A Prospective, Randomized, Controlled, Double-Blind Study That Evaluates the Safety and Efficacy of Three Active REVIAN Caps Versus a Non-Active REVIAN Cap (Sham) in Participants With Pattern Hair Loss (Androgenic Alopecia)
Phase: NA
Conditions: Androgenetic Alopecia
Sponsor: PhotonMD, Inc

REVIAN® Trial 
Confidential and Proprietary  
 Page 1 of 54    
  Version 6.0 2018-08-22 
Clinical Investigational Plan 
Study Title: A Prospective, Randomized, Controlled, Double-Blind Study that Evaluates 
the Safety and Efficacy of Three Active REVIAN Caps versus a Non-Active REVIAN Cap 
(SHAM) in Participants with Pattern Hair Loss (Androgenic Alopecia) 
Short Title: REVIAN Trial 
 Protocol No: REV-01 
Version 6.0  
2018-08-22 
NCT04019795
Study Sponsor: 
PhotonMD, Inc. 
4222 Emperor Blvd, Suite 470 
Durham, NC 27703 
(919) 229-4640
This document is a confidential communication of PhotonMD, Inc. The recipient agrees that no unpublished information contained herein 
will be published or disclosed without prior written approval of PhotonMD, Inc. except that this document may be disclosed to 
appropriate institutional review boards, international ethics committees or duly authorized representatives of the U.S. Food and Drug 
Administration or other responsible regulatory authorities under the condition that confidentiality is maintained. 
CONFIDENTIAL and PROPRIETARY 

REVIAN® Trial 
Confidential and Proprietary  
 Page 2 of 54    
  Version 6.0 2018-08-22 
Investigator Protocol Signature Page and Protocol Agreement 
Study Title: A Prospective, Randomized, Controlled, Double-Blind Study that Evaluates the Safety and 
Efficacy of Three Active REVIAN Caps versus a Non-Active REVIAN Cap (SHAM) in Participants with 
Pattern Hair Loss (Androgenic Alopecia) 
Short Title: REVIAN Trial 
Protocol No: REV-01 Version 6.0 
I agree to conduct the investigation in accordance with the agreement and the investigational plan. 
I agree to adhere to applicable Good Clinical Practices (GCP) regulations and requirements that 
govern the conduct of clinical studies as stated in the Code of Federal Regulations, Title 21 (21 
CFR): 
•
21 CFR 50, Protection of Human Subjects, provides the requirements and
general elements of informed consent;
•
21 CFR 56, Institutional Review Boards/Ethic Committee, covers the procedures and
responsibilities for institutional review boards (IRBs) and ethic committees (ECs) that
approve clinical investigations protocols;
•
21 CFR 54, Financial Disclosure by Clinical Investigators, covers the disclosure of
financial compensation to clinical investigators which is part of FDA’s assessment of
the reliability of the clinical data.
I agree to ensure that all participants will have provided signed Informed Consent prior to 
enrollment in the study. 
I will ensure that the IRB/HREC complies with the requirements of ICH E6, 21 CFR Part 50, and 
21 CFR Part 56 and will be responsible for the initial and continuing review and approval of the 
investigation. 
I agree to comply with all state and federal laws and regulations governing financial disclosure and 
to supply updated disclosure information, as it becomes known to me, during the Trial and for one 
year following completion of the Trial, unless otherwise required by law or regulation. 
I agree to supervise all testing of the device involving human participants and ensure that the 
investigational products supplied by the Sponsor for this study protocol will be used only for 
participants enrolled for treatment under this protocol, and unused devices will be returned to the 
Sponsor at the close of the study or sooner as determined by the Sponsor. 
I agree to report all unanticipated adverse device effects and serious adverse events as requested to 
the Sponsor within 24 hours.  I agree that all data relevant to the clinical evaluation and regarding 
the participant response and safety will be documented and forwarded to the Sponsor.  I agree to 
attend a training session on the use of the REVIAN Cap prior to the initiation of the clinical 
investigation.  
I have NOT been restricted from participating in clinical research, nor is any action pending that 
could result in such restriction, nor involved in an investigation or other research that was 
terminated.   
Investigator Signature 
Date (YYYY-MM-DD) 
Investigator Name (please print or type) 

REVIAN® Trial 
Confidential and Proprietary  
 Page 3 of 54    
  Version 6.0 2018-08-22 
REVIAN Protocol Revision History 
REVIAN Investigational Plan 
Release Date 
Version 1.0 
2016-11-25 
Version 2.0 
2017-02-14 
Version 3.0 
2017-03-20 
Version 4.0 
2017-07-10 
Version 5.0 
2017-10-01 
Version 6.0 
2018-08-22 

