A Prospective Study Evaluating the Safety and Effectiveness of the CLEAR + BRILLIANT TOUCH(R) Diode Laser 1440-nm and 1927-nm Combination Wavelength Treatment.
Phase: NA
Conditions: Photoaging
Sponsor: Bausch Health Americas, Inc.

Protocol [V01-CBT-401]
Bausch Health Americas, Inc.
Page 1 of 49 
Version 3.0 09/13/2021
CONFIDENTIAL
Clinical Study Protocol
A Prospective Study Evaluating the Safety and Effectiveness of the CLEAR + 
BRILLIANT TOUCH£ diode laser 1440-nm and 1927-nm Combination Wavelength 
Treatment
Protocol Number: V01-CBT-401
Sponsor
Bausch Health Americas, Inc. 
400 Somerset Corporate Boulevard
Bridgewater, NJ 08807
Main Office: (908) 927-1400
Sponsor Contact: 
Sr. Clinical Trial Manager
Protocol Version / Date:
Version 1.0, 04/07/2021
Version 2.0, 06/22/2021
Version 3.0, 09/13/2021
The study will be conducted according to the protocol and in compliance with EN ISO 14155:2020   
Clinical Investigation of Medical Devices for Human Subjects – Good Clinical Practices, International 
Conference of Harmonization Good Clinical Practice Guidelines and all other applicable regulatory 
requirements and standards.
CONFIDENTIALITY STATEMENT
THE INFORMATION PROVIDED IN THIS STUDY PROTOCOL IS INTENDED FOR REVIEW BY THE 
PRINCIPAL INVESTIGATOR(S), ALL RESEARCH RELATED PERSONNEL, IRBS/ETHICS 
COMMITTEE(S) AND HEALTH AUTHORITIES. INFORMATION PROVIDED AND CAPTURED IN THIS 
PROTOCOL IS STRICTLY CONFIDENTIAL AND WILL ONLY BE DISCLOSED WITH WRITTEN 
CONSENT FROM THE SPONSORS.
The Sponsor, Bausch Health Americas, Inc., is funding this clinical investigation. 
1&7

Protocol [V01-CBT-401]
Bausch Health Americas, Inc.
 
Page 3 of 49 
Version 3.0 09/13/2021
CONFIDENTIAL
Study Administrative Structure
Study Title: A Prospective, Study Evaluating the Safety and Effectiveness of the 
CLEAR + BRILLIANT TOUCH£ diode laser 1440-nm and 1927-nm 
Combination Wavelength Treatment
Medical Monitor
Contract Research Organization (CRO)
SGS Stephens, Inc
Cheryl Vaughan, Clinical Investigator
SGS Stephens, Inc.            
1801 North Glenville Drive
Richardson, TX 75081
Canfield Scientific, Inc
4 Wood Hollow Road
Parsippany, NJ 07512
Imaging
ProPath
1355 River Bend Drive
Dallas, TX 75247
Biopsy sample analysis
Investigative Clinical Site1
Dallas Center for Dermatology and Aesthetics
8201 Preston Road #350
Dallas, TX 75225
1 All contractual and financial agreements between clinical site and the Sponsor will be administrated by the Sponsor 
and approved at a minimum by both Investigators and the Sponsor in writing.

Protocol [V01-CBT-401] 
 
Bausch Health Americas, Inc. 
 
Page 5 of 49 
Version 3.0 09/13/2021 
 
CONFIDENTIAL 
LIST OF ABBREVIATIONS 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
ABBREVIATION/TERM 
DEFINITION 
AE 
Adverse Event 
CFR 
Code of Federal Regulations 
CRF 
Case Report Form 
EDC 
Electronic Data Capture  
EOS 
End of Study 
FDA 
Food and Drug Administration 
FDF 
Financial Disclosure Form 
GAIS 
Global Aesthetic Improvement Scale 
GCP 
Good Clinical Practice 
ICF/ICD 
Informed consent form/ Informed consent document 
ICH 
International Conference on Harmonization 
IEC 
Independent Ethics Committee 
IRB 
Institutional Review Board 
ITT 
Intent To Treat 
IQIS 
Investigator Quartile Improvement Score 
MTZ 
Microthermal treatment zone 
PI 
Principal Investigator 
QA 
Quality Assurance 
QC 
Quality Control 
QHS 
Every Night At Bedtime 
SAE 
Serious Adverse Event 
UADE 
Unanticipated Adverse Device Effect 
UV 
Ultraviolet 
VAS 
Visual Analog Scale 

Protocol [V01-CBT-401] 
 
Bausch Health Americas, Inc. 
 
Page 6 of 49 
Version 3.0 09/13/2021 
 
CONFIDENTIAL 
Table of Contents 
PROTOCOL REVIEW AND APPROVALS .................................................................................................................... 2 
STUDY ADMINISTRATIVE STRUCTURE .................................................................................................................... 3 
PRINCIPAL INVESTIGATOR PROTOCOL AGREEMENT PAGE ..................................................................................... 4 
LIST OF ABBREVIATIONS ........................................................................................................................................ 5 
1. STUDY SYNOPSIS ................................................................................................................................................ 9 
2. INTRODUCTION: BACKGROUND INFORMATION .............................................................................................. 11 
2.1   DEVICE DESCRIPTION ............................................................................................................................................. 12 
2.1.1   Mechanical Specifications ........................................................................................................................ 13 
2.1.2   Laser Safety Standards ............................................................................................................................. 13 
2.1.3   Study Device Accountability ..................................................................................................................... 14 
3. STUDY OBJECTIVE: ........................................................................................................................................... 14 
4. STUDY DESIGN AND ENDPOINTS ...................................................................................................................... 14 
4.1   DESCRIPTION OF STUDY DESIGN: .............................................................................................................................. 14 
4.2   STUDY ENDPOINTS ................................................................................................................................................ 14 
4.2.1   Primary Endpoint ...................................................................................................................................... 14 
4.2.2   Secondary Endpoint .................................................................................................................................. 15 
4.2.3   Safety Endpoints ....................................................................................................................................... 15 
4.2.4   Exploratory Endpoints .............................................................................................................................. 15 
5. INVESTIGATOR SELECTION AND STUDY POPULATION: ..................................................................................... 16 
5.1   INVESTIGATOR SELECTION ....................................................................................................................................... 16 
5.2   NUMBER OF PARTICIPANTS ..................................................................................................................................... 16 
5.3   INCLUSION CRITERIA .............................................................................................................................................. 16 
5.4   EXCLUSION CRITERIA.............................................................................................................................................. 16 
5.5   STRATEGIES FOR RECRUITMENT AND RETENTION ......................................................................................................... 17 
5.6   SUBJECT ENROLLMENT ........................................................................................................................................... 18 
5.7   SUBJECT SCREEN FAILURES ...................................................................................................................................... 18 
5.8   SUBJECT COMPLETION ........................................................................................................................................... 18 
5.9  SUBJECT DISCONTINUATION ..................................................................................................................................... 18 
5.9.1   Reason for Withdrawal or Termination.................................................................................................... 18 
5.9.2   Handling of Subject Withdrawal or Termination...................................................................................... 18 
6.   STUDY PROCEDURES AND SCHEDULE: ............................................................................................................ 19 
6.1   INFORMED CONSENT ............................................................................................................................................. 19 
6.2   PRE-PROCEDURE .................................................................................................................................................. 19 
6.3   STUDY PROCEDURE ............................................................................................................................................... 20 
6.4   FOLLOW-UP PROCEDURE ........................................................................................................................................ 21 
6.5   DATA COLLECTION ................................................................................................................................................ 21 
6.5.1 Photography............................................................................................................................................... 22 
6.5.2   Specimens ................................................................................................................................................. 22 
6.6   FINAL STUDY VISIT ................................................................................................................................................ 22 
6.7   STUDY COMPLETION .............................................................................................................................................. 23 
6.8   SCHEDULE OF EVENTS TABLE ................................................................................................................................... 23 
7.   EVALUATION TOOLS ....................................................................................................................................... 25 

Protocol [V01-CBT-401] 
 
Bausch Health Americas, Inc. 
 
Page 7 of 49 
Version 3.0 09/13/2021 
 
CONFIDENTIAL 
7.1   INVESTIGATOR EVALUATION STANDARD 2D PHOTOGRAPHY .......................................................................................... 25 
7.2   INVESTIGATOR EVALUATIONS QUARTILE IMPROVEMENT SCORE ...................................................................................... 25 
7.3   PUNCH BIOPSIES ................................................................................................................................................... 26 
7.4   VISUAL ANALOG SCALE (VAS) ................................................................................................................................. 26 
7.5   SUBJECT SATISFACTION .......................................................................................................................................... 27 
7.6   SUBJECT MODIFIED GLOBAL AESTHETIC IMPROVEMENT SCORE ...................................................................................... 27 
7.7   INDEPENDENT PHOTOGRAPHIC ASSESSMENTS ............................................................................................................. 27 
8.   ASSESSMENT OF SAFETY ................................................................................................................................ 28 
8.1   SPECIFICATION OF SAFETY PARAMETERS .................................................................................................................... 28 
8.1.1   Definition of Serious Adverse Events (SAE) ............................................................................................... 28 
8.1.2   Definition of Adverse Events (AE) ............................................................................................................. 29 
8.1.3   Definition of Unanticipated Adverse Device Effect (UADEs) ..................................................................... 29 
8.1.4   Definition of Device Malfunction .............................................................................................................. 29 
8.2   ADVERSE EVENT / DEVICE MALFUNCTION REPORTING ................................................................................................. 29 
8.3   CLASSIFICATION OF ADVERSE EVENTS ........................................................................................................................ 30 
8.4   RELATIONSHIP TO THE STUDY DEVICE AND/OR PROCEDURE ............................................................................................ 30 
8.5   TERMINATION OF STUDY RULES FOR SAFETY ............................................................................................................... 31 
9.   RISKS AND BENEFITS ...................................................................................................................................... 31 
9.1   BENEFITS ............................................................................................................................................................. 31 
9.2   RISKS .................................................................................................................................................................. 31 
9.2.1   Expected Responses ................................................................................................................................. 31 
9.2.2   Unexpected Responses ............................................................................................................................. 32 
9.2.3   Biopsy Risks .............................................................................................................................................. 32 
9.3   MITIGATION OF RISKS ............................................................................................................................................ 33 
10.   STATISTICS.................................................................................................................................................... 33 
10.1   STATISTICAL ANALYSIS POPULATIONS AND DEMOGRAPHICS ......................................................................................... 33 
10.2   STATISTICAL ANALYSIS PLAN (SAP) ........................................................................................................................ 34 
10.2.1 Descriptive Statistical Summary ............................................................................................................... 34 
10.2.2 Additional Analysis ................................................................................................................................... 34 
10.2.3 Minimization of Bias and Potential Confounding Factors ........................................................................ 35 
11.   SOURCE DOCUMENTS AND ACCESS TO DATA/DOCUMENTS ........................................................................ 35 
12.   QUALITY ASSURANCE AND QUALITY CONTROLS .......................................................................................... 35 
12.1   STUDY MONITORING ........................................................................................................................................... 35 
13.   ETHICS OF HUMAN SUBJECTS AND ADMINISTRATIVE ISSUES ....................................................................... 36 
13.1   ETHICAL STANDARD ............................................................................................................................................. 36 
13.2   INSTITUTIONAL REVIEW BOARD ............................................................................................................................. 36 
13.3   INFORMED CONSENT PROCESS .............................................................................................................................. 36 
13.4   PARTICIPANT AND DATA CONFIDENTIALITY ............................................................................................................... 37 
13.4.1 Research Use of Stored Human Samples, Specimens or Data .................................................................. 37 
13.5   FINANCIAL DISCLOSURE ........................................................................................................................................ 38 
13.6  FINANCE ............................................................................................................................................................ 38 
14.   DATA HANDLING AND RECORD KEEPING...................................................................................................... 38 
14.1   DATA COLLECTION AND MANAGEMENT ................................................................................................................... 38 
14.2   STUDY RECORDS RETENTION ................................................................................................................................. 39 

Protocol [V01-CBT-401] 
 
Bausch Health Americas, Inc. 
 
