A Multi-Center, Evaluator Blinded, Randomized Clinical Study to Evaluate the Efficacy and Tolerance of Two Acne Treatment Regimens on Subjects With Mild to Moderate Acne Vulgaris
Phase: NA
Conditions: Acne Vulgaris
Sponsor: Johnson & Johnson Consumer Inc. (J&JCI)

PROTOCOL # PS-1701 0314 5529-SACT 
 
    
Page 1 of 73 
 
This study will be performed in compliance with International Conference on Harmonisation Guidelines 
for Good Clinical Practice (E6). 
 
CONFIDENTIAL: The 
information in this document contains trade secrets and commercial information that are 
privileged or confidential and may not be disclosed unless such disclosure is required by Federal or State law 
or regulations. Subject to the foregoing, this information may be disclosed only to those persons involved in 
the study who have a need to know, but all such persons must be instructed not to further disseminate this 
information to others. These restrictions on disclosure will apply equally to all future information supplied to 
you, which is indicated as privileged or confidential. 
PROTOCOL TITLE: 
A Multi-Center, Evaluator Blinded, Randomized Clinical Study to Evaluate the 
Efficacy and Tolerance of Two Acne Treatment Regimens on Subjects with Mild 
to Moderate Acne Vulgaris  
PROTOCOL 
IDENTIFICATION: 
PS-1701 0314 5529-SACT 
DATE & VERSION: 
06 March 2017, Final Version 1.0  
SPONSOR: 
JOHNSON & JOHNSON Consumer Inc.  
  
 
STUDY SITES: 
Academic Dermatology Associates (Site 1001) 
  
Albuquerque, NM 87106 USA  
 
 
Thomas J. Stephens and Associates, Inc. (Site 1002) 
 
Richardson, TX 75081 USA 
 
 
PRINCIPAL 
INVESTIGATORS (PIs): 
Alicia Bucko, D.O. 
Academic Dermatology Associates 
 
Lily Jiang, Ph.D.  
Thomas J. Stephens and Associates, Inc. 
 
 
 
 
 
 
 
 
 
 

Protocol Title:  A Multi-Center, Evaluator Blinded, Randomized Clinical Study to Evaluate the Efficacy and Tolerance of Two Acne 
Treatment Regimens on Subjects with Mild to Moderate Acne Vulgaris 
Protocol Number: PS-1701 0314 5529-SACT 
Date & Version: 06 March 2017, Final Version 1.0 
 
Page 2 of 73 
 
 
VERSION TRACKING 
 
VERSION DATE 
STATE 
REASON FOR CHANGE DESCRIPTION OF CHANGE 
1.0 
06 March 2017 
Issued 
 New 
 N/A  
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

Protocol Title:  A Multi-Center, Evaluator Blinded, Randomized Clinical Study to Evaluate the Efficacy and Tolerance of Two Acne 
Treatment Regimens on Subjects with Mild to Moderate Acne Vulgaris 
Protocol Number: PS-1701 0314 5529-SACT 
Date & Version: 06 March 2017, Final Version 1.0 
 
Page 3 of 73 
 
 
SYNOPSIS 
 
PROTOCOL IDENTIFICATION 
PS-1701 0314 5529-SACT 
PROTOCOL TITLE 
A Multi-Center, Evaluator Blinded, Randomized Clinical Study to 
Evaluate the Efficacy and Tolerance of Two Acne Treatment Regimens 
on Subjects with Mild to Moderate Acne Vulgaris 
PRINCIPAL INVESTIGATORS (PIs) 
Alicia Bucko, D.O. 
Academic Dermatology Associates 
 
Lily Jiang, Ph.D. 
Thomas J. Stephens and Associates, Inc. 
STUDY SITES 
Academic Dermatology Associates (Site 1001) 
  
Albuquerque, NM 87106 USA  
 
Thomas J. Stephens and Associates, Inc. (Site 1002) 
 
Richardson, TX 75081 USA 
OBJECTIVE 
To evaluate and compare the efficacy and tolerance of two different 
acne treatment regimens (a cleanser used with a currently marketed 
red and blue light acne light therapy mask alone vs. the cleanser used 
with the same mask in conjunction with a light therapy topical gel-
cream) in subjects with mild to moderate acne over a 12-week period. 
STUDY DESIGN 
Multi-center, 2-cell, full-face, randomized, evaluator-blind 
STUDY POPULATION 
 Males (up to 50%) and females, 12 to 40 years old 
 Mild to moderate acne vulgaris on the face (10-100 non-
inflammatory lesions, 10-50 inflammatory lesions; no cysts; up to 2 
nodules; Investigator Global Acne [IGA] assessment score of 2-3.5 
using the Modified Cook’s Scale) 
SAMPLE SIZE 
A sufficient number of subjects will be screened to enroll up to 136 
subjects to finish with at least 90 subjects (targeting 45 subjects per 
cell).
 
INVESTIGATIONAL  
PRODUCTS (IP) 
Regimen/Cell 1: 
1) AM & PM Cleanser, 
 
2) PM Mask Treatment, 
 
3) Replacement Mask Activators, 
 
 
Regimen/Cell 2: 
1) 
AM & PM Cleanser, 
 
2) PM Gel-Cream,
 
3) PM Mask Treatment, 
 
4) Replacement Mask Activators, 
 

Protocol Title:  A Multi-Center, Evaluator Blinded, Randomized Clinical Study to Evaluate the Efficacy and Tolerance of Two Acne 
Treatment Regimens on Subjects with Mild to Moderate Acne Vulgaris 
Protocol Number: PS-1701 0314 5529-SACT 
Date & Version: 06 March 2017, Final Version 1.0 
 
Page 5 of 73 
 
 
SUCCESS CRITERIA 
 
 
 
STATISTICAL METHODS 
The primary efficacy variable is the percent change from baseline in 
Week 12 global face total lesion count, defined as the sum of 
inflammatory lesions (papules and pustules), open comedones, and 
closed comedones.   
 
For the primary efficacy variable, treatment means and between-
treatment differences will be assessed by means of a one-way 
Analysis of Covariance (ANCOVA) model with treatment, gender, and 
center as factors and the corresponding baseline score as a covariate.  
Monadic efficacy for a treatment will be concluded if the respective 
mean percent change from baseline is significantly different from 
zero.  Non-inferiority will be concluded if monadic efficacy is 
demonstrated in both treatments and the upper bound of the two-
side 95% confidence interval of treatment difference (mask with 
topical gel-cream minus the mask alone) is less than 15 percentage 
points.  If non-inferiority is demonstrated, the testing will proceed to 
superiority test.  Superiority of the mask with topical gel-cream 
treatment will be concluded if the upper bound of the two-sided 95% 
confidence interval of the treatment difference is less than 0.   
 
Each comparison will be tested at the 0.05 significance level, two-
sided.  With the stepwise procedure, the familywise error rate is 
controlled at the 0.05 level. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

Protocol Title:  A Multi-Center, Evaluator Blinded, Randomized Clinical Study to Evaluate the Efficacy and Tolerance of Two Acne 
Treatment Regimens on Subjects with Mild to Moderate Acne Vulgaris 
Protocol Number: PS-1701 0314 5529-SACT 
Date & Version: 06 March 2017, Final Version 1.0 
 
Page 7 of 73 
 
 
TABLE OF CONTENTS  
 
1. BACKGROUND 
..................................................................................................................................... 
10 
2. OBJECTIVE 
........................................................................................................................................... 
11 
3. OVERALL STUDY DESIGN AND PLAN DESCRIPTION 
............................................................................. 
11 
4. STUDY DURATION 
............................................................................................................................... 
13 
5. SUBJECT SELECTION AND ENROLLMENT ............................................................................................ 
13 
5.1. INFORMED CONSENT 
.................................................................................................................. 
13 
5.2. STUDY POPULATION ................................................................................................................... 
14 
5.2.1. Inclusion Criteria 
................................................................................................................. 
14 
5.2.2. Exclusion Criteria 
................................................................................................................. 
15 
5.3. SUBJECT RESPONSIBILITIES 
......................................................................................................... 
17 
5.4. CONCURRENT PRODUCTS 
........................................................................................................... 
17 
5.5. CONCURRENT MEDICATION ....................................................................................................... 
18 
5.6. SCREENING FAILURE ................................................................................................................... 
18 
6. INVESTIGATIONAL PRODUCTS (IPs) .................................................................................................... 
19 
6.1. IDENTITY OF IPs 
........................................................................................................................... 
19 
6.2. PACKAGING AND LABELING 
........................................................................................................ 
19 
6.3. STORAGE AND ACCOUNTABILITY 
................................................................................................ 
20 
6.4. PRODUCT QUALITY COMPLAINTS 
............................................................................................... 
20 
6.5. RANDOMIZATION 
........................................................................................................................ 
21 
6.6. BLINDING..................................................................................................................................... 
21 
6.7. APPLICATION/USE OF THE IPs & SUBJECT COMPLIANCE 
............................................................ 
22 
7. INVESTIGATIONAL PLAN ..................................................................................................................... 
22 
7.1. STUDY PROCEDURES AND EVALUATION SCHEDULE 
................................................................... 
22 
7.1.1. Pre-Study 
............................................................................................................................. 
22 
7.1.2. Visit 1 
................................................................................................................................... 
23 
7.1.3. Visit 2 (Week 1), Visit 3 (Week 2), Visit 4 (Week 4), Visit 5 (Week 8), & Visit 6 (Week 12) 26 
7.2. 
 
 
 
 
 
7.3. SUBJECT COMPLETION/WITHDRAWAL 
....................................................................................... 
31 
7.3.1. Subject Completion 
............................................................................................................. 
31 
7.3.2. Subject Withdrawal 
............................................................................................................. 
31 

Protocol Title:  A Multi-Center, Evaluator Blinded, Randomized Clinical Study to Evaluate the Efficacy and Tolerance of Two Acne 
Treatment Regimens on Subjects with Mild to Moderate Acne Vulgaris 
Protocol Number: PS-1701 0314 5529-SACT 
Date & Version: 06 March 2017, Final Version 1.0 
 
Page 8 of 73 
 
 
8. STATISTICAL ANALYSIS METHODS 
....................................................................................................... 
32 
8.1. Statistical Analysis Population ............................................................................................................ 
32 
8.2. Efficacy Analysis 
.................................................................................................................................. 
33 
8.2.1. Analysis of Primary Variable ............................................................................................... 
33 
8.2.2. Analysis of Secondary Variables 
.......................................................................................... 
34 
8.2.3. Analysis of Tertiary Variables 
.............................................................................................. 
34 
8.3. Tolerance and Safety Analysis............................................................................................................. 
36 
8.4. Sample Size Determination 
................................................................................................................. 
36 
9. SUCCESS CRITERIA 
............................................................................................................................... 
36 
10. MANAGEMENT OF INTERCURRENT EVENTS 
....................................................................................... 
36 
10.1. 
AMENDMENTS TO THE PROTOCOL 
......................................................................................... 
36 
10.2. 
PROTOCOL DEVIATIONS 
.......................................................................................................... 
37 
10.3. 
ADVERSE EVENT REPORTING 
.................................................................................................. 
37 
10.3.1. Introduction 
........................................................................................................................ 
37 
10.3.2. Definitions 
........................................................................................................................... 
37 
10.3.3. Procedures for Reporting Adverse Events 
.......................................................................... 
40 
10.3.4. Monitoring and Resolution of Adverse Events 
................................................................... 
42 
10.4. 
EXPOSURE IN UTERO 
............................................................................................................... 
43 
11. ETHICAL CONSIDERATIONS 
................................................................................................................. 
43 
11.1. 
STUDY SUBMISSION TO INSTITUTIONAL REVIEW BOARD/ INDEPENDENT ETHICS 
COMMITTEE OR HEALTH AUTHORITIES 
.................................................................................................. 
44 
12. DATA HANDLING AND RECORD KEEPING ........................................................................................... 
44 
13. STUDY MONITORING, QUALITY CONTROL AND QUALITY ASSURANCE 
.............................................. 
45 
14. SPONSOR DISCONTINUATION CRITERIA 
............................................................................................. 
45 
15. FINAL REPORT 
..................................................................................................................................... 
46 
16. CONFIDENTIALITY................................................................................................................................ 
46 
17. PUBLICATION ...................................................................................................................................... 
46 
18. REFERENCES 
........................................................................................................................................ 
46 
19. PROTOCOL SIGNATURES PAGE 
........................................................................................................... 
48 
20. PRINCIPAL INVESTIGATOR RESPONSIBILITY STATEMENT 
................................................................... 
49 
21. APPENDICES 
........................................................................................................................................ 
50 
Appendix I.  Fitzpatrick Skin Type Classification 
..................................................................................... 
51 
Appendix II.  Skin Sensitivity ................................................................................................................... 
52 

