB) 
• 
Urine Strip Test (for Pregnancy) or equivalent.  
3.5 
Study Duration 
The expected duration of this study for each subject is up to 3-4 weeks. Subjects will 
undergo at least a 14-day washout period followed by a qualification screening 
baseline visit. Subjects whose screening baseline samples meet the minimum values 
described in the Inclusion Criteria (Section 4.1) will be notified and invited to participate 
in the treatment phase of the study. The treatment phase will be scheduled no sooner 
than 72 hours from the screening baseline collection. 
3.6 
Study Termination/Subject Discontinuation or Withdrawal/Subject Revocation 
of Authorization 
3.6.1 
Study Termination 
Zurex Pharma, Inc. or the Investigator has the right to discontinue the study 
at any time for medical and/or administrative reasons. As far as possible, this 
should occur after mutual consultation. 
3.6.2 
Subject Discontinuation and Withdrawal 
The Investigator may discontinue individual subjects from the study at any 
time. Subjects may voluntarily withdraw from the study at any time without 
reason or consequence. The subject will be asked to report the reason for 
withdrawal, when possible. The Investigator will record the reason for early 
discontinuation on the data capture form and transcribe on the appropriate 
eCRF including the date and reason for discontinuance. Subjects who qualify 
on Screening Day and begin the treatment phase may not be re-entered into 
the study, regardless of whether or not they completed the study. 
Any enrolled subject will be discontinued for the following reasons:  


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1. A skin irritation rating of 3 for any individual skin condition at any 
evaluation following the application of study treatment. (A skin irritation 
rating of 2 for any individual skin condition at any evaluation following 
the application of study material may also be the cause for subject 
discontinuation at the discretion of the Investigator.) 
2. Experiencing a serious protocol deviation that compromises the data 
results, for example, using a topical antibiotic at a test site during the 
study. 
See Section 8.5 for handling of withdrawn subject data.  
3.6.3 
Subject Revocation of Authorization to Use and Disclose Protected 
Health Information 
In order to implement a valid revocation of authorization, the subject or their 
representative must make the request in writing to Microbac, 
 
. The revocation cannot stop the use or disclosure 
of information that has been collected prior to the revocation, or is needed to 
ensure complete and accurate study results, and/or is required by law or 
government regulation (e.g., reporting adverse events, etc.). Revocation of 
an authorization may not be used to withhold normal medical care from the 
subject, but may [or will] make the subject ineligible to receive the study 
treatment or care. 
3.7 
Treatment Material Accountability 
Zurex Pharma, Inc. requires Investigators to maintain accountability and adequate 
inventory security of the study material at all times. The Investigator or designee will: 
• 
complete the Confirmation of Release and Receipt of Study Materials form 
(Appendix 14.8) upon receipt of the shipment and maintain and account for 
inventory on the Study Material Disposition form (Appendix 14.9). 
• 
keep study materials in a secure storage area, accessible only to authorized 
individuals. 
• 
dispense study material only to subjects properly enrolled into the study. 
• 
return all unused study materials to Zurex Pharma, Inc. at the end of the study or 
dispose of unused study materials as agreed upon. 
3.8 
Source Data 
Data capture forms will serve as the source document. Data will be recorded directly 
onto the data capture form and then transcribed into the eCRF. The electronic data 
will be consistent with the source documents or the discrepancies will be explained.  
Wherever the data are entered first is considered the source document. 


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3.9 
Protocol Modifications 
3.9.1 
Protocol Amendments 
The party initiating an amendment must confirm it clearly in writing using the 
Project Sheet that will contain the Amendment. It must be signed and dated 
by Zurex Pharma, Inc. and, in the case of a significant amendment, the 
Investigator. A significant amendment means one that affects the safety, 
rights or welfare of subjects, the scope of the investigation or the scientific 
quality of the study. 
Zurex Pharma, Inc. will submit significant protocol amendments to the 
Investigator for submission to the IRB. Zurex Pharma, Inc. will also notify the 
Investigator when a protocol amendment may be implemented. 
3.9.2 
Protocol Deviations 
A deviation is a departure from the protocol that will likely affect the safety, 
rights or welfare of subjects, the scope of the investigation or the scientific 
quality of the study. Protocol deviations are documented on a Protocol 
Deviation Form and transcribed on the appropriate eCRF, if applicable. 
Sponsor Notification 
Deviations that potentially affect 1) subject safety, rights or welfare, 2) data 
integrity or 3) compromise the statistical analysis of the study require 
immediate communication to Zurex Pharma, Inc. The Investigator must 
contact the Zurex Pharma, Inc. study monitor within 24 hours of occurrence 
at 
the 
following 
phone 
number: 
 
 
 
 A Protocol 
Deviation Form must be completed by the Investigator and include a 
description of the circumstances surrounding and the reason for the 
deviation, any actions taken, and whether or not the subject was allowed to 
continue in the study. A copy of the deviation form or completion in the eCRF 
must be sent to the Zurex Pharma, Inc. study monitor within 24 hours of 
identifying the occurrence. 
IRB Notification 
Deviations which are made to protect the life or physical well-being of a 
subject in an emergency must be reported by the Investigator to the IRB as 
soon as possible, or no later than 5 working days after the investigative site 
learns of the occurrence. 
3.10 Computerized System  
• 
 


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4. 
Subject Selection 
Healthy volunteers with no dermatological conditions or known history of sensitivity to 
natural rubber latex, adhesive skin products (e.g., Band-Aids, medical tapes), isopropyl 
alcohol, citric acid, methylparaben, propylparaben, or chlorhexidine gluconate will be 
enrolled into this study. A sufficient number of volunteers will be enrolled in the screening 
phase such that the total number of abdominal regions and the total number of groin regions 
meets or exceeds the number determined for the study (72 abdominal regions and 72 groin 
regions for each treatment). Subjects must satisfy all Screening Day and Treatment Day 
Inclusion/Exclusion Criteria prior to screening sample collection and Treatment Day 
procedures. Volunteers will be recruited and treated until the count of results in the per 
protocol data set meets or exceeds the required test material/region counts. 
A subject must qualify for both the abdominal portion and the groin portion of the study and 
the right and left sides of the abdomen and groin must meet the minimum baseline values 
stated in the Inclusion Criteria in order to be eligible for Treatment Day procedures. 
Sites which are treated but discovered to have Treatment Day baseline counts below the 
minimum values or above the maximum values stated in Table 3.2 will not be included in 
the primary efficacy analysis (per-protocol data set). Additional subjects will be recruited and 
treated identically to the treatments for the subjects who had non-qualifying sites until a 
sufficient number of qualifying sites have been treated. 
Subjects will be identified at screening by their initials and a screening ID number. Subject 
numbers will not be assigned until a subject has passed the screening criteria, including 
baseline bacterial counts. 
All volunteers will be given verbal and written information about the study procedures, and 
Subject Instructions (Appendix 14.6) will be provided to each subject for the pre-treatment 
phase of the study. The following Inclusion/Exclusion Criteria will be reviewed on Screening 
Day and on Treatment Day to establish eligibility for participation: 
4.1 
Subject Inclusion Criteria 
Subjects to whom all of these conditions apply will be eligible for enrollment in this 
study: 
• 
Healthy male and female volunteers, 18 years of age or older. 
• 
Are in good general health. 
• 
Be able to present a valid identification card that includes name and date of birth. 
• 
Have skin within 6 inches of the test sites that is free of tattoos, dermatoses, 
abrasions, cuts, lesions or other skin disorders. 
• 
Willing to avoid antihistamines, immunosuppressants, or oral steroids for the 
duration of the study. (other than hormones for contraception or post-menopausal 
reasons).  
• 
Wiling to avoid topical or systemic antimicrobial exposure for the duration of the 
study. Restrictions include, but are not limited to antimicrobial soaps, 


