A Pilot Clinical Study to Determine the Effect Denture Gel Has on the Prevention of Gum Abrasions
Phase: NA
Conditions: Gum Injury
Sponsor: Procter and Gamble

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The Procter & Gamble Company 
Cincinnati, Ohio USA 
Title Page 
A PILOT CLINICAL STUDY TO DETERMINE THE EFFECT DENTURE GEL HAS ON THE PREVENTION OF 
GUM ABRASIONS 
12 MAY 2021 
PROTOCOL NUMBER 2020089 
 
Investigator’s Agreement Statement: 
I have read, I understand, and I will conduct the 
study according to this Protocol and Good Clinical 
Practices. 
 
 
 
 
 
Dr. Jeff Milleman 
 
(D-Mon-Yr) 
 
 
Signatories will approve with e-signatures 
 
• 
Malgorzata Klukowska, DDS, PhD: Clinical Scientist/Medical Monitor 
• 
Julie Grender PhD: Statistician 
• 
Phyllis Hoke M.Ed.: Clinical Data Manager 
• 
Erinn Conde, BS: Clinical Trial Manager 
• 
Svetlana Farrell, DDS, PhD: Senior Director 
Global Oral Care-Clinical Operations and Performance Testing 
Sponsor: 
The Procter & Gamble Company 
Global Oral Care Clinical Operations 
8700 Mason-Montgomery Road 
Mason, OH 45040 
Principal Investigator 
Dr. Jeff Milleman, DDS, MPA 
Salus Research Inc 
1220 Medical Park Drive, Building #4 
Fort Wayne, IN 46825 
(260)-755-1099 
PII 

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Table of Contents 
  
Title Page ......................................................................................................................... 1 
1. 
STUDY OBJECTIVE............................................................................................................ 3 
2. 
OVERALL STUDY DESIGN AND PLAN .................................................................................. 3 
3. 
INCLUSION CRITERIA ....................................................................................................... 5 
4. 
EXCLUSION CRITERIA....................................................................................................... 5 
5. 
CONTINUANCE CRITERIA .................................................................................................. 5 
6. 
IDENTITY OF INVESTIGATIONAL AND ACCLIMATION PRODUCT(S)......................................... 5 
7. 
PRODUCT USAGE.............................................................................................................. 5 
8. 
BLINDING, LABELING, AND SHIPPING PLAN ........................................................................ 6 
9. 
METHOD OF ASSIGNING SUBJECTS TO TREATMENT GROUPS................................................ 6 
10. 
DETERMINATION OF SAMPLE SIZE ..................................................................................... 6 
11. 
SAFETY VARIABLES .......................................................................................................... 6 
12. 
EFFICACY VARIABLE ........................................................................................................ 7 
13. 
HYPOTHESES ................................................................................................................... 8 
14. 
STATISTICAL AND ANALYTICAL PLANS .............................................................................. 9 
APPENDIX ................................................................................................................... 10 
 
 
 
List of Abbreviations and Definition of Terms 
Abbreviation 
 
Definition 
ADA 
 
AE 
 
American Dental Association 
 
Adverse Event 
CFR 
 
Code of Federal Regulations 
CRF(s) 
 
Case Report Form(s) 
FDA 
 
Food and Drug Administration 
GCP 
 
Good Clinical Practices 
IRB/IEC 
 
Institutional Review Board/Independent Ethics Committee 
OST 
 
Oral Soft Tissue Exam 
SOP 
 
Standard Operating Procedure 
 
 
 
 
 
 
 
 
 
 

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1. Study Objective 
The objective of this pilot study is to evaluate the effectiveness of denture gel at treating and preventing gum 
abrasions while eating peanuts. 
2. Overall Study Design and Plan 
This is a single center, two-treatment, parallel design study.  Up to 40 subjects will be enrolled with a full 
mandibular and full maxillary denture with a history of food related abrasions.  
 
At each visit, an Oral Soft Tissue exam, a Mucosa Condition Assessment  and a Gum Abrasion Evaluation 
will be performed. At Baseline, the subjects will be randomized to a treatment group.  At Baseline, Week 2, 
and Week 4 subjects will be asked to eat 20 grams of peanuts 4 times for a total consumption of 80 g of 
peanuts (subjects will be permitted to take breaks if needed and drink small sips of water).   Following the 
peanut challenge, a licensed dental professional will re-evaluate the number and size of abrasions.  Subjects 
will receive a consumer questionnaire to complete as well prior to the Baseline, Week 2, and Week 4 
assessments.   
 