Page 8 of 49 
Version 3.0 09/13/2021 
 
CONFIDENTIAL 
14.3   PROTOCOL DEVIATIONS ........................................................................................................................................ 39 
14.4   PUBLICATIONS AND DATA SHARING ........................................................................................................................ 40 
15. LITERATURE REFERENCES ............................................................................................................................... 41 
APPENDIX SECTION .............................................................................................................................................. 42 
APPENDIX A: GLOGAU PHOTODAMAGE SCALE ................................................................................................................... 42 
APPENDIX B: FITZPATRICK WRINKLE AND ELASTOSIS SCALE .................................................................................................. 42 
APPENDIX C: FITZPATRICK SKIN TYPE ............................................................................................................................... 43 
APPENDIX D: SERIOUS ADVERSE EVENT / UNANTICIPATED ADVERSE DEVICE EFFECT REPORT FORM ............................................. 44 
APPENDIX E: DEVICE MALFUNCTION REPORT FORM ........................................................................................................... 47 
APPENDIX F: PATIENT SKIN RESPONSE SEVEN-DAY DIARY .................................................................................................... 49 

Protocol [V01-CBT-401] 
 
Bausch Health Americas, Inc. 
 
Page 9 of 49 
Version 3.0 09/13/2021 
 
CONFIDENTIAL 
1. STUDY SYNOPSIS 
Name of Sponsor/Company 
Bausch Health Americas, Inc. 
Name of Device 
CLEAR + BRILLIANT TOUCH£ diode laser 1440-nm and 1927-nm  
Title of Study 
A Prospective, Single-Center Study Evaluating the Safety and Effectiveness of 
the CLEAR + BRILLIANT TOUCH£ diode laser 1440-nm and 1927-nm 
Combination Wavelength Treatment. 
Number of Clinical Centers 
Single Center  
Study Design 
This is a prospective study of up to 30 subjects designed to assess the safety 
and effectiveness of a non-ablative fractional laser combination wavelength 
treatment for general resurfacing of photoaged skin. All study subjects will be 
treated on the whole face with the CLEAR + BRILLIANT TOUCH£ 1440-nm and 
1927-nm handpieces. Subjects will be treated with a consecutive series of four 
(4) treatments spaced 1 month apart, along with follow-up study visits at one (1) 
and three (3) months after final treatment. 
Study Population 
To be eligible for the study, the subjects must have mild (I) to moderate (II) 
photoaging by Glogau Photodamage Scale, no more than fine wrinkles and mild 
elastosis by Fitzpatrick Wrinkle and Elastosis Scale (Class I-II, Score 1-6). Both 
males and females will be considered, between the ages 18 and 65 years and 
Fitzpatrick skin Types I-VI with 70% skin types I-III and 30% skin types IV-VI. 
 
Number of subjects: Up to 30 subjects who meet all study inclusion/exclusion 
criteria will be considered for entry. 
Study Objective 
The objective is to evaluate the effectiveness and safety of the CLEAR + 
BRILLIANT TOUCH£ diode laser combination treatment of 1440-nm and 1927-
nm.  
Study Endpoints 
Primary Effectiveness Endpoint: improvement in the appearance of at least one 
measurement of photoaging damage (fine wrinkles, skin texture, 
dyschromia/pigment, skin radiance, pore size or overall appearance) by the 
investigator using the quartile improvement score comparing standard 2D 
baseline photograph captured via Canfield VISIA CA system and the 3 months 
post final treatment photograph. Reported percent change in improvement. 
Secondary Effectiveness Endpoint: improvement in the appearance of at least 
one measurement of photoaging damage (fine wrinkles, skin texture, 
dyschromia/pigment, skin radiance, pore size and overall appearance) by the 
investigator using the quartile improvement score comparing standard 2D 
baseline photograph captured via Canfield VISIA CA system to 1 month post 
final treatment photograph. Reported percent change in improvement. 
Safety:  
- 
Serious Adverse Events (SAEs) related and unrelated to the treatment 
procedure or to the CLEAR + BRILLIANT TOUCH£ diode laser system. 
- 
The severity of post-treatment skin responses: 
 
• Immediate post-treatment erythema and edema.  
• Prolonged post-treatment erythema, edema, dryness/flakiness, 
hypopigmentation, hyperpigmentation, blistering, scarring. 
- 
The evaluation of pain and discomfort immediately after the treatment 
(within 60 minutes) as reported by the subject on a visual analog scale 
(VAS) 
 
 

Protocol [V01-CBT-401] 
 
Bausch Health Americas, Inc. 
 
Page 10 of 49 
Version 3.0 09/13/2021 
 
CONFIDENTIAL 
Exploratory Endpoints 
Subject Modified Global Aesthetic Improvement Scale (GAIS) comparing their 
overall appearance in photos at 3 months post treatments with baseline photos. 
Subject Satisfaction with procedure recorded at 3 months post treatments. 
Five (5) patients will have 3 punch biopsies from an area of photoaging 
comparing baseline to 14 days and 3 months post treatments (location on the 
face at discretion of investigating physician either pre-auricular or at temple 
hairline. If face location unattainable the forearm exposed to photoaging may be 
used as an alternate biopsy location). 
Blinded Investigator: analysis of unmarked 2D photo sets via Canfield clinical 
system. Reviewers will select the order of baseline and post treatment one-
month photos. Then based on their selection assess photos for percentage 
improvement in photoaging damage using the quartile improvement scale and 
score 0-4. Reported percent change in improvement of correct order sets. 
Blinded Investigator: analysis of unmarked 2D photo sets via Canfield clinical 
system. Reviewers will select the order of baseline and post treatment three-
months photos. Then based on their selection assess photos for percentage 
improvement in photoaging damage using the quartile improvement scale and 
score 0-4. Reported percent change in improvement of correct order sets. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

Protocol [V01-CBT-401] 
 
Bausch Health Americas, Inc. 
 
Page 11 of 49 
Version 3.0 09/13/2021 
 
CONFIDENTIAL 
2. INTRODUCTION: BACKGROUND INFORMATION 
 
Skin is susceptible to aging, much like all the other organs of the body. There are two 
different processes at work that lead to skin alterations. Intrinsic aging is a chronological, 
biological progression of degenerative changes associated with time, gravity, hormones, 
and genetics. Exposure to environmental factors contributes significantly to the aging 
process of the skin. The second process called extrinsic aging is a direct consequence of 
external elements, mainly induced by chronic exposure to ultraviolet (UV) radiation, and 
hence called photoaging.3 UV changes vary considerably among different Fitzpatrick skin 
types and ethnicity.1 
Extrinsic aging occurs in habitually exposed areas of the body such as face, neck, chest, 
and arms. Alterations in the skin from photoaging include uneven pigmentation, 
telangiectasia, wrinkles, roughness (textural changes), and occur in both the epidermis and 
dermis.2 Histologically damage to the skin’s dermal connective tissue occurs because of the 
loss of collagen, elastosis, and alterations of components in the extracellular matrix.1 
Increased and uneven pigmentation in photoaging are mostly a result of changes in 
melanocytes located in the basal epidermal layer.7 
Patients seek out treatment options for both intrinsic and extrinsic skin concerns for general 
skin resurfacing. Laser treatments for photoaging began with ablative CO2 (10,600 nm) 
lasers, which vaporized the epithelium and heated the dermis. These treatments had 
prolonged downtime and an increased risk of side effects. Non-ablative lasers were created 
to spare the epidermis and stimulate collagen in the dermis; they had a better safety profile; 
however, efficacy was limited.3  
Non-ablative fractional lasers utilize different wavelengths to ablate or coagulate tissue in 
columns or microthermal treatment zones (MTZs). Tissue is not vaporized and the stratum 
corneum remains intact.6 The skin then heals from both the edge of the wound and 
underlying tissue. The dermis undergoes necrosis leaving a dead space to be filled with new 
collagen and repair of tissue related to photoaging.4 The spared areas shortened downtime 
and presented a smaller range of side effects, increasing the safety profile. Fractional 
resurfacing treatments utilizing multiple wavelengths in a single session over a series of 
treatments has clinical benefits for treating superficial and underlying dermal effects 
associated with photodamage.5 
The CLEAR + BRILLIANT TOUCH£ diode laser is a low powered and low density (0.9- 2.5 
watt) non-ablative fractional diode laser that targets water as its chromophore. The system 
utilizes the principle of fractional photo thermolysis which means only limited areas of the 
skin are exposed to laser optical energy at one time. Healing time is minimized because the 
fractional photo thermolysis laser affects only a pre-determined percentage of the skin 
surface at any one time and does not cause full epidermal wounds. It can deliver a 1927 nm 
(170 μm fixed depth) and 1440 nm (280-390 μm depth) wavelength depending upon the 
handpiece desired while using the same credit key during a session.8,9 
In this study, the effect and safety of delivering two wavelengths in the same session 
treatment, over a series of four treatments addressing alterations of photoaging using the 
CLEAR + BRILLIANT TOUCH£ fractionated diode laser, will be assessed.  
 

Protocol [V01-CBT-401]
Bausch Health Americas, Inc.
Page 12 of 49
Version 3.0 09/13/2021
CONFIDENTIAL
2.1   Device Description
The CLEAR + BRILLIANT TOUCH® System is manufactured by Solta Medical, Inc. (11720 
North Creek Parkway N., Suite 100, Bothell WA 98011, USA) and is indicated for use in 
dermatological procedures requiring the coagulation of soft tissue and general skin resurfacing
procedures. The CLEAR + BRILLIANT TOUCH® System consists of a console and two 
versions of the laser handpiece. The console connects to the facility power source and the 
handpieces produce laser energy delivered through removable, disposable treatment tips. A 
credit key is required to activate treatments and is inserted into the side of the console. 
Additional details on the CLEAR + BRILLIANT TOUCH® System can also be found in the 
CLEAR + BRILLIANT TOUCH® Laser System User Manual Revision D provided by the 
Sponsor.
The system includes the Original Handpiece (1440 nm) and the Perméa™ Handpiece (1927 
nm), allowing for targeted treatment of different tissue depths.
Front and Rear view of the system
Control/Connection/Description
Function
1
Credit Key
Contains treatment credits. Credit Keys are removable and are to be disposed of 
when finished.
2
Emergency Stop Switch
Stops the laser treatment beam when pressed during an emergency. To restart, 
twist the button and release it from the latched Off position.
3
Console
Houses the electro-mechanical components that operate the system.
4
Touch Screen
Displays information on operating the system, including system status, progress 
of the self-test, instructions, and general messaging. The Touchscreen is 
interactive: Select by tapping the onscreen buttons.
5
Power Button
Powers on and off the system.
6
AC Power Inlet, Network 
Connection, and USB Ports
Connects the Console to the Power Cord.
Used by Solta Medical Maintenance. Downloads Charting information and used 
by Solta Medical Maintenance.
7
Handpieces
Generate laser energy, and where the Treatment Tips are attached. Two 
Handpieces are available: The Original Handpiece (1440 nm) in gray, and the 
Perméa™ Handpiece (1927 nm) in blue.
8
Handpiece Connection Ports
Connect the Handpieces to the Console. Disconnect using the workable latches.
9
Cradle
Holds the Handpieces when they are not being used.  Installed Handpieces 
need to be resting in the Cradle when the self-test runs during the initialization of 
the system. This is automatically controlled by the software.
1
2
3
4
5
6
7
8
9

Protocol [V01-CBT-401] 
 
Bausch Health Americas, Inc. 
 