Protocol Title:  A Multi-Center, Evaluator Blinded, Randomized Clinical Study to Evaluate the Efficacy and Tolerance of Two Acne 
Treatment Regimens on Subjects with Mild to Moderate Acne Vulgaris 
Protocol Number: PS-1701 0314 5529-SACT 
Date & Version: 06 March 2017, Final Version 1.0 
 
Page 9 of 73 
 
 
Appendix III.  Investigator Global Acne (IGA) Assessment 
...................................................................... 
53 
Appendix IV.  Additional Investigator Efficacy Assessments .................................................................. 
54 
 
Appendix VI.  Subject Instructions – Regimen 1 
..................................................................................... 
56 
Appendix VII.  Subject Instructions – Regimen 2 
.................................................................................... 
58 
Appendix VIII.  PM Mask Treatment Package Insert 
............................................................................... 
60 
Appendix IX.  PM Gel-Cream & PM Mask Treatment Package Insert 
..................................................... 
63 
Appendix X.  Replacement Mask Activator Package Insert .................................................................... 
67 
 
 
 
Appendix XIV. Ingredient Lists 
................................................................................................................ 
72 
Appendix XV.  Contact Information 
........................................................................................................ 
73 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

Protocol Title:  A Multi-Center, Evaluator Blinded, Randomized Clinical Study to Evaluate the Efficacy and Tolerance of Two Acne 
Treatment Regimens on Subjects with Mild to Moderate Acne Vulgaris 
Protocol Number: PS-1701 0314 5529-SACT 
Date & Version: 06 March 2017, Final Version 1.0 
 
Page 10 of 73 
 
 
1. 
BACKGROUND 
 
Acne vulgaris is a common chronic skin disease involving blockage and/or inflammation of the 
pilosebaceous units (hair follicles and their accompanying sebaceous gland).  It is a multifactorial disease 
which results from an interplay of the following four main factors: (1) follicular epidermal 
hyperproliferation with subsequent plugging of the follicle, (2) excess sebum production, (3) increased 
proliferation and activity of the commensal bacteria such as Propionibacterium acnes (P. acnes), and (4) 
inflammation.   
 
Research has shown the benefits of red and blue light therapy in the treatment of mild to moderate acne, 
with red and blue light shown to target the acne-causing bacteria and have an effect on inflammation 
reduction.
1,2 
 
Light-based therapies have been used successfully to treat dermatological conditions since the early 
1900s, with various parts of the electromagnetic spectrum (i.e. ultraviolet [UV], visible, near-infrared, etc.) 
demonstrating different benefits.3 Light-emitting diodes (LEDs) offer delivery of light to the skin in a 
gentler manner as compared to light delivered by lasers, primarily due to the lower energy output.  It has 
been reported that LEDs do not deliver enough power to damage tissues and do not have the same risk 
of accidental eye damage that lasers do.  Visible-LED light therapy has been deemed a non-significant risk 
by the U.S. Food and Drug Administration (FDA) and has been approved for use in humans.
4 
 
It is well established in the literature5-10 that visible light penetration into the epidermal and dermal layers 
of human skin is primarily governed by absorption and scattering events, with the latter being the more 
impactful of the two.
8  Specifically, it is recognized that scattering in the Mie regime, where the size of the 
particles is equal to or greater than the wavelength of the incoming radiation, is the major obstacle to 
penetration.  Mie scattering is primarily anisotropic, making both forward and backward scattering 
possible.6 This is particularly relevant considering the structural heterogeneity of the epidermal and 
dermal layers.  Both in vivo and in vitro measurements have shown that scattering in the epidermal layer 
is due to melanin grains, which normally range from 30 – 400 nm in size, while scattering in the dermis is 
caused by collagen and 
its fibrillary suprastructure.
6,11 
Also relevant to note 
is the wavelength dependence 
of Mie scattering, with 
longer wavelengths being more penetrative.7 
 
It follows from the above that visible 
light penetration into human skin can be increased by reducing Mie scattering.  This can be accomplished 
by temporary hydrogen bonding disruption, which leads to the reversible rearrangement of epidermal 
and dermal structures that cause scattering.  Glycerol (i.e. glycerin), a known optical clearing agent, is 
hypothesized to generate the level of hydrogen bonding disruption described above, and therefore will 
be investigated in the present study.11 
 
This study will 
look to evaluate and then compare the acne clearing efficacy and tolerance of two different 
acne treatment regimens – 
a cleanser used with a currently marketed red and blue 
light acne 
light therapy 
mask alone vs. the cleanser used with the same mask in conjunction with a 
light therapy topical gel-cream 
– 
to determine the efficacy of these treatments and then to assess if the efficacy of the 
light therapy mask 
used with the topical gel-cream treatment is non-inferior to the mask alone in the reduction of lesions in 
mild to moderate acne. 
 
If non-inferiority 
is demonstrated, the 
mask with topical gel-cream treatment will 
be further assessed for its superiority to the mask alone. 
 
 

Protocol Title:  A Multi-Center, Evaluator Blinded, Randomized Clinical Study to Evaluate the Efficacy and Tolerance of Two Acne 
Treatment Regimens on Subjects with Mild to Moderate Acne Vulgaris 
Protocol Number: PS-1701 0314 5529-SACT 
Date & Version: 06 March 2017, Final Version 1.0 
 
Page 11 of 73 
 
 
2. 
OBJECTIVE 
 
The objective of this study is to evaluate and compare the efficacy and tolerance of two different acne 
treatment regimens (a cleanser used with a currently marketed red and blue light acne light therapy 
mask alone vs. the cleanser used with the same mask in conjunction with a light therapy topical gel-
cream) in subjects with mild to moderate acne over a 12-week period. 
 
3. 
OVERALL STUDY DESIGN AND PLAN DESCRIPTION 
 
This 
is a multi-center, 2-cell, full-face, randomized, evaluator-blind 
clinical usage study. 
 Up to 136 subjects 
will be enrolled to finish with at least 90 subjects (targeting 45 subjects per cell).  The target population is 
12- to 40-year-old males and females of any skin type who have mild to moderate acne vulgaris on the 
face.  Up to 50% of the enrolled subjects may be male. 
 
Subjects will be randomly assigned to use one of the two acne treatment regimens at home for 12 weeks.   
Each subject will be instructed to wash his/her face twice daily (morning and evening) with the AM & PM 
Cleanser.  In the evening after washing, subjects assigned to Regimen 1 will use the PM Mask Treatment 
for 10 minutes, while subjects assigned to Regimen 2 will apply the PM Gel-Cream full-face and let it dry 
prior to using the PM Mask Treatment for 10 minutes (mask treatment should begin within 15 minutes 
after PM Gel-Cream application). 
 
Subjects will be assessed at Baseline (Week 0), within 20 minutes after the first product usage, Week 1, 
Week 2, Week 4, Week 8, and Week 12, according to the Schedule of Events in Table 1 below.   
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

Protocol Title:  A Multi-Center, Evaluator Blinded, Randomized Clinical Study to Evaluate the Efficacy and Tolerance of Two Acne 
Treatment Regimens on Subjects with Mild to Moderate Acne Vulgaris 
Protocol Number: PS-1701 0314 5529-SACT 
Date & Version: 06 March 2017, Final Version 1.0 
 
Page 13 of 73 
 
 
4. 
STUDY DURATION 
 
The study will consist of 6 visits over 12 weeks.  Visit 1 (Week 0) will consist of Screening/Baseline and 
Post-1st 
Product Usage time points. 
 The Post-1st 
Product Usage time point should occur within 20 minutes 
after the initial product usage.   Subsequent visits will occur at Week 1 (Visit 2), Week 2 (Visit 3), Week 4 
(Visit 4), Week 8 (Visit 5), and Week 12 (Visit 6).  
 
As necessary, Visit 2 may be adjusted ± 1 day and Visits 3-6 may be adjusted ± 3 days.  All scheduling 
windows are versus Visit 1. 
 
If a subject misses a scheduled visit but notifies the study site, he/she will be allowed to re-schedule the 
missed visit 
if 
it 
is within the scheduling 
window as specified above.  
If 
it 
is outside the scheduling window, 
the Study Manager should be notified to determine if the visit should be rescheduled outside the 
scheduling window.  Study staff will need to assess subject compliance with IP usage to ensure the 
missed/altered visit did not result in lack of compliance.  A lack of compliance will be documented as a 
deviation and the Sponsor should be notified.  
 
5. 
SUBJECT SELECTION AND ENROLLMENT 
 
The study can fulfill its objective only if the required number of appropriate subjects are enrolled. The 
eligibility criteria are designed to select subjects for whom protocol procedures are considered 
appropriate.  All relevant medical and non-medical conditions should be taken into consideration, in 
addition to the inclusion/exclusion criteria below, when deciding if a particular individual is suitable for 
this protocol.  The inclusion and exclusion criteria will be reviewed for each subject and confirmed by the 
PI or, if the PI does not have a medical background, a medically qualified designee (M.D./D.O.) at Visit 1 
in order to determine subject eligibility. 
 
Prior to any review of personal data, the Informed Consent Document (and Assent, as applicable) should 
be signed. 
 
5.1. INFORMED CONSENT  
The Informed Consent Document (ICD) will be read by the subject and explained to the subject by the PI 
or designee.  For subjects below the age of consent (i.e. 12-17 years old), the subject’s legally acceptable 
representative will review the ICD and the subject will be given an IRB-approved Assent Form in place of 
the ICD.  The PI or designee must ensure that each study subject (and his/her legally acceptable 
representative, as applicable) is fully informed about the nature and objectives of the study and possible 
risks associated with participation (to the extent compatible with their understanding). After 
understanding and agreeing, the subject (and his/her 
legally acceptable representative, as applicable) will 
express his/her consent (or assent, as applicable) to the subject’s participation in the study by signing the 
ICD (or Assent Form, as applicable). 
 
No subject will be evaluated without a signed ICD (and Assent Form, as applicable), which should be kept 
by the PI as part of the Site Master File (SMF). The ICDs (and Assent Forms, as applicable) of subjects who 
are not enrolled in the study will also be part of the SMF.  
 

Protocol Title:  A Multi-Center, Evaluator Blinded, Randomized Clinical Study to Evaluate the Efficacy and Tolerance of Two Acne 
Treatment Regimens on Subjects with Mild to Moderate Acne Vulgaris 
Protocol Number: PS-1701 0314 5529-SACT 
Date & Version: 06 March 2017, Final Version 1.0 
 
Page 14 of 73 
 
 
One copy of the signed ICD (and Assent Form, as applicable) must be given to the subject (and his/her 
legally acceptable representative, as applicable); the subject (and his/her legally acceptable 
representative, as applicable) will remain free to withdraw this consent (or assent, as applicable) at any 
time without any negative consequence to the subject. 
 
The ICD and Assent Form must be approved by the Sponsor and the IRB/IEC and must be in compliance 
with ICH GCP, local regulatory requirements, and legal requirements. 
 
5.2. STUDY POPULATION 
 
5.2.1. Inclusion Criteria 
 
Individuals must meet all of the following inclusion criteria for enrollment into the study: 
 
a) Subject (and/or his/her legally acceptable representative, as applicable) has read, understood, 
signed, dated, and received a copy of the Photograph Release and Informed Consent Document 
(including HIPAA disclosure) after the nature of the study has been fully explained.  The legally 
acceptable representative’s consent and the subject’s assent must be secured for subjects under 
the age of 18 years (i.e. 12 – 17 years of age). 
b) Male or female (up to 50% of subjects may be male). 
c) 12 to 40 years old. 
d) Has 10-100 total non-inflammatory lesions (open comedones plus closed comedones), 10-50 
total inflammatory lesions, no cysts, and up to 2 nodules (if deemed appropriate by the PI or 
designee) on the face (see section 7.1.2.4.1).  
e) Has mild to moderate acne vulgaris on the face, as defined by an IGA assessment score of 2, 2.5, 
3, or 3.5 using the Modified Cook’s Scale (see section 7.1.2.4.2). 
f) Able to read, write, speak, and understand English. 
g) In generally good health as determined by the PI or designee, based on medical history reported 
by the subject. 
h) Males and females of reproductive potential must agree to practice a medically acceptable form 
of birth control during the study and for 30 days after study completion.  Females must have 
used such birth control for at least 3 months prior to Visit 1.  Medically acceptable forms of birth 
control that may be used by the subject and/or his/her partner include:   
o Established use of hormonal methods of contraception (oral, injected, implanted, 
patch, or vaginal ring). 
o Barrier methods of contraception with spermicide: condom or occlusive cap 
(diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/suppository.  
o Intrauterine device or intrauterine system. 
o Surgical sterilization (e.g., in a monogamous relationship with male partner with 
vasectomy that has been confirmed effective by sperm count check, tubal occlusion, 
hysterectomy, bilateral salpingectomy).   