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antiperspirants/deodorants, shampoos, lotions, perfumes, after shaves, colognes, 
and topical or systemic antibiotics. 
• 
Cooperative and willing to follow Subject Instructions (Appendix 14.6). 
• 
Cooperative and willing to sign Consent Form / HIPAA Authorization Form. 
• 
Have Screening Day baseline counts of at least 1.0 x 103 CFU/cm2 per abdominal 
site (left and right) and at least 1.0 x 105 CFU/cm2 per groin site (left and right).  
4.2 
Subject Exclusion Criteria 
Subjects to whom any of these conditions apply will be excluded from this study: 
• 
Topical or systemic antimicrobial exposure within 14 days prior to Screening Day 
and up to and including Treatment Day. Restrictions include, but are not limited to 
antimicrobial soaps, antiperspirants/deodorants, shampoos, lotions, perfumes, 
after shaves, colognes, and topical or systemic antibiotics. 
• 
Taking antihistamines, immunosuppressants, or oral steroids within 14 days prior 
to Screening Day and up to and including Treatment Day (other than hormones for 
contraception or post-menopausal reasons). 
• 
Swimming in chemically treated pools or bathing in hot tubs, spas and whirlpools 
within 14 days prior to Screening Day and up to and including Treatment Day. 
• 
Use of tanning beds, hot waxes, or depilatories, including shaving (in the 
applicable test areas) within 14 days prior to Screening Day and up to and including 
Treatment Day. 
• 
Contact with solvents, acids, bases, fabric softener-treated clothing or other 
household chemicals in the applicable test areas within 14 days of the Screening 
Day and up to and including Treatment 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, 
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 pregnancy test will be performed 
before 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 the 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), currently enrolled in another clinical 
trial, or has previously participated in this study.  


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4.3 
Subject Consent 
The Investigator, or designated sub-investigators trained by the Investigator, must 
ensure that written informed consent to participate in the investigation is obtained 
before including any individual as a subject in the investigation. The Investigator, or 
designated sub-investigators trained by the Investigator, must provide the prospective 
subject or the representative sufficient opportunity to consider whether or not to 
participate, and minimize the possibility of coercion or undue influence. The process 
is designed to 1) give the subject all the information needed, 2) ensure that the subject 
understands the information, and 3) give the subject a chance to consider study 
participation. The process should permit the subject to ask questions and exchange 
information freely. 
Specifically, the Investigator, or designated sub-investigators trained by the 
Investigator, is to explain to each subject all elements of informed consent as specified 
in 21 CFR 50.25 (Appendix 14.5). After the explanation, subjects or their 
representative will voluntarily sign and date the consent form if they wish to participate 
in the study. A copy of the consent form must be provided to the subject. A signed and 
dated consent form must be maintained in the Investigator study documentation file at 
all times. 
4.4 
Subject Authorization for Use and Disclosure of Protected Health Information  
The Investigator, or designated sub-investigators trained by the Investigator, must 
ensure that written authorization for use and disclosure of Protected Health 
Information (PHI) is obtained before including any individual as a subject in the 
investigation. 
Specifically, the Investigator, or designated sub-investigators trained by the 
Investigator, is to explain to each subject all elements of authorization as specified in 
45 CFR 164.508. After the explanation, subjects or their representative must 
voluntarily sign and date the authorization form if they wish to participate in the study. 
A copy of the authorization form must be provided to the subject. A signed and dated 
authorization form must be maintained in the Investigator study documentation file at 
all times. 
An authorization form may be combined with a consent form (i.e., compound 
authorization) if required by the IRB. All required elements for both informed consent 
and authorization must be included in a compound authorization. 
5. 
Study Treatment  
These study procedures are based on the American Society for Testing and Materials 
(ASTM) “Standard Test Method for Evaluation of Preoperative, Precatheterization, or 
Preinjection Skin Preparations” (E 1173-151).  


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5.1 
Study Procedures 
Procedures will be performed by the Investigator or designated personnel trained by 
the Investigator.  
5.1.1 
Screening Phase Study Procedures 
5.1.1.1 Washout Period 
The Inclusion/Exclusion Criteria will be reviewed with each subject 
to ensure eligibility for the study. If these criteria are satisfied, 
subjects will sign the consent form / HIPAA Authorization Form 
before screening phase study procedures begin. Prior to the 
scheduled Screening Day, subjects will undergo a minimum 14-day 
washout period. The subjects will be instructed to avoid contact with 
any topical or systemic antimicrobial products for the duration of 
their involvement in the study as written in the Subject Instructions 
(Appendix 14.6). If it becomes necessary to take systemic 
antibiotics or to apply topical medications to the test areas within 
this pre-treatment period, the subject must contact the Investigator 
as soon as reasonably possible so that another volunteer may be 
recruited. 
Restrictions include, but are not limited to: 
• 
Use of antimicrobial soaps, shampoos, lotions, perfumes, after 
shaves, colognes, antiperspirants, deodorants 
• 
Contact with materials such as acids, bases, solvents 
• 
Swimming in chemically treated pools and bathing in hot tubs, 
spas and/or whirlpools 
• 
Use of tanning beds, hot waxes or depilatories (including 
shaving) 
Subjects will be provided a Product Washout Kit with non-
antimicrobial personal care products for exclusive use during the 
study. Subjects will also be provided with written instructions 
regarding the use of these products (Appendix 14.6). 
A visual skin assessment of the test areas will be performed. If 
subjects require hair removal to facilitate sample collection, the 
subject will be asked to return to the test facility at least 48 hours 
before the Screening Day. 
Subjects will be required to refrain from bathing or showering for 72 
hours prior to both the Screening Day and Treatment Day. 
Sponge bathing will be allowed, however, the subject must avoid 
the lower abdomen and upper thigh region. 


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5.1.1.2 Screening Day (Qualification Baseline Sampling) 
Subjects will be required to refrain from bathing or showering 72 
hours prior to Treatment Day and hair will be clipped at least 48 
hours prior to Screening Day. 
After the washout period and at least 3-days before Treatment Day, 
the Investigator or a designated assistant will complete the 
Screening Day Inclusion/Exclusion Criteria data capture form.  
Prior to performing the Screening Day baseline sample collection, 
a skin irritation assessment will be performed  
If an irritation score of 1 for any individual skin condition at the 
Screening Day baseline is assigned, the subject will be excluded 
from the study.  
A baseline screening sample will be collected from each test area 
using the Williamson-Kligman scrub cup technique3. Baseline 
samples will be taken from the center of each contra lateral test 
area within each anatomical region. Samples from both the left and 
right sides of a body region must meet the minimum value indicated 
in the Inclusion Criteria for the subject to be enrolled into the 
treatment phase of the study for that region. Subjects must qualify 
for both the abdominal portion and the groin portion of the study.  
Subjects who qualify for the study will be notified and will continue 
to follow the subject instructions until completion of the scheduled 
Treatment Day. 
Subjects will again be required to refrain from bathing or showering 
72 hours prior to Treatment Day and hair will be clipped at least 48 
hours prior to Treatment Day. 
5.1.2 
Treatment Phase Study Procedures 
A sufficient number of subjects who meet the entrance criteria will be enrolled 
into the treatment phase of the study for each region, such that the total 
number of abdominal regions and the total number of groin regions meets or 
exceeds the number required (72 abdominal regions and 72 groin regions for 
each treatment). The Randomization Scheme, given in the randomization 
document, will designate the treatment to each side of the abdomen and 
groin. A basic outline of a Randomization Scheme for the abdominal and 
groin sites is provided in Appendix 14.4. Additional details on the 
randomization will be found in the randomization document. 
The Treatment Day Inclusion/Exclusion Criteria will be completed on the 
source document and transcribed in the eCRF. If these criteria are satisfied, 