Page 13 of 49 
Version 3.0 09/13/2021 
 
CONFIDENTIAL 
2.1.1   Mechanical Specifications 
 
Size 
31.75cm (W) x 28.58cm (L) x 27.94cm (H) 
12.5” (W) x 11.25” (H) X 11” (D) 
Weight 
Approximately 15.5LBS (7kg) 
Power Cord length 
3m (10ft) 
Handpiece Cable length 
2m (6.6ft) 
 
2.1.2   Laser Safety Standards 
 
The CLEAR + BRILLIANT TOUCH® System meets applicable electrical and laser safety 
standards (per IEC 60601 series and IEC 60825-1) for a Class 1C laser. 
The CLEAR + BRILLIANT TOUCH® System contains a Class 1C laser, according to 
IEC/EN 60825-1 standards. The user and associated staff must take precautions to 
prevent direct exposure of laser energy to the eyes. 
Handpiece Technical Specifications: 
Original Handpiece (1440 nm)  
Equipment classification IEC 60601-1 
Class 1 
Handpiece 
Type BF Applied Part 
IEC 60825-1 Classification 
Class 1C – Invisible Laser Radiation 
Wavelength 
1440 ± 20 nm; min:1420 max:1460      
Maximum Power (average) 
2.5 W  
Maximum Pulse Energy 
9 mJ 
Maximum Pulse Width 
3 ms 
Pulse Repetition Rate 
< 400 Hz 
 
Perméa™ Handpiece (1927 nm)  
Equipment classification IEC 60601-1 
Class 1 
Handpiece 
Type BF Applied Part 
IEC 60825-1 Classification 
Class 1C – Invisible Laser Radiation 
Wavelength 
1927 ± 20 nm; min:1907 max:1947      
Maximum Power (average) 
0.9 W  
Maximum Pulse Energy 
5 mJ 
Maximum Pulse Width 
5 ms 
Pulse Repetition Rate 
< 150 Hz 
 
 
 

Protocol [V01-CBT-401] 
 
Bausch Health Americas, Inc. 
 
Page 14 of 49 
Version 3.0 09/13/2021 
 
CONFIDENTIAL 
2.1.3   Study Device Accountability 
 
The Investigator will be responsible for keeping current and accurate device 
accountability records. At various time points throughout the study and/or upon 
completion of the study, the Sponsor or Sponsor’s representative will review and verify 
the Investigator’s accountability records.  
 
Credit Keys and disposable Treatment Tips are used to restrict access to the device to 
only authorized users. Laser light can only be produced by the system when a valid 
Credit Key with available treatment credits is inserted into the Console and a Treatment 
Tip is attached to the Handpiece. One Credit Key is loaded with 12 treatment credits. 
The Investigator will be provided with sufficient Credit Keys /Treatment Tips to provide 
treatment for subjects enrolled into the study. Credit Key lot number and Treatment Tip 
lot number will be recorded for each subject treatment on the CRF.  
 
Following study completion, study devices must be returned to the Sponsor. The 
Sponsor will be responsible for complete study accountability, returns, and reconciliation 
of the returned devices at the conclusion of the study. 
3. STUDY OBJECTIVE:  
 
The objective is to evaluate the effectiveness and safety of the CLEAR + BRILLIANT 
TOUCH£ diode laser combination treatment of 1440-nm and 1927-nm. 
4. STUDY DESIGN AND ENDPOINTS 
4.1   Description of Study Design: 
 
This is a prospective, non-randomized study of up to 30 subjects designed to assess the 
safety and effectiveness of a non-ablative fractional combination laser wavelength 
procedure for general resurfacing of photoaged skin. All study subjects will be treated on 
the whole face with the with the CLEAR + BRILLIANT TOUCH£ diode laser 1927-nm & 1440-
nm handpieces. Subjects will be treated with a consecutive series of four (4) treatments 
spaced 1-month apart, along with follow-up study visits at one (1) and three (3) months 
after final treatment. As primary and secondary effectiveness endpoints aim to evaluate 
improvement in photoaging damage post-treatment as compared to baseline following 
treatment with the FDA-cleared CLEAR + BRILLIANT TOUCH® System, no control group 
will be utilized. 
 
4.2   Study Endpoints 
 
4.2.1   Primary Endpoint  
 
Primary Effectiveness Endpoint: improvement in the appearance of any one or 
more measurement of photoaging damage (fine wrinkles, skin texture, 
dyschromia/pigment, skin radiance, pore size and overall appearance) by the 
investigator using the quartile improvement score comparing standard 2D baseline 

Protocol [V01-CBT-401] 
 
Bausch Health Americas, Inc. 
 
Page 15 of 49 
Version 3.0 09/13/2021 
 
CONFIDENTIAL 
photograph and the 3 months post final treatment photograph. Reported percent 
change in improvement. 
 
4.2.2   Secondary Endpoint 
 
Secondary Effectiveness Endpoint: improvement in the appearance of any one or 
more measurement of photoaging damage (fine wrinkles, skin texture, 
dyschromia/pigment, skin radiance, pore size and overall appearance) by the 
investigator using the quartile improvement score comparing standard 2D baseline 
photograph and the 1 month post final treatment photograph. Reported percent 
change in improvement. 
 
4.2.3   Safety Endpoints 
 
Serious Adverse Events (SAEs) related and unrelated to the treatment procedure 
or to the CLEAR + BRILLIANT TOUCH£ diode laser. 
 
The severity of post-treatment skin responses: 
 
 
x 
Immediate post-treatment erythema and edema (Visits: 1 and or 2 if 
screening and treatment on same day, Visits 3, 4 and 5) 
x 
Prolonged post-treatment erythema, edema, dryness/flakiness, 
hypopigmentation, hyperpigmentation, blistering, scarring. (Visits 6 & 7) 
 
The evaluation of pain and discomfort immediately after the treatment (within 60 
minutes) as reported by the subject on a visual analog scale (VAS). 
 
4.2.4   Exploratory Endpoints 
 
i. Subject Modified Global Aesthetic Improvement Scale (GAIS) comparing their 
own photos at 3 months post treatments compared to baseline photos. 
ii. Subject Satisfaction with procedure recorded at 3 months post treatments. 
iii. Five (5) patients will have 2-mm punch biopsies from area of photoaging 
comparing baseline to 14 days and 3 months post treatments (location on face 
at discretion of investigating physician: either pre-auricular or at temple hairline. 
If face location is unattainable, the forearm, exposed to photoaging may be used 
as an alternate biopsy location). Pre- and post-treatment biopsies must be taken 
from the same general location for each patient. 
iv. Blinded Investigator: analysis of unmarked 2D photo sets via Canfield clinical 
system. Reviewers will select the order of baseline and post treatment one-
month photos. Then based on their selection assess photos for percentage 
improvement in photoaging damage using the quartile improvement scale and 
score 0-4. Reported percent change in improvement of correct order sets. 
v. Blinded Investigator: analysis of unmarked 2D photo sets via Canfield clinical 
system. Reviewers will select the order of baseline and post treatment three-
months photos. Then based on their selection assess photos for percentage 

Protocol [V01-CBT-401] 
 
Bausch Health Americas, Inc. 
 
Page 16 of 49 
Version 3.0 09/13/2021 
 
CONFIDENTIAL 
improvement in photoaging damage using the quartile improvement scale and 
score 0-4. Reported percent change in improvement of correct order sets. 
5. INVESTIGATOR SELECTION AND STUDY POPULATION: 
5.1   Investigator Selection 
 
Investigators will be qualified based on professional experience in the diagnosis and 
treatment of photoaged skin including fine and coarse wrinkles, dyspigmentation, loss of 
tone, texture and elastosis using energy-based devices including lasers. 
 
Investigators should be familiar with the risks and benefits described in Section 9. 
Investigator training and experience will be determined by the Sponsor to be suitable based 
on the Investigator’s medical training and licensure. 
5.2   Number of Participants 
 
Up to 30 subjects who meet all study/exclusion criteria will be considered for entry. 
Application of the inclusion and exclusion criteria in the following sections will result in the 
selection of an investigational population which is approximately representative of the 
intended target population. 
 
5.3   Inclusion Criteria  
 
       Subjects must meet all the following inclusion criteria. 
1. Male or female. 
2. 18 to 65 years of age. 
3. Written and oral informed consent must be obtained.  
4. No more than Mild (I) to Moderate (II) classification on Glogau Photodamage 
Scale. 
5. Fitzpatrick skin types I-VI. 
6. Fitzpatrick wrinkle & elastosis scale class I-II, score 1-6 (fine wrinkles and mild 
elastosis). 
7. Ability to read, understand and sign the informed consent form. 
8. Agree not to take any new medications (unless prescribed by the study 
investigator) or undergo any other procedures that may potentially treat 
photodamaged skin (any other aesthetic treatments) during the study. 
 
5.4   Exclusion Criteria  
 
Subjects will be excluded from the study if they meet any of the following criteria. 
1.   Pregnant, breastfeeding, or planning to become pregnant during the study. 
2    History of any type of allergic reaction to lidocaine. 
3.   Recent and/or active localized or systemic infections. 

Protocol [V01-CBT-401] 
 
Bausch Health Americas, Inc. 
 
Page 17 of 49 
Version 3.0 09/13/2021 
 
CONFIDENTIAL 
4.   Diagnosis/possibility of actinic keratosis, melasma, rosacea, or other significant 
skin conditions (e.g. skin cancer, active infections, cold sores, open wounds, 
rashes, burns, inflammation eczema, psoriasis). 
5.   Predisposition to keloid formation or excessive scarring. 
6. Diagnosis of a condition that may compromise the immune system, such as: HIV, 
lupus, scleroderma, and/or systemic infections. 
7.   Known sensitivity to light or photosensitizing agents/medications are being taken. 
8.   Systemic steroids (e.g. prednisone, dexamethasone), which should be rigorously 
avoided prior to and throughout course of the treatment. 
9.   Use of retinoids less than 2 weeks prior to or during the study to completion.  
10. Individuals undergoing Accutane™ treatment or drugs in a similar class. 
11. Having skin that is still recovering from a cosmetic procedure: such as a chemical 
peel, or mechanical peel, or laser resurfacing within the previous 6 months. 
12. Having had Botox injections, neurotoxin injections, or dermal fillers (such as 
collagen) within the past four months. 
13. Sunburn and/or recent sun exposure on the treatment area in the last 2 weeks. 
14. Subjects must agree to seek the advice of their medical doctor regarding any 
known or suspicious skin condition before laser treatment. 
15. Any condition or situation that would prevent the subject from safely completing 
all protocol requirements for participation. 
16. Subjects who are unable to communicate or cooperate with the investigator due 
to language problems, poor mental development, or impaired cerebral function. 
5.5   Strategies for Recruitment and Retention 
 
The recruitment process planned for this study will include any of the following scenarios: 
• 
An individual voluntarily schedules an appointment at the physician’s office (that in 
the context of this study also functions as the investigator’s test site) relating to the 
treatment of photoaging. 
• 
The study population may also be drawn from the investigator’s existing database of 
subjects who have expressed an interest in treatment of photoaging.  
• 
During the visit, if the physician perceives the subject may satisfy the study 
qualification criteria, the physician will present to the subject the option of being a 
subject in the study. 
• 
If the subject is interested in possibly taking part in the study, the physician – now in 
the role of study investigator – will personally review the informed consent form with 
the individual and answer any questions. The individual may sign the informed 
consent form at that visit or he or she may think about it for a while and sign the 
informed consent form later. No timeline may be set for the subject to sign the 
consent form. Furthermore, the subject can refuse to participate in the study. 
• 
An individual who decides to sign the consent form and proceed with participation in 
the study will receive a subject ID and proceed to the study qualification phase. 
• 
Treatment will include a screening visit, four treatment visits and two follow up visits; 
a total of seven office visits to complete participation. (Screening visit and first 
treatment may be on same day if no biopsy is taken.) Biopsy patients will have a total 
of eight office visits to include an additional biopsy collection at 14 days post 
treatment #1 for enrollment completion. 

Protocol [V01-CBT-401] 
 
Bausch Health Americas, Inc. 
 