 
Table 1.  Study Schedule by Procedure Type and Visit 
 
PROCEDURE 
BASELINE 
DAYS 3, 6 
WEEK 2 
WEEK 4 
Informed Consent 
X 
 
 
 
Medical History Review 
X 
 
 
 
Demographics 
X 
 
 
 
Inclusion/Exclusion Criteria 
X 
 
 
 
Randomization 
X 
 
 
 
Continuance Criteria 
 
X 
X 
X 
OST 
X 
X 
X 
X 
Mucosa Condition Assessment 
X 
X 
X 
X 
Pre-Peanut Gum Abrasion Evaluation 
X 
X 
X 
X 
Product distribution/instruction 
X 
 
 
 
Subject eats 80 g of peanuts (20g, 4 times) 
X 
 
X 
X 
Post-Peanut Gum Abrasion Evaluation  
X 
 
X 
X 
Questionnaire* 
 
 
X 
X 
General Comments 
X 
X 
X 
X 
AEs 
X 
X 
X 
X 
Subject Accountability 
 
 
 
X** 
*This questionnaire will be analyzed outside of this protocol. 
**Subject accountability will be completed after subjects  
complete the study at any time.  
 
 
 
Baseline 

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Prior to the Baseline, subjects will be asked to refrain from eating approximately 4 hours prior to their 
appointment. Previously screened subjects will review and sign an informed consent and receive a copy 
at the Baseline visit.  The subjects’ medical history will be collected or updated on site source documents.  
Demographic information and Inclusion/Exclusion Criteria will be obtained and documented on the 
appropriate case report form (CRF).   
 
 Subjects will be asked to remove their mandibular and maxillary full dentures and the dentures will be 
cleaned (if applicable) and examined by a dental professional.  An OST will be performed followed by a 
Mucosa Condition Assessment, and a baseline pre-peanut challenge Gum Abrasion Evaluation.   
 
Subjects will be asked to eat 20 grams of peanuts 4 times for a total consumption of 80 g of peanuts 
(subjects will be permitted to take breaks if needed and drink small sips of water). Additionally, subjects will 
be timed for each peanut challenge.  If subjects are unable to finish the peanuts due to being too full or for 
any other reason, this will be noted in the eCRF General Comments. After completion of the peanut 
challenge, subjects will have a post-peanut challenge Gum Abrasion Evaluation.  
 
Next subjects will be randomized to one of two treatments balanced on their baseline post-peanut challenge 
gum abrasion evaluations (area and number) mucosa condition, and age. The subjects will  receive their 
products and site staff will review and provide written product use instructions.   
 
Subjects will be reminded to refrain from eating approximately 4 hours prior to next visit.     
 
Day 3, 6 
Continuance criteria will be assessed.  Subjects will be asked to remove their mandibular and maxillary full 
dentures and the dentures and subjects’ mouths will be cleaned by a dental professional if applicable.  An 
OST will be performed followed by a Mucosa Condition Assessment and then a Gum Abrasion Evaluation. 
Subjects will be reminded to refrain from eating approximately 4 hours prior to next visit.  
 
Week 2 
Continuance criteria will be assessed, and subjects will be asked to complete a questionnaire. Subjects will 
be asked to remove their mandibular and maxillary full dentures and the dentures and subjects’ mouths will 
be cleaned by a dental professional if applicable.   An OST will be performed followed by a Mucosa 
Condition Assessment and then a pre-peanut challenge Gum Abrasion Evaluation.   
 
Subjects will then be asked to eat 20 grams of peanuts 4 times for a total consumption of 80 g of peanuts 
(subjects will be permitted to take breaks if needed and drink small sips of water). Additionally, subjects will 
be timed for each peanut challenge.  If subjects are unable to finish the peanuts due to being too full or for 
any other reason, this will be noted in the eCRF General Comments. After completion of the peanut 
challenge, subjects will have a post-peanut challenge Gum Abrasion Evaluation.  Subjects will be reminded 
to refrain from eating approximately 4 hours prior to next visit.     
 