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a visual skin assessment will be performed to evaluate the condition of each 
test area. 
5.1.2.1 Preparation of Test Areas on Treatment Day  
A Test Site Diagram for the abdominal and groin test areas is shown 
in Appendix 14.3. Note: skin irritation will be assessed for all 
assigned test areas prior to treatment of any test area.  
5.1.2.1.1 Preparation of Abdominal Test Area 
The test site within the abdominal region (abdominal test 
area) is defined as the area below the umbilicus and 
above the groin. Using a 5” x 5” sterile template, the 
corners of each abdominal test area will be marked 
directly on the skin using a non-toxic skin marker. Four 
sampling sites will be numbered within each abdominal 
test area, on each side of the abdominal region. The 
positioning and numbering of the abdominal sampling 
sites are standard for all subjects. Sampling sites on the 
contra-lateral side of the abdomen will be numbered in 
a mirror-image orientation. The four sampling sites 
within each abdominal test area represent one baseline 
(pre-prep) site, one post-prep sampling site for each of 
two sampling times (30 seconds and 6 hours), and one 
unused sampling site. 
Prior to performing the Treatment Day baseline sample 
collection, a skin irritation assessment will be performed. 
If an irritation score of 1 for any individual skin condition 
at the Treatment Day baseline is assigned, the subject 
will be excluded from the treatment phase of the study. 
After abdominal test areas are marked and sample sites 
numbered, baseline samples will be collected from the 
appropriate site per the Randomization Scheme in each 
test area using the scrub cup technique. 
5.1.2.1.2 Preparation of Groin Test Area 
The test site within the groin region (groin test area) is 
defined as the inner aspect of the upper thigh within and 
parallel to the inguinal crease below the groin. Using a 
1.5” x 5” sterile template, the corners of each groin test 
area will be marked directly on the skin using a non-toxic 
skin marker. Four sampling sites will be numbered within 
each groin test area, on each side of the groin region. 
The positioning and numbering of the groin sampling 


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sites are standard for all subjects. Sampling sites on the 
contra-lateral side of the groin will be numbered in a 
mirror-image orientation. The four sampling sites within 
each groin test area represent one baseline (pre-prep) 
site, one post-prep sampling site for each of two 
sampling times (30 seconds and 6 hours), and one 
unused sampling site. 
Prior to performing the Treatment Day baseline sample 
collection, a skin irritation assessment will be performed. 
If an irritation score of 1 for any individual skin condition 
at the Treatment Day baseline is assigned, the subject 
will be excluded from the treatment phase of the study. 
After groin test areas are marked and sample sites 
numbered, baseline samples will be collected from the 
appropriate site per the Randomization Scheme in each 
test area using the scrub cup technique. 
5.1.2.2 Treatment Materials Application 
Following baseline sample collection, randomly assigned contra-
lateral test areas will be treated with the applicable treatment 
materials. The post-application sampling times will be randomized 
among the sampling sites within a test area. 
The treatment materials will be applied and the sampling 
configurations will be performed per the Randomization Scheme 
and the Study Material Treatment Application Instructions 
(Appendix 14.7). The duration of each application procedure will be 
recorded on the appropriate data capture form and transcribed in 
the eCRF. 
The applicator weight (ZuraPrep™ 
 
 
 
or the pre-filled applicator for the reference control article 
or vehicle and empty applicator for the negative control) will be 
measured and documented before and after application to the 
treatment site. See Appendix 14.7 for details.  
5.1.2.3 Timing of Post-Application Sample Collection 
Microbial samples will be collected at 30 seconds (± 5 seconds) and 
6 hours (± 30 minutes) post-treatment application for both the 
abdomen and the groin regions. Post-application timing begins 
upon completion of the treatment material application, including 
drying time. Microbial samples will be collected using the scrub cup 
technique (see Section 5.2.1). 


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After the 30 seconds (± 5 seconds) samples have been collected, 
sampling sites for 6 hours (± 30 minutes) will be covered indvidually 
with a piece of sterile gauze and a non-occlusive dressing to allow 
subjects restricted mobility and to protect the sites from 
contamination between sampling times. The subjects will be 
allowed to leave the clinical test facility, but must return at 6 hours 
(± 30 minutes) for the final post application sample collection 
A skin irritation assessment will be performed prior to collection of 
the post-treatment microbial sample collection (30 seconds and 6 
hours) and a corresponding rating score using the Skin Irritation 
Rating Scale for each individual skin condition will be recorded on 
the subject’s data capture form and transcribed in the eCRF. See 
Appendix 14.11.  
If an irritation score of 3 for any individual skin condition at any post-
treatment observation is assigned, the subject will be discontinued 
from the study and an adverse event will be recorded. See Section 
7.3 (Adverse Events). Following final sample collection, residual 
study materials will be wiped/cleansed from the subject’s skin using 
mild soap and/or tap water with a paper towel. 
5.2 
Microbiological Methods 
5.2.1 
Microbial Sample Collection / Scrub Cup Technique 
Quantitative cultures (screening baselines, treatment baselines and post-
treatment application) will be obtained by a modification of the cylinder 
sampling technique of Williamson-Kligman scrub cup technique. To collect 
the samples, a sterile scrub cup 
 will be placed on the site and 
held firmly to the skin. Sampling solution (SS) 
 will be pipetted into 
the cup and the skin will be scrubbed in a circular motion with moderate 
pressure for 1 minute using a sterile rubber policeman. Using a sterile 
transfer pipette, the SS will be removed and placed in a sterile test tube. An 
additional 
of fresh sampling solution will be pipetted into the cup and 
the scrub procedure will be repeated. This solution will be pooled with the 
first solution collected.  
5.2.2 
Sampling Solution (SS) 
The SS consists of sterile [75mM phosphate buffer 
 
containing 
 
SS). 
5.2.3 
Bacterial Enumeration Methods 
Following sample collection, 10-fold serial dilutions 
 
 will be prepared using Butterfield’s Phosphate Buffered Water with 


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neutralizers (PBW). One mL aliquots of appropriate dilutions will be pour-
plated in triplicate using Trypticase Soy Agar containing neutralizers 
(TSA+N). Samples must be plated within 30 minutes of collection. After 72  
4 hours of aerobic incubation at 30  2C, colonies will be counted and viable 
cells in the original sample will be calculated according to Standard Operating 
Procedures. After incubation, plates may be refrigerated up to 48 hours prior 
to counting.  
Raw colony counts from each dilution will be recorded on the appropriate 
data capture forms for each subject. The average number of microorganisms 
recovered (CFU/cm2) of skin for the screening and treatment day baseline 
samples will be calculated using the following formula to convert the plate 
CFU values into log10 CFU/cm2 of skin: 
R = log10 
 
 
Where: 
 
 
R = the average CFU count in log10 scale per cm2 of skin. 
 