REVIAN® Trial 
Confidential and Proprietary  
 Page 4 of 54    
  Version 6.0 2018-08-22 
TABLE OF CONTENTS
PROTOCOL SUMMARY .................................................................................................................... 6 
PRINCIPAL CONTACTS .................................................................................................................. 10 
ABBREVIATIONS AND TERMS ..................................................................................................... 11 
1.0 
STUDY PURPOSE ............................................................................................................ 12 
1.1 
Introduction and Background ............................................................................................... 12 
1.2 
Study Rationale .................................................................................................................... 15 
1.3 
Device Name ........................................................................................................................ 18 
1.4 
Brief Description of the Device ........................................................................................... 18 
2.0 
PROTOCOL ...................................................................................................................... 19 
2.1 
Study Purpose and Objectives .............................................................................................. 19 
2.2 
Study Design Overview ....................................................................................................... 19 
2.3 
Study Scope and Participating Institutions ........................................................................... 20 
2.4 
Study Endpoints ................................................................................................................... 20 
2.4.1 Primary Efficacy Endpoint: .............................................................................................. 20 
2.4.2 Secondary Efficacy Endpoints: ......................................................................................... 20 
2.4.3 Primary Safety Endpoint(s):.............................................................................................. 21 
2.5 
Study Population and Source of Participants ....................................................................... 21 
2.6 
Participant Eligibility Criteria .............................................................................................. 22 
2.7 
Study Duration ..................................................................................................................... 24 
3.0 
STUDY PROCEDURES ................................................................................................... 24 
3.1 
Enrollment Procedure .......................................................................................................... 24 
3.2 
Process for Obtaining Informed Consent ............................................................................. 24 
3.3 
Blinding Procedure .............................................................................................................. 25 
3.4 
Participant Assessments ....................................................................................................... 25 
3.4.1 Screening – Visit 1 ............................................................................................................ 25 
3.4.2 Baseline – Visit 2 .............................................................................................................. 25 
3.4.4 Week 1 Phone Call – (7±3 Days), Visit 3 ......................................................................... 27 
3.4.5 Week 8 Follow-Up Visit – (56±5 Days), Visit 4 .............................................................. 27 
3.4.6 Week 16 Follow-Up Visit – (112±10 Days), Visit 5 ........................................................ 27 
3.4.7 Week 26 Follow-Up Visit – (182±10 Days), Visit 6 ........................................................ 27 
3.4.8 Unscheduled Visit:  Visit within 26-weeks Follow-Up .................................................... 27 
3.5 
Termination of Participants ................................................................................................. 29 
4.0 
SAFETY REPORTING..................................................................................................... 29 
4.1 
Adverse Events .................................................................................................................... 29 
4.2 
Anticipated Adverse Events ................................................................................................. 31 
4.3 
Unanticipated Adverse Device Effects ................................................................................ 31 
4.4 
Medical Monitor .................................................................................................................. 31 
5.0 
STATISTICAL ANALYSIS PLAN .................................................................................. 32 
5.1 
Study Objective/Purpose ...................................................................................................... 32 
5.2 
Study Analysis, Sample Size and Pooling of Data ............................................................... 33 
5.3 
Analysis Populations ............................................................................................................ 34 
5.4 
Safety Outcomes .................................................................................................................. 34 
5.5 
Baseline Variables................................................................................................................ 34 
5.6 
Participant Accountability .................................................................................................... 34 
5.7 
Missing Values ..................................................................................................................... 35 

REVIAN® Trial 
Confidential and Proprietary  
 Page 5 of 54    
  Version 6.0 2018-08-22 
5.8 
Follow-Up and Reporting .................................................................................................... 35 
5.9 
Protocol Deviations .............................................................................................................. 35 
6.0 
STUDY MANAGEMENT ................................................................................................. 36 
6.1 
Sponsor Ethical and Regulatory Considerations .................................................................. 36 
6.2 
Investigator Responsibilities ................................................................................................ 38 
6.2.1 IRB/HREC Approval and Informed Consent .................................................................... 38 
6.2.2 Data Collection and Reporting .......................................................................................... 38 
6.2.3 CRF Completion and Submission ..................................................................................... 39 
6.2.4 Data Management ............................................................................................................. 39 
6.2.5 Device Accountability ....................................................................................................... 39 
6.2.6 Source Documents ............................................................................................................ 39 
6.2.7 Audits/Inspections............................................................................................................. 40 
6.2.8 Publication Policy ............................................................................................................. 40 
7.0 
RISK ANALYSIS .............................................................................................................. 41 
7.1 
Potential Risks ..................................................................................................................... 41 
7.2 
Justification for Investigation ............................................................................................... 41 
7.3 
Study Population .................................................................................................................. 42 
8.0 
ANTICIPATED CHANGES DURING INVESTIGATION .......................................... 42 
9.0 
MONITORING PLAN ...................................................................................................... 42 
9.1 
Site Qualification/Initiation ................................................................................................. 42 
9.2 
Periodic Monitoring ............................................................................................................. 43 
9.3 
Site Close-Out ...................................................................................................................... 43 
9.4 
Monitoring Trip Reports and Follow up Letters .................................................................. 44 
9.5 
Frequency of Monitoring Visits ........................................................................................... 44 
9.6 
Qualifications of Study Monitor .......................................................................................... 44 
9.7 
Name and Address of Monitor ............................................................................................. 44 
10.0 REFERENCES .......................................................................................................................... 45 
APPENDIX A: DEFINITIONS ........................................................................................................ 48 
APPENDIX B: HAIR SPECIFIC SKINDEX-29 QUALITY OF LIFE QUESTIONNAIRE .......... 51 
APPENDIX C: Physician’s Global Assessment (PGA) Scoring and Subjective Scalp Hair Growth 
(SSHG) Evaluations ............................................................................................................. 52 
APPENDIX D: TrichoScan Procedure for Hair Counts ................................................................... 54 
APPENDIX E: Informed Consent Form (ICF) ................................................................................. 55 