Protocol Title:  A Multi-Center, Evaluator Blinded, Randomized Clinical Study to Evaluate the Efficacy and Tolerance of Two Acne 
Treatment Regimens on Subjects with Mild to Moderate Acne Vulgaris 
Protocol Number: PS-1701 0314 5529-SACT 
Date & Version: 06 March 2017, Final Version 1.0 
 
Page 15 of 73 
 
 
o Abstinence from heterosexual intercourse: when this is in line with the preferred and 
usual lifestyle of the subject.  Periodic abstinence (e.g. calendar, ovulation, 
symptothermal, post-ovulation methods) and withdrawal are not acceptable methods 
of contraception.  
A female is not considered of reproductive potential if she is post-menopausal (i.e. amenorrheic 
[not menstruating] for at least 12 months prior to study start). 
i) Intends to complete the study and is willing and able to fulfill the subject responsibilities (see 
section 5.3). 
 
5.2.2. Exclusion Criteria 
 
Subjects meeting any of the following criteria must be excluded from the study: 
 
a) Has very sensitive skin or known allergies or sensitivities to skincare products, toiletries or their 
components, or ingredients contained in the IPs (Appendix XIV). 
b) Has a known light or photosensitivity disorder, or is currently using medication that may cause 
sensitivity of the skin to light, as determined by the PI or designee based on subject report.  
c) Has severe acne or acne conglobata. 
d) Has a pre-existing or dormant facial dermatologic condition (e.g., psoriasis, rosacea, rashes, 
many and/or severe excoriations, etc.) that could interfere with the evaluations, confound study 
results, or increase health risk to the subject, as determined by the PI or designee. 
e) Has a history of immunosuppression/immune deficiency disorders (including HIV infection or 
AIDS) or is currently using immunosuppressive medications (e.g., azathioprine, belimumab, 
cyclophosphamide, Enbrel®, Imuran®, Humira®, mycophenolate mofetil, methotrexate, 
prednisone, Remicade®, Stelara®, etc.) and/or radiation (based on subject report). 
f) Is currently using, planning to use during the study (other than the IPs), or has used any of the 
following in the specified time range (based on subject report): 
 
Any of the following on the face: 
 Light therapy  
 OTC topical medications/products 
(including anti-acne or antibacterial agents, 
topical anti-inflammatories, topical 
retinoids, etc.).  Sunscreens (SPF) are 
acceptable. 
2 weeks prior to Visit 1 
Natural or prescription testosterone blocker 
(e.g. saw palmetto, black cohosh, chaste tree, 
chasteberry, spironolactone, drospirenone, 
progestins).  Oral contraceptives are 
acceptable. 
Currently at Visit 1 
Prescription (oral or topically applied on the 
face) antibiotics, inhaled steroids (except 
1 month prior to Visit 1 

Protocol Title:  A Multi-Center, Evaluator Blinded, Randomized Clinical Study to Evaluate the Efficacy and Tolerance of Two Acne 
Treatment Regimens on Subjects with Mild to Moderate Acne Vulgaris 
Protocol Number: PS-1701 0314 5529-SACT 
Date & Version: 06 March 2017, Final Version 1.0 
 
Page 16 of 73 
 
 
those prescribed for allergies), or hormones 
(pre- or post-menopausal hormone-
replacement therapy; insulin, etc.), or other 
medications that could make skin more 
sensitive or have an effect on the skin, as 
determined by the PI or designee.  Oral 
contraceptives are acceptable. 
Prescription medication for acne (e.g. 
doxycycline, minocycline, clindamycin, 
sulfamethoxazole and trimethoprim 
[Bactrim], tetracycline, erythromycin, 
azithromycin, or Vibramycin®) 
1 month prior to Visit 1 
Topical prescription retinoids (e.g. Retin-A®, 
Retin-A Micro®, Renova®, Adapalene, 
Tazarotene, Avita®, Tazorac®, Avage®, 
Differin®), azelaic acid, benzoyl peroxide, 
dapsone, sodium sulfacetamide, Epiduo®, or 
other similar prescription drug on the face 
1 month prior to Visit 1 
Accutane or other oral retinoid 
6 months prior to Visit 1 
 
g) Female who (to the best of her knowledge) is pregnant, lactating, or planning to become 
pregnant during the study or within 30 days of study completion.  (Subject must document her 
response in ICD/Assent Form). 
h) Male whose female partner is (to the best of his/her knowledge) pregnant or planning to 
become pregnant during the study or within 30 days of study completion.  (Subject must 
document his response in ICD/Assent Form). 
i) Has a surgery and/or invasive medical procedure planned during the study. 
j) Has observable suntan, scars, nevi, tattoo, excessive hair (including beard, mustache, or goatee), or
 
other dermal conditions on the face that that could interfere with study evaluations or confound 
study results, as determined by the PI or designee. 
k) Concurrently participating in any other clinical study or has participated in another clinical study 
within 4 weeks prior to study start (Visit 1). 
l) Has a medical history of a disease/condition, a concurrent illness, or any other 
condition/situation that could interfere with study evaluations, confound study results, or 
increase health risk to the subject, as determined by the PI or designee. 
m) Is related to those persons involved directly or indirectly with the conduct of this study (i.e., Sponsor, 
PI, Sub-I, study coordinators, other site personnel, and the immediate families of each). 
 
 
 
 

Protocol Title:  A Multi-Center, Evaluator Blinded, Randomized Clinical Study to Evaluate the Efficacy and Tolerance of Two Acne 
Treatment Regimens on Subjects with Mild to Moderate Acne Vulgaris 
Protocol Number: PS-1701 0314 5529-SACT 
Date & Version: 06 March 2017, Final Version 1.0 
 
Page 17 of 73 
 
 
5.3. SUBJECT RESPONSIBILITIES 
 
The subject responsibilities are as follows: 
 
 Use the provided AM & PM Cleanser twice daily (morning and evening) to wash your full face for 
the duration of the study.  
 Regimen 1 subjects only:  Every evening for the duration of the study:  after washing and drying 
your face, use the PM Mask Treatment for 10 minutes. 
 Regimen 2 subjects only:  Every evening for the duration of the study:  after washing and drying 
your face, apply the provided PM Gel-Cream full-face and let it dry prior to using the PM Mask 
Treatment for 10 minutes (mask treatment should begin within 15 minutes after PM Gel-Cream 
application). 
 Use only the assigned products and your regular, non-medicated (other than SPF, which is 
acceptable) facial products that you have used for at least one month and that have been 
recorded/approved by the study staff at Visit 1 (see section 5.4). 
 Do not use any other light-based devices or receive any professional or aesthetic facial spa 
procedures during the study. 
 Do not shave or use any hair removal method on your face within the 24 hours prior to a study 
visit. 
 Do not start using any new personal care products (e.g. makeup, lotions, etc.) or change your 
currently used brands during the study. 
 On the day of study visits:  remove all leave-on facial products (including eye makeup) and wash 
with the provided facial cleanser 30 minutes to 2 hours prior to the visit and then do not apply 
any leave-on facial products until the visit is completed.  Note:  if you do not follow these 
directions, you will be asked to remove your makeup/products and wash your face with the 
provided cleanser on-site and then wait 30 minutes before evaluations are performed. 
 Avoid excessive sun/UV exposure (including tanning beds) for the duration of the study.  
 Attend all scheduled visits. 
 Do not begin any other clinical study during the current study. 
 Report any side effects, changes in health/medication, pregnancies, issues, or questions to the 
study staff. 
 Bring your study products to all visits.  Products must be returned at the final study visit.  Failure 
to return your products may result in forfeiture of compensation. 
 
See section 6 regarding detailed product usage instructions. 
 
5.4. CONCURRENT PRODUCTS 
 
During the study, subjects may not use any products on their face other than the assigned IPs and the 
subject’s regular facial products that have been recorded and approved by study staff at Visit 1.  
 

Protocol Title:  A Multi-Center, Evaluator Blinded, Randomized Clinical Study to Evaluate the Efficacy and Tolerance of Two Acne 
Treatment Regimens on Subjects with Mild to Moderate Acne Vulgaris 
Protocol Number: PS-1701 0314 5529-SACT 
Date & Version: 06 March 2017, Final Version 1.0 
 
Page 18 of 73 
 
 
To be approved, the subject’s regular facial products (moisturizers, eye makeup removers, color 
cosmetics, etc.): 
 must be recorded by the study staff at Visit 1.   
 must have been used for at least one month prior to study start. 
 must be non-medicated [other than SPF] and not contain benzoyl peroxide, salicylic acid, alpha 
hydroxy acids (AHAs), vitamins A (retinol) or C (ascorbic acid) or their analogs or derivatives.  The 
presence of SPF in products is acceptable. 
 cannot include cleansers, scrubs, cleansing products, masks, makeup removers/wipes (except to 
remove eye makeup only), or light-based devices. 
 must be maintained over the course of the study.  Intermittent recreational sunscreen usage 
(minimum SPF 30 recommended for face) is allowed if sun exposure is unavoidable. 
 
A subject should not shave or use any hair removal method on his/her face within the 24 hours prior to 
a study visit.  Subjects should not receive any professional or aesthetic facial spa procedures during the 
study. 
 
For the rest of the body, subjects should not start using any new personal care products (e.g. cleanser, 
treatments) or change their currently used brands during the study. 
 
5.5. CONCURRENT MEDICATION 
 
If a subject is taking any medication during the course of the study or within 1 month prior to the study, 
it must be recorded on the Concomitant Medication Form.  Minimum information required is the name 
of the medication. 
 
If this medication is linked to the treatment of a study/IP-related AE, the dose and duration of the 
treatment should be specified. 
 
Medications/therapies excluded are indicated in the Subject Exclusion criteria; the use of any excluded 
medications/therapies during the study will result in discontinuation of the subject.   
 
5.6. SCREENING FAILURE 
 
All individuals who signed the ICD/Assent Form and withdraw their participation or fail to meet all of the 
screening criteria during the initial evaluation will be considered a “screening failure.”  Data for screen 
failures will not be considered in the final report. 
 
An 
individual who 
is screen-failed but may qualify at a 
later time may be re-screened at the PI’s discretion, 
but the 
individual should be treated as a new candidate (i.e. new subject ID, new ICD, etc.). 
 
Any 
individual 
who screen fails and has an AE will not be re-screened. 
 
 
 
 
 
 

Protocol Title:  A Multi-Center, Evaluator Blinded, Randomized Clinical Study to Evaluate the Efficacy and Tolerance of Two Acne 
Treatment Regimens on Subjects with Mild to Moderate Acne Vulgaris 
Protocol Number: PS-1701 0314 5529-SACT 
Date & Version: 06 March 2017, Final Version 1.0 
 
Page 20 of 73 
 
 
 
 
   
 
 
   
 
 
   
 
Units of the AM & PM Cleanser will also be available for on-site usage prior to acclimation, as needed.  
Additional PM Mask Treatment units will also be available should a subject need a replacement. 
 
6.3. STORAGE AND ACCOUNTABILITY 
 
The PI or designee must ensure that deliveries of IPs from the Sponsor are correctly received by a 
responsible person and that the products are stored in a secure area under recommended storage 
conditions. The products for this study will be secured in a locked room or cabinet that is only accessible 
to site personnel and kept at 20-25°C (68-77°F) with relative humidity up to 60%.  Temperature and 
relative humidity should be recorded at least daily on business days (an alarm should be utilized to signal 
if conditions go out of range).  The PI or designee must maintain adequate records documenting the 
receipt, use, loss, or other disposition of the products on the Product Accountability Log or equivalent.  
 