Week 4: 
Continuance criteria will be assessed, and subjects will be asked to complete a questionnaire. Subjects will 
be asked to remove their mandibular and maxillary full dentures and the dentures and subjects’ mouths will 
be cleaned by a dental professional if applicable.   An OST will be performed followed by a Mucosa 
Condition Assessment and then a pre-peanut challenge Gum Abrasion Evaluation.   
 
Subjects will then be asked to eat 20 grams of peanuts 4 times for a total consumption of 80 g of peanuts 
(subjects will be permitted to take breaks if needed and drink small sips of water). Additionally, subjects will 
be timed for each peanut challenge.  If subjects are unable to finish the peanuts due to being too full or for 
any other reason, this will be noted in the eCRF General Comments. After completion of the peanut 
challenge, subjects will have a post-peanut challenge Gum Abrasion Evaluation.  Subjects will return their 
kit boxes and will be dismissed from the study.    
 
General Comments and Adverse Events, if applicable, will be recorded.  Subject Accountability will be 
recorded as subjects are dismissed from the study at any point.   
 

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3. Inclusion Criteria 
In order to be included in the study, each subject must: 
1. Be 18 years of age;  
2. Read, sign, and receive a copy of the Informed Consent prior to initiation of study procedures; 
3. Have a full maxillary and mandibular denture and wear on a daily basis; 
4. Have a history of food particles getting under their full denture and causing gum irritation; 
5. Are willing to abstain from eating at least four hours prior to the visits; 
6. Are willing to eat 4 X 20 grams of peanuts three times (Baseline, Week 2 and Week 4) without denture 
adhesive; 
7. Clean their dentures on a daily basis; 
8. Agree not to change their regular denture cleaning routine; 
9. Agree to abstain from using denture adhesive during the study; 
10. Agree to not participate in any other oral/dental product studies during the study. 
 
4. Exclusion Criteria 
Subjects are excluded from study participation if they: 
1. Exhibit evidence of obvious oral pathology, as determined by the Study Dentist, as a result of a 
mandatory OST examination on the first day of the study; 
2. Are allergic to any of the ingredients contained in the study product gel; 
3. Are allergic to peanuts;  
4. Wear dentures overnight; 
5. Are insulin-dependent and/or have any health condition(s) which would prevent compliance with study 
procedures; 
6. Are routinely using denture adhesive;  
7. Present with any disease or conditions that could be expected to increase their susceptibility to gum 
abrasion (like diabetes or xerostomia); or 
8. Present with any disease or conditions that could be expected to interfere with examination 
procedures or the subject’s safe completion of the study. 
 
5. Continuance Criteria 
Subjects may be excluded from the study or the analysis if they: 
1. Become intolerant to study procedures; 
2. Develop insulin dependence and/or any health condition(s) which would prevent compliance with 
study procedures; 
3. Did not abstain from eating at least four hours prior to the visits; 
4. Have their denture altered during study; 
5. Use denture adhesive;  
6. Change their denture cleaning routine; 
7. Wear their denture overnight; 
8. Develop any disease or conditions that could be expected to increase their susceptibility to gum 
abrasion (like diabetes or xerostomia); or 
9. Are non-compliant with the protocol. 
 
6. Identity of Investigational Product(s) 
• 
Control: Current Denture Care  
• 
Treatment: Current Denture Care + Treatment Gel    
 
7.  Product Usage 
 
Control Group: 
Evening denture care: 

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In the evening subjects will perform their regular denture cleaning routine (if subjects brush their oral mucosa 
with brush, they will be allowed to continue doing so). They will be instructed to sleep without dentures.  
 
Treatment Group: 
Evening denture care: 
In the evening subjects will perform their regular denture cleaning routine. They will be instructed to sleep 
without dentures.  
 
Evening gel application: 
Subjects will rinse out their mouth with water (if subjects brush their oral mucosa with brush, they will be 
allowed to continue doing so) and apply gel to their mucosa where they normally wear upper or lower 
denture.  
 