F = total mL of stripping fluid added to the sampling cylinder 
  
 
Σci/n = average of the triplicate colony counts for each sample collected 
 
D = Dilution of the plates counted (100, 101, 102, 103, 104, or 105) 
 
A = Inside area of the sampling cylinder (
 
 
Dilution may be reported as dilution factor, which is the base 10 logarithm of the 
dilution. In that case, the factor of ‘D’ in the equation above will be replaced with 
10D. 
5.2.4 
Growth Promotion Control 
For each batch of plating medium, TSA+N, fewer than 100 CFU of 
 will be inoculated in a single plate 
pour plate. A 20-26 hours aged culture of 
 will be 
serially diluted in dilution fluid. The CFU added will be confirmed using 
triplicate trypticase soy agar (TSA) spread plates. The plates will be 
incubated for 72  4 hours of aerobic incubation at 30  2C. 
5.2.5 
Neutralizer Validation 
The effectiveness of the neutralizer system must be validated prior to the 
study start date to demonstrate that the antimicrobial is effectively neutralized 
and there is no effect on the growth of microorganisms. A procedure that will 
include in-vivo sampling will be combined with an in-vitro evaluation using 
procedures in accordance with ASTM E1054-084 (2013). The procedure is 
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A
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attached as Appendix 14.10. These data must be provided in the final report.  
5.3 
Medication(s)/Treatment(s) Not Permitted 
Topical or systemic antimicrobial exposure is not permitted within 14 days prior to the 
day of Screening Day, and during the study. Restrictions include, but are not limited to 
antimicrobial soaps, antiperspirants/deodorants, shampoos, lotions, perfumes, after 
shaves, colognes, and topical or systemic antibiotics. Exposure to antihistamines, 
immunosuppressants, or oral steroids within 14 days prior to Screening Day and up to 
and including Treatment Day (other than hormones for contraception or post-
menopausal reasons) is not permitted. 
5.4 
Subject Compliance 
Answers to the inclusion/exclusion questions (captured in the source documents and 
entered in the subject’s eCRF) asked at the beginning of the screening and treatment 
phases will determine compliance to the Subject Instructions (Appendix 14.6) provided 
to each subject upon study participation. Documentation of the Inclusion/Exclusion 
criteria shall serve as confirmation of subject compliance with the Protocol. 
6. 
Assessment of Efficacy 
6.1 
Efficacy Parameters 
The primary measure of antimicrobial efficacy is the reduction of skin flora on the 
abdominal and groin sites 30 seconds following application of the study treatments 
relative to the Treatment Day baseline counts. 
Product effectiveness will be measured using superiority and non-inferiority estimates 
for the 30-second sample time calculated using Average Treatment Effects (ATEs). 
The ATE will be estimated from a linear regression of the 30-second post-treatment 
bacterial count (log10 scale) on the additive effect of a treatment indicator and the 
baseline or pre-treatment measurements (log10 scale). To show effectiveness the test 
product will be 1) non-inferior to ChloraPrep® 
with a 0.5 margin (upper bound of 
95% confidence interval of the ATE of the test product versus active control value < 
0.5) and (2) superior to the ZuraPrep 
Vehicle (negative control) by a margin of 
1.2 (lower bound of 95% confidence interval of the ATE of the test product versus the 
vehicle value > 1.2). Superiority and non-inferiority will be calculated separately for 
each body area (abdomen and groin). 
6.1.1 
Secondary Endpoints/Analysis 
Persistence or long-term efficacy is defined in the Final Rule as having the 6 
hours post-treatment log10 CFU/cm2 values lower than or equal to the 
baseline log10 CFU/cm2 values for 100 percent of the subjects in each 
indication and body area. Due to the normal variability associated with this 
biological system, the test article is considered to have persistent effect if the 
percentage of body sites with log10 CFU/cm2 values less than or equal to 


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baseline for the 6-hour sample is between 95 to 100%. All subjects that do 
not achieve the 6-hour efficacy goal will be documented and discussed. This 
only applies to ZuraPrep™ 
 for the purpose of determining 
efficacy, but the same calculation will be performed for ChloraPrep® 
 
for information purposes only. 
6.1.2 
Study Validity 
There are no study validity criteria. All calculations performed for ZuraPrep™ 
 will be performed for ChloraPrep® 
, but for informational 
purposes only. 
6.2 
Assessment Methods  
Efficacy will be assessed by sampling the skin using the cup scrub method described 
in Section 5.2. See Section 8 for analysis methods. 
7. 
Assessment of Safety 
7.1 
Safety Parameters 
The principal measures of safety will be the recording of skin irritation scores and the 
incidence of adverse events reported during the study. 
7.2 
Assessment Methods for Skin Irritation 
After the washout period, the Investigator or designated sub-investigators trained by 
the Investigator will assess the subject’s skin condition and assign a skin irritation 
rating score using the Skin Irritation Rating Scale (see Appendix 14.11). A skin irritation 
score will be recorded at both the screening and treatment phases prior to baseline 
sample collections and prior to each post-treatment application sample collection (30 
seconds, and 6 hours). 
A corresponding rating score for each individual skin condition, for each site will be 
recorded on the appropriate data capture form and entered in the subject’s eCRF. 
(See Appendix 14.11, which includes the following four independent evaluation 
categories: Erythema, Edema, Rash, and Dryness).  
If an irritation score of 1 or greater for any individual skin condition prior to the baseline 
sample collection (at either the screening or treatment day phases) is assigned, the 
subject will be excluded from the study (no study treatment will be applied). 
If an irritation score of 3 for any individual skin condition at any observation period is 
assigned, the subject will be discontinued from the study and an adverse event will be 
recorded. See Section 7.3 (Adverse Events). 
7.3 
Adverse Events 
The Investigator is responsible for identifying adverse events that occur to each 


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subject throughout the study and follow-up period. An adverse event can occur at any 
time during the conduct of the study. Adverse events will be captured for all subjects 
from the time of screening baselines are taken until the time of discharge from the 
study. An adverse event can be identified by the Investigator or reported by the 
subject.  
 
Note: The Federal Privacy Rule (HIPAA) specifically permits the use and disclosure of 
protected health information “without written authorization of the individual” when used 
for public health activities such as reporting adverse events, tracking FDA-related 
products, enabling recalls, repairs, replacements, lookbacks, or conducting post-
market surveillance [45 CFR 164.512]. This use and disclosure is subject to the 
minimum necessary standard, i.e. “the minimum necessary to accomplish the intended 
use, disclosure, or request” [45 CFR 164.502(b)(1)]. 
Definitions: 
Adverse Event/Experience 
An Adverse Event/Experience is any unexpected or undesirable experience occurring 
to a subject during a study, which may or may not be related to the test article. All 
adverse event/experiences will be recorded and reported according to the Standard 
Operating Procedures of the laboratory. 
All adverse events, regardless of severity or the causal/effect relationship, will be 
recorded. The severity of the effect will be noted as “Mild,” “Moderate,” or “Severe” 
according the following definitions: 
Mild 
Awareness of signs or symptom, but easily tolerated. 
Moderate 
Discomfort to a degree as to cause interference with normal daily 
life activities and /or requiring medication. 
Severe 
Incapacity with inability to work or do usual daily life activities and 
requiring medical attention/intervention. 
 
Causal Relations of Adverse Event/Experience 
When determining the causal/effect relationship to the test article, the relationship will 
be described as “None,” “Possible,” “Probable,” or “Definite.” The following definitions 
will be utilized: 
None 
No association to the test article. Related to other etiologies such as 
concomitant medications or conditions or subject’s known clinical 
state. 
Possible 
Uncertain association. Other etiologies are also possible.  
Probable 
Clear-cut association with improvement upon withdrawal of the test 
article. Not reasonably explained by the subject’s known clinical state  


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Definite 
An adverse event with a clear-cut temporal association with exposure 
to study materials and cannot reasonably be explained by the 
subject’s known clinical state. Association with study material is 
confirmed by laboratory testing if possible.  
 