At the end of the study, all IP units (used and/or unused) must be returned to the Sponsor
 
 
  
 
6.4. PRODUCT QUALITY COMPLAINTS 
 
A Product Quality Complaint (PQC) is any written, electronic, or oral communication that alleges 
deficiencies related to the identity, quality, durability, reliability, or safety of a product, including its 
labeling, delivery system, or packaging integrity.  It also includes device malfunctions. This does not 
include effectiveness, preference, or performance measures, which will be reviewed in aggregate at 
appropriate intervals.  Any PQC discovered during the initial inventory should follow the instructions 
provided on the receipt letter; no PQC form should be filed for issues identified when opening or 
unpacking a shipment. Subsequently, any observation of a PQC requires immediate notification to the 
Study Manager via a completed PQC form and telephone call. The PI or designee should complete, sign, 
and forward a copy of the PQC form to the Study Manager listed in Appendix XV. 
In addition, PQC information must be included on the Product Accountability Log or equivalent in the 
comments field.  The Study Manager listed can assist you or answer questions related to this process. To 
aid in the initial conversation and understanding of a PQC, the site staff may be asked to photograph the 
issue and send it to the Study Manager.  
 

Protocol Title:  A Multi-Center, Evaluator Blinded, Randomized Clinical Study to Evaluate the Efficacy and Tolerance of Two Acne 
Treatment Regimens on Subjects with Mild to Moderate Acne Vulgaris 
Protocol Number: PS-1701 0314 5529-SACT 
Date & Version: 06 March 2017, Final Version 1.0 
 
Page 21 of 73 
 
 
When enrolling subjects into this study, it is the site’s responsibility to instruct subjects not to use the 
product if they have a concern related to the product, labeling, or package integrity and to immediately 
report it to the study site. 
 
6.5. RANDOMIZATION 
 
Subjects who sign the ICD (or Assent Form, as applicable) will be sequentially assigned a Subject ID.  The 
Subject ID will begin with the four-digit center ID (Academic Dermatology Associates: “1001”; Thomas J. 
Stephens and Associates, Inc.: “1002”) followed by a unique four-digit subject identifier assigned in 
ascending order and beginning with “1001,” resulting in an eight-digit Subject ID (e.g. “10011001,” 
“10011002,” etc.).  Once a Subject ID has been assigned to a subject, it cannot be reassigned to another 
subject.   
 
Upon enrollment in the study, each subject will be assigned a unique randomization number, which will 
determine the treatment assignment for each subject according to a randomization schedule.  The 
randomization scheme will be devised by the Sponsor’s Quantitative Sciences Department.  For subjects 
with a score of 2.0 or 2.5 on the IGA assessment, the site will assign randomization numbers in 
ascending sequential order within the site, i.e. starting with the lowest available number.  For subjects 
with a score of 3.0 or 3.5 on the IGA assessment, the site will assign randomization numbers in 
descending sequential order, i.e. starting with the highest available number.  Once a randomization 
number has been assigned to a subject, it cannot be reassigned to another subject.   
 
6.6. BLINDING 
 
The randomization numbers will be incorporated into the product labeling and the regimen-specific 
products will be packaged in opaque kits, as described in section 6.2. 
 
This study will be evaluator-blinded, so the PI/evaluators will not know which treatment cell each 
subject is in.  Personnel dispensing the IPs, supervising IP use, and/or administering/databasing Part B of 
the Subject Questionnaire will not participate in the evaluation of subjects in order to minimize potential 
bias.  IPs will be kept separate from the site personnel involved in assessing or evaluating the subjects, 
and subjects will be instructed not to discuss their assigned IPs with the evaluators. 
 
The randomization schedule will be used by the Sponsor to generate randomization number-specific 
single disclosure envelopes.  In the event that the PI or medically qualified designee believes an un-
blinding is necessary and circumstances allow, the PI or designee will contact the Study Manager who 
will consult with the Designated Physician Representative (DPR) to determine whether a code break is 
needed.  If there is a medical emergency and the PI or medically qualified designee deems it necessary 
to urgently know which IP the subject is using for the subject’s proper medical care, then the PI or 
designee may break the treatment code immediately by opening the provided randomization number-
specific disclosure envelope for that subject.  The time, date, and reason for the un-blinding should be 
noted in the subject’s source document and documentation should be provided to the Sponsor.  Upon 
completion of the study, all disclosure envelopes will be returned to the Sponsor. 
 
Blinding should only be broken for serious, unexpected, and related adverse events, and only for the 
subject in question, or when required by local regulatory authorities.  
 

Protocol Title:  A Multi-Center, Evaluator Blinded, Randomized Clinical Study to Evaluate the Efficacy and Tolerance of Two Acne 
Treatment Regimens on Subjects with Mild to Moderate Acne Vulgaris 
Protocol Number: PS-1701 0314 5529-SACT 
Date & Version: 06 March 2017, Final Version 1.0 
 
Page 23 of 73 
 
 
7.1.2. Visit 1  
 
Selected candidates will report to the test facility.  On the day of the study visit, candidate subjects 
should remove all leave-on facial products and arrive at the visit with a clean face.  Note:  if a candidate 
subject arrives with facial products on, he/she may remove the facial products and wash his/her face 
with a non-medicated cleanser on-site and then wait 30 minutes before screening evaluations are 
performed.  This will not be recorded as a deviation.  They will take part in the following procedures: 
 
7.1.2.1. Informed Consent 
 
Informed consent (and assent, as applicable) will be obtained as described in section 5.1.  The ICD will 
include a Health Insurance Portability and Accountability Act (HIPAA) disclosure.  Subjects (and their 
legally acceptable representatives, as applicable) will also review and sign a Photograph Release. 
 
Subjects 
who sign the ICD (or Assent Form, as applicable) will be sequentially assigned a Subject ID (see section 
6.5). 
 
7.1.2.2. Acclimation 
 
Subjects will acclimate to conditions in the facility for at least 15 minutes before clinical evaluations of 
eligibility are conducted.   
 
7.1.2.3. Medical History, Concomitant Medications, and Review of Eligibility 
 
The demographics (including Fitzpatrick Skin Type [Appendix I] and skin sensitivity [Appendix II]), 
medical history, and concomitant medications of each candidate subject will be collected and reviewed 
(this interview may occur during the acclimation period).   
 
All of the eligibility requirements of the study will also be reviewed to assess each candidate subject’s 
eligibility.  As part of this review, the Expert Grader will conduct a visual examination of the subject’s 
face and conduct the applicable clinical evaluations (see sections 7.1.2.4.1 and 7.1.2.4.2) after the 
acclimation period is completed in order to determine if the individual meets the eligibility 
requirements.  In addition, the PI or designee will record each subject’s regular facial products and 
review them for continued use during the study (see section 5.4). 
 
The PI or, if the PI does not have a medical background, a medically qualified designee (M.D./D.O.) will 
review the above information (medical history, concomitant medications, and eligibility review) to 
confirm the eligibility of each subject prior to their enrollment in the study.   
 
Upon enrollment, each subject will be assigned a randomization number (see section 6.5). 
 
7.1.2.4. Clinical Evaluations of Efficacy 
 
 
7.1.2.4.1. Acne Lesion Counts 
 
Each subject will have their open comedones, closed comedones, total inflammatory lesions (papules 
and pustules counted together in a combined “total inflammatory lesions” count), and nodules (defined 

Protocol Title:  A Multi-Center, Evaluator Blinded, Randomized Clinical Study to Evaluate the Efficacy and Tolerance of Two Acne 
Treatment Regimens on Subjects with Mild to Moderate Acne Vulgaris 
Protocol Number: PS-1701 0314 5529-SACT 
Date & Version: 06 March 2017, Final Version 1.0 
 
Page 24 of 73 
 
 
as greater than or equal to 5mm in size) counted by the Expert Grader and individually recorded for the 
total face.  The total face consists of the forehead, left and right checks, and the chin (including the area 
above the upper lip). 
 
Note:  For enrollment (see Inclusion Criterion d), an individual must have 10-100 total non-inflammatory 
lesions (open comedones plus closed comedones), 10-50 total inflammatory lesions, no cysts, and up to 2 
nodules (if deemed appropriate by the PI or designee) on the face.    
 
7.1.2.4.2. Investigator Global Acne (IGA) Assessment  
 
The Expert Grader will assign each subject an IGA assessment score using the grading scale in Appendix 
III.  Intermediate (i.e. half-point) grades will be used to permit for finer distinctions in the skin condition. 
 
Note:  For enrollment (see Inclusion Criterion e), an individual must have an IGA assessment score of 2, 
2.5, 3, or 3.5. 
 
7.1.2.4.3. Additional Investigator Efficacy Assessments 
 
The Expert Grader 
will assess each subject’s facial skin for the additional efficacy parameters shown below 
using the grading scales in Appendix IV.  Intermediate (i.e. half-point) grades will be used to permit for 
finer distinctions in the skin condition.  
 
 Overall Redness of Inflammatory Lesions 
 Overall Size of Inflammatory Lesions 
 
 
 
  
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 

Protocol Title:  A Multi-Center, Evaluator Blinded, Randomized Clinical Study to Evaluate the Efficacy and Tolerance of Two Acne 
Treatment Regimens on Subjects with Mild to Moderate Acne Vulgaris 
Protocol Number: PS-1701 0314 5529-SACT 
Date & Version: 06 March 2017, Final Version 1.0 
 
Page 25 of 73 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
7.1.2.7. IP Dispensing and First Use 
 
Each subject will receive a starter kit of the randomly assigned IP regimen (see section 6), along with a 
daily diary for the subject to record his/her product usage.  The site designee will review the IP usage 
instructions with the subjects prior to their first use of the regimen on-site. The first use will follow the 
evening instructions regardless of the time of the visit (this will not be considered a deviation).  Subjects 
attending a visit in the morning should wash their face again in the evening but not use the PM Mask 
Treatment or PM Gel-Cream again that first evening.   
 
 
 
 
 
 
 
 
 
 
7.1.2.9. Adverse Event Collection 
 
Individuals that have signed the ICD/Assent Form will be questioned and assessed for AEs before leaving 
the facility. 
 
 
 
 

Protocol Title:  A Multi-Center, Evaluator Blinded, Randomized Clinical Study to Evaluate the Efficacy and Tolerance of Two Acne 
Treatment Regimens on Subjects with Mild to Moderate Acne Vulgaris 
Protocol Number: PS-1701 0314 5529-SACT 
Date & Version: 06 March 2017, Final Version 1.0 
 
Page 26 of 73 
 
 
7.1.3. Visit 2 (Week 1), Visit 3 (Week 2), Visit 4 (Week 4), Visit 5 (Week 8), & Visit 6 (Week 12) 
 
On the day of each study visit, subjects should remove all leave-on facial products (including eye 
makeup) and wash with the provided facial cleanser 30 minutes to 2 hours prior to the visit and then not 
apply any leave-on facial products until the visit is completed.  Note:  if a subject does not follow these 
directions, he/she will be asked to remove his/her facial products and wash his/her face with the 
provided cleanser on-site and then wait 30 minutes before evaluations are performed (Note:  this will 
not be considered a deviation). 
 
At each visit: 
 
 Subjects will be interviewed for compliance with study instructions.  This may occur during the 
acclimation period. 
 Subjects will acclimate to conditions in the test facility for at least 15 minutes before the 
evaluations are conducted.   
 Visit 2:  The IGA assessment, additional investigator efficacy assessments, 
 
 will be repeated as described in sections 7.1.2.4.2 to 7.1.2.4.4.    
 Visit 3, Visit 4, Visit 5, and Visit 6:  All of the clinical evaluations of efficacy 
 will 
be repeated as described in section 7.1.2.4. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 A trained site designee will review each subject’s daily diary and weigh/review the IPs (as 
applicable) to assess subject compliance (see section 6.7).   
 Visit 4 and Visit 5:  A replacement kit of IPs will be dispensed.  The used Activators will be 
collected and retained by study staff. 
 Visit 6 only:  the daily diary and IP will be collected and retained by study staff. 
 Subjects will be questioned and assessed for AEs and any changes in their health or 
concomitant medications. 
 