Subjects will apply gel in the following order, reapplying gel onto the applicator each time: 
• 
onto the mucosa (right half) under the upper denture  
• 
onto the mucosa (left half) under the upper denture  
• 
onto the mucosa (right half) under the lower denture  
• 
onto the mucosa (left half) under the lower denture  
 
Subjects will leave the gel overnight. 
Subjects will not eat or drink anything in the evening after applying the gel. 
 
8. Blinding, Labeling, and Shipping Plan 
 
The take home kit boxes for the Control Group will contain a subject instruction sheet.  The take home kit 
boxes for the Treatment Group will contain disguised and labeled gel, an applicator, and a subject instruction 
sheet.   All instructions will be given (written and verbal). All labels will contain the study number, emergency 
phone number, distributor name/address, appropriate caution statements, and other information as required 
by internal regulations and clinical Standard Operating Procedures (SOPs).  The shipping containers will be 
labeled with the "ship to" clinical site address and a "content statement" listing study number and number of 
kit boxes contained within.  Supplemental product will be provided to the site.   
 
9. Method of Assigning Subjects to Treatment Groups 
Subjects who meet enrollment criteria will be stratified based on Baseline post-challenge number of lesions 
(< 1.6 vs. ≥1.6), size of lesion (<16mm vs ≥16mm), mucosa condition (≤ 1 vs. ≥ 1), and age (≤ 64 vs. >64).   
 
Subjects will then be randomized to one of the two (2) treatment groups using a balance and assignment 
procedure on site. This assignment process and the distribution of test products will be conducted in a 
protected area that will ensure blinding of the examiner to the identity of the test products.  Product will be 
distributed according to a randomization schedule provided by the Sponsor. Product distribution and product 
return will be recorded on the Clinical Materials Inventory provided by the Sponsor. Subjects from the same 
household will be assigned to the same treatment group. The balance and assignment cut points may be 
adjusted during the study. 
10. Determination of Sample Size 
The sample size of 40 subjects was chosen for logistical reasons. 
 
11. Safety Variables 
Safety Observations and/or Measurements 
Safety will be assessed by the absence of irreversible side effects.   
 
Oral Examination 

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Assessment of the oral soft tissue is conducted via a visual examination of the oral cavity and perioral area 
utilizing a standard dental light, dental mirror, and gauze.  The structures examined include the ridge , hard 
and soft palate, oropharynx/uvula, buccal mucosa, tongue, floor of the mouth, labial mucosa, 
mucobuccal/mucolabial folds, lips, and perioral area.    All abnormal findings will be recorded and 
categorized by their location.  An AE will be recorded if a new abnormal finding is noted after product 
distribution or any previously noted abnormal finding increases in severity during the treatment period.  
Subjects who experience an AE may be examined by the Medical Monitor, if necessary.     
 
12. Efficacy Variable 
Gum Abrasion Evaluation: 
 
A dental professional will assess the gingiva for any gum abrasions.  A periodontal probe will be used to 
measure the size of any presenting abrasions and will be documented in the eCRF.  The gum abrasion will 
continue to be measured throughout the duration of the study to track healing of the abrasion.    
 
 
Staining Procedure 
Staining solution: Mira-2-Ton (Mira-2-Ton® Hager & Werken GmbH & Co. KG. Duisburg, Germany) – same 
batch of stain solution will be used through the whole study. 
 
Prior to the staining oral mucosa will be dried with the air blast.  Subjects will swish 5 mL of Mira-2-Ton dye 
for 10 seconds followed by 5 mL of water for 10 seconds as well.  
 
Abrasion assessment 
Prior to the assessment, the mucosa under the denture will be dried with the air blast. During the 
measurement, the size of each lesion (colored dark blue) will be measured using periodontal probe 
(assessing the length and width  of the lesion). The location of the lesion(s) will also be documented on the 
diagram below, including whether the lesion is on the ridge or the mucosa (Pre-challenge Abrasion 
Evaluation).  The assessment notes on Figure 1 below will be summarized into ECRF.  All abrasion 
assessments will be carried out in the same quadrant ordering.  Loosely attached discolorations will be 
excluded from evaluation. If examiner has difficulty with assessment (plaque or abrasion), she/he will 
carefully try to remove the staining (non-removable stains will be assessed as abrasion). After the peanut 
eating exercise (no adhesive period), subjects will be instructed to rinse out their mouth till all of the particles 
are removed and the oral mucosa under the denture will be re-stained again prior to the 2nd assessment 
(Post-challenge Abrasion Evaluation). 
 