Page 18 of 49 
Version 3.0 09/13/2021 
 
CONFIDENTIAL 
5.6   Subject Enrollment 
 
A subject is considered enrolled in the study at the time of the first treatment (Treatment #1) 
following confirmation of eligibility according to inclusion/exclusion criteria at the Screening 
Visit and again at Visit 2 (Treatment #1).  
5.7   Subject Screen Failures 
 
A subject who fails to meet eligibility criteria or discontinues from the study of their own 
volition before the first treatment will be considered a screen failure.   
5.8   Subject Completion 
 
The subject has completed the study when he/she completes Visit 7 (3-month follow-up). A 
subject who has missed visits or is missing study measurements will remain in the study. 
Subjects who require further follow-up for an adverse event (AE) or adverse device effect 
(ADE) will be followed according to Section 8.2.  The same standard of care will be available 
for subjects who complete the study as for discontinued subjects (see Section 5.9) if such 
additional care is necessary because of the subjects’ participation in the clinical investigation 
and where it differs from that normally expected for the medical condition in question. 
5.9  Subject Discontinuation 
 
 
A subject may discontinue from the study at any time without any penalty or loss of benefits 
to which the subject is otherwise entitled. An investigator may also discontinue a subject 
from the study without the subject's consent, if the investigator feels it is in the best medical 
interest of the subject. The date and reason for study withdrawal will be indicated on the 
study exit case report form. Every effort should be made to contact subjects lost to follow-up, 
and all such efforts should be documented in the subject’s file.  
If the subject withdraws from the study and also withdraws consent for disclosure of future 
information, no further evaluations will be performed, and no additional data will be 
collected.  The Sponsor may retain and continue to use any data collected before such 
withdrawal of consent. 
5.9.1   Reason for Withdrawal or Termination 
A study subject will be discontinued from participation in the study if: 
• Any clinical adverse event (AE), laboratory abnormality, intercurrent illness, or 
other medical condition or situation occurs such that continued participation in 
the study would not be in the best interest of the subject. 
• The subject meets any exclusion criteria (either newly developed or not 
previously recognized). 
Subjects who are withdrawn will not be replaced. 
5.9.2   Handling of Subject Withdrawal or Termination 
If a subject voluntarily withdrawals, they will not be asked to continue the scheduled 
evaluations due to the short study duration. If subject is withdrawn from study because of 
adverse events they will be provided with the appropriate care under medical supervision.  

Protocol [V01-CBT-401] 
 
Bausch Health Americas, Inc. 
 
Page 19 of 49 
Version 3.0 09/13/2021 
 
CONFIDENTIAL 
6.   STUDY PROCEDURES AND SCHEDULE: 
 
6.1   Informed Consent 
 
The investigator must ensure that written informed consent to participate in the study and 
written authorization for use and disclosure of protected health information is obtained 
before including any individual as a subject in the study, and before conducting any study 
related assessments. The investigator must provide the prospective subject with sufficient 
opportunity to consider whether to participate and minimize the possibility of coercion or 
undue influence.  
 
To participate in the study a subject must sign and date an IRB-approved consent 
document. The original, signed documents will be kept with these subjects’ files and copies 
will be provided to the subjects. The informed consent process must be followed, and the 
subjects’ participation in the study must be documented in the subjects’ medical record/CRF.  
 
6.2   Pre-Procedure 
 
Study subjects will have verification of eligibility criteria, a brief general examination 
including medical history, vital signs and pre-procedure assessments as detailed below, 
completed within 30 days prior to undergoing the study procedure. Up to two urine 
pregnancy tests must be obtained prior to study procedure for females with childbearing 
potential (one at pre-procedure screening and one on the day of the procedure prior to the 
procedure if the pre-procedure screening and procedure are not performed on the same 
day). 
The following pretreatment assessments will be performed: 
• 
Standard 2D photographic images will be captured via the Canfield Scientific Inc, 
VISIA CA imaging system. The same standardized photography views (right, left, 
front facing) will be used throughout the study as documented in the image capture 
document developed for the study. 
• 
Urine pregnancy test for females of childbearing potential; any premenopausal 
female capable of becoming pregnant. (Excluded: Non-childbearing potential, i.e. 
post-menopause, bilateral tubal ligation, oophorectomy, hysterectomy) 
• 
Abbreviated general physical exam including medical history, vital signs, collection 
of subject’s demographic information, Glogau photodamage assessment, Fitzpatrick 
skin type, Fitzpatrick Wrinkle and Elastosis Scale. (Appendixes A, B, C respectively) 
 
Medications the subject is taking upon entry into the study should also be documented in the 
case report forms. Documentation should include medications that study subjects take on an 
elective basis in addition to prescribed medications.  
 
After confirming fulfillment of all inclusion and exclusion criteria, the subject will be 
scheduled to undergo a CLEAR + BRILLIANT TOUCH® 1440-nm and 1927-nm combination 
wavelength treatment. 
 
Patient Pre-treatment instructions: 

Protocol [V01-CBT-401]
Bausch Health Americas, Inc.
Page 20 of 49
Version 3.0 09/13/2021
CONFIDENTIAL
x
Skin types IV-VI: Begin Hydroquinone 8% QHS at discretion of treating physician, 2-
3 weeks prior to first treatment. Hold while skin is healing between treatments, then 
restart QHS or as directed.
x
Wash face with CeraVe® cleanser.
x
Do not apply any topical facial products the morning of your treatment.
x
Do not wear jewelry.
x
Hair pulled back.
x
Bring a hat to wear that shields from the sun.
x
Bring on day of treatment the sponsor provided CeraVe® moisturizer and SPF to 
apply after treatment.
6.3   Study Procedure
During the study procedure, subjects will be treated with the CLEAR + BRILLIANT TOUCH£
diode laser device combination wavelength 1440-nm and 1927-nm treatment. 
Perform pattern preview test prior to use of device.
1. First the face will be cleansed with alcohol, topical anesthetic of 7% 
Lidocaine/7% Tetracaine will be applied 30 minutes prior to treatment.
2. Prior to treatment, the anesthetic will be fully wiped off and then face is cleaned 
again with rubbing alcohol to ensure face is free of all moisture and water. Allow 
to dry.
3. Provide patient protective eyewear. (Disposable or Non-disposable laser eye 
shields). Laser goggles for staff. With appropriate protection range for the system 
laser wavelengths (1440 nm ± 20 nm and 1927 ± 20 nm) and optical density of 5 
or greater. 
4. Attach single-use treatment tip.
5. Pre-set for 3200 cm2 treatment area coverage or Time: 40 minutes.
6. Full face will be treated with 4 passes of the 1440-nm Original handpiece on high 
setting for all skin types I-VI, with two passes in the horizontal direction and two 
passes in the vertical direction (Fig A.) in each treatment zone (Fig B, C). 
(Adjustments may be made to lower setting for patient tolerance)
7. Full face will be treated with 4 passes of the 1927-nm Perméa on high setting for 
all skin types I-VI, with two passes in the horizontal direction and two passes in 
Fig. A
Fig. C
Fig. B

Protocol [V01-CBT-401] 
 
Bausch Health Americas, Inc. 
 
Page 21 of 49 
Version 3.0 09/13/2021 
 
CONFIDENTIAL 
the vertical direction in each treatment zone. (Adjustments may be made to lower 
setting for patient tolerance) 
8. The total is a combined 8 passes in each treatment zone. 
9. CeraVe® moisturizer and SPF 30+ to be applied to entire face immediately after 
treatment. 
6.4   Follow-up Procedure 
 
Following the procedure, the research staff and the subject will care for the treated area 
using the Post-Procedure Care Guidelines listed below: 
 
Post Care and Instructions: 
1. Wash face with CeraVe® gentle cleansing product only. 
2. Do not use an abrasive cleanser or brush device to clean face. 
3. Apply CeraVe® moisturizer minimum twice a day while skin is healing and then as 
needed. 
4. SPF 30+ daily. (approved by investigator) 
Sun exposure before and during treatment can increase the risk of unwanted 
pigmentation. After treatment the skin is more sensitive to the sun, which can 
increase the risk of unwanted pigmentation and sunburn. Post-treatment individuals 
should plan to use a high SPF sunscreen on a regular basis whenever they are 
outside. Ideally, a dual UVA/UVB sunscreen should be applied containing both a 
physical sun block (either or both zinc oxide or titanium dioxide) with a sun protection 
factor of 30 or above. Applying sunscreen helps maintain good results. In general, it 
is recommended that direct sunlight is avoided and to wear sun-protective clothing 
(i.e. a wide-brimmed hat) when possible. 
5. Schedule next appointment. 
6. Review and dispense the Subject home diary for post treatment skin effects. 
7. For patients on the 8% hydroquinone therapy (Skin types IV-VI) hold this application 
while skin is healing, then restart QHS or as directed. 
 
Subjects will be asked to return to the study site for subsequent procedures and post 
treatment follow up. 
 
Post procedure Standard 2D images will be captured via the Canfield Scientific Inc, VISIA 
CA imaging system during the follow-up visits.  
6.5   Data Collection 
 
Subject demographic information, procedural data, adverse events, treatment observations 
and study required assessments will be documented on the case report forms (CRFs). 
Study subjects will complete satisfaction and modified global aesthetic improvement scale 
evaluations at the 3-month follow up. The Investigators will assess post treatment skin 
effects immediately post treatment, at follow up visits (prolonged post treatment) and quartile 
improvement scores at one (1) month and three (3) months in comparison to baseline 
photography. Blinded Investigators will provide analysis of unmarked 2D photo sets via 
Canfield clinical system. Reviewers will select the order of baseline and post treatment at 
one (1) month and three (3) months. Then based on their selection assess photos for 

Protocol [V01-CBT-401] 
 
Bausch Health Americas, Inc. 
 
Page 22 of 49 
Version 3.0 09/13/2021 
 
CONFIDENTIAL 
percentage improvement in photoaging damage using the quartile improvement scale and 
score 0-4.   
 
6.5.1 Photography 
VISIA CA facial photography system and services will be provided by the 
photography vendor, Canfield Scientific, Inc. (Parsippany, NJ) to document 
treatment effect from baseline to follow up visits. The camera system standardizes 
the facial (front, left and right oblique) images captured and lighting modalities.     
All consenting subjects’ study photographs will be captured using the equipment, 
supplies, and guidelines provided by Canfield to have consistent visual 
representation of the facial appearance during the study treatment.   
Images will be captured, viewed, and uploaded using Canfield Clinical Services 
website which automatically checks, sums, encrypts, packages, and transfers the 
data to a secure, validated and compliant web server hosted by Canfield. Only 
approved individuals by the Sponsor have access to the study database on 
the website. 
Detailed instructions for all aspects of the photography procedures will be supplied 
separately in the investigator user manual to be provided by Canfield.  Images will 
be utilized for study research purposes (add other purposes, analysis if 
applicable).  
6.5.2   Specimens 
Five patients who provide additional consent to provide biopsies will have three (3) 
punch biopsies taken by the Investigator or site designee in the treatment area 
(area of photodamage). Location of biopsies will be pre-auricular, at temporal 
hairline, or the forearm. Pre- and post-treatment biopsies must be taken from the 
same general location for each patient.  
 
x 
The first biopsy will be collected at Screening/Baseline visit (pre-Treatment #1) 
The first treatment will be subsequently scheduled at the discretion of the 
principal investigator as they determine the biopsy site to be healed for 
treatment. 
x 
The second biopsy will be collected at 14 days following the first treatment. 
The second treatment will be subsequently scheduled at the discretion of the 
principal investigator as they determine the biopsy site to be healed for 
treatment. 
x 
The third biopsy will be collected at 3-month follow up (3-months post final 
treatment, Treatment #4).  
6.6   Final Study Visit 
 
Three-month 2D follow-up photographs will be taken captured via the Canfield Scientific Inc, 
VISIA CA imaging system. 
 
Subjects will complete satisfaction surveys and GAIS overall improvement scores. 
 

Protocol [V01-CBT-401] 
 
Bausch Health Americas, Inc. 
 
Page 23 of 49 
Version 3.0 09/13/2021 
 
CONFIDENTIAL 
Investigators will complete Quartile Improvement Scales comparing baseline photography to 
3 months photography. 
 
6.7   Study Completion 
 
The Sponsor or its representative will notify the Investigator and/or the IRB, as applicable, to 
inform them when the study is complete. The study will be considered complete when all 
enrolled subjects either have completed study visits through Visit 7 (3-month follow up) or 
have been discontinued from the study prior to Visit 7 for any reason. 
 