 
 
 
 
 
 

Protocol Title:  A Multi-Center, Evaluator Blinded, Randomized Clinical Study to Evaluate the Efficacy and Tolerance of Two Acne 
Treatment Regimens on Subjects with Mild to Moderate Acne Vulgaris 
Protocol Number: PS-1701 0314 5529-SACT 
Date & Version: 06 March 2017, Final Version 1.0 
 
Page 27 of 73 
 
 
 
 
 
 
 
 
 
 
 
 
   
 
 
 
 
   
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
   
 
 
 

Protocol Title:  A Multi-Center, Evaluator Blinded, Randomized Clinical Study to Evaluate the Efficacy and Tolerance of Two Acne 
Treatment Regimens on Subjects with Mild to Moderate Acne Vulgaris 
Protocol Number: PS-1701 0314 5529-SACT 
Date & Version: 06 March 2017, Final Version 1.0 
 
Page 29 of 73 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
    
 
 
 
   
 
 
 skin within the given ROI normalized by the total 
number of pixels within the redness mask.   
 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
  
 
 
 
    
 

Protocol Title:  A Multi-Center, Evaluator Blinded, Randomized Clinical Study to Evaluate the Efficacy and Tolerance of Two Acne 
Treatment Regimens on Subjects with Mild to Moderate Acne Vulgaris 
Protocol Number: PS-1701 0314 5529-SACT 
Date & Version: 06 March 2017, Final Version 1.0 
 
Page 32 of 73 
 
 
• Lack of efficacy 
• Protocol deviation/violation (other than non-compliance) 
• Death (must be reported in accordance with the reporting requirements defined in the SAE 
section) 
• Other AE/SAE (must be reported in accordance with the reporting requirements defined in 
the AE/SAE section) 
 Pregnancy (must be reported in accordance with the reporting requirements defined in the 
Exposure in Utero section) 
 Study terminated by Sponsor 
• Lost to follow-up 
• Other 
Subjects may withdraw from the study at any time at their request, or they may be withdrawn at any time 
at the discretion of the Sponsor, PI, or designee for safety, behavioral, or administrative reasons. If a 
subject does not return for a scheduled visit, at least 3 documented attempts will be made to contact the 
subject in order to establish the reason for withdrawal, and the outcome will be documented. The PI or 
designee should inquire about the reason for withdrawal, request that the subject return for a final visit, 
if applicable, and follow-up with the subject regarding any unresolved adverse events.  
 
Should a subject withdraw from the study and also withdraw consent for disclosure of future 
information, 
no further evaluations should be performed and no additional data should be collected. The PI and staff 
may retain and continue to use any data collected before such withdrawal of consent.   
 
In case of early subject withdrawal, subjects may be replaced based upon overall enrollment numbers and 
with the approval of the Sponsor.  
 
8. 
STATISTICAL ANALYSIS METHODS 
 
The Sponsor’s Quantitative Sciences Department will be responsible for the data management and 
statistical analyses of this trial, 
 
 
 
Demographic and baseline characteristics will be summarized by treatment.  For continuous variables, 
descriptive summary will include number of subjects, mean, standard deviation, median, minimum and 
maximum values.  For categorical variables, descriptive summary will include the number and 
percentage of subjects in each response category. 
 
8.1. Statistical Analysis Population 
 
Tolerance and efficacy data will be evaluated for all intent-to-treat (ITT) subjects who used the IP and 
had baseline and at least one post-baseline data point.  Adverse events will be summarized for all 
subjects who signed the ICD (or Assent Form, as applicable), differentiating Treatment Emergent 
Adverse Events (see section 10.3.2.1).   
 
 

Protocol Title:  A Multi-Center, Evaluator Blinded, Randomized Clinical Study to Evaluate the Efficacy and Tolerance of Two Acne 
Treatment Regimens on Subjects with Mild to Moderate Acne Vulgaris 
Protocol Number: PS-1701 0314 5529-SACT 
Date & Version: 06 March 2017, Final Version 1.0 
 
Page 33 of 73 
 
 
8.2. Efficacy Analysis 
 
For each efficacy variable, summary statistics will be provided by treatment group at each time point.  
For continuous variables, descriptive summaries will include number of subjects, mean, standard 
deviation, median, minimum and maximum values.  Distributions of categorical variables will be 
summarized by presenting the number and percent of subjects in each response category.      
 
8.2.1. Analysis of Primary Variable 
 
The primary efficacy variable is the percent change from baseline in global face total lesion count at 
Week 12.  The total lesion count is the sum of inflammatory lesions (papules and pustules), open 
comedones, and closed comedones.   
 
The following comparisons will be performed: 
 
1. 
Mask alone treatment Week 12 vs. baseline 
2. 
Mask with topical gel-cream treatment Week 12 vs. baseline  
3. 
Mask with topical gel-cream treatment vs. mask alone treatment for non-inferiority 
4. 
Mask with topical gel-cream treatment vs. mask alone treatment for superiority 
 
To evaluate the efficacy of the mask alone treatment and the mask with topical gel-cream treatment, 
statistical comparisons for the primary variable will be based on a stepwise procedure starting with 
comparisons #1 and #2, which evaluate the monadic efficacy of mask alone treatment and the mask 
with topical gel-cream treatment, respectively.  If both comparisons are significant, testing will proceed 
to comparison #3 to evaluate the non-inferiority of the mask with topical gel-cream treatment to the 
mask alone treatment; otherwise, comparison #3 will be exploratory.   The difference between 
treatment groups will be computed as the mask with topical gel-cream treatment minus the mask alone 
treatment, and non-inferiority will be concluded if the upper bound of the two-side 95% confidence 
interval is less than 15 percentage points.  If the mask with topical gel-cream treatment is demonstrated 
to be non-inferior to the mask alone treatment, then testing will proceed to comparison #4; otherwise, 
comparison #4 will be exploratory. 
 
Comparison #4 will evaluate the superiority of the mask with topical gel-cream treatment versus the 
mask alone treatment.  Superiority will be concluded if the upper bound of the two-sided 95% 
confidence interval of the treatment difference is less than 0.   
 
Each comparison will be tested at the 0.05 significance level, two-sided. With the stepwise procedure, 
the familywise error rate is controlled at the 0.05 level. 
 
For the primary efficacy variable, treatment means and between-treatment differences will be assessed 
by means of an Analysis of Covariance (ANCOVA) model with treatment, gender, and center as factors 
and the corresponding baseline score as a covariate.       
 
If the global face total lesion count is missing at Week 12 for more than 5% of the subjects, the missing 
value will be imputed by using the last observation carried forward (LOCF) method.  
 

Protocol Title:  A Multi-Center, Evaluator Blinded, Randomized Clinical Study to Evaluate the Efficacy and Tolerance of Two Acne 
Treatment Regimens on Subjects with Mild to Moderate Acne Vulgaris 
Protocol Number: PS-1701 0314 5529-SACT 
Date & Version: 06 March 2017, Final Version 1.0 
 
Page 34 of 73 
 
 
8.2.2. Analysis of Secondary Variables 
 
The secondary efficacy variables are:  
 
a) The percent change from baseline in global face total lesion count: 
 Mean across all post-baseline visits (Week 2, Week 4, Week 8, and Week 12) 
 Mean of Week 2 and Week 4 
 Mean of Week 4 and Week 8 
 Mean of Week 8 and Week 12  
 Week 2, Week 4, and Week 8 analyzed separately 
 
b) Acne lesion counts at Week 2, Week 4, Week 8, and Week 12.  Each of the following lesions will be 
analyzed for the total global face: 
 Open comedones  
 Closed comedones  
 Inflammatory acne lesions (papules and pustules are counted together) 
 Non-inflammatory acne lesions (sum of open comedones and closed comedones) 
 Total lesion counts (sum of inflammatory and non-inflammatory acne lesions counts)  
 
c) IGA assessment using Modified Cook’s Scale at Week 1, Week 2, Week 4, Week 8, and Week 12.  
 
d) Additional investigator efficacy assessment at Week 1, Week 2, Week 4, Week 8, and Week 12:  
 Overall redness of inflammatory lesions 
 Overall size of inflammatory lesions 
 
For these variables, summary statistics will be summarized by visit and treatment.  The mean change 
from baseline within group and the corresponding 95% confidence interval will be calculated for each 
variable by treatment and time point.  Treatment means and between-treatment differences in change 
from baseline will be assessed by means of an Analysis of Covariance (ANCOVA) model with treatment, 
gender, and center as factors and the corresponding baseline score as a covariate.  The two-sided 95% 
confidence interval of the between-treatment difference will be constructed to provide information 
regarding the extent of the difference between two groups.  Percent change from baseline in acne 
lesion counts will be analyzed using the same methods as for the primary endpoint. 
 
8.2.3. Analysis of Tertiary Variables  
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
  
 
  

Protocol Title:  A Multi-Center, Evaluator Blinded, Randomized Clinical Study to Evaluate the Efficacy and Tolerance of Two Acne 
Treatment Regimens on Subjects with Mild to Moderate Acne Vulgaris 
Protocol Number: PS-1701 0314 5529-SACT 
Date & Version: 06 March 2017, Final Version 1.0 
 
Page 35 of 73 
 
 
 
  
 
 
 
  
 
 
 
  
 
 
 
   
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
     
 
 
 
 
 
 
 
 
 
 
 
 
   
 
 
 
 
 

Protocol Title:  A Multi-Center, Evaluator Blinded, Randomized Clinical Study to Evaluate the Efficacy and Tolerance of Two Acne 
Treatment Regimens on Subjects with Mild to Moderate Acne Vulgaris 
Protocol Number: PS-1701 0314 5529-SACT 
Date & Version: 06 March 2017, Final Version 1.0 
 
Page 37 of 73 
 
 
 
The only circumstance in which an amendment may be initiated prior to IRB approval 
is where the change 
is necessary to eliminate apparent immediate hazards to the subjects. In that event, the PI or designee 
must notify the IRB and the Sponsor in writing within 3 working days after the implementation. 
 
10.2. PROTOCOL DEVIATIONS 
 
Protocol deviations should be avoided whenever possible. When a protocol deviation occurs, it must be 
captured on a Deviation Log and on the individual subject source documentation and CRF, as applicable. 
 
The PI or designee will also contact the Study Manager (see Contact Information in Appendix XV).  
Contact with the Study Manager will be made as soon as possible in order to discuss the situation and 
agree on an appropriate action. If it is determined that the subject safety/well-being was affected, the 
IRB/IEC, if any, will also be notified. The final report will describe the deviation from the protocol and 
the circumstances requiring it. 
 
10.3. ADVERSE EVENT REPORTING 
 
10.3.1. Introduction 
 
Timely, accurate, and complete reporting and analysis of safety information from clinical studies are 
crucial for the protection of subjects, investigators, and the Sponsor, and are mandated by regulatory 
agencies worldwide. The Sponsor has established procedures in conformity with regulatory requirements 
to ensure appropriate reporting of safety information.  
 
If a screen-failed subject reports an AE, only the safety data (Demography, Subject Disposition, and 
Adverse Event) will be entered in the EDC system. 
 
10.3.2. Definitions 
 
10.3.2.1. Adverse Event (AE) 
 
An AE 
is any untoward medical occurrence 
in a clinical study subject temporally associated with the clinical 
investigation, whether or not the event has a causal relationship to the subject’s participation in the trial. 
It is therefore any unfavorable and unintended sign (including an abnormal finding), symptom, or disease 
that occurs during the trial. This can include any occurrence that is new in onset, an aggravation of 
severity/frequency of a baseline condition, or abnormal results of diagnostic procedures, including 
laboratory test abnormalities. 
 
Examples of AEs include but are not limited to: 
 Abnormal test findings, 
 Clinically important symptoms and signs, 
 Changes in physical examination findings, 
 Hypersensitivity, and 
 Progression/worsening of underlying disease. 