REVIAN® Trial 
Confidential and Proprietary  
 Page 6 of 54    
  Version 6.0 2018-08-22 
PROTOCOL SUMMARY 
Protocol Title 
A Prospective, Randomized, Controlled, Double-Blind Study that Evaluates 
the Safety and Efficacy of Three Active REVIAN Caps versus a Non-Active 
REVIAN Cap (SHAM) in Participants with Pattern Hair Loss (Androgenic 
Alopecia) 
Protocol Number 
REV-01, Version 6.0 
Investigational 
Device 
REVIAN (PhotonMD, Durham, NC, USA) is a mobile soft dome-shaped Cap 
using LED modulated light therapy (MLT™) for the treatment of androgenic 
alopecia. The Cap is controlled and operated by a mobile app and is intended 
to be used in a home environment. 
Study Objective 
The primary objective of this study is to collect data on the safety and efficacy 
of REVIAN in participants with androgenetic alopecia through 26-weeks of 
treatment. 
Study Design 
This study is designed as a prospective, randomized, controlled, double-blind, 
four-arm study.  Eligible participants with androgenic alopecia will be enrolled 
and randomized to one of the four study arms presented below.  
Study Arm 1:  Active REVIAN Cap 101 
Study Arm 2:  Active REVIAN Cap 102 
Study Arm 3:  Active REVIAN Cap 103 
Study Arm 4:  Non-Active REVIAN (Sham) Cap 100 
Study Population 
The study population will consist of adult men and women between 18 and 65 
years of age with diagnosis of Androgenic Alopecia, consistent with males 
who have Norwood Hamilton Classification IIa to V patterns of hair loss and 
females who have Ludwig-Savin Scale I-1 to I-4, II -1, II-2 or frontal, both 
with Fitzpatrick Skin Types I – IV. 
Participants will be excluded for the following conditions: 
• 12-month usage taking Propecia or any other hair growth supplements prior
to enrollment,
• using Rogaine or Minoxidil based products for 6-months prior to
enrollment,
• having previous hair transplant, cell treatment, micro-needling, tattooing, or
any other treatment to the scalp,
• suffering from an active autoimmune disease such as serum lupus
erythematosus or alopecia areata,
• photosensitivity to visible light operating within 400 – 850 nm,
• currently suffering from a dermatological condition in the treatment area or
has a significant scar in the hair treatment area that will make hair growth
difficult (such as a systemic burn, malignancy, etc.),
• has a sensitivity or allergy to tattoo ink,
• using any medication deemed to inhibit hair growth as determined by the
physician investigator, or
• have had radiation or chemotherapy in the last 12 months
Number of 
Participants and Sites 
Up to a total of 200 (approximately 120 men and 80 women) participants 
will be enrolled in this study at up to 4 centers. 

REVIAN® Trial 
Confidential and Proprietary  
 Page 7 of 54    
  Version 6.0 2018-08-22 
Primary Efficacy 
Endpoint 
The primary efficacy endpoint of this study is mean change in hair count from 
baseline to 16-weeks following the initial application at baseline 
Primary and 
Secondary Safety 
Endpoints 
The primary and secondary safety outcomes will be determined by evaluating 
by the type, frequency, severity, and relatedness of adverse events through the 
16- and 26-week period, respectively, for all participants.
Secondary Efficacy 
Endpoints 
Secondary Efficacy Endpoint(s): 
Clinical outcomes will be determined using the following outcome measurement 
tools to evaluate changes at each follow up visit compared to baseline: 
1. Change from Baseline Hair Count: Like the primary endpoint, change from
baseline hair count, will also be assessed at 8 and 26 weeks.
2. Rate of Change in Hair Growth: The rate of change in hair growth at 8, 16,
and 26 weeks will be calculated as a ratio of change from baseline to
baseline.
3. Independent Physician’s Global Assessment (iPGA):
An independent reviewer will assess over hair growth over baseline from
photographs, using PGA scores at weeks 8, 16 and 26. The PGA score hair
growth as: -3=greatly decreased, -2=moderately decreased, -1=slightly
decreased, 0=no change, 1=slightly increased, 2=moderately increased and
3=greatly increased
4. Site Physician’s Global Assessment (sPGA): The site investigator will
assess over hair growth using the PGA scores at weeks 8, 16, and 26.
In addition, the percentage of participants who achieve success as defined
by a PGA ≥2 will be summarized by treatment and by weeks.
5. Subjective Scalp Hair Growth Score (SSHG): SSHG will be administered
beginning at 8 weeks and then at 16 and 26 weeks.
6. Hair Specific Skindex-29 Quality of Life Score Questionnaire (HSSQOL):
The hair specific Skindex-29 QOL questionnaire will be administered at
baseline, 8, 16, and 26 weeks.
7. Overall Treatment Success (OTS): Overall treatment success will be defined 
as the number of participants who achieve ≥50% reduction in overall QOL
scores, plus reported SSHG ≥2 on every question.
  