Figure 1. The location (and shape) of each gingival abrasion would be drawn on a maxillary and mandibular 
denture ridge chart.  
 

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. 
 
 
The exact dimension (as measured with the periodontal probe) of the abrasion will be recorded. For analysis 
purposes, abrasion might be divided into the following categories: 
 
• 
small, if Ø ≤ 2.5 mm, 
• 
medium, if Ø > 2.5, but ≤ 5 mm, 
• 
large, if Ø > 5 mm. 
 
Images (traditional or 3D) of abrasions might be taken for documentation and exploratory purposes.  
 
Mucosa Condition Assessment: 
 
The entire mucosal region under the denture will be assessed with one score per arch. 
 
0 = pink firm tissue absent of redness and inflammation; 1 = mild redness or inflammation – slight change 
in color and little change in texture; 2 = moderate redness and/or inflammation – moderate glazing, redness, 
edema and hypertrophy 3 = severe redness and/or inflammation – marked redness and hypertrophy 
 
13. Hypotheses 
 
Treatment  
 
Null Hypothesis: There is no difference between treatment groups for the abrasion endpoints (number of 
abrasions and size of abrasions, and mucosa assessment) across first 7 days after adjusting for the 
respective Baseline visit post-challenge abrasion endpoint. 
 
Alternative Hypothesis:  There is a difference between treatment groups in abrasion endpoints (number 
of abrasions and size of abrasions, and mucosa assessment) across first 7 days  after adjusting for the 
respective Baseline visit post-challenge abrasion endpoint. 
 
Prevention 
 
Null Hypothesis: There is no difference between treatment groups for the abrasion endpoints (number of 
abrasions and size of abrasions, and mucosa assessment) across weeks 2 and 4 after adjusting for the 
respective Baseline visit post-challenge abrasion endpoint. 

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Alternative Hypothesis:  There is a difference between treatment groups in abrasion endpoints (number 
of abrasions and size of abrasions, and mucosa assessment) across weeks 2 and 4 after adjusting for the 
respective Baseline visit post-challenge abrasion endpoint. 
 
 
14. Statistical and Analytical Plans 
 
To assess the impact of the product on the treatment of lesions, the average size of the Pre-challenge 
Abrasions (in mm) and the average Number of Pre-challenge Abrasions, and Mucosa Assessment across 
days 3 and 6 will be analyzed using a repeated measures analysis of covariance with factors in the analysis 
for treatment, day and respective baseline post-challenge lesion variable as the covariate.  The treatment 
by baseline lesion and treatment by day interactions will be assessed at the 10% level.  Additionally, the by 
day responses  will also be carried out separately from the repeated measures model,    
 
To assess the impact of the product on the prevention of lesions, the average size of the Pre-challenge 
Abrasions (in mm), the average Number of Pre-challenge Abrasions, and Mucosa Assessment across 
weeks 2 and 4 will be analyzed using a repeated measures analysis of covariance with factors in the analysis 
for treatment, week and respective baseline post-challenge lesion variable as the covariate.  The treatment 
by baseline lesion and treatment by week interactions will be assessed at the 10% level.  Additionally, the 
by week responses will also be carried out separately from the repeated measures model,    
 
 
The size of the Pre-challenge Abrasions might be collapsed into pre-defined categories.   
 
Additional analysis of the data might be carried out for exploratory purposes.  If the data does not satisfy the 
normality assumption, then a non-parametric analysis will be utilized. All statistical tests will be two-sided 
with 10% Type I error rate.   
 
Demographic data will be summarized for all subjects randomized in the study.    
 