Protocol Title:  A Multi-Center, Evaluator Blinded, Randomized Clinical Study to Evaluate the Efficacy and Tolerance of Two Acne 
Treatment Regimens on Subjects with Mild to Moderate Acne Vulgaris 
Protocol Number: PS-1701 0314 5529-SACT 
Date & Version: 06 March 2017, Final Version 1.0 
 
Page 38 of 73 
 
 
Any change in existing medical condition (Medical History) would be considered an AE and recorded 
appropriately. 
Additionally, they may include the signs or symptoms resulting from: 
 Investigational product overdose, 
 Investigational product withdrawal, 
 Investigational product abuse, 
 Investigational product misuse, 
 Investigational product interactions, 
 Medication errors, 
 Investigational product dependency, 
 Exposure in utero, and 
 Study related procedure. 
The criteria for determining whether an abnormal objective test finding should be reported as an AE are 
as follows: 
 Test result is associated with accompanying symptoms, and/or 
 Test result requires additional diagnostic testing or medical/surgical intervention, and/or 
 Test result leads to a discontinuation from the study, significant additional concomitant 
treatment, or other therapy, and/or  
 Test result is considered to be an adverse event by the PI (or designee) or the Sponsor. 
Merely repeating an abnormal test, in the absence of any of the above conditions, does not constitute an 
AE. Any abnormal test result that is determined to be an error does not require reporting as an AE. 
 
Expected Events 
 
All IPs have the potential to cause some skin reactions, including erythema, scaling/peeling, edema, 
burning/stinging, tightness/dryness, itching, or rash.   
 
Any signs or symptoms of irritation are considered a clinical endpoint and may or may not be coded as 
adverse events based on the PI’s or trained designee’s assessment.  Irrespective of whether the sign(s) or 
symptom(s) 
is (are) coded as an adverse event, the signs or symptoms must be documented on the clinical 
evaluation source documentation.  If any of these irritation parameters appear to be exacerbated, more 
than normally associated with use of these types of products, the event will be recorded as an AE.  This 
can only be determined by the PI or trained designee.  If a subject is discontinued due to worsening of a 
sign or symptom (including worsening of the signs and or symptoms recorded as part of the evaluations), 
then it should be recorded as an AE. 
 
Treatment Emergent AE (TEAE) 
 
A TEAE is defined as any event not present prior to the initiation of the IP.  Note that AEs will be 
summarized for all subjects who signed the ICD (or Assent Form, as applicable), differentiating TEAEs. 
 
AEs are considered serious and require expedited reporting if they meet the definition of a Serious 
Adverse Event (see below). 

Protocol Title:  A Multi-Center, Evaluator Blinded, Randomized Clinical Study to Evaluate the Efficacy and Tolerance of Two Acne 
Treatment Regimens on Subjects with Mild to Moderate Acne Vulgaris 
Protocol Number: PS-1701 0314 5529-SACT 
Date & Version: 06 March 2017, Final Version 1.0 
 
Page 39 of 73 
 
 
10.3.2.2. 
Serious Adverse Event (SAE) 
 
An AE (untoward medical occurrence) will be considered an SAE if it meets either of the following 
definitions: 
Definition 1:   
The event fulfills at least one of the following criteria: 
 results in death 
 is life-threatening (immediate risk of death) 
 requires inpatient hospitalization or prolongation of existing hospitalization 
 results in a persistent or significant incapacity or substantial disruption of the ability to conduct 
normal life functions 
 is a suspected transmission of any infectious agent via a medicinal product (medically significant) 
and should be reported as an SAE in the category “Other medically important conditions” 
 results in a congenital anomaly/birth defect 
 is another medically significant event (i.e. a medically significant condition that may jeopardize 
the subject or require medical or surgical intervention to prevent any of the previously listed 
outcomes). Medical and scientific judgment should be exercised in deciding whether expedited 
reporting is appropriate in situations other than those listed above. Examples of such medical 
events include allergic bronchospasm requiring intensive treatment in an Emergency Room or at 
home, blood dyscrasia, or convulsions that do not result in hospitalization; or development of 
drug dependency or drug abuse, or malignancy). 
Definition 2:   
 
 the event involves subject contact with a device AND 
 the event results in: 
o death 
o serious injury, which means an injury or illness that: 
 is life-threatening (immediate risk of death) 
 results in permanent impairment of a body function or permanent damage to a 
body structure, or 
 necessitates medical or surgical intervention to preclude permanent impairment 
of a body function or permanent damage to a body structure (permanent means 
irreversible impairment or damage to a body structure or function, excluding 
trivial impairment or damage). 
o Persistent or significant incapacity or substantial disruption of the ability to conduct 
normal life functions 
o Congenital anomaly/birth defect 
o  Any suspected transmission of any infectious agent via a product (medically significant). 
 
10.3.2.3. 
Severity 
 
The severity of all AEs must be evaluated by the PI or, if the PI does not have a medical background, by a 
medically qualified individual (M.D./D.O.). The severity classifications are: 

Protocol Title:  A Multi-Center, Evaluator Blinded, Randomized Clinical Study to Evaluate the Efficacy and Tolerance of Two Acne 
Treatment Regimens on Subjects with Mild to Moderate Acne Vulgaris 
Protocol Number: PS-1701 0314 5529-SACT 
Date & Version: 06 March 2017, Final Version 1.0 
 
Page 40 of 73 
 
 
 Severe – Extreme distress, causing significant impairment of functioning or incapacitation; 
interferes significantly with subject's usual function; prevents normal everyday activities. 
 Moderate – Sufficient discomfort is present to cause interference to some extent with subject's 
usual function or normal everyday activity.  
 Mild – Awareness of symptoms that are easily tolerated, causing minimal discomfort and not 
interfering with subject's usual function or normal everyday activities. 
Note the distinction between the severity and the seriousness of an AE. A severe event is not necessarily 
a serious event. For example, a headache may be severe (interferes significantly with subject's usual 
function) but would not be classified as serious unless it met one of the criteria for SAEs, listed above. 
 
10.3.2.4. 
Causality Assessment 
 
An AE (serious or non-serious) is considered “study-related” if the causality assessment is possible, 
probable, or very likely. The PI or, if the PI does not have a medical background, a medically qualified 
individual (M.D./D.O.) determines the causality by using the following definitions: 
 
 Not related – an AE that is not related to the participation in the study. 
 Doubtful – an AE for which an alternate explanation is more likely (e.g. concomitant drug), or the 
relationship in time suggests that a causal relationship is unlikely. 
 Possible – an AE that might be a result of participation in the study. An alternative explanation is 
inconclusive and the relationship in time is reasonable so a causal relationship cannot be excluded. 
 Probable – an AE that might be a result of participation in the study. The relationship in time is 
suggestive (e.g. confirmed by the challenge). An alternative explanation is less likely. 
 Very Likely 
– 
an AE that 
is 
listed as a possible adverse reaction and cannot be reasonably explained 
by an alternative explanation. The relationship in time is very suggestive (e.g. confirmed by 
dechallenge and rechallenge). 
 
10.3.3. Procedures for Reporting Adverse Events 
 
All AEs will be reported from the time a signed and dated ICD is obtained until completion of the subject’s 
last study 
procedure or visit (or termination 
if the subject terminates early from the study for any reason). 
 
AEs that occur within 30 calendar days after completion of the study will only be reported to the Sponsor 
if they are serious (SAEs).  SAEs are reportable beyond this period if the event is considered study-related. 
The Sponsor will evaluate any safety information that is spontaneously reported by the PI or designee 
beyond the timeframe specified in the protocol. 
 
Subjects are encouraged to report AEs spontaneously and in response to questioning during the visit (e.g. 
if they have had any side effects/issues or changes in their health since their last appointment). For each 
AE reported by the subject or observed by the study team, the study team member should notify the PI 
or designee, who will collect information about the event. 
 
All AEs, regardless of seriousness, severity, or presumed relationship to study procedures, must be 
recorded using medical terminology on the paper AE form. 
 
Whenever possible, diagnoses should be given 
when signs and symptoms are due to a common etiology (e.g., cough, runny nose, sneezing, sore throat, 
and head congestion should be reported as “upper respiratory infection”).  The PI or, if the PI does not 

Protocol Title:  A Multi-Center, Evaluator Blinded, Randomized Clinical Study to Evaluate the Efficacy and Tolerance of Two Acne 
Treatment Regimens on Subjects with Mild to Moderate Acne Vulgaris 
Protocol Number: PS-1701 0314 5529-SACT 
Date & Version: 06 March 2017, Final Version 1.0 
 
Page 41 of 73 
 
 
have a medical background, a medically qualified designee (MD/DO), must record or confirm on the 
source document their opinion concerning the seriousness, severity, and relationship of the AE to the 
study.   All measures required for adverse event management must be recorded in the source document 
and reported according to Sponsor instructions. 
 
These events must be entered into the EDC system within 3 business days of the site’s awareness.   
 
The PI or designee must also report AEs to the appropriate IRB unless otherwise required and documented 
by the IRB. 
 
If an SAE occurs, in addition to the above reporting procedures, the Site will immediately notify the Study 
Manager and Study Director by telephone or encrypted e-mail (see Appendix 
XV 
for Contact Information).  
 
Subsequent to a telephone or encrypted e-mail report of an SAE, a Clinical Trial SAE Report Form (provided 
to the study site 
at the 
initiation of the study) must be completed by the 
investigational staff with as much 
information as possible (however at a minimum, the subject identification number, name of 
investigational product [if applicable], SAE description, investigator’s assessment of causality, and name 
of site personnel reporting event are required), signed by the PI (or the medically qualified designee), and 
securely transmitted to the Study Manager and Study Director within 24 hours of becoming aware of the 
event. 
 
This timeframe also applies to additional new information (follow-up) on previously forwarded SAE 
reports.  
 
In the rare event that the Investigator’s site does not become aware of the occurrence of a SAE 
immediately (e.g., if an outpatient study subject initially seeks treatment elsewhere), the Investigator’s 
site 
is to report the event 
immediately after 
learning of 
it 
as described and document the time of the study 
site’s first awareness of the SAE. 
 
The Study Manager or designee will notify the DPR within 1 calendar day of SAE information receipt. The 
DPR will request more information as necessary. The Study Manager or designee will send an e-mail 
appropriate document to Sponsor’s OCMS group per local procedures within the following timelines: 
 fatal/life-threatening reports:  within 2 calendar days from regulatory clock start date 
 other SAEs and pregnancy exposure reports: within 3 calendar days from regulatory clock start 
date 
 
For all SAEs, the PI or designee is obligated to pursue and provide information to the Sponsor in 
accordance with the timeframes for reporting specified above. In addition, the PI or designee may be 
requested by the Sponsor to obtain specific additional follow-up 
information 
in an expedited fashion. This 
information may be more detailed than that captured on the paper AE form. In general, this will include 
a description of the SAE in sufficient detail to allow for a complete medical assessment of the case and 
independent determination of possible causality. Information on other possible causes of the event, such 
as concomitant medications and illnesses, must be provided.  
 
In the case of a subject death, a summary of available autopsy findings (if available) and death certificate 
should be collected if permission is obtained from the subject’s family.  

Protocol Title:  A Multi-Center, Evaluator Blinded, Randomized Clinical Study to Evaluate the Efficacy and Tolerance of Two Acne 
Treatment Regimens on Subjects with Mild to Moderate Acne Vulgaris 
Protocol Number: PS-1701 0314 5529-SACT 
Date & Version: 06 March 2017, Final Version 1.0 
 
Page 42 of 73 
 
 
 
For a hospitalization, a copy of the hospital discharge summary should be requested. If obtained, these 
documents (with subject’s personal 
identifiers redacted) should be securely submitted as soon as possible 
to the Sponsor or its designated representative. 
 
10.3.4. Monitoring and Resolution of Adverse Events 
 
10.3.4.1. 
Non-Serious AEs 
 
All study-related AEs will be followed until resolution, until a stable clinical endpoint is reached, or at least 
30 days post-study withdrawal/completion. This information will be captured in the paper source 
documents and entered into the EDC system. 
 
10.3.4.2. 
Serious AEs (SAEs) 
 
The PI or, if the PI does not have a medical background, the medically qualified designee (M.D./D.O.) will 
monitor SAEs until resolution or until one of the conditions in 10.3.4.3 is met. The information will be 
captured in the source document and entered into the EDC system. The PI/designee will also document 
follow-up information on an updated SAE form, which will be reviewed by the PI or medically qualified 
designee and sent to the Study Manager or designee. The Study Manager or designee will forward the 
document(s) to the DPR, the Study Director or designee, and to OCMS per local procedures. 
 