 
Serious Adverse Event/Experience 
A Serious Adverse Event/Experience is any adverse experience occurring at any dose 
that results in any of the following outcomes: 
• 
Death; 
• 
A life-threatening adverse drug experience; 
• 
Inpatient hospitalization or prolongation of existing hospitalization; 
• 
A persistent or significant disability/incapacity; 
• 
Congenital anomaly/birth defect; 
• 
An important medical event that may require medical or surgical intervention 
to prevent one of the previously listed outcomes. 
Unexpected Adverse Event/Experience 
An Unexpected Adverse Event/Experience is any adverse drug event/experience not 
listed in the current labeling for the test article or the current Investigator’s brochure. 
Where test article labeling or Investigator’s brochure is not available, anticipated 
experiences will be based on the known pharmacological/toxicological properties of 
the test article or ingredients. 
Recording and Reporting 
The Investigator or designee records all adverse events on an Adverse Event Record 
that will be transcribed in the subject’s eCRF. Documentation includes the AE 
description, term, severity, seriousness, date of onset and resolution, relationship to 
the test article, action taken and outcome. 
The Investigator must promptly report all treatment related adverse events to the 
Sponsor within two business days. All serious adverse events must be reported to the 
Sponsor and to the IRB within 24 hours of the Investigator awareness/notification of 
the event. 
If a subject has no adverse event during the study, the absence of such must be 
recorded on the eCRF. 
7.4 
Follow-up 
If an adverse event/experience occurs, the subject under the direction of the 
Investigator (or designee) may be referred to the nearest acute care facility for 
treatment. Serious or Unexpected Drug Event/Experience will be followed to resolution 
or until the AE has stabilized. Any adverse event will be documented on an Adverse 
Event Report and entered on the eCRF.  


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8. 
Statistics 
8.1 
Data Sets Analyzed 
The Intent-to-Treat (ITT) population will consist of all subjects who pass the pre-test 
period prior to baseline screening and are assigned a subject number for treatment. 
The ITT data set will include data for all of the ITT population. The ITT data set will be 
used for the safety analysis. 
Since each body site (left or right for abdomen or groin) can pass or fail Treatment Day 
baseline requirements separately, the per-protocol data set will be defined as those 
sites passing treatment day baselines on a site-by-site basis. Subjects are therefore 
included in the per-protocol population if and only if they have at least one qualifying 
body site. The per-protocol data set will be evaluated for efficacy. 
8.2 
Statistical Methods 
8.2.1 
Efficacy Analyses 
CFU values will be calculated as per the Bacterial Enumeration methods 
above. Individual plate CFU counts that are zero will be treated as 0.5 for 
further calculations. 
Product effectiveness will be measured using superiority and non-inferiority 
estimates for the 30-second sample time calculated using average treatment 
effects (ATEs). ATEs will be estimated from a linear regression of the 30 
second post-treatment bacterial counts (log10 scale) on the additive effect of 
a treatment indicator and the baseline or pre-treatment measurements (log10 
scale). Superiority and non-inferiority will be estimated as follows: 
a. ZuraPrep™ 
 will be compared to the ChloraPrep® 
. 
To show effectiveness, ZuraPrep™ 
 should be non-inferior 
to ChloraPrep® 
 with a 0.5 margin at 30 seconds. Specifically, the 
upper bound of the 95% confidence interval of the ATE of ZuraPrep™ 
 minus the ATE of ChloraPrep® 
 should be less than 
0.5. 
b. ZuraPrep™
 will be compared to ZuraPrep™ 
 
 Vehicle. To show effectiveness, ZuraPrep™ 
 
should be superior to ZuraPrep™ 
 Vehicle by a 1.2 margin 
at 30 seconds. Specifically, the lower bound of the 95% confidence 
interval of the ATE of ZuraPrep™ 
 Vehicle minus the ATE 
of ZuraPrep™ 
 should be greater than 1.2. 
Superiority and non-inferiority will be calculated separately for each body 
area. 
Persistence or long-term efficacy is defined as having the 6 hours post-


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treatment log10 CFU/cm2 values lower than or equal to the baseline log10 
CFU/cm2 values for 100% of the subjects in each body area. Due to the 
normal variability associated with this biological system, the test article is 
considered to have persistent effect if the percentage of body sites with log10 
CFU/cm2 values less than or equal to baseline for the 6-hour sample is 
between 95 to 100%.  All subjects that do not achieve the 6-hour efficacy 
goal will be documented and discussed. 
The efficacy calculations (superiority and persistence) only apply to 
ZuraPrep™ 
 for the purpose of determining efficacy, but the 
same calculations will be performed for ChloraPrep® 
 for information 
purposes only. 
Summary statistics for the log10 CFU/cm2 values at each time point and the 
respective changes from baseline will be calculated, grouped by time point, 
test product, and body area. These statistics are for information purposes 
only and are not part of efficacy calculations. 
8.2.2 
Safety Analysis 
The ITT population will be analyzed for safety. Skin irritation scores assessed 
in accordance with Appendix 14.11 will be reported for any subject who is 
scored with a 1 or more at any observation [baseline (screening day and 
treatment day), post-application/prior to 30 second and 6 hour sampling 
procedures], in any category for any site. 
Adverse events (including post-treatment skin irritation scores of 3 in 
accordance with Appendix 14.11, will be summarized. Summary tables will 
present incidence rates of adverse events by treatment group for all subjects 
who enter the treatment period. Listings of adverse events will be provided. 
The statistical significance of differences in skin irritation between the three 
treatments will be evaluated using Fisher’s exact test on skin irritation data 
summarized as follows: any reaction above zero (no reaction) on the skin 
irritation rating scale for any category (erythema, edema, rash, and dryness) 
for any post-treatment sampling time will be considered a positive signal for 
that substance. If Fisher’s exact test shows statistically significant skin 
irritation between the three treatments, a secondary analysis will be 
conducted to determine how the reactions differ. 
8.3 
Sample Size Justification  
The number of subjects for each treatment (ZuraPrepTM 
, ChloraPrep® 
 and ZuraPrepTM 
 
 Vehicle) is based off of the following 
assumptions: the primary efficacy parameters are as defined above; the power is 80%; 
and the ATEs (as approximated by mean reductions from baseline) and standard 
deviations of the ATEs are equivalent to the results 
 
 
 


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 all other components/ingredients remain 
consistent 
. Using the standard normal approximation, this 
requires 65 subjects per treatment. The number 108 was used to make randomization 
blocking easier and to be conservative. See Appendix 14.12 for the full Estimation of 
Sample Size report. 
8.4 
Subject Discontinuation Criteria 
A summary and/or listing of reasons for discontinuation will be provided.  
8.5 
Procedures for Accounting for Missing Data and Protocol Deviations 
Missing data will be reported as missing. No imputation will be performed. Calculations 
that use missing data points will still be performed if the calculation is still logically 
possible. 
Other irregularities or deviations which could affect the results will be handled on a 
case-by-case basis. Handling will be documented in the statistical report. 
8.6 
Deviations to Statistical Plan 
Any deviation(s) from the original statistical analysis plan will be described and justified 
in the final report. 
9. 
Monitoring 
Zurex Pharma, Inc., as sponsor of this study along with the Investigator, is responsible for 
ensuring the proper conduct of the study with regard to protocol adherence and validity of 
the data recorded on the source documents and eCRFs. Zurex Pharma, Inc. has, therefore, 
assigned a study monitor to this study. The progress of the study will be monitored by: 
• 
Periodic on-site review 
• 
Telephone communications and e-mail 
• 
Review of eCRFs and source documents  
The Investigator will give the Zurex Pharma, Inc. study monitor direct access to source 
documents that support data on the eCRFs and make available such records to authorized 
Zurex Pharma, Inc., quality assurance, IRB, and regulatory personnel for inspection and/or 
copying. 
Note: The Federal Privacy rule (HIPAA) specifically permits the use and disclosure of 
protected health information “to a person subject to the jurisdiction of the Food and Drug 
Administration (FDA) [e.g., study sponsor] with respect to an FDA-related product or activity 
for which that person has responsibility, for the purpose of activities related to the quality, 
safety, or effectiveness of such FDA-regulated product or activity” [45 CFR 
164.512(b)(1)(iii)]. 