 
 
 
 

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APPENDIX 
Adverse Event Reporting 
Abnormal findings which may qualify as AEs are those that: 1) were not present at Baseline and 
occurred after product usages of any duration, or, 2) were present at Baseline and worsened in severity 
after product usage of any duration.  All AEs will be recorded on the CRF. If a question should arise 
about the causal relationship of an AE to product usage, the Medical Monitor will be contacted to make 
the determination of relatedness. 
 An unexpected event is defined as one that is not identified in nature, severity, or frequency in the 
current safety assessment. The events will be reported to the FDA as required, upon receipt of pertinent 
clinical data and completion of the required forms. 
Any clinically significant abnormal laboratory finding, serious or unexpected AE, or medical event which 
results in the withdrawal of a subject from the study, must be followed to resolution with appropriate 
medical management, or as deemed necessary (with the Sponsor’s agreement).   
Advertising 
Any advertisements used in recruitment of subjects must receive prior approval from P&G and the 
Investigator’s IRB.  A copy of the IRB-approved advertising and the documentation thereof must be 
provided to P&G. 
Data Collection 
The Investigator has the responsibility for ensuring that all source documents (i.e., study and/or medical 
records) and CRFs are completed and maintained according to the study protocol and are available at 
the site. 
Any biological samples collected from subjects will be stored by the P&G lab. After a time period of two 
years from the last study visit, any remaining samples will be discarded. The P&G lab will provide a 
statement of proof to the sponsor’s Clinical Trial Manager.  
Case Report Forms 
The Data Manager will supply the paper and/or electronic CRFs to be used in this study.  It is the 
responsibility of the Investigator to maintain and submit accurate and timely CRFs to the Sponsor. All hard 
copy CRFs will be filled out legibly in ink.  
All questions should be answered.  For paper CRFs, if an entry requires correction, a single line will be 
placed through the entry so as not to obscure the original record, the corrected entry will be initialed and 
dated by the individual making the change, and a reason will be given for the change.  There will be no 
whiteouts or erasures.  For electronic CRFs, if an entry requires correction, the change is made directly 
to the CRF in the database, the user is prompted to provide a reason for the change, and the correction 
is logged in by an electronic audit trail. 
As necessary, the Data Manager may make specified allowable changes to the database without issuing 
a query to the site, as agreed upon by study site per this protocol. Examples of allowable changes include 
incorrect date formats, incorrect current year recorded (as in the start of a new year), and unambiguous 
spelling errors. Changes to common abbreviations and symbols to equivalent text to meet system or 
coding constraints (e.g., @ = at, ~ = approximately), may also be allowable. Values that are ambiguous 
or open to interpretation will be queried to the sites. It is the responsibility of the Data Manager to ensure 
all changes are supported by information contained elsewhere and/or are unambiguous. 

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Source Documents 
The Investigator has the responsibility for ensuring that all source documents (i.e., study and/or medical 
records) and CRFs are completed and maintained according to the study protocol and are available at 
the site. Any CRF used as a source document must be identified as such in the Investigator Notebook. 
Protocol Amendments/Changes 
Changes to the Protocol following IRB approval affecting the safety of subjects, scope or objectives of the 
investigation, or the scientific quality of the study will be documented as amendments.  Such changes will 
require the Sponsor, Investigator, and IRB approval prior to implementation, unless immediate action is 
required to safeguard subject safety.  Administrative or minor changes (e.g ., typographical errors, 
changes in Sponsor personnel, etc.) will be documented as revisions but may not need to be submitted 
as amendments unless required by the IRB.  Any change in the Sponsor’s monitoring staff, Clinical Trial 
Manager or Medical Monitor during the conduct of the study, will be reported to the Investigator. 
Good Clinical Practices 
This study is classified non-AMG, non-MPG according to German study classification but conducted in 
compliance with applicable sections of the US Federal Regulations governing informed consent (21 CFR 
50) and IRBs (21 CFR 56).  The conduct of this study will be in accordance with ICH-GCPs as published 
by the FDA, with the Commission Directive 2005/28/EC published by the European Union, and ISO 
14155:2011. During the course of the trial, the clinical site will allow monitoring by the Sponsor (Clinical 
Trial Manager or designee) to check compliance with the Protocol, regulations and guidelines, adequacy 
of the equipment and facilities, and satisfactory data collection. 
Institutional Review 
Prior to study initiation, the Investigator must obtain institutional review and approval of the Protocol, the 
consent form, and other necessary study-related documents in compliance with the US Code of Federal 
Regulations, Title 21, Part 56 or the ICH-GCPs Consolidated Guidelines, Chapter 3 and in compliance 
with Procter & Gamble SOP QS-CL-05 (“Institutional Review Board/Independent Ethics Committee 
Review and Approval”). The Investigator will maintain any original authorization letter(s) and will be 
available for review by the Sponsor. IRB approval letters should include the study title, Sponsor study 
number, the address of the IRB, date of request, and the signature of the IRB chairperson or designate.  
Additionally, the letter must acknowledge that both the Protocol and consent form have been approved 
by the IRB.  The study will not begin until the Sponsor has received confirmation of IRB approval.  The 
IRB shall also review the investigation at least once a year during study execution. The Investigator will 
notify the IRB when the study is terminated and provide confirmation that the study has been closed with 
the IRB to the Sponsor. 
Investigator Final Report 
Following completion of the study, the Investigator shall submit a final report to the Sponsor describing 
the conduct of the study, deviations from planned conduct, early withdrawals and subject accountability, 
adverse events, and other information on study conduct.  The Investigator’s IRB may require more 
frequent status reports. 
Records Retention 
The Investigator must retain the subject identification codes, informed consent documentation, clinical 
materials inventory, CRFs (paper or electronic media), medical records and other source data for a 
minimum of 2 years after the last regulatory approval has been received or the discontinuation of the 
study.  The Investigator must receive written authorization from the Sponsor before destroying any study 
document. The Investigator will make the records available for inspection and copying upon the request 