Secondary Safety 
Endpoint 
The secondary safety outcome will be determined by evaluating by the type, 
frequency, severity, and relatedness of adverse events through the 26-week
period for all participants. 
Statistical Analyses 
Primary Statistical Analysis: The primary efficacy analysis of this study is to 
compare the mean change in hair count change from baseline to 16-weeks 
following the initial application at baseline of REVIAN to the Sham.  This will 
be performed using mixed effects analysis of covariance where baseline 
characteristics and demographics may be considered as covariates. 
Safety Analyses: All Adverse Events (AEs) will be tabulated and summarized 
as counts and percentages.  AEs will also be cross-tabulated per the following 
categories: 
•
Severity (Mild, Moderate, Severe)
•
Seriousness (Serious, Non-serious)
•
Device-Relatedness (Unrelated, Probably Related, Possibly Related,
Definite)
•
Procedure-Relatedness (Unrelated, Probably Related, Possibly Related,
Definite)

REVIAN® Trial 
Confidential and Proprietary  
 Page 8 of 54    
  Version 6.0 2018-08-22 
Study Duration 
Study enrollment will be completed over approximately 7-months. 
All participants included in this clinical investigation will be evaluated for safety 
and efficacy at 8-, 16- and 26-weeks. The primary study endpoint will be 
evaluated at 16-weeks and secondary endpoints will be evaluated at 8-, 16- and 
26-weeks.
The total duration of the enrollment period and completion of the 26-week 
endpoint is approximately 54-weeks (Approx. 13.5 months) for primary and 
secondary endpoint evaluation. 

REVIAN® Trial 
Confidential and Proprietary  
 Page 10 of 54  
    Version 6.0 2018-08-22 
PRINCIPAL CONTACTS 
Name, Address and Contact 
Study - Principal Investigator 
Study Sponsor/Monitor 
Study Statistician 
Terminal Hair Count and Macro-
Photographic Independent 
Reviewer 
Medical Monitor 
Official Commercial 
Correspondent 

REVIAN® Trial 
Confidential and Proprietary  
 Page 11 of 54  
    Version 6.0 2018-08-22 
ABBREVIATIONS AND TERMS 
Table 1. Abbreviations and Terms 
AE 
Adverse Event 
AGA 
Androgenetic Alopecia 
ANCOVA 
One-way Analysis of Covariance 
CCO 
Cytochrome C Oxidase 
CRF 
Case Report Form 
DHT 
Dihydrotestosterone 
FDA 
Food and Drug Administration 
FPHL 
Female Pattern Hair Loss 
FPCB 
Flexible Printed Circuit Board 
GCP 
Good Clinical Practice 
HF 
Hair Follicles 
HREC 
Human Research Ethics Committee 
ICF 
Informed Consent Form 
IFU 
Instructions for Use 
ITT 
Intent-to-Treat 
ISO 
International Organization for Standardization 
IRB 
Institutional Review Board 
LED 
Light Emitting Diode 
LOCF 
Last Observation Carried Forward 
LLLT 
Low-Level Laser Light Therapy 
LTFU 
Lost to Follow up 
MDD 
Medical Device Directive 
MLT 
Modulated Light Therapy 
MPHL 
Male Pattern Hair Loss 
NO 
Nitric Oxide 
PCB 
Electronically Controlled Circuit Board 
PHI 
Personal Health Information 
PGA 
Physician Global Assessment Score 
PI 
Principal Investigator 
PP 
Per-Protocol Patient Population 
QOL 
Quality-of-Life 
SAE 
Serious Adverse Event 
SD 
Standard Deviation 
SSHG 
Subjective Scalp Hair Growth 
UADE 
Unanticipated Adverse Device Effect 