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10. 
Quality Control and Quality Assurance 
Zurex Pharma, Inc. and the Investigator are responsible for implementing and maintaining 
quality assurance and quality control systems through written standard operating 
procedures (SOPs) to ensure that this study is conducted and data are generated, 
documented and reported in compliance with the protocol, GCP and regulations cited in 
Section 1.4 of this protocol. Study monitoring may be carried out to accomplish this. 
11. 
Ethics 
This study will be conducted in accordance with the principles that have their origin in the 
Declaration of Helsinki, 21 CFR 50 (Informed Consent) and 56 (IRBs). Laboratory 
operations will be conducted in accordance with 21 CFR 58 (Good Laboratory Practice for 
Nonclinical Laboratory Studies). 
The study will start only after approval of the protocol and consent form by the IRB. The 
approval letter or notice must contain the IRB name and identification number, meeting date, 
and sufficient information to identify the protocol and informed consent by name and number 
that were reviewed. Zurex Pharma, Inc., prior to study initiation, must receive a copy of the 
IRB approval letter. 
12. 
Data Handling and Record Keeping 
12.1 Study Personnel 
Prior to study initiation, the Investigator must provide Zurex Pharma, Inc. with a signed 
Investigator agreement as documentation of the Investigator’s commitment to conduct 
the study according to the protocol and all applicable state and federal regulations.  
12.2 Pre-Study Documentation Requirements 
Prior to study initiation, the Investigator must provide Zurex Pharma, Inc. with the 
following documents: 
• 
Signed protocol including any amendments in place prior to study initiation 
• 
Curriculum vitae for the Investigator and any co-Investigators 
• 
IRB-approved informed consent form containing subject authorization for use and 
disclosure of Protected Health Information statement.  
• 
IRB study approval letter (including approval of the protocol, consent form, 
Investigator and study facility) 
• 
IRB name, location and board membership listing  
• 
Signed Investigator agreement 
• 
Signed Study Agreement and Confidentiality agreement 


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12.3 Completion of Electronic Case Report Forms 
The primary source document for this study will be the subject's data capture form. 
The source documents will be retained at the site. 
For this study, an electronic data management system (EDMS) will be used for the 
collection of the study data in an electronic format. The EDMS will be designed based 
on the protocol requirements, the approved eCRF layouts and specifications, and in 
accordance with 21 CFR Part 11. The eCRF layouts and specifications define and 
identify the applicable source data that will be collected and captured into the EDMS. 
The applicable source data will be electronically transcribed by the site designee onto 
the eCRF (data entry screens) in the EDMS. The investigator is ultimately responsible 
for the accuracy of the data entered into eCRFs. Data monitoring and management 
will be performed in the EDMS by the study clinical monitor.  
12.4 Final Report 
The Investigator will prepare a final study report. The final report will be a record of the 
total study conduct and will be subject to review by Zurex Pharma, Inc. The final report 
will assess and summarize all data collected and include: test material identification, 
type of assay, randomization schedule, dates of study initiation and completion, and 
data demonstrating neutralization effectiveness. A review of the final report by Quality 
Assurance, including compliance statements will also be included with the final report. 
A copy of the final report will be sent to the study sponsor. 
12.5 Records, Reports and Retention Requirements 
The Investigator will maintain study records for a minimum of 2 years following the 
date a marketing application is approved for the indication for which is being 
investigated, or, if no application is to be filed or if the application is not approved for 
such indication, until 2 years after the investigation is discontinued and FDA is notified. 
Records that must be maintained by the Investigator include, but are not restricted to: 
● Signed study protocol, amendments, deviations 
● IRB approval of protocol, consent form, authorization form, waiver of consent 
and/or authorization and amendments to any of these documents 
● Applications to the IRB 
● Signed consent and authorization forms 
● eCRFs 
● Adverse event reports 
● Records of receipt, use or disposition of the study material 
● Correspondence relating to the study 
● Investigator Final Report 
● Sponsor Final Report (if provided) 


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13. 
References 
1. Annual Book of ASTM Standards, Vol 11.08. E 1173-15 (Reapproved 2009) Standard 
Test Method for Evaluation of Preoperative, Precatheterization, or Preinjection Skin 
Preparations. 
2. Butterfield, C.T. The Selection of a Dilution Water for Bacteriological Examinations. J. 
Bacteriol. 23: 355-368, 1931. 
3. Williamson, P., Kligman, A.M. A New Method for the Quantitative Investigation of 
Cutaneous Bacteria. J. Invest. Dermatol. 45:498-503, 1965.  
4. ASTM International. ASTM E1054-08 (2013), standard test methods for evaluation of 
inactivators of antimicrobial agents. West Conshohocken [PA]: ASTM Int’l; 2013. 
 
 


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14. 
Appendices 
14.1 Key Study Personnel, Titles, Responsibilities 
Zurex Pharma, Inc. Personnel: 
 
 
 
 
 
 
Microbac Personnel: 
M. Hamid Bashir, MD, CCRP, Laboratory Manager  
Principal Investigator 
 
 
  
 
: 
Statistical Consultant:  
 
 
 
 
 


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14.2 Study Summary 
Pre-Study 
Screening Phase 
Treatment Phase 
Preparation 
14 Day Washout 
Period 
Screening Day 
Abdominal Region 
Groin Region 
 
Staff reviews 
study protocol 
 
Initiation of 
consenting 
process 
 
 
Complete 
Screening 
Inclusion/ 
Exclusion Criteria 
form 
 
Complete Treatment  
Inclusion/ Exclusion Criteria form 
Prepare 
consent form 
Review study 
Consent Form 
and Inclusion/ 
Exclusion Criteria 
Visual skin 
assessment 
 
Visual skin assessment 
 
Obtain IRB 
approval 
Review subject 
instructions 
Collect screening 
baseline samples 
from abdominal 
and groin regions 
Mark test areas, 
Collect baseline samples 
Recruit 
volunteers for 
screening 
phase 
(14 day washout / 
screening day) 
Subject signs 
consent form 
Count screening 
plates, determine 
which volunteers 
qualify for study 
 
Apply test articles 
 
Prepare 
subject kits 
Visual skin 
assessment  
(abdominal and 
groin regions) 
Contact and enroll 
eligible subjects, 
schedule 
Treatment Day 
Visual skin 
assessment,  
30 seconds (± 5 
sec.) and 6 hours (± 
30 min.) post-prep 
sample 
Visual skin 
assessment,  
30 seconds (± 5 sec.) 
and 6 hours (± 30 
min.) post-prep 
sample 
 
Dispense subject 
kits 
Schedule for 
clipping, if needed, 
48 hrs. prior to 
Treatment Day 
visit 
 
Schedule for 
clipping, if 
needed, 48 hrs. 
prior to screening 
visit 
No bathing / 
showering 72 hrs. 
prior to Treatment 
Day visit 
Count Treatment 
Day Baseline plates, 
determine 
qualification and 
enroll additional 
subjects as required 
Count Treatment Day 
Baseline plates, 
determine 
qualification and 
enroll additional 
subjects as required 
 
No bathing / 
showering 72 hrs. 
prior to screening 
visit 
 
 
 
 
 
 


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14.3 Abdomen and Groin Diagram 
 
Follow the randomization scheme for each subject for the exact placement of study materials.  
 