6.8   Schedule of Events Table 
 
Schedule of Events 
 
VISIT 1 
VISIT 2 
VISIT 2a 
VISIT 3 
VISIT 4 
VISIT 5 
VISIT 6 
VISIT 7 
PROCEDURES 
Screening 
Visit 
(Day -30 to 
0) 
Treatment 
#1 
(Baseline) 
Day 14 
Biopsy 
(14 days 
post 
treatment 
#1, +/- 7 
days) 
Treatment #2 
(1-month post 
treatment #1, 
+/- 7 days) 
Treatment #3 
(1-month post 
treatment #2, 
+/- 7 days) 
Treatment #4 
(1-month post 
treatment #3, 
+/- 7 days) 
1-Month 
F/U  
(1 month 
post final 
treatment, 
+/- 7 days) 
3-Month 
F/U 
(3 months 
post final 
treatment, 
+/- 7 days) 
Informed Consent/Photo 
Release 
X 
 
 
 
 
 
 
 
Demographics 
X 
 
 
 
 
 
 
 
Medical History 
X 
X 
 
 
 
 
 
 
Vital Signs 
X 
 
 
 
 
 
 
 
Concomitant Medications 
X 
X 
 
X 
X 
X 
X 
X 
Inclusion/Exclusion 
Criteria 
X 
X 
 
 
 
 
 
 
Previous Therapies 
X 
X 
 
 
 
 
 
 
Urine Pregnancy Test  
X 
X 
 
 
 
 
 
 
2D Standard Photography 
 
X 
 
X 
X 
X 
X 
X 
Investigator Intake 
Assessments  
X 
X 
 
 
 
 
 
 
Punch Biopsy  
X 
 
X 
 
 
 
 
X 
Laser Treatment 
 
X 
 
X 
X 
X 
 
 
VAS Visual Analog Scale 
 
X 
 
X 
X 
X 
 
 
Side Effects Evaluation 
 
X 
 
X 
X 
X 
X 
X 
Adverse Events Review 
X 
X 
 
X 
X 
X 
X 
X 
Investigator Quartile 
Improvement Evaluation 
 
 
 
 
 
 
X 
X 
Prolonged Treatment 
Effects 
 
 
 
 
 
 
X 
X 
Subject GAIS 
 
 
 
 
 
 
 
X 
Subject Diarya 
 
X 
 
X 
X 
X 
 
 
Subject Satisfaction 
 
 
 
 
 
 
 
X 
End of Treatment(s) 
 
 
 
 
 
X 
 
 
End of Study 
 
 
 
 
 
 
 
X 
a. Subject’s will log post-treatment skin responses, side effects (e.g., erythema, edema) using a scale of 0 to 3 (none to marked) after each 
treatment for seven (7) days in the subject diary. 
 
 
 

Protocol [V01-CBT-401]
Bausch Health Americas, Inc.
Page 24 of 49
Version 3.0 09/13/2021
CONFIDENTIAL
A prospective subject is to be examined to determine if they qualify for entry into the study. This initial 
examination will include:
x
Obtain written Informed Consent and photographic release
x
Review Inclusion/Exclusion Criteria 
x
Record Medical History/Meds/Vital Signs
x
Urine Pregnancy Test (if applicable): only one is necessary prior to start of treatments.
x
Dispense CeraVe® Products
x
Skin types IV-VI: Begin Hydroquinone 8% QHS at discretion of treating physician 2-3 weeks prior 
to first treatment. Hold while skin is healing, then restart QHS or as directed.
x
Investigator Assessments: Glogau Photodamage, Fitzpatrick Skin Type and Wrinkle & Elastosis
Scale
x
Biopsy #1 of five patients (baseline)
Note: Screening and Baseline visits may occur on the same day for non biopsy patients.
This treatment visit will include:
x
Photographs prior to treatment: wait at least 15 min indoors, 2D standard photography captured 
via Canfield VISIA CA. 
x
Urine Pregnancy Test (if applicable): only one is necessary prior to start of treatments.
x
Laser treatment to the face
x
VAS Scale
x
Post Treatment Skin effects (provider)
x
Review for Adverse Events (provider)
x
Subject Diary post treatment (7 days) given to patient.
x
Biopsy #2 of selected five patients
This treatment visit will include:
x
Prior to treatment: wait at least 15 min indoors, 2D standard photography via Canfield VISIA CA
x
Laser treatment to the face
x
VAS Scale
x
Post Treatment Skin effects (provider)
x
Review for Adverse Events (provider)
x
Subject Diary post treatment (7 days) given to patient
This treatment visit will include:
x
Prior to treatment: wait at least 15 min indoors, 2D standard photography via Canfield VISIA CA 
x
Laser treatment to the face
x
VAS Scale
x
Post Treatment Skin effects (provider)
x
Review for Adverse Events (provider)
x
Subject Diary post treatment (7 days) given to patient
This treatment visit will include:
x
Prior to treatment: wait at least 15 min indoors, 2D standard photography via Canfield VISIA CA 
Screening
Baseline/Treatment #1   (Screening/Baseline may be on same day)
Biopsy Patients Only (14 days post treatment #1, +/- 7 days )
Treatment #2       (one-month post treatment #1, +/- 7 days)
Treatment #3      (one -month post treatment #2, +/- 7 days)
Treatment #4   (one-month post treatment #3,+/- 7 days,)

Protocol [V01-CBT-401]
Bausch Health Americas, Inc.
Page 25 of 49
Version 3.0 09/13/2021
CONFIDENTIAL
x
Laser treatment to the face
x
VAS Scale
x
Post Treatment Skin effects (provider)
x
Review for Adverse Events (provider)
x
Subject Diary post treatment (7 days) given to patient
This follow-up examination will include:
x
Photography: wait at least 15 min indoors, 2D standard photography via Canfield VISIA CA
x
Prolonged Post Treatment Skin effects
x
Review for Adverse Events
x
Investigator Quartile Percent Improvement Evaluation
This follow-up examination will include:
x
Photography: wait at least 15 min indoors, 2D standard photography via Canfield VISIA CA
x
Prolonged Post Treatment Skin effects
x
Review for Adverse Events
x
Subject GAIS and satisfaction
x
Investigator Quartile Percent Improvement Evaluation
x
Biopsy #3 of selected five patients
7.   EVALUATION TOOLS
7.1   Investigator Evaluation Standard 2D Photography
Two-dimensional (2D) facial photographic images will be captured by the Canfield Scientific, 
Inc. VISIA CA imaging system.
x
The camera system standardizes the facial (front, left and right oblique) images 
captured and lighting modalities.
x
All makeup should be removed, hair pulled back in consistent manner and 
behind the ears, all jewelry removed.
x
Patients will be notified in their informed consent about the collection and use of 
their photographs for research purposes which may be used for scientific, 
educational presentations or publications.
The data will be comparing baseline photos to 1- and 3-months post treatment for results.
7.2   Investigator Evaluations Quartile Improvement Score
Treating Investigators will compare: 
1. Baseline photographs to one-month post treatment. 
2. Baseline photographs to three-months post treatment.
A Quartile Improvement Scale will be used to individually score each category: (a) fine 
wrinkles, (b) skin texture, (c) dyschromia/pigment, (d) skin radiance, (e) pore size and (f) 
overall appearance.
Follow-Up Visit  (one-month post treatment #4, +/- 7 days)
Follow-Up Visit (three months post treatment #4, +/- 7 days)

Protocol [V01-CBT-401] 
 
Bausch Health Americas, Inc. 
 
Page 26 of 49 
Version 3.0 09/13/2021 
 
CONFIDENTIAL 
 
 
 
 
 
 
 
 
7.3   Punch Biopsies 
     
Up to five (5) subjects will be consented to provide skin biopsies. Each subject will provide 
up to three (3) punch biopsies. 2 mm punch biopsies will be taken from the location on the 
face in an area of photoaging at discretion of investigating physician either pre-auricular or 
at temple hairline. If face location is unattainable the forearm (exposed to photoaging) may 
be used as an alternate biopsy location and will receive the combined laser treatment in 
addition to receiving a facial treatment. Pre- and post-treatment biopsies must be taken from 
the same general location for each patient. 
Biopsies will be obtained using standard sterile technique after an intradermal local 
anesthesia, closed with suture (at the discretion of the Sub-Investigator/Study Physician), 
and treated with topical antibiotic and sterile dressing in routine fashion. Subjects’ skin may 
be marked with a surgical marker to use as reference. Complete anesthesia of the biopsy 
site will be confirmed prior to the punch being inserted.  
The biopsies will be immediately transferred into 10% formalin solution and stored at room 
temperature.  Collected biopsy samples will be sent to Propath for biopsy sample analysis. 
IHC staining for Procollagen I, elastin, CD31, lymphocyte count, Masson’s trichrome, GAG 
(Colloidal/Fe), and H&E, with images. 15 samples total will be collected (5 sets at baseline, 
day 14 and final visit). 
The biopsy sample manifest will be sent to Propath and will contain the subject number, 
product information, total number of biopsies collected, and any other relevant information 
needed to identify the samples post-analysis. 
7.4   Visual Analog Scale (VAS) 
 
The study subjects will be asked to complete an eleven point visual analog scale (VAS, 0-
10) for the level of pain and discomfort associated with the study procedure to be completed 
by the subjects on the day of the procedure immediately after or within 60 minutes from the 
end of the procedure and recorded in the CRF treatment record. They may verbally respond 
with a numeric pain score. 
 
 
 
 
 
Scoring will be reported by the provider on the treatment record.  
Investigator Quartile Improvement Score 
Rating 
Percentage (%) 
Score 
No Improvement 
0% 
0 
Minor/Mild Improvement 
1%-25% 
1 
Moderate Improvement 
26%-50% 
2 
Marked Improvement 
51%-75% 
3 
Very Significant Improvement 
76%-100% 
4 

Protocol [V01-CBT-401] 
 
Bausch Health Americas, Inc. 
 
Page 27 of 49 
Version 3.0 09/13/2021 
 
CONFIDENTIAL 
 
7.5   Subject Satisfaction 
 
Using a five (5) point Likert scale the study subjects will be asked to complete a satisfaction 
survey to rate their overall treatment results at the three-month follow-up visit.  
 
Overall how would you rate your satisfaction with the 
treatment results? 
Very Dissatisfied 
1 
Dissatisfied 
2 
Neither Satisfied nor Dissatisfied 
3 
Satisfied 
4 
Very Satisfied 
5 
7.6   Subject Modified Global Aesthetic Improvement Score 
 
The Modified Global Aesthetic Improvement Scale (GAIS) is a subjective rating of 
improvement of treatment results compared to pre-treatment. The subjects will grade the 
overall improvement of the appearance of the treatment areas. The subject will compare 
their appearance at three months against a photograph taken at baseline. 
7.7   Independent Photographic Assessments 
 
 
Two experienced, blinded photographic reviewers will compare 2D photographs via Canfield 
Scientific, Inc VISIA data access system: 
1. The reviewer will select between 2 sets of unmarked photos and determine which 
is baseline and one-month post treatment. Based on their selection of baseline to 
one-month post treatment the reviewer will rate improvement. 
2. The reviewer will select between 2 sets of unmarked photos and determine which 
is baseline and three-months post treatment. Based on their selection of baseline 
to three-months post treatment they will rate improvement. 
A Quartile Improvement Scale will be used to individually score each category: (a) fine 
wrinkles, (b) skin texture, (c) dyschromia/pigment, (d) skin radiance, (e) pore size and (f) 
overall appearance. 
 
 
 
 
SUBJECT MODIFIED GLOBAL AESTHETIC IMPROVEMENT SCALE 
Comparing baseline photograph to three-months photograph. 
                   Rating 
 
How do you rate your overall appearance compared to before 
treatment? 
 
Very Much Improved 
 
Much Improved 
 
Improved 
 
No Change 
 
Worse 
 
Much Worse 
 
Very Much Worse 

Protocol [V01-CBT-401] 
 
Bausch Health Americas, Inc. 
 