REVIAN® Trial 
Confidential and Proprietary  
 Page 12 of 54  
    Version 6.0 2018-08-22 
1.0 
STUDY PURPOSE 
1.1 Introduction and Background 
Androgenetic Alopecia 
Male and female pattern hair loss is a common, chronic dermatologic disorder. Male pattern hair 
loss (MPHL) or androgenetic alopecia (AGA) affects 50% of men by 50 years of age, and the 
frequency and severity increase with age. MPHL is characterized by a dihydrotestosterone-
dependent process with miniaturization of terminal hair follicles (HFs) into vellus HFs. The 
frequency and severity of female pattern hair loss (FPHL) also increase with age, with a prevalence 
of over 50% in women over the age of 80 years. While the role of androgens in all cases of FPHL 
is less certain, FPHL also undergoes follicular miniaturization.  
Current Care 
Pharmacologic Approaches 
Current medical treatments for MPHL include pharmaceutical agents such as topical minoxidil 
(available in 2% and 5% solutions or 5% foam, and sometimes combined with other active 
ingredients such as tretinoin), finasteride, dutasteride (US FDA approved for the treatment of 
benign prostatic hyperplasia, and prescribed off-label for treatment of MPHL), topical 
ketoconazole, anti-androgens and estrogens (for FPHL), and surgical treatment using follicular unit 
transplantation. Finasteride and minoxidil are well-known, effective treatment methods, but 
patients who exhibit a poor response to these methods have no additional adequate treatment 
modalities.  
Minoxidil (Rogaine) 
This topical medication is available over the counter, and no prescription is required. It can be used 
in men and women. It works best on the crown, less on the frontal region. Minoxidil is available as 
a 2% solution, 4% solution, an extra-strength 5% solution, and a new foam or mousse preparation. 
Rogaine may grow a little hair, but it's better at holding onto what's still there. There are few side 
effects with Rogaine. The main problem with this treatment is the need to keep applying it once or 
twice daily, and most men get tired of it after a while. In addition, minoxidil tends to work less well 
on the front of the head, which is where baldness bothers most men. Inadvertent application to the 
face or neck skin can cause unwanted hair growth in those areas. 
Finasteride (Propecia) 
This medication is FDA approved for use in only men with androgenic hair loss. Finasteride is in 
a class of medications called 5-alpha reductase inhibitors. It is thought to help reduce hair loss by 
blocking the action of natural hormones in scalp hair follicles. Propecia is a lower-dose version of 
a commercially available drug called Proscar that helps shrink enlarged prostates in middle-aged 
and older men. Propecia may grow and thicken hair to some extent for some people, but its main 
use is to keep (maintain) hair that's still there. Studies have shown that this medication works well 
in some types of hair loss and must be used for about six to 12 months before full effects are 
determined. This medication does not "work" in days to weeks, and its onset of visible improvement 
tends to be gradual. It may be best for men who still have enough hair to retain but also can help 
some regrow hair. Possible but very unlikely side effects include impotence or a decreased sex 
drive (libido). Studies have shown that these side effects were possibly slightly more common than 
seen in the general population and are reversible when the drug is stopped. The cost is about $70-
$100/month, which is generally not reimbursed by most health insurers. 

REVIAN® Trial 
Confidential and Proprietary  
 Page 13 of 54  
    Version 6.0 2018-08-22 
Experimental 
Dutasteride 
Dutasteride is a more potent 5α-reductase inhibitor than finasteride, working by inhibiting both 
type I and type II 5α-reductase. Whereas type II 5α-reductase concentrations are much higher than 
those of type I 5α-reductase, the additional inhibitory effect on androgen activity produced by 
dutasteride may translate into greater clinical efficacy. It is commonly used to treat benign prostatic 
hypertrophy but is not approved by the US FDA for the treatment of either male or female AGA. 
Phase 1 and 2 trials conducted exclusively in men demonstrated that at a dose of 2.5–5.0 mg/day, 
dutasteride suppresses almost 100% of serum Dihydrotestosterone (DHT) activity, whereas 
finasteride at a dose of 5 mg/day suppresses only 70% of DHT. Phase 2 preclinical trials showed 
that after 6 months of treatment, there was a 30% increased improvement in hair count when 
comparing 0.5 mg of dutasteride with 5 mg of finasteride. 
Current Surgical Treatment Options 
Hair Transplantation 
Surgical treatment of AGA has been successfully performed for the past 4 decades. Although the 
cosmetic results are often satisfactory, the main problem is covering the bald area with donor plugs 
(or follicles) sufficient in number to be effective.  Micrografting produces a more natural 
appearance than the old technique of transplanting plugs. 
A review of surgical procedures concluded that both patients and physicians alike are pleased with 
the results of contemporary hair transplantation. However, patients with less than 40 follicular 
units/cm2 in their donor areas are poor candidates for the procedure.  
Scalp Reduction 
This option is less popular compared with hair transplantation. It involves bringing hair-bearing 
skin closer together by removing the central scalp affected by the alopecia. Sometimes it is 
performed in conjunction with hair transplantation to optimize cosmetic outcomes. Disadvantages 
of this procedure increase with time and include diminishing efficacy due to the unpredictability of 
subsequent individual hair loss, increasing cosmetic visibility of excision scars, potential gradual 
widening of scars due to stretching of adjacent scalp skin, and the usual need for more than one 
scalp reduction to effectively address hair loss. 
In addition, there are numerous oral supplements and topical treatments claimed to have hair 
growth-promoting or anti-hair loss effects that are marketed directly to the consumers, without 
independent data supporting the claims. 
Alternative Treatments – Light Therapy 
Despite the current treatment options for different types of alopecia and given the prevalence of 
MPHL and FPHL, there is a need for more effective management options.  In recent years, low-
level laser/light therapy (LLLT), or photobiomodulation or photobiostimulation, has been promoted 
to prevent hair loss and stimulate hair growth in both MPHL and FPHL. There have been several 
commercially available devices designed for home use (daily or several times a week), and they are 
relatively inexpensive compared with current medical treatment and hair transplantation surgery.  
These low-level laser therapy (LLLT) devices have been evaluated for stimulating hair growth as 
an effective alternative for pattern hair loss. 