10.3.4.3. 
Resolution 
 
The PI will be required to assess the outcome of each AE as one of the following:  
 Resolved 
 Not Resolved 
 Fatal 
 Resolved with sequelae 
 Resolving 
 Unknown 
 
SAEs that have not been resolved by the end of the study, or that have not been resolved upon 
discontinuation of the subject’s participation in the study, must be followed until any of the following 
occurs:  
 the event resolves 
 the event stabilizes 
 the event returns to baseline, if a baseline value is available 
 the event can be attributed to factors unrelated to study conduct 
 when it becomes unlikely that any additional information can be obtained (subject or 
healthcare practitioner refusal to provide additional information, lost to follow-up after 
demonstration of due diligence with follow-up efforts). 
 
 

Protocol Title:  A Multi-Center, Evaluator Blinded, Randomized Clinical Study to Evaluate the Efficacy and Tolerance of Two Acne 
Treatment Regimens on Subjects with Mild to Moderate Acne Vulgaris 
Protocol Number: PS-1701 0314 5529-SACT 
Date & Version: 06 March 2017, Final Version 1.0 
 
Page 43 of 73 
 
 
10.4. EXPOSURE IN UTERO  
 
For IPs within clinical studies, an exposure in utero (EIU) occurs if:  
 
 A woman is exposed to the IP at any time between her last menses prior to conception through 
the delivery of the baby.  
 There is a possibility of intrauterine exposure to the product via semen from the male partner 
who is using the IP at the time of conception, thereby possibly exposing the fetus to the product.  
 
If any study subject or a subject’s partner becomes or is found to be pregnant during the study or within 
30 days of the subject’s participation, the PI or designee must report the pregnancy to the Sponsor on a 
Pregnancy Notification Form (to be provided by the Sponsor when applicable). Initial notification via 
telephone to the Sponsor’s study team contact must occur immediately upon the Investigator site’s 
awareness of the pregnancy. The Pregnancy Notification Form must then be sent to the Sponsor within 
24 hours of the site’s awareness. The information submitted should include the anticipated date of 
delivery (see below for information to document termination of pregnancy).  
 
Follow-up is conducted to obtain pregnancy outcome information on all EIU reports. The PI or designee 
will follow the pregnancy until completion or until pregnancy termination (i.e., induced abortion) and then 
notify the Sponsor of the outcome. The PI or designee will provide this information as a follow-up to the 
initial Drug Exposure During Pregnancy Collection Form A and/or End of Pregnancy Collection Form B 
(provided by the Sponsor when applicable). The reason(s) for an induced abortion should be specified. An 
EIU report is not created when an ectopic pregnancy report is received since this pregnancy is not usually 
viable. Rather, a SAE case is created with the event of ectopic pregnancy. 
 
The PI or designee should follow the procedures for reporting SAEs 
if the outcome of the pregnancy meets 
the criteria for immediate classification as a SAE (i.e., spontaneous abortion, stillbirth, neonatal death, or 
congenital anomaly [including that in an aborted fetus, stillbirth, or neonatal death]). In the case of a live 
birth, the “normality” of the newborn can be assessed at the time of birth (i.e., no minimum follow-up 
period of a presumably normal infant is required before an End of Pregnancy Collection Form B can be 
completed). The “normality” of an aborted fetus can be assessed by gross visual inspection, unless pre-
abortion test findings are suggestive of a congenital anomaly.  
 
Additional pregnancy outcomes that are classified as SAEs and should be reported as such include:  
 “Spontaneous abortion” includes miscarriage and missed abortion; 
 All neonatal deaths that occur within 1 month of birth, without regard to causality; 
 Any infant death after 1 month that the PI (or designee) assesses as possibly related to in 
utero exposure to the IP. 
 
11. 
ETHICAL CONSIDERATIONS 
 
The privacy 
information such as the ICD/Assent Form 
and health related questionnaire of the subjects 
will 
be kept confidential during the study and clearly separated from the Trial Master File (TMF). 
 

Protocol Title:  A Multi-Center, Evaluator Blinded, Randomized Clinical Study to Evaluate the Efficacy and Tolerance of Two Acne 
Treatment Regimens on Subjects with Mild to Moderate Acne Vulgaris 
Protocol Number: PS-1701 0314 5529-SACT 
Date & Version: 06 March 2017, Final Version 1.0 
 
Page 44 of 73 
 
 
11.1. STUDY SUBMISSION TO INSTITUTIONAL REVIEW BOARD/ INDEPENDENT ETHICS COMMITTEE 
OR HEALTH AUTHORITIES 
 
This study (protocol, ICD, recruiting material [advertisements, phone script, etc.], and all addenda) will be 
reviewed and approved by an Institutional Review Board/Independent Ethics Committee (IRB/IEC) 
contacted by the Study Site.   
 
Details of the IRB/IEC for this study are in Appendix XV.  
 
It is the responsibility of the PI to have approval of the study protocol, protocol amendments, ICD(s), and 
other relevant documents, e.g., advertisements, as applicable from the IRB/IEC.  
 
The study will not be activated, subjects will not be recruited, consented, or receive test materials until 
such time as the IRB/IEC has approved the required documentation. In addition, the IRB/IEC will review 
the study before any significant change in the protocol is initiated. After each review, the IRB/IEC’s 
approval letter will be forwarded to the Sponsor. 
 
All correspondence with IRB/IEC should be retained in the SMF. Copies of IRB/IEC approvals should be 
forwarded to the Sponsor and will be filed in the TMF. 
 
The only circumstance in which an amendment may be initiated prior to IRB/IEC approval is where the 
change is necessary to eliminate apparent immediate hazards to the subjects. In that event, the PI or 
designee must notify the IRB/IEC and the Sponsor in writing within 3 working days after the 
implementation. 
 
12. 
DATA HANDLING AND RECORD KEEPING 
 
All subject source documents are the site’s subject records and are to be maintained at the trial site. These 
source documents must be attributable, legible, contemporaneous, original, and accurate and must 
collect only relevant data required by this protocol. All documentation should be completed using good 
documentation and data integrity practices. 
 
 
 
 
 
EDC pages should be completed for each randomized subject. The completed pages of the EDC system are 
the sole property of the Sponsor and should not be made available in any form to third parties, except for 
authorized representatives of the Sponsor or appropriate 
regulatory authorities, without written permission 
from the Sponsor. 
 
It is the PI’s responsibility to ensure completion and to review and approve all information captured in the 
EDC system.  The subject’s data in the EDC system must be electronically signed by the PI.  These signatures 
serve to attest that the 
information contained 
in the EDC system 
is true.  
 
At all times, the PI 
has final personal 
responsibility for the accuracy and authenticity of all clinical data entered in the EDC system. 
 

Protocol Title:  A Multi-Center, Evaluator Blinded, Randomized Clinical Study to Evaluate the Efficacy and Tolerance of Two Acne 
Treatment Regimens on Subjects with Mild to Moderate Acne Vulgaris 
Protocol Number: PS-1701 0314 5529-SACT 
Date & Version: 06 March 2017, Final Version 1.0 
 
Page 45 of 73 
 
 
The Sponsor or its designee will have responsibility for verifying for accuracy of the data entered into the 
EDC system against the source documents. 
 
All data entered in the EDC system will be sent to the Sponsor’s Quantitative Sciences Department for 
statistical analysis.  All final data recorded in the EDC system will be retained in the TMF and the SMF. 
 
The site shall maintain and archive records of all source documentation generated by the activity 
(including emails, questionnaires, and reports) and personnel training records relating to Sponsor 
obligations under this project for 2 years from the time the final report is issued.  
 
Before the site destroys any of the above safety records, it will notify the Sponsor of its intention to do 
so, affording the Sponsor the opportunity to retain such records if it so wishes. 
 
If it becomes necessary for the Sponsor or a Regulatory Authority to review any documentation relating 
to the study, the PI must permit access to such records.  
 
If the PI relocates, retires, or for any reason withdraws from the study, the Sponsor must be prospectively 
notified. 
 
13. 
STUDY MONITORING, QUALITY CONTROL AND QUALITY ASSURANCE 
 
The study will be monitored (in accordance with a study- or site-specific Monitoring Plan) by the Sponsor, 
or its designee.  A Monitoring Plan and frequent communications (via telephone or e-mail) will be utilized 
to provide Sponsor oversight and to assist in resolving any difficulties encountered while the study is in 
progress. The visits may occur during the trial or shortly after study completion to ensure that the 
investigation is/was conducted according to the protocol and that ICH GCP is/was being followed. The 
monitors may review source documents to confirm that the data recorded is complete and accurate.  
 
The PI and institution will allow the Sponsor’s monitors or its designee and appropriate regulatory 
authorities direct access to source documents to perform this verification. If there are any issues noted, 
the PI will be notified. 
 
Any contact concerning this study should be made with the Study Manager or the Study Director (see 
Appendix XV). 
 
The study site may be subject to review by the IRB/IEC, and/or to quality assurance audits performed by 
the Sponsor, and/or to inspection by appropriate regulatory authorities. 
 
It is important that the PI(s) and their relevant personnel are available during monitoring and possible 
audits or inspections and that sufficient time is devoted to the process. 
 
14. 
SPONSOR DISCONTINUATION CRITERIA 
 
Premature termination of this clinical trial may occur because of a change in opinion of the IRB/IEC, IP or 
study safety problems, or at the discretion of the Sponsor. If a trial is prematurely terminated or 
discontinued, the Sponsor will promptly notify the PI.  After notification, the PI or designated staff must 

Protocol Title:  A Multi-Center, Evaluator Blinded, Randomized Clinical Study to Evaluate the Efficacy and Tolerance of Two Acne 
Treatment Regimens on Subjects with Mild to Moderate Acne Vulgaris 
Protocol Number: PS-1701 0314 5529-SACT 
Date & Version: 06 March 2017, Final Version 1.0 
 
Page 46 of 73 
 
 
contact all participating subjects within 10 business days (phone, voicemail, or certified letter), as 
applicable. As directed by the Sponsor, all trial materials must be collected, all study documents/EDC 
completed to the greatest extent possible, and termination reported to the IRB/IEC. 
 
15. 
FINAL REPORT 
 
The final report will be prepared by Thomas J. Stephens and Associates, Inc. and will include (but is not 
limited to) the following information:  
  
  
  
  
 
 
 
 
 
 
  
 
 
 
16. 
CONFIDENTIALITY 
 
All the information, data, and results of the study will be confidential. Every person having access to these 
data will be informed of this confidentiality
. 
 
Medical information concerning the subjects obtained by the site during the recruitment and admission 
will be handled confidentially.  
 
17. 
PUBLICATION 
 
The publication agreement, if any, between the Sponsor and the site is detailed in the clinical trial 
agreement. 
 
18. 
REFERENCES 
 
1) Ashkenazi, H., et al. (2003). Eradication of Propionibacterium acnes by its endogenic porphyrins 
after illumination with high intensity blue light.  FEMS Immunology and Medical Microbiology, 35, 
17-24. 
2) Kjeldstad, B. (1984). Photoinactivation of Propionibacterium acnes by near-ultraviolet light. Z 
Naturforsch, 39, 329-335. 
3) Roelandts, R. (2005). A new light on Niels Finsen, a century after his Nobel Prize. Photodermatol 
Photoimmunol Photomed, 21, 115-117. 
4) Barolet, D. (2008). Light-emitting diodes (LEDs) in dermatology.  Semin Cutan Med Surg, 27, 227-
238. 
5) Salomatina, E., et al. (2006). 
 
Optical properties of normal and cancerous human skin 
in the visible 
and near-infrared spectral range.  J Biomed Opt, 11(6). 
6) Bashkatov, A.N., et al. (2000). Optical properties of melanin in the skin and skin-like phantoms. 
Proc. of SPIE, 4162, 219-226. 