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of an authorized employee of a government authority or the Sponsor, at reasonable times.  In the event 
the Investigator retires, relocates, or for any other reason withdraws from the responsibility for maintaining 
records for the period of time required, custody of the records may be transferred to another person who 
will accept responsibility for the records.  Notice of such a transfer must be given in writing to the Sponsor. 
The Research Participant’s identification codes are a unique identifier assigned by the Principal 
Investigator to each trial subject to protect the Research Participant’s identity and privacy.  The 
identification codes are used in lieu of the Research Participant’s name when the Principal Investigator 
reports all adverse events and other trial related data. These codes will be used on all study documents 
for the Research Participant’s confidentiality, in order to protect the confidentiality of information 
concerning Research Participants, as stated in section 2.11 of the International Conference on 
Harmonization Good Clinical Practice: Consolidated Guideline (ICH-GCP). 
Serious Adverse Event Reporting 
A serious adverse event is defined as an event, which suggests a definite hazard or handicap to the 
subjects. Serious adverse events are any events resulting in death, life threatening situation, disability or 
permanent damage, hospitalization or prolongation of existing hospitalization, or congenital anomaly/birth 
defects; events requiring intervention to prevent permanent impairment/damage; or other serious 
(important) medical events. 
When an Investigator is notified of a serious AE, the Investigator must promptly (within 24 hours) notify 
the Sponsor (Clinical Trial Manager or the Medical Monitor) of the serious or unexpected event, regardless 
of causality.  Within 5 working days, a written and/or electronic report describing the circumstances of the 
event must be submitted to the Sponsor. The Investigator will be responsible for SAE reporting to the 
IRB.  
Study Medication Dispensing and Storage 
Study products will be stored in a secure area, under environmental condition as required by label 
instructions or as described in the Protocol and dispensed only under the authorization of the Investigator.  
The storage condition shall be properly documented.  Both the receipt and dispensation of all test products 
(used and unused) will be documented using forms provided by the Sponsor or suitable forms provided 
by the site. Study products will be returned to the Sponsor following the trial, or alternatively, they will be 
destroyed at the clinical site provided the site has an existing SOP for the destruction of clinical materials 
and prior written approval from the Sponsor. 
Subject Consent 
The Investigator will obtain written informed consent for each subject prior to participation in the study, 
per the US Code of Federal Regulations, Title 21, Parts 50.25 and 50.27 and ICH-GCPs, Chapter 4, 
subpart 4.8 and in compliance with Procter & Gamble SOP QS-CL-04 (“Informed Consent Form, Ethics 
Approval and Investigator Use”). Subjects, or their legal guardian, are required to read, sign and date an 
IRB approved consent form with the Investigator also maintaining a signed and dated copy.  The subject 
or legal guardian will be given a copy of the consent form. All study procedures must be explained in non-
technical terms.