REVIAN® Trial 
Confidential and Proprietary  
 Page 14 of 54  
    Version 6.0 2018-08-22 
Review of prospective, randomized, multicenter clinical studies to determine safety and efficacy of 
LLLT home devices like the HairMax LaserComb (Lexington International), Handi-Dome Laser 
(Capillus, LLC), and TOPHAT655 Rejuvenation System (Apira Science, Inc) are considered both 
safe and effective. 
Other products using laser diodes to treat patients with AGA include; iRestore Hair Rejuvenation 
System (Freedom Laser Therapy) LaserCap 80-300 (Dermascalp, LLC), Capillus 272 Pro and 
OfficePro (Capillus, LLC), Laser Helmet LH40-EVO (Theradome, Inc), Nutrastim Hair Laser 
Helmet (Nutra LuxeMD, LLC), and Lasercap 120-300 (Transdermal Cap, Inc.).  These medical 
products have United States FDA clearance without clinical trials. 
Conclusions 
Both physicians and patients are frustrated with the inconsistent outcomes from these treatment 
options.  Given the increasing prevalence of alopecia in patients and the evident potential of 
modifying therapies that overcome the limitations of the current treatment options this study is 
both warranted and necessary. 

REVIAN® Trial 
Confidential and Proprietary  
 Page 15 of 54  
    Version 6.0 2018-08-22 
1.2 Study Rationale 
Low level laser therapy (LLLT) utilizing red light (625-680 nm) is clinically proven to be both safe 
and effective at promoting hair growth in men and women with AGA.  The ability of red light to 
grow hair was accidentally discovered in 1967 by Endre Mester when he observed that shaved mice 
exposed to red laser light regrew hair faster than mice not exposed.23 While the exact mechanism 
of action for light-induced hair growth is unknown, nearly 50 years of research has led to the 
development of several hypotheses which will be outlined below. 
For light to have a therapeutic effect, the light must first be absorbed by molecules in the body, 
termed photoacceptors.  Various wavelengths of light target different photoacceptors. For example 
500-600 nm light is absorbed by hemoglobin while IR light (<1050 nm) is absorbed by water.24-25
Work pioneered by Professor Karu PhD., (Institute on Laser and Informatic Technologies of the
Russian Academy of Sciences) discovered that cellular mitochondria are photoacceptors of red
light in the skin and scalp.26-28  The primary hypothesis for why LLLT with red light induces hair
growth is that it releases nitric oxide (NO) from the cell mitochondria.29-30  Nitric oxide is a potent
signaling molecule that regulates many physiological processes including vasodilation, the immune
response, and neurotransmission.  Nitric oxide is generated by nitric oxide synthase enzymes (i.e.,
endothelial, neuronal, and inducible nitric oxide synthases) that convert L-arginine to NO and L- 
citrulline.31-32 The resulting NO is highly reactive and binds to small molecule or proteins to form
a non-active state.  One protein that NO binds to is Cytochrome C Oxidase (CCO), a protein found
in the christa of mitochondria and acts as part of the electron transport chain.33 When light from
LLLT enters a cell, the light energy excites CCO, changing its electronic state and subsequently
releasing the bound NO.30, 34    When NO is bound to CCO, it blocks the respiratory activity of the
mitochondria by preventing oxygen from binding to CCO.33
Releasing NO from CCO using LLLT 
therefore increases cellular respiration.   
In its unbound (bioactive) state, NO 
alters gene transcription, resulting in 
increased expression of growth factors 
and reduced expression of inflammatory 
cytokines.29-30   LLLT has been shown to 
upregulate growth factors associated 
with the anagen (growth) phase of the 
hair cycle, which include vascular 
endothelial 
growth 
factor, 
basic 
fibroblast 
growth 
factor 
and 
keratinocyte 
growth 
factor.35,38 By 
increasing these growth factors, LLLT 
is believed to prolong the growth phase 
of the hair cycle and prevent entry into 
the catagen phases where the hair 
follicle undergoes massive apoptosis. 29,
39-40
In the scalp, NO released by LLLT acts 
as a potent vasodilator, increasing blood 
flow to the scalp and hair follicles.41-43
Increased 
NO 
levels 
also 
stimulate 
epithelial cell proliferation, leading to 
Figure 1.  Proposed mechanism of action of LLLT for 
the treatment of androgenetic alopecia. 