Protocol Title:  A Multi-Center, Evaluator Blinded, Randomized Clinical Study to Evaluate the Efficacy and Tolerance of Two Acne 
Treatment Regimens on Subjects with Mild to Moderate Acne Vulgaris 
Protocol Number: PS-1701 0314 5529-SACT 
Date & Version: 06 March 2017, Final Version 1.0 
 
Page 47 of 73 
 
 
7) Bashkatov, A.N. et al. (2005). Optical properties of human skin, subcutaneous and mucous tissues 
in the wavelength range from 400 to 2000 nm. J Phys D: Appl Phys, 38, 2543-2555. 
8) Jacques, S.L. (2013). Optical properties of biological tissues: a review. 
Phys Med Biol, 58, R37-R61. 
9) Lamouche, G., et al. (2012). Review of tissue simulating phantoms with controllable optical, 
mechanical and structural properties for use in optical coherence tomography.  Biomed Opt 
Express, 3(6), 1381-1398. 
10) Pogue, B.W., & Patterson, M.S. (2006). Review of tissue simulating phantoms for optical 
spectroscopy, imaging and dosiometry. J Biomed Opt, 11(4). 
11) Hirshburg J., et al. (2007). Correlation between collagen solubility and skin optical clearing using 
sugars. Lasers in Surg and Med, 39, 140-144. 
12) Wiegand, B., Luedtke, K., Rapp, SR. Acne Profile. Johnson & Johnson, One Johnson & Johnson 
Plaza, New Brunswick, NJ 08933-7003, assignee. Patent US 2006/0008484 A1. 12 Jan. 2006. 
Print.  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

Protocol Title:  A Multi-Center, Evaluator Blinded, Randomized Clinical Study to Evaluate the Efficacy and Tolerance of Two Acne 
Treatment Regimens on Subjects with Mild to Moderate Acne Vulgaris 
Protocol Number: PS-1701 0314 5529-SACT 
Date & Version: 06 March 2017, Final Version 1.0 
 
Page 50 of 73 
 
21. 
APPENDICES 
 
Appendix I.  Fitzpatrick Skin Type Classification 
..................................................................................... 
51 
Appendix II.  Skin Sensitivity ................................................................................................................... 
52 
Appendix III.  Investigator Global Acne (IGA) Assessment 
...................................................................... 
53 
Appendix IV.  Additional Investigator Efficacy Assessments .................................................................. 
54 
 
Appendix VI.  Subject Instructions – Regimen 1 
..................................................................................... 
56 
Appendix VII.  Subject Instructions – Regimen 2 
.................................................................................... 
58 
Appendix VIII.  PM Mask Treatment Package Insert 
............................................................................... 
60 
Appendix IX.  PM Gel-Cream & PM Mask Treatment Package Insert 
..................................................... 
63 
Appendix X.  Replacement Mask Activator Package Insert .................................................................... 
67 
 
 
 
Appendix XIV. Ingredient Lists 
................................................................................................................ 
72 
Appendix XV.  Contact Information 
........................................................................................................ 
73 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

Protocol Title:  A Multi-Center, Evaluator Blinded, Randomized Clinical Study to Evaluate the Efficacy and Tolerance of Two Acne 
Treatment Regimens on Subjects with Mild to Moderate Acne Vulgaris 
Protocol Number: PS-1701 0314 5529-SACT 
Date & Version: 06 March 2017, Final Version 1.0 
 
Page 51 of 73 
 
Appendix I.  Fitzpatrick Skin Type Classification  
 
The skin classification is based on the subject-reported, unprotected skin response to the first 30 to 45 
minutes of sun exposure after a winter season without sun exposure.  The categories of skin types are as 
follows: 
 
 
Skin 
Type 
Characteristics 
I 
White; very fair; red or blonde hair; blue eyes; freckles; Always burns easily; never 
tans 
II 
White; fair; red or blonde hair; blue, hazel, or green eyes; Always burns easily; tans 
minimally 
III 
Cream white; fair with any eye or hair color; very common; Burns moderately; tans 
gradually 
IV 
Brown; typical Mediterranean white skin; Burns minimally; always tans well 
V 
Dark brown; mid-eastern skin types, black hair, olive skin; Rarely burns; tans profusely 
VI 
Black; black hair, black eyes, black skin; Never burns; deeply pigmented 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

Protocol Title:  A Multi-Center, Evaluator Blinded, Randomized Clinical Study to Evaluate the Efficacy and Tolerance of Two Acne 
Treatment Regimens on Subjects with Mild to Moderate Acne Vulgaris 
Protocol Number: PS-1701 0314 5529-SACT 
Date & Version: 06 March 2017, Final Version 1.0 
 
Page 52 of 73 
 
Appendix II.  Skin Sensitivity  
Subjects will rate their self-perceived skin sensitivity as per the scale below:  
 
Do you consider you skin to be sensitive: 
 None of the time  
 Some of the time  
 Most of the time  
 All of the time  
 
This is for demographic information collection purposes only and is not considered an evaluation 
endpoint. 
 
 

Protocol Title:  A Multi-Center, Evaluator Blinded, Randomized Clinical Study to Evaluate the Efficacy and Tolerance of Two Acne 
Treatment Regimens on Subjects with Mild to Moderate Acne Vulgaris 
Protocol Number: PS-1701 0314 5529-SACT 
Date & Version: 06 March 2017, Final Version 1.0 
 
Page 53 of 73 
 
Appendix III.  Investigator Global Acne (IGA) Assessment 
 
The following scale (Modified Cook’s Scale) will be used for the IGA assessment.   
Half points may be used: 
 
0  Clear  
Residual hyperpigmentation and erythema may be present.  
1  Almost 
Clear  
A few scattered comedones and a few (less than five) small papules.  
2  Mild  
Easily recognizable; less than half the face is involved. Many comedones and many 
papules and pustules.  
3  Moderate  
More than half of the face is involved. Numerous comedones, papules, and pustules.  
4  Severe  
Entire face is involved. Covered with comedones, numerous papules and pustules, 
and few nodules and cysts.  
5 Very Severe Highly inflammatory acne covering the face; with nodules and cysts present. 
 
 

Protocol Title:  A Multi-Center, Evaluator Blinded, Randomized Clinical Study to Evaluate the Efficacy and Tolerance of Two Acne 
Treatment Regimens on Subjects with Mild to Moderate Acne Vulgaris 
Protocol Number: PS-1701 0314 5529-SACT 
Date & Version: 06 March 2017, Final Version 1.0 
 
Page 57 of 73 
 
Other Instructions: 
 Use only the assigned products and your regular, non-medicated (other than SPF, which is 
acceptable) facial products that you have used for at least one month and that have been 
recorded/approved by the study staff at Visit 1. 
 Do not use any other light-based devices or receive any professional or aesthetic facial spa 
procedures during the study. 
 Do not shave or use any hair removal method on your face within the 24 hours prior to a study 
visit. 
 Do not start using any new personal care products (e.g. makeup, lotions, etc.) or change your 
currently used brands during the study. 
 On the day of study visits:  remove all leave-on facial products (including eye makeup) and wash 
with the provided facial cleanser 30 minutes to 2 hours prior to the visit and then do not apply 
any leave-on facial products until the visit is completed.  Note:  if you do not follow these 
directions, you will be asked to remove your makeup/products and wash your face with the 
provided cleanser on-site and then wait 30 minutes before evaluations are performed. 
 Avoid excessive sun/UV exposure (including tanning beds) for the duration of the study.  
 Attend all scheduled visits. 
 Do not begin any other clinical study during the current study. 
 Report any side effects, changes in health/medication, pregnancies, issues, or questions to the 
study staff. 
 Bring your study products to all visits.  Products must be returned at the final study visit.  Failure 
to return your products may result in forfeiture of compensation. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

Protocol Title:  A Multi-Center, Evaluator Blinded, Randomized Clinical Study to Evaluate the Efficacy and Tolerance of Two Acne 
Treatment Regimens on Subjects with Mild to Moderate Acne Vulgaris 
Protocol Number: PS-1701 0314 5529-SACT 
Date & Version: 06 March 2017, Final Version 1.0 
 
Page 61 of 73 
 

Protocol Title:  A Multi-Center, Evaluator Blinded, Randomized Clinical Study to Evaluate the Efficacy and Tolerance of Two Acne 
Treatment Regimens on Subjects with Mild to Moderate Acne Vulgaris 
Protocol Number: PS-1701 0314 5529-SACT 
Date & Version: 06 March 2017, Final Version 1.0 
Page 62 of 73 
 
 
 
 

Protocol Title:  A Multi-Center, Evaluator Blinded, Randomized Clinical Study to Evaluate the Efficacy and Tolerance of Two Acne 
Treatment Regimens on Subjects with Mild to Moderate Acne Vulgaris 
Protocol Number: PS-1701 0314 5529-SACT 
Date & Version: 06 March 2017, Final Version 1.0 
 
Page 63 of 73 
 
Appendix IX.  PM Gel-Cream & PM Mask Treatment Package Insert 
PM Gel-Cream & PM Mask Treatment Package Insert 

Protocol Title:  A Multi-Center, Evaluator Blinded, Randomized Clinical Study to Evaluate the Efficacy and Tolerance of Two Acne 
Treatment Regimens on Subjects with Mild to Moderate Acne Vulgaris 
Protocol Number: PS-1701 0314 5529-SACT 
Date & Version: 06 March 2017, Final Version 1.0 
Page 64 of 73 
 

Protocol Title:  A Multi-Center, Evaluator Blinded, Randomized Clinical Study to Evaluate the Efficacy and Tolerance of Two Acne 
Treatment Regimens on Subjects with Mild to Moderate Acne Vulgaris 
Protocol Number: PS-1701 0314 5529-SACT 
Date & Version: 06 March 2017, Final Version 1.0 
Page 65 of 73 
 

Protocol Title:  A Multi-Center, Evaluator Blinded, Randomized Clinical Study to Evaluate the Efficacy and Tolerance of Two Acne 
Treatment Regimens on Subjects with Mild to Moderate Acne Vulgaris 
Protocol Number: PS-1701 0314 5529-SACT 
Date & Version: 06 March 2017, Final Version 1.0 
Page 66 of 73 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

Protocol Title:  A Multi-Center, Evaluator Blinded, Randomized Clinical Study to Evaluate the Efficacy and Tolerance of Two Acne 
Treatment Regimens on Subjects with Mild to Moderate Acne Vulgaris 
Protocol Number: PS-1701 0314 5529-SACT 
Date & Version: 06 March 2017, Final Version 1.0 
 
Page 67 of 73 
 
Appendix X.  Replacement Mask Activator Package Insert 
 
Replacement Mask Activator Package Insert 
 
 
 
 
 
 
 
 
 
 
 

Protocol Title:  A Multi-Center, Evaluator Blinded, Randomized Clinical Study to Evaluate the Efficacy and Tolerance of Two Acne 
Treatment Regimens on Subjects with Mild to Moderate Acne Vulgaris 
Protocol Number: PS-1701 0314 5529-SACT 
Date & Version: 06 March 2017, Final Version 1.0 
Page 68 of 73 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

Protocol Title:  A Multi-Center, Evaluator Blinded, Randomized Clinical Study to Evaluate the Efficacy and Tolerance of Two Acne 
Treatment Regimens on Subjects with Mild to Moderate Acne Vulgaris 
Protocol Number: PS-1701 0314 5529-SACT 
Date & Version: 06 March 2017, Final Version 1.0 
Page 69 of 73 
 
 
 
 
 
 
 

Protocol Title:  A Multi-Center, Evaluator Blinded, Randomized Clinical Study to Evaluate the Efficacy and Tolerance of Two Acne 
Treatment Regimens on Subjects with Mild to Moderate Acne Vulgaris 
Protocol Number: PS-1701 0314 5529-SACT 
Date & Version: 06 March 2017, Final Version 1.0 
Page 70 of 73 
 

Protocol Title:  A Multi-Center, Evaluator Blinded, Randomized Clinical Study to Evaluate the Efficacy and Tolerance of Two Acne 
Treatment Regimens on Subjects with Mild to Moderate Acne Vulgaris 
Protocol Number: PS-1701 0314 5529-SACT 
Date & Version: 06 March 2017, Final Version 1.0 
Page 71 of 73 
 
 
 
 
 
 

Protocol Title:  A Multi-Center, Evaluator Blinded, Randomized Clinical Study to Evaluate the Efficacy and Tolerance of Two Acne 
Treatment Regimens on Subjects with Mild to Moderate Acne Vulgaris 
Protocol Number: PS-1701 0314 5529-SACT 
Date & Version: 06 March 2017, Final Version 1.0 
 
Page 72 of 73 
 
Appendix XIV. Ingredient Lists 
 
 
 
 
 
 
 
 
 

Protocol Title:  A Multi-Center, Evaluator Blinded, Randomized Clinical Study to Evaluate the Efficacy and Tolerance of Two Acne 
Treatment Regimens on Subjects with Mild to Moderate Acne Vulgaris 
Protocol Number: PS-1701 0314 5529-SACT 
Date & Version: 06 March 2017, Final Version 1.0 
 
Page 73 of 73 
 
Appendix XV.  Contact Information