Page 28 of 49 
Version 3.0 09/13/2021 
 
CONFIDENTIAL 
 
 
 
 
 
 
 
 
If the incorrect order is selected that grouping will not be used to calculate improvement. 
The percentage of correct to incorrect will be calculated for both one-month and three-month 
assessments. 
8.   ASSESSMENT OF SAFETY 
8.1   Specification of Safety Parameters 
 
x 
Post-treatment skin responses, side effects (e.g., erythema, edema) will be scored 
by the study investigators, as appropriate, using a scale of 0 to 3 (none to marked), 
immediately after treatment, for each treatment. 
x 
Side effects (prolonged erythema, edema, skin darkening or lightening in the 
treatment area, scarring, dryness/flakiness, blistering) will be scored, using a scale of 
0 to 3 (none to marked), by study investigators at the beginning of every subsequent 
treatment, and at all follow-up visits. 
x 
Subject’s will log post-treatment skin responses, side effects (e.g., erythema, edema) 
using a scale of 0 to 3 (none to marked), after each treatment for seven (7) days in 
the patient diary. 
x 
In addition, study subjects will be instructed to report all complications experienced 
post study procedure to the site personnel as soon as they occur/are observed.  
x 
It is the Investigator’s responsibility to determine seriousness, severity, and 
relatedness of the Adverse Event to the device and the procedure using the 
definitions below.  
 
8.1.1   Definition of Serious Adverse Events (SAE) 
 
Serious Adverse Event (SAE) is an adverse event that: 
• Led to a death or 
• Led to a serious deterioration in the health of a subject that: 
 
Resulted in a life-threatening illness or injury, 
 
Resulted in a permanent impairment of a body structure or body function,  
 
Required inpatient hospitalization or prolongation of existing 
hospitalization,  
 
Resulted in medical or surgical intervention to prevent impairment to body 
structure or a body function, or  
 
Lead to fetal distress, fetal death or congenital abnormality or birth defect. 
 
Blinded Investigator Quartile Improvement Score 
Rating 
Percentage (%) 
Score 
No Improvement 
0% 
0 
Minor/Mild Improvement 
1%-25% 
1 
Moderate Improvement 
26%-50% 
2 
Marked Improvement 
51%-75% 
3 
Very Significant Improvement 
76%-100% 
4 

Protocol [V01-CBT-401]
Bausch Health Americas, Inc.
 
Page 29 of 49 
Version 3.0 09/13/2021
CONFIDENTIAL
All SAEs that occur during the study period, whether considered to be related to 
the study device or not, must be reported to the Sponsor within 24 hours of 
knowledge of the event. IRB reporting requirements may also apply to SAEs.
8.1.2   Definition of Adverse Events (AE)
An adverse event (AE) is any untoward or unfavorable medical occurrence in a 
human subject, including any abnormal sign (for example, abnormal physical exam 
or laboratory finding), symptom or disease temporarily associated with the 
subject’s participation in research whether or not considered related to the 
subject’s participation in the research period.
A pre-existing condition (one that is present at the start of the study) will be 
recorded as an AE only if the frequency, intensity or the character of the condition 
worsens during the study period.
8.1.3   Definition of Unanticipated Adverse Device Effect (UADEs)
Any serious adverse effect on health or safety or any life-threatening problem or 
death caused by, or associated with, a device, if that effect, problem, or death, was 
not previously identified in a nature, severity, or degree of incidence in the 
investigational plan or application (including a supplementary plan or application), 
or any other unanticipated serious problem associated with a device that relates to 
the rights, safety, or welfare of subjects
In addition, any UADEs will be reported to the Sponsor and the reviewing IRB as 
soon as possible, but no later than within 24 hours of knowledge of the event.
All adverse events, anticipated or unanticipated, will be monitored until they are 
adequately resolved or explained.
8.1.4   Definition of Device Malfunction
Malfunction means the failure of a device to meet its performance specifications or 
otherwise perform as intended. Performance specifications include all claims made 
in the labeling for the device. The intended performance of a device refers to the 
intended use for which the device is labeled or marketed, as defined in 21 CFR §
801.4.
8.2   Adverse Event / Device Malfunction Reporting
In the case of an AE (Serious and Significant Non-Serious) or UADE the Investigator must:
Report the AE or UADE to the Medical Monitor within 24 hours of knowledge of the event 
using the Sponsor-provided form (SAE/UADE reporting form, Appendix D) by emailing the 
completed form to the Medical Monitor

Protocol [V01-CBT-401]
Bausch Health Americas, Inc.
 
Page 30 of 49 
Version 3.0 09/13/2021
CONFIDENTIAL
The Medical Monitor will email/fax a copy of the form immediately (within 24 hours) for 
SAEs/UADEs only to
upon 
receipt.
In the case of Device Malfunctions, the Investigator must:
Report the Device Malfunction within 24 hours using the Sponsor-provided form (Device 
Malfunction reporting form, Appendix E) by emailing the completed form to 
All AEs observed by study subjects, Investigators or other study staff from first exposure to 
the study product through last study follow-up visit will be recorded. If a device-related AE,
SAE, unanticipated serious device related effect or device malfunction is ongoing at the final 
study visit, the subject will be followed until resolution, until the condition stabilizes, until the 
event is otherwise explained, or the subject is lost to follow-up. The Investigator should 
make every effort to ensure the follow-up includes any supplemental investigations as may 
be indicated to elucidate, as completely practical, the nature and or causality of the AE or 
SAE. This may include unscheduled follow up visits for AE assessment. 
Study subjects will be instructed to report all adverse events to the clinical study staff and
information will be collected throughout the study and recorded on the case report forms and 
reported to Solta Medical Customer Service.
8.3   Classification of Adverse Events
The severity of adverse events will be categorized using the following criteria:
•
Mild: easily tolerated by the subject causing minimal discomfort and not 
interfering with everyday activities. These events generally do not require 
treatment.
•
Moderate: sufficiently discomforting to interfere with normal everyday activities.
These events are usually relieved by simple therapeutic measures. 
•
Severe: prevents normal everyday activities these events may require systemic
drug therapy or other medical treatment.
8.4   Relationship to the study device and/or procedure
The causality assessment is a determination of the relationship between the investigational 
device or surgical procedure and the occurrence of an AE/SAE. 
The possibility of a link between the study device or surgical procedure and an AE will take 
into consideration (as a minimum) the following criteria:
x
Existence of a temporal link between the event and administration of the study 
device.
x
Event is not explained by any other condition, measure or environmental factor.

Protocol [V01-CBT-401] 
 
Bausch Health Americas, Inc. 
 
Page 31 of 49 
Version 3.0 09/13/2021 
 
CONFIDENTIAL 
For this study, causality will be defined as: 
 
x Related:  There is at least a reasonable possibility that the AE/SAE is related to 
the study device or surgical procedure. Reasonable possibility means that there 
is evidence to suggest a causal relationship or association between the study 
device and the AE.  Also referred to as an ADE. 
x Unrelated:  There is little or no reasonable possibility that the AE/SAE is related 
to the study device or surgical procedure.  This assessment implies that the 
AE/SAE has no evidence to suggest either a causal relationship or association to 
the study device or surgical procedure and more likely or certain an alternative 
etiology exists. 
 
8.5   Termination of Study Rules for Safety 
 
The Sponsor and/or Investigator may recommend termination or modification of the study if 
there is an occurrence of any device or treatment related Serious Adverse Event using the 
following clinical protocol definitions of Serious Adverse Event in section 8.1.1 of this 
protocol. In addition, termination, or modification may be recommended for any other 
perceived safety concern based on clinical judgment, including but not limited to a higher 
than anticipated rate for any component of the safety measures, device failures result 
resulting in Adverse Events or unexpected SAEs.  
9.   RISKS AND BENEFITS 
9.1   Benefits 
 
A possible benefit of using the CLEAR + BRILLIANT TOUCH£ diode laser technology in a 
combination wavelength same session treatment, over a series of four treatments, is an 
enhanced improvement in the tone, texture, radiance, fine lines, pore size and overall 
appearance of the skin compared to no treatment at all. 
 
9.2   Risks  
 
9.2.1   Expected Responses 
Clinical studies have shown that CLEAR + BRILLIANT diode laser treatments have a 
demonstrated safety profile. There is a very low incidence of side effects and 
complications associated with treatment. Risks and discomforts for subjects who 
participate in this study are the same as for subjects undergoing any 
dermatological laser treatment. Eye injury due to use of the laser system is a risk to 
the subject and the operator. Appropriate eye protection will be used to minimize 
that risk. Mild to moderate local pain is a typical reaction to laser treatments. 
Topical anesthetic will be applied prior to laser treatments. Eye injuries may result 
from numbing cream getting into the eyes. Eyes will be covered with protective 
eyewear during treatment and should remain closed during the treatment. 
 
 

Protocol [V01-CBT-401] 
 
Bausch Health Americas, Inc. 
 
Page 32 of 49 
Version 3.0 09/13/2021 
 
CONFIDENTIAL 
Expected Responses: 
 
• Erythema (Redness) 
 
• Edema (Swelling) 
. 
• Itching/Dryness 
 
• Increased Skin Sensitivity 
 
• Pain or Discomfort 
 
• Pinpoint Bleeding/Petechia 
 
 
9.2.2   Unexpected Responses 
 
The following complications are very rare but may be associated with non-ablative 
laser treatments.  This is not intended to be an all-inclusive list, nor a substitute for 
informed consent, which should be provided by every individual. 
 
Complication 
Description 
Discoloration 
The possibility of temporary and permanent skin color change is known to 
exist with any laser treatment. Post-inflammatory hypopigmentation and 
hyper-pigmentation are known complications of many laser treatments 
and may occur with CLEAR + BRILLIANT TOUCH£ treatment. Following 
appropriate instructions for sun protection will lower the risk for 
pigmentation changes. 
Infection 
A risk of infection exists whenever the skin is wounded.  The possibility 
for infection exists even with non-ablative fractional laser devices such as 
the CLEAR + BRILLIANT TOUCH£ System. An infection should be 
treated appropriately with topical and/or systemic medications. 
Prolonged Redness 
Mild-moderate transient erythema is an expected response with any laser 
treatment.  However, if erythema is severe or persists significantly longer 
than expected, re-treatment should be avoided until the condition 
resolves. Reaction may vary on a person-to-person basis. 
Scarring 
The possibility for scarring exists with any laser treatment, even with non-
ablative laser devices such as CLEAR + BRILLIANT TOUCH£ System. 
Local scarring may occur directly from laser exposure if treatment 
procedures are not followed properly, or from infection or physical 
irritation such as picking and rubbing. 
Delayed Wound 
Healing/Skin Textural 
Changes 
Following any laser treatment, re-epithelialization may not occur as 
expected due to an individual’s physiology (i.e. poor wound healing 
ability, or post-treatment care). This may result in undesirable textural 
changes. 
Temporary Bruising 
Temporary bruising may develop over the treated areas and typically 
dissipates within several days. 
 
9.2.3   Biopsy Risks 
 
Skin Biopsy - There will be temporary discomfort when the local anesthetic is 
injected and when its effect wears off. Some slight bleeding may occur after the 
biopsy. There is a rare risk of infection. The biopsy may leave a small scar. The 
scar may be permanent. 
 
 
 

Protocol [V01-CBT-401] 
 
Bausch Health Americas, Inc. 
 
Page 33 of 49 
Version 3.0 09/13/2021 
 
CONFIDENTIAL 
9.3   Mitigation of Risks 
 
These risks are mitigated by utilizing qualified clinical investigators who have training and 
are experienced in (1) performing energy based and laser procedures and (2) following 
study treatment procedures. In addition, risks are mitigated by including only those subjects 
that meet the study eligibility criteria. The study also includes evaluation of study subject 
satisfaction with this procedure. Given the anticipated acceptable risk, the risk benefit 
assessment of the use of the CLEAR + BRILLIANT TOUCH£ diode laser device to improve the 
appearance of photoaged skin appears to offer a substantial clinical benefit at a reasonable 
risk.  
 