 
 
 
 
Groin (anterior) – 1.5”’ x 5” area                                         Abdomen (anterior) – 5” x 5” area 
 
 
 
1 
2 
3 
4 
2 
1 
3 
4 
1 
2 
4 
3 


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14.4 Randomization Scheme Example 
 
Abdominal and Groin Sites Bilateral Sampling Procedure Configurations  
GROUP 1 
                  
Key: 
A = ZuraPrep™ 
 
B = ChloraPrep®
 (active control) 
C = ZuraPrep™ 
 Vehicle (negative control) 
Subject 
Left 
Treatment 
Right 
Treatment 
Site 1 
Site 2 
Site 3 
Site 4 
1001 
 
 
 
 
 
 
 
Treatment 
block 1 
 
 
 
 
 
 
 
 
 
Treatment 
block 2 
 
 
 
Subjects will be numbered sequentially from 1001 to 
the number of subjects treated during the study. 
Randomization will be performed by group issued 
prior to study initiation. 
 
 
 
 
 
 
Sample order group 1 
1002 
1003 
1004 
1005 
1006 
1007 
1008 
1009 
1010 
1011 
1012 
1013 
1014 
1015 
1016 
1017 
1018 
1019 
1020 
1021 
1022 
1023 
1024 
… 
 
 


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14.5 Required Elements of Informed Consent 
These elements of consent should be included as applicable to the study being 
conducted. 
 
1. Statement that the study involves research. 
2. Purpose(s) of the research. 
3. Expected duration of subject’s participation. 
4. Procedures to be followed and identification of any procedures that are 
experimental. 
5. A description of any reasonable foreseeable risks or discomforts to the subject. 
a) 
Risks/discomforts from study procedures. 
b) 
Foreseeable risks, which include adverse experiences listed in the 
Investigator’s Brochure or package insert. 
6. A description of any benefits to the subject or to others which may reasonably 
be expected from the research. 
7. A disclosure of appropriate alternative procedures or courses of treatment, if any, 
that might be advantageous to the subject. 
8. Extent to which confidentiality of records identifying subject will be maintained. 
a) 
Possibility that representatives of Zurex Pharma, Inc. and the FDA may 
inspect and make copies of the records. 
b) 
Suggested text: “Information on the Confidential Follow-up form (where 
used) will be held and treated with strict confidentiality and will be used only 
in the event that long-term follow-up is needed. 
c) 
Suggested text: “I understand that, at any time, an agent of Zurex Pharma, 
Inc. may also review any hospital, physician, or insurance billing or any 
other costs which relate to therapy incurred as a direct result of my 
participating in this study. 
9. An explanation as to whether any compensation or medical treatments are 
available if injury occurs for research involving more than minimal risk. The 
explanation should involve a description of the compensation or treatment 
available or a statement describing where further information may be obtained. 
10. Whom to contact for answers to pertinent questions about research and research 
subject’s rights. 
11. Whom to contact in the event of research-related injury to the subject. 
12. Participation is voluntary: 
a) 
Refusal to participate will involve no penalty or loss of benefits to which 
subject is otherwise entitled. 
b) 
Subject may discontinue participation at any time without penalty or loss of 
benefit to which subject is otherwise entitled. 


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ADDITIONAL ELEMENTS OF CONSENT 
 
When appropriate, one or more of the following elements of information shall also 
be provided to each subject. 
 
13. A statement that the particular treatment or procedure may involve risks to the 
subject (or embryo or fetus, if subject became pregnant) which are currently 
unforeseeable. 
14. Anticipated circumstances under which subject’s participation may be terminated 
by the Investigator without regard to subject’s consent. 
15. Any additional costs to the subject that may result from participation in the 
research. 
16. A statement explaining the consequences of subject’s decision to withdraw 
during the course of the research which may relate to subject’s willingness to 
continue participation will be provided to the subject. 
17. A statement that significant new findings developed during the course of the 
research which may relate to subject’s willingness to continue participation will 
be provided to the subject. 
18. Approximate number of subjects involved in the study. 
 
Nothing in these regulations is intended to limit the authority of a physician to provide 
emergency medical care to the extent the physician is permitted to do so under 
applicable federal, state, or local laws. 
 
Informed consent allows the subject to fully understand his/her participation and 
serves to protect the Investigator and Sponsor from potential negligence claims. A 
fully informed subject is the best protection against such claims. 
 
The informed consent requirements in these regulations are not intended to preempt 
any applicable federal, state, or local laws that require additional information be 
disclosed for informed consent to be legally effective. Some states, such as 
California and Oregon, require further action on the Investigator’s part concerning 
subject consent. 
 
 


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14.6 Subject Instructions – Washout, Screening Visit, Treatment Visit 
The following instructions are to be followed until the completion of the study. 
o 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Additional Instructions for Screening Visit:  
o 
 
 
 
 
 
  
 
 
  
 
You will be contacted by telephone as to whether you have met the established criteria 
and therefore will be returning for a Treatment visit (if selected). Remember to continue 
to use your kit products until you have been eliminated or have completed the study. 
 
 
Additional Instructions for Treatment Visit (if you are selected):  
o 
 
 
 
 
 
  
 
 
  
 
 
 
 
 
 
 
 
 


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14.7 Treatment Application Instructions 
ZuraPrep™ 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
Treatment Site Application Instructions 
Abdominal Test Site  
1. Using repeated back-and-forth strokes of the sponge for thirty (30) 
seconds, completely wet the treatment area with test material.  
2. Allow the area to air-dry for three (3) minutes. Do not blot or wipe away.  
Inguinal Test Site  
1. Using repeated back-and-forth strokes of the sponge for two (2) minutes, 
completely wet the treatment area with test material.  
2. Allow the area to air-dry for three (3) minutes. Do not blot or wipe away.  
 
ChloraPrep® 
 (active control) 
 
 
  
 
 
 
 
 
 
 
  
 
 


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Treatment Site Application Instructions 
Abdominal Test Site  
1. Using repeated back-and-forth strokes of the sponge for thirty (30) 
seconds, completely wet the treatment area with test material.  
2. Allow the area to air-dry for three (3) minutes. Do not blot or wipe away.  
Inguinal Test Site  
1. Using repeated back-and-forth strokes of the sponge for two (2) minutes, 
completely wet the treatment area with test material.  
2. Allow the area to air-dry for three (3) minutes. Do not blot or wipe away. 
ZuraPrep™ 
 Vehicle (negative control) 
 
 
 
 
 
 
 
 
  
 
 
 
Treatment Site Application Instructions 
Abdominal Test Site  
1. Using repeated back-and-forth strokes of the sponge for thirty (30) 
seconds, completely wet the treatment area with test material.  
2. Allow the area to air-dry for three (3) minutes. Do not blot or wipe away.  
Inguinal Test Site  
1. Using repeated back-and-forth strokes of the sponge for two (2) minutes. 
Completely wet the treatment area with test material.  
2. Allow the area to air-dry for three (3) minutes. Do not blot or wipe away.  
 