REVIAN® Trial 
Confidential and Proprietary  
 Page 16 of 54  
    Version 6.0 2018-08-22 
increased angiogenesis and improved microcirculation in the scalp.44-45 Therefore, LLLT results in 
short- and long-term improvements to scalp blood flow. This enhanced circulation supports cell 
metabolism and proliferation while decreasing inflammation, ultimately resulting in healthier 
follicles which are more capable of producing hair.29    
Figure 2. Hair Growth Cycle.  The hair growth cycle consists of three main phases:  anagen, catagen, and 
telogen. The length of these phases is controlled by the vascularization and blood flow around the hair 
follicle and the expression of growth factors and cytokines by cells in the hair follicle. LLLT promotes 
entry into the anagen (hair growth) phase and prevents transition to the catagen (hair death) phase. This is 
achieved by improving circulation in the scalp, increasing the expression of growth factors and decreasing 
inflammation. 
Most of the research on LLLT as a treatment for AGA to date has focused on specific wavelengths 
of light based on historical studies (e.g., Mester’s accidental induction of hair growth with red lasers 
in 1967) and the commercial availability of lasers. Unfortunately, this means the potential to treat 
AGA with light therapy has been hindered.  While current LLLT products release NO from CCO, 
they do not attempt to generate NO via the upregulation of nitric oxide synthase enzymes. 
PhotonMD’s preclinical work has focused on developing modulated light therapy (MLT)TM via two 
mechanisms: 
1) Increase the concentration of NO in hair follicles by using new wavelengths of light that are
more effective at releasing NO from CCO, and the other small molecules and proteins on
which it is stored.
2) Regenerate the NO released during LLLT by increasing the expression of nitric oxide synthase
enzymes which produce NO from L-arginine.
Systematic in vitro experiments were performed to determine the efficacy of different wavelengths 
of light at releasing NO from its bound, inactive state. Using chemiluminescent detection of NO, it 
was shown that wavelengths of light used in current LLLT devices were less effective at liberating 
NO than the wavelengths used in REVIAN 102.  These experiments were corroborated by cell 
studies performed by an unbiased third party which measured intracellular NO generated in human 
cell lines relevant to hair growth. These studies showed significant improvement in concentration 

REVIAN® Trial 
Confidential and Proprietary  
 Page 17 of 54  
    Version 6.0 2018-08-22 
of unbound (bioactive) NO using the wavelengths of light in REVIAN 102 when compared to 
traditional forms of red LLLT.  Additionally, irradiation with the wavelength of light used in 
REVIAN 102 enhances the expression of nitric oxide synthase enzymes in human dermal 
fibroblasts and keratinocytes, while 
red light had no effect.  
These results suggest the REVIAN 
102 will increase the amount of NO 
generated and stored in hair follicles 
and the surrounding tissue. 
REVIAN 103 combines both the 
current red light therapy technology 
as well as the new wavelengths of 
light used in REVIAN 102.  As red 
light therapy is associated with 
decreased inflammation, combining 
both treatment modalities may 
further improve hair growth.  By 
comparing 
REVIAN 
102 
and 
REVIAN 103, we hope to determine 
whether combining these treatments 
improves hair growth in an additive 
or synergistic manner.  
While LLLT has been clinically 
proven to be safe, the design of these 
devices makes them prone to misuse 
and risks the potential for eye 
damage. First, REVIAN 102 and 103 do not use lasers, which can damage the retina due to the 
intensity of their highly focused light beam. Instead, REVIAN 102 and 103 use light emitting 
diodes (LEDs), which are inherently safer than lasers due to the wide-angle dispersion of light in 
LEDs.  In addition to improving safety the use of LEDs provides uniform coverage of light to the 
scalp instead of creating areas of high and low light dosing caused using lasers.  Of note, recent 
scholarship agrees that lasers provide no advantage over LEDS in providing LLLT.38, 46   
Another safety feature of REVIAN 102 and 103 is the addition of a sensor that automatically dims 
the LEDS if the Cap is removed from the head to protect the eyes from damage.  Finally, the mobile 
app controls the Cap and helps participants establish a treatment regimen which both improves 
patient compliance during treatment. The mobile app prevents the Cap from being used more than 
once a day (ensuring that participants cannot give themselves more light therapy than is necessary), 
reminds participants to treat daily, and allows them to set reminder alarms.   
In summary, the development of new treatments for AGA is highly desirable as current available 
therapies fail to deliver the outcomes desired by patients. While current light therapy devices for 
hair growth have proven clinical safety and efficacy, these therapies were  
Figure 3.  Dual mechanisms of NO generation used by  
REVIAN 102 and 103.  The REVIAN products a) release NO 
bound to proteins such as CCO and, b) increase the enzymatic 
generation of NO by increasing the expression of NOS 
proteins that convert L-arginine to NO and L-citrulline 