Further discussion of risks of the of the CLEAR + BRILLIANT TOUCH® System can also be 
found and should be accessed in the CLEAR + BRILLIANT TOUCH® Laser System 
User Manual provided by the Sponsor. 
10.   STATISTICS 
10.1   Statistical Analysis Populations and Demographics 
 
The intent-to-treat (ITT) population will be the primary population for all statistical analyses. 
The ITT population will include all subjects who received treatment, participated in at least 1 
post-baseline evaluation, and were not otherwise disqualified. 
Subjects may be removed from the analysis in the case of an AE, SAE, noncompliance, or 
Investigator decision. The reason for any subject(s) excluded from an analysis population 
will be documented in a note to file and included in the study report. 
Demographic data and baseline characteristics, including age, gender, ethnicity, Fitzpatrick 
skin type, Glogau rating, and Fitzpatrick wrinkle & elastosis scale rating, will be summarized 
according to the analysis population for all subjects. For continuous variables, descriptive 
statistics including number of subjects (N), mean, median, standard deviation (SD), 
minimum (MIN) and maximum (MAX) values will be presented. For categorical variables, the 
count and percentage of each category will be provided. The denominator for all 
percentages will be the number of subjects with non-missing data at the given visit for each 
respective study treatment, unless otherwise indicated. 
The sample size determination of this study is based on the Sponsor’s recommendations to 
quantify the effectiveness and safety of the CLEAR + BRILLIANT TOUCH£ diode laser 
1440-nm and 1927-nm Laser in the context of this study. Power calculations were 
performed based on estimates for expected mean change and variance in overall 
appearance at 3 months as rated by the Investigator using the Quartile Improvement Scale 
from study 12-133-CBP-F (‘Evaluation of the skin after treatment with the Clear + Brilliant 
1927-nm wavelength laser by means of the VISIA-CA Imaging System’). The power 
calculations demonstrated a sample size of 25 has greater than 95% power to reject the null 
hypothesis (change from baseline=0) for the primary efficacy endpoint. Thus, up to 30 
subjects will be enrolled to account for potential drop-out. 
 

Protocol [V01-CBT-401] 
 
Bausch Health Americas, Inc. 
 
Page 34 of 49 
Version 3.0 09/13/2021 
 
CONFIDENTIAL 
10.2   Statistical Analysis Plan (SAP) 
 
10.2.1 Descriptive Statistical Summary 
A descriptive statistical summary will be provided for Investigator Quartile Improvement 
Score (IQIS, 0-4), tolerability parameters, VAS scores, and biopsy parameters. The 
descriptive statistical summary includes the N, mean, median, SD, MIN, and MAX of 
scores/values at all applicable time points.  
 
Counts and percentages will be provided for Investigator Quartile Improvement Score 
(rating), SAE parameters, tolerability parameters, VAS (in category), and individual response 
data (GAIS and subject satisfaction). 
 
10.2.2 Additional Analysis 
Additional analysis will be provided as following: 
For IQIS (0-4), the mean score will be compared to a constant value of 0 to test the null 
hypothesis that there is no improvement after the product use, using the method described 
in the SAP table. 
  
For GAIS and subject satisfaction data, a binomial (sign) test will be performed to test if the 
proportion of the combined designated favorable responses (Very Much Improved, Much 
Improved, and Improved for GAIS; Very Satisfied and Satisfied for subject satisfaction) is 
equal to the combined designated unfavorable responses. 
 
Statistical Analysis Plan Table 
 
Evaluation 
Change from baseline 
Notes/Interpretation 
Investigator 
Quartile 
Improvement 
Score  
The mean score (0-4) will 
be compared to the 
constant 0, using Wilcoxon 
signed rank test  
Significantly greater than 0 
indicates improvement. 
SAEs 
NA 
Zero or low number of SAEs is 
favorable 
Tolerability 
parameters 
NA 
Lower score indicates better 
tolerability 
VAS  
NA 
Lower score indicates better 
tolerability  
Biopsy parameters 
NA 
Descriptive statistics only 
Individual 
response data 
(GAIS and 
satisfaction) 
NA 
A binomial test (sign test) P value 
will be provided. A higher 
percentage of combined favorable 
responses with a significant P 
value indicates positive subject 
perceptions of the test material. 
Blinded 
Investigators 
The mean score (0-4) will 
be compared to the 
constant 0, using Wilcoxson 
signed rank test  
Significantly greater than 0 indicates 
improvement. 

Protocol [V01-CBT-401] 
 
Bausch Health Americas, Inc. 
 
Page 35 of 49 
Version 3.0 09/13/2021 
 
CONFIDENTIAL 
 
All statistical tests will be 2-sided at significance level alpha=0.05 unless specified 
otherwise. P values will be reported to 3 decimal places (0.000).  
No multiple testing corrections will be considered in the study. Statistical analyses are 
performed using SAS software version 9.4 (SAS Statistical Institute). The statistical results 
will be sent to the Sponsor along with raw data in a Microsoft Excel document at completion 
of the study. 
 
10.2.3 Minimization of Bias and Potential Confounding Factors 
Blinded investigator photo evaluation is intended to minimize bias. 
11.   SOURCE DOCUMENTS AND ACCESS TO DATA/DOCUMENTS 
 
The PI shall supply the study monitor or IRB on request with any required background data 
from the study documentation or clinic records.  
 
This clinical investigation will permit the investigator to proceed with “data entry” directly onto 
the case report forms (CRFs).  In this case, the CRFs will also serve as the source record 
for each participating subject.  A copy of the CRFs will be collected by SGS Stephen’s Inc. 
for data analysis.  
12.   QUALITY ASSURANCE AND QUALITY CONTROLS 
 
Each investigational site will undergo a detailed training that highlights the key tenets for 
maintaining quality management. The investigational sites will be instructed regarding 
protocol compliance, use of CRFs, and proper treatment administration. The investigator 
must assure that subject confidentiality will be maintained and that participant identities shall 
be protected from unauthorized parties. 
 
12.1   Study Monitoring 
 
The Sponsor and its representatives must be allowed to visit the study site location to 
assess the data, quality, and study integrity. 
 
Prior to the start of the study, member(s) of the Sponsor (or designees) will review the 
protocol, CRF, regulatory obligations, and other material or equipment relevant to the 
conduct of the study with the Investigator and relevant study site personnel. 
 
Monitoring visits and telephone consultations will occur as necessary, as per the monitoring 
plan, during the course of the investigation. During the course of the study, all data will be 
100% source document-verified by the monitors when possible. All subject source 
documents must be made available to the monitors. 
 

Protocol [V01-CBT-401] 
 
Bausch Health Americas, Inc. 
 
Page 36 of 49 
Version 3.0 09/13/2021 
 
CONFIDENTIAL 
13.   ETHICS OF HUMAN SUBJECTS AND ADMINISTRATIVE ISSUES 
13.1   Ethical Standard 
 
The investigator will ensure that this study is conducted in full conformity with the principles 
set forth in the Declaration of Helsinki, EN ISO 14155:2020 Clinical Investigation of Medical 
Devices for Human Subjects – Good Clinical Practices, 21 CFR 803 Medical Device 
Reporting, International Conference of Harmonization Good Clinical Practice Guidelines and 
all other applicable regulatory requirements and standards. The study will also be carried 
out in keeping with applicable regulations and guidelines governing clinical study conduct 
and local legal requirements.  
 
Each investigator confirms this by signing this study protocol. 
13.2   Institutional Review Board 
 
Before commencing with and enrolling volunteers for this proposed study, the appropriate 
documents (including the Protocol, Investigator’s Brochure, Informed Consent Form, 
information sheets, CRF’s and advertisements) will be submitted to the IRB. The investigator 
will be responsible for obtaining IRB approval for the study. Protocol deviations will also be 
reported to the IRB according to the policy of the board. Protocol amendments will be 
reviewed and approved by the IRB prior to implementation of any changes made to the 
study design in the amendment. 
 
The investigators will inform the IRB: 
• 
All subsequent protocol amendments, informed consent changes or revisions of 
other documents originally submitted for review 
• 
Serious and/or unexpected adverse events occurring during the study, where 
required 
• 
New information that may affect adversely the safety of the participants or the 
conduct of the study 
• 
An annual update and/or request for re-approval, where required barring 
unforeseen circumstances, this study is anticipated to be completed within 9-10 
months.  
• 
When the study has been completed. 
 
13.3   Informed Consent Process 
 
Informed consent is a process that is initiated prior to the individual’s agreeing to participate 
in the study and continues throughout the individual’s study participation. Extensive 
discussion of risks and possible benefits of this therapy will be provided to the subjects and 
their families. Consent forms describing in detail the study interventions/products, study 
procedures, and risks are given to the subject and written documentation of informed 
consent is required prior to starting intervention/administering study product. Consent forms 
will be IRB-approved, and the subject will be asked to read and review the document. Upon 
reviewing the document, the investigator will explain the research study to the subject and 
answer any questions that may arise. The subject will sign the informed consent document 
(ICD) prior to any procedures being done specifically for the study. The subjects should 

Protocol [V01-CBT-401] 
 
Bausch Health Americas, Inc. 
 
Page 37 of 49 
Version 3.0 09/13/2021 
 
CONFIDENTIAL 
have the opportunity to discuss the study with their surrogates or think about it prior to 
agreeing to participate. The subjects may withdraw consent at any time throughout the 
course of the trial. A copy of the ICD will be given to the subjects for their records. The rights 
and welfare of the subjects will be protected by emphasizing to them that the quality of their 
medical care will not be adversely affected if they decline to participate in this study. The 
subject will be asked to sign and date prior to participating in the study.  
 
The informed consent will require a signature. Additionally, subjects will be provided with a 
copy of consent form to disseminate to all pertinent parties for proper discussion in order to 
make an informed decision concerning their participation. Should a protocol addendum be 
made, the subject consent form may be revised to reflect the changes of the protocol. If the 
consent form is revised, it is the responsibility of the investigator to ensure that an amended 
consent is reviewed and approved by the IRB. The approved amended consent form should 
be signed by all subjects subsequently entered in the study and by those subjects currently 
in the study, if required by the IRB. The terms of the consent and when it was obtained must 
also be documented in the CRF. 
 
13.4   Participant and Data Confidentiality 
 
Subject confidentiality is strictly held in trust by the participating investigators, their staff, and 
the sponsor(s) and their agents. This confidentiality is extended to cover all recorded 
information during the clinical study. The clinical investigation will be registered in a publicly 
available database. In addition, the results of the study will be published in a publicly 
available database.  
 
The study protocol, documentation, data, and all other information generated will be held in 
strict confidence. No information concerning the study, or the data, will be released to any 
unauthorized third party without prior written approval of the sponsor.  
 
The study monitors or other authorized representatives of the sponsor may inspect all 
documents and records required to be maintained by the investigator, including but not 
limited to, medical records (office, clinic, or hospital) and pharmacy records for the subjects 
in this study.  
 
Subjects’ identities will be kept confidential by assigning each subject a subject ID upon 
acceptance into the study. The subject ID will comprise the site ID and a three-digit number 
that will be based upon the subject’s order of entry into the study. The study Sponsor will not 
receive any additional identifying information about a subject and will therefore have no way 
of linking a subject ID to a subject and his or her results.   
 
   13.4.1 Research Use of Stored Human Samples, Specimens or Data 
ProPath may dispose of biohazard human biopsy samples per local and federal 
guidelines after processing of samples. 
 
 
 

Protocol [V01-CBT-401] 
 
Bausch Health Americas, Inc. 
 
Page 38 of 49 
Version 3.0 09/13/2021 
 
CONFIDENTIAL 
13.5   Financial Disclosure 
 
Financial disclosures will be obtained from all investigators in order to document any 
potential conflicts of interest. An original Financial Disclosure Form (FDF) must be 
completed, signed and dated by the principal investigator (PI) and any sub-investigators. All 
FDFs will be collected by the Sponsor or its designee and filed in the study Trial Master File. 
A copy of all FDFs will be retained in the Investigator Site Binder. 
 
 
13.6  Finance 
 
The study is financed by the Sponsor. The Sponsor carries insurance that covers clinical 
trials, which is filed under the company’s Master Policy for clinical trials conducted within the 
U.S. 
14.   DATA HANDLING AND RECORD KEEPING 
14.1   Data Collection and Management 
 
Data collection is the responsibility of the study staff at the site under the supervision of the 
site principal investigator. During this study the investigator must maintain complete and 
accurate documentation for the study. 
 