 


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14.8 Confirmation of Release and Receipt of Study Materials 
 
CONFIRMATION OF RELEASE and RECEIPT OF STUDY MATERIALS 
 
Investigator: M. Hamid Bashir, MD, CCRP 
Study No: Microbac 865-107 
Test Site: Microbac Laboratories, Inc., 105 Carpenter Drive, Sterling, VA 20164 
 
.  
 
Quantity 
(Units) 
Description 
ID/Lot 
Number 
Exp. Date 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
Supplies Released to Site by:   
_________________________________ 
 
 
 
 
 
 
Sponsor Signature 
 
 
 
Supplies Sent to Site (Date):  
 
___________________________________ 
 
 
 
Supplies Checked and Verified by:  
____________________________________________ 
 
 
 
 
 
 
Signature 
 
 
                           Date 
 
 
 
 
 
 
 
_____________________________________________ 
 
 
 
 
 
 
Print Name, Title 
 
Once the supplies have been verified and this form is signed / dated, a signature copy will be sent to the 
sponsor representative:
  
 
 


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14.9 Study Material Disposition Form 
Use one form for each study material. 
Study Number: Microbac 865-107 
Investigator: M. Hamid Bashir, MD, CCRP 
Investigator Site: Microbac Laboratories Inc., 
 
 
 
Study 
 Material ID: 
Date Received: 
Quantity 
Received: 
Lot Number/ Serial 
Number: 
Date Returned 
to Sponsor: 
 
 
 
 
 
 
Date Dispensed/Distributed 
Subject 
Number 
Quantity Dispensed 
Quantity Remaining 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 


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14.10 Procedure for Neutralization Validation 
1. 
Background 
The sampling solution, SS, sterile [75mM phosphate buffer 
 
 containing 
lecithin, 
Tween® 80, and 
 
Tamol, 
 is a buffered detergent solution that is commonly used in studies 
where microbial sampling of skin is conducted. Neutralizers have been added to inactivate 
the antimicrobial, isopropyl alcohol and chlorhexidine gluconate, present in test treatments. 
The effectiveness and toxicity of this neutralizer system must be assessed to demonstrate 
that there is no effect on the growth of microorganisms and that the active ingredient is 
inactivated. 
The density of normal human skin flora generally ranges from 102 to 105 CFU/cm2 depending 
on the body site. However, since significant neutralizer or toxic effects are more easily 
detected at a lower cell density, the efficacy and toxicity of this neutralizer system will be 
assessed against a lower bacterial concentration. 
This is a test where the study materials are applied to the abdomen and the treated areas 
will be sampled. After sampling, 
 a selected representative of 
normal skin flora will be added into a portion of each sample. Each sample will then be 
processed using procedures in accordance with ASTM E1054-08 (2013).  
2. 
Objective 
This control assay will determine the ability of the SS to completely neutralize the active 
ingredients in the test treatments when applied to the abdomen by recovering and 
quantifying microorganism populations on agar media and is appropriate for antimicrobial 
agents that can be chemically inactivated or diluted to sub-inhibitory levels. 
Neutralization validation will be conducted prior to the conduct of efficacy testing.  
3. 
Subject Entry Criteria 
 subjects will be used for the neutralization validation required for this study. Each 
subject must meet the inclusion and exclusion criteria described in Sections 4.1 and 4.2 
except for the baseline bacterial count, the 72-hour exclusion from showering/bathing and 
the length of the washout period. No minimum bacterial count is required and the washout 
period is only necessary for 7 days (not 14 days). The subjects will be asked to provide 
information on demographics and inclusion/exclusion criteria and sign the Consent and 
Authorization Forms before beginning the 7-day washout period. When the subjects return 
to begin their participation in the study they will again be asked to provide information 
relative to inclusion/exclusion criteria. If they meet all inclusion/exclusion criteria, they may 
be enrolled. The subjects will be identified by the letter “N” for neutralization and a subject 
number of 
 
The test, vehicle and reference control articles will be applied to the abdomen regions using 
bilateral applications so that 
applications are performed for each treatment using bilateral 


Microbac Laboratories, Inc. 
105 Carpenter Drive 
Sterling, Virginia 20164 
Page 47 of 53 
Zurex Pharma, Inc. Project:  ZX-ZP-0092 
Microbac Protocol: 865.1.03.25.18 
Microbac Project: 865-107 
 
Microbac - Confidential  
application 
 One area will be located on one side of the body and 
the remaining area on the other side. 
The treatments per subject will be randomized. The randomization scheme will be 
generated before the test.  
4. 
Test Organisms 
The test organisms for this study are: 
a. 
  
 
  
5. 
Treatment Materials 
a. 
ZuraPrep™
 (containing 70% v/v Isopropyl 
Alcohol) 
b. 
ChloraPrep® 
 (reference control article containing 2% 
chlorhexidine gluconate) 
c. 
ZuraPrep™
 Vehicle (negative control article) 
6. 
Materials, Supplies and Equipment 
See section 3.4.3 of the Microbac 865-107 Protocol. In addition, 70% v/v isopropyl alcohol 
swabs. 
7. 
In-vivo Test Procedures (collection of samples) 
Preparation of Test Area and Post-Prep Sampling: Neutralization samples will be taken from 
the abdomen. The subject number, location of the prep application, location of the sites 
sampled within the prep area, and the time of sample collection will be documented on the 
appropriate data capture form. The subject will be treated with the study materials based on 
the following. 
• 
For each side of the body, mark the abdominal test areas using a sterile 1.5” x 
5” template. The 1.5” x 5” areas will be delineated with each containing two 1” 
x 1” sampling site. 
• 
After the test areas are marked, each area will be processed using three 70% 
isopropyl alcohol swabs for a total of one minute to prepare the site; the areas 
will be allowed to dry. This step is to prepare the skin for the neutralization test.  
• 
Prep the test areas with the appropriate treatment according to the instructions 
provided in Appendix 14.7, Microbac 865-107 Protocol for groin. 
• 
Using the scrub cup technique at approximately 30 seconds post-prep, begin 
collecting samples from each of two sampling sites within each test area using 


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Microbac Laboratories, Inc. 
105 Carpenter Drive 
Sterling, Virginia 20164 
Page 52 of 53 
Zurex Pharma, Inc. Project:  ZX-ZP-0092 
Microbac Protocol: 865.1.03.25.18 
Microbac Project: 865-107 
 
Microbac - Confidential  
14.11 Skin Irritation Rating Scale 
 
a = A rating of 3 on the skin irritation scale in any category will be recorded as Adverse Event 
and will require subject’s removal from the study.  
 
 
Skin Irritation Rating Scale 
Reactive area(s) within the treatment site only 
Condition 
Rating Description 
Erythema 
0 
No reaction 
1 
Mild and/or transient redness  
2 
Moderate redness  
3a 
Severe redness  
Edema 
0 
No reaction 
1 
Mild and/or transient swelling  
2 
Moderate swelling  
3a 
Severe swelling  
Rash 
0 
No reaction 
1 
Mild and/or transient rash  
2 
Moderate rash  
3a 
Severe rash  
Dryness 
0 
No reaction 
1 
Mild and/or transient dryness  
2 
Moderate dryness  
3a 
Severe dryness  


Microbac Laboratories, Inc. 
105 Carpenter Drive 
Sterling, Virginia 20164 
Page 53 of 53 
Zurex Pharma, Inc. Project:  ZX-ZP-0092 
Microbac Protocol: 865.1.03.25.18 
Microbac Project: 865-107 
 
Microbac - Confidential  
14.12 Estimation of Sample Size Report 
 
 
See attached report. 
 
14.13 Informed Consent Forms 
 
 
   See attached forms.