Data management and oversight is the responsibility of the Sponsor and SGS Stephens Inc. 
Responsibilities include but are not limited to the following  
• 
Clinical strategy and oversight  
• 
Clinical study operations  
• 
File management and study documentation  
• 
Site initiation visit and study closeout visits  
• 
Clinical quality assurance  
• 
Statistical support and programming  
• 
Data management including database development and programming and electronic 
data capture programming training and management  
 
Additionally, management and oversight of photographic imaging is the responsibility of the 
Sponsor and SGS Stephens Inc (Clinical Research Organization). 
 
Responsibilities may be delegated to applicable vendors.  
 
Data will be recorded on case report forms (CRFs). A CRF is required and should be 
completed for each included subject. 
 
A single-entry method will be used to enter the data captured on paper records into an 
electronic data capture (EDC) system. Numerical data described in Section 7 will be 
recorded using the SGS Stephens EDC system, which documents the identity of the 
evaluator/technician as well as the time and date of all entries, or all corrected entries. The 

Protocol [V01-CBT-401] 
 
Bausch Health Americas, Inc. 
 
Page 39 of 49 
Version 3.0 09/13/2021 
 
CONFIDENTIAL 
SGS Stephens EDC is a computerized system designed for the collection of clinical data in 
electronic format. The 3 major aspects of EDC are a graphical user interface for data entry, 
a validation component to check for user data, and a reporting tool for analysis of the 
collected data. The entries will be compared to the paper CRFs with 100% source document 
verification by the monitors when possible to ensure that the data is transferred accurately 
from the paper records to the electronic database, and any missing data and/or 
inconsistencies will be identified and corrected. 
 
It is the investigator’s responsibility to ensure completion, review and approve all CRFs. 
CRFs must be signed by the investigator or authorized staff member. These signatures 
serve to attest that the information contained on the CRFs are true. At all times, the 
investigator has final personal responsibility for the accuracy and authenticity of all clinical 
and laboratory data entered on the CRFs. 
 
Photographic images will be captured utilizing the Canfield Scientific, Inc. VISIA CA Imaging 
system.  
 
14.2   Study Records Retention 
 
To enable evaluations and/or audits from regulatory authorities or the Sponsor, the 
investigator agrees to keep records including the identity of all participating subjects 
(sufficient information to link records, e.g., CRFs and hospital records), all original signed 
informed consent forms, copies of all CRFs, serious adverse event forms, source 
documents, and detailed records of treatment disposition.  The records should be retained 
by the investigator according to ICH guidelines of 10 years, local regulations, or as specified 
in the Clinical Study Agreement, whichever is longer. 
 
If the investigator relocates, retires, or for any reason withdraws from the study, the Sponsor 
should be prospectively notified.  The study records must be transferred to an acceptable 
designee, such as another investigator, another institution, or to the Sponsor. The 
investigator must obtain Sponsor's written permission before disposing of any records, even 
if retention requirements have been met. 
 
14.3   Protocol Deviations 
 
A protocol deviation is any non-conformance with the conduct of the study as described in 
this protocol, Good Clinical Practice (GCP), or the investigational device Manual of 
operations.   
 
The non-conformance may be either initiated by the subject, the investigator, or the study 
staff. Protocol deviations must be tracked and reported to the Sponsor in a timely manner, 
and corrective action implemented and documented. Protocol deviations affecting the safety 
of the subject or the integrity of the study must be reported by the Investigator to the IRB 
promptly. Reporting of all other protocol deviations must adhere to the requirements of the 
governing IRB. 
 

Protocol [V01-CBT-401] 
 
Bausch Health Americas, Inc. 
 
Page 40 of 49 
Version 3.0 09/13/2021 
 
CONFIDENTIAL 
Protocol waivers will not be allowed. However, the Investigator may implement a deviation 
from, or a change of, the protocol in an emergency situation to protect the rights, safety and 
well-being of subjects and to eliminate an immediate hazard to study subjects without prior 
IRB or Sponsor approval. As soon as possible after such an occurrence, the implemented 
deviation or change, the reasons for it, and any proposed protocol amendment(s) should be 
submitted to the IRB for review and approval, to the Sponsor for agreement, and to the 
regulatory authorities, if required. 
 
 
14.4   Publications and Data Sharing 
 
The publication policy will be in accordance with the investigator agreement with each 
principal investigator or similar agreement. No information on individual subjects will be 
revealed in any publications or presentations.  
 
The SGS Stephens group will compose the study report for the Company Sponsor. 
 
 

Protocol [V01-CBT-401] 
 
Bausch Health Americas, Inc. 
 
Page 41 of 49 
Version 3.0 09/13/2021 
 
CONFIDENTIAL 
15. LITERATURE REFERENCES 
 
1. Ayer, J., Griffiths, C. (2019). Photoaging in Caucasians, Cutaneous Photoaging; pp. 1-30. 
Doi: 10.1039/9781788015981-00001 
2. Bauer, J., Alabdulrazzaq, H., Bae, YS. (2015). Evaluation of a low energy, low density, non-
ablative fractional 1927nm wavelength laser for facial skin resurfacing. Journal of Drugs in 
Dermatology, 14(11). 1262-1267. 
3. Borges, J., Manela-Azulay, M., Cuzzi, T. (2016). Photoaging and the clinical utility of 
fractional laser. Clinical, Cosmetic, and Investigational Dermatology, (9), 107-114. 
4. Manstein D, Herron GS, Sink RK, Tanner H, Anderson RR. Fractional photothermolysis: a 
new concept for cutaneous remodeling using microscopic patterns of thermal injury. Lasers 
Surg Med 34(5): 426-38. (2004). 
5. Narukar, V., Alster, T., Bernstein, E., Lin, T., Loncaric, A., (2018). Safety and efficacy of a 
1550 nm/1927 nm dual-wavelength laser for the treatment of photodamaged skin. Journal of 
Drugs in Dermatology (17)1, 41-46. 
6. Rahman, Z., Alam, M., Dover, J.S. (2006). Fractional laser treatment for pigmentation and 
texture improvement. Skin Therapy Letter (11)9.  
7. Rittie, L., Fisher, G. (2015). Natural and sun-induced aging of human skin. Cold Spring 
Harbor Perspective Medicine. Cold Spring Harbor Laboratory Press. Doi: 
10.1101/cshperspect.a015370 
8. Solta Medical, Inc. (2020) CLEAR + BRILLIANT TOUCH laser system user manual. 
Bothell, WA; Solta Medical Inc. 
9. Solta Medical, Inc. (2013) CLEAR + BRILLIANT laser system operator manual. Bothell, 
WA; Solta Medical, Inc. 
 
 
 
 
 

Protocol [V01-CBT-401] 
 
Bausch Health Americas, Inc. 
 
Page 42 of 49 
Version 3.0 09/13/2021 
 
CONFIDENTIAL 
Appendix Section  
 
Appendix A: Glogau Photodamage Scale 
 
Appendix B: Fitzpatrick Wrinkle and Elastosis Scale 
 
Fitzpatrick Wrinkle and Elastosis Scale 
Class 
Wrinkling 
Score 
Degree of Elastosis 
I 
Fine wrinkles 
1-3 
Mild: fine texture changes with subtly 
accentuated skin lines 
II 
Fine to moderate depth wrinkles, 
moderate number of lines 
4-6 
Moderate: distinct popular elastosis 
(individual papules with yellow 
translucency under direct lighting) and 
dyschromia. 
III 
Fine to deep wrinkles, numerous 
lines. With or without redundant 
skin folds 
7-9 
Severe: multipapular and confluent 
elastosis (thickened, yellow and pallid) 
approaching or consistent with cutis 
rhomboidalis. 
 
 
Glogau Photodamage Scale 
Group 
Classification 
Typical Age 
Description 
Skin Characteristics 
I Mild 
28-35 
No Wrinkles 
Early Photoaging: mild pigment changes, no keratosis, 
minimal wrinkles, minimal or no makeup 
II Moderate 
35-50 
Wrinkles in 
motion 
Early to Moderate Photoaging: Early brown spots 
visible, keratosis palpable but not visible, parallel smile 
lines begin to appear, wears some foundation 
III Advanced 
50-65 
Wrinkes at 
rest 
Advanced Photoaging: Obvious discolorations, visible 
capillaries (telangiectasias), visible keratosis, wears 
heavier foundation always 
IV Severe 
60-75 
Only wrinkles 
Severe Photoaging; Yellow-gray skin color, prior skin 
malignancies, wrinkles throughout-no normal skin, 
cannot wear makeup because it cakes and cracks 

Protocol [V01-CBT-401] 
 
Bausch Health Americas, Inc. 
 
Page 43 of 49 
Version 3.0 09/13/2021 
 
CONFIDENTIAL 
Appendix C: Fitzpatrick Skin Type 
 
 
 
 
 
Fitzpatrick Skin Type 
Skin 
Type 
Usual Characteristics 
Descent/Ethnicity 
Burn/Tan 
I 
White; very fair; red or blond 
hair; blue eyes, often freckles. 
Redheads, Celtics, Irish, 
Scottish 
Always burns, never tans 
II 
White; fair; red or blonde hair; 
blue, hazel or green eyes, 
often freckles. 
Caucasians 
Usually burns, tans with 
difficulty 
III 
Cream white; fair with any eye 
or hair color 
Caucasians 
Sometimes mild burn, 
gradually tans 
IV 
Brown; typical Mediterranean, 
Caucasian skin 
Mediterranean, Asians, 
Hispanics, American 
Indian 
Rarely burns, tans with ease 
V 
Dark browns; Middle Eastern 
skin types 
Middle Eastern, East 
Indian, some Hispanics, 
some African Americans, 
some Asians 
Very rarely burns, tans very 
easily 
VI 
Black 
Usually African 
Never burns, tans very easily 

Protocol [V01-CBT-401]
Bausch Health Americas, Inc.
 
Version 3.0 09/13/2021
CONFIDENTIAL

Protocol [V01-CBT-401]
Bausch Health Americas, Inc.
 
Page 45 of 49 
Version 3.0 09/13/2021
CONFIDENTIAL

Protocol [V01-CBT-401]
Bausch Health Americas, Inc.
 
Page 46 of 49 
Version 3.0 09/13/2021
CONFIDENTIAL

Protocol [V01-CBT-401]
Bausch Health Americas, Inc.
 
Page 47 of 49 
Version 3.0 09/13/2021
CONFIDENTIAL

Protocol [V01-CBT-401]
Bausch Health Americas, Inc.
Page 48 of 49 
Version 3.0 09/13/2021
CONFIDENTIAL

Protocol [V01-CBT-401] 
 
Bausch Health Americas, Inc. 
 
Page 49 of 49 
Version 3.0 09/13/2021 
 
CONFIDENTIAL 
Appendix F: Patient Skin Response Seven-Day Diary 
 
Using the severity scale, please rate the following conditions after your treatment: 
Answer for all conditions each day:  
 
  
0= None 1= Mild 2= Moderate 3= Severe 
Rating 
  
  
  
Day 1 
Erythema (redness) 
  
Edema (swelling) 
  
Heat sensation after treatment 
  
  
  
  
Day 2 
Erythema (redness) 
  
 
Edema (swelling) 
  
 
Heat sensation after treatment 
  
  
  
  
Day 3 
Erythema (redness) 
  
 
Edema (swelling) 
  
 
Heat sensation after treatment 
  
  
  
  
Day 4 
Erythema (redness) 
  
 
Edema (swelling) 
  
 
Heat sensation after treatment 
  
  
  
  
Day 5 
Erythema (redness) 
  
 
Edema (swelling) 
  
 
Heat sensation after treatment 
  
  
  
  
Day 5 
Erythema (redness) 
  
Edema (swelling) 
  
Heat sensation after treatment 
  
  
  
  
Day 6 
Erythema (redness) 
  
Edema (swelling) 
  
Heat sensation after treatment 
  
  
  
  
Day 7 
Erythema (redness) 
  
Edema (swelling) 
  
Heat sensation after treatment