REVIAN® Trial 
Confidential and Proprietary  
 Page 18 of 54  
    Version 6.0 2018-08-22 
developed 
based 
on 
limited 
preclinical testing and do not 
represent 
optimum 
modes 
of 
treatment including dosing and 
wavelength.  REVIAN 102 and 
103 are improvements on the 
current products because they 
improve the ability to release NO 
from its bound form and increase 
enzymatic generation of NO.  The 
downstream effects of NO in the 
scalp 
include 
improved 
microcirculation (via vasodilation 
and 
angiogenesis), 
increased 
proliferation of hair follicle cells, 
decreased 
inflammation, 
and 
elongation of the anagen phase of 
hair growth. These downstream 
effects of NO are believed to 
improve the health of hair follicles, 
promote hair growth, and increase 
hair 
thickness 
(diameter). 
Additionally, 
the 
REVIAN 
products have been designed with 
safe 
LEDs, 
a 
sensor 
based 
automatic 
turn-off, 
and 
programmed treatment schedule to 
help improve both safety and 
compliance. 
1.3 Device Name 
For purposes of this study, “investigational device” or “test device” refers to the REVIAN System 
(herein after referred to as “REVIAN”).  A non-active version of the device will serve as a SHAM 
comparator (herein after referred to SHAM). 
1.4 Brief Description of the Device 
The REVIAN is a soft dome-shaped Cap that contains integrated electronics and battery 
technology to control delivery of modulated light therapy (MLT™) for a daily 10-minute 
treatment to treat AGA and promote hair growth in men and women. The Cap contains a flexible 
printed circuit board (FPCB), LEDs, electronic control circuit board (PCB), lithium-polymer 
battery, elastic fabric and foam fitting pieces.  The cap is controlled and operated by a mobile app. 
Figure 4.  Differences in coverage between LED and 
Laser medical devices.  a)  LEDs emit light with a wide 
distribution angle compared to Lasers, making them both 
safer and more effective.  b) The differences in coverage of 
light shining from a single LED or single laser through 
human skin. The irradiance (mW) and distance from the 
sample was matched for both light sources. 

REVIAN® Trial 
Confidential and Proprietary  
 Page 19 of 54  
    Version 6.0 2018-08-22 
2.0 
PROTOCOL 
2.1 Study Purpose and Objectives 
The primary objective of this study is to collect data on the safety and effectiveness of REVIAN 
in male and female participants with AGA through 26-weeks of treatment. 
2.2 Study Design Overview 
This study is designed as a prospective, randomized, controlled, double-blind, four-arm study.  Up 
to 4 clinical sites will enroll up to 200 participants over an approximate 7-month duration.  Eligible 
participants with AGA meeting inclusion and exclusion criteria will be enrolled and randomized 
to one of four study arms.  
Study Arm 1:  Active REVIAN 101 (___ mW/cm2 of 625 nm and 660 nm) 
Study Arm 2:  Active REVIAN 102 (___ mW/cm2 of 425 nm) 
Study Arm 3:  Active REVIAN 103 (___ mW/cm2 of 425 nm + ___ mW/cm2 of 625 nm and 660 nm) 
Study Arm 4:  Non-Active REVIAN (SHAM) Cap 100 
The outcome measures in this study will include the following: 
•
Quantitative Scalp Hair Growth (Macrophotography of 1-cm2 area of interest)
•
Subjective Scalp Hair Growth (SSHG) score
•
Physician's Global Assessment (PGA) score
•
Hair Specific Skindex-29 Quality of Life Score Questionnaire
All participants will be asked to complete self-administering scalp hair growth and life quality 
questionnaires at each follow-up visit. Investigators will be required to complete global 
assessments of scalp hair growth for each enrolled participant at each follow-up visit.  
Macrophotography evaluations will be performed at baseline, 8-, 16-, and 26 weeks for all 
participants. Global photographs of superior and vertex scalp will be taken by the PI to be assessed 
by a blinded reviewer once all photos have been captured for each participant per visit. 

REVIAN® Trial 
Confidential and Proprietary  
 Page 20 of 54  
    Version 6.0 2018-08-22 
2.3 Study Scope and Participating Institutions 
Participating Institutions 
This study will include a maximum of 4 sites. A list of participating institutions will be 
provided to regulatory authorities as required. 
Participant Population 
Detailed enrollment criteria are provided in Section 2.6 Participant Eligibility Criteria of the 
protocol. In general, the study population will consist of adult men and women between 18 and 65 
years of age with diagnosis of Androgenic Alopecia, consistent with males who have Norwood 
Hamilton Classification IIa to V patterns of hair loss and females who have Ludwig-Savin Scale 
I-1 to I-4, II -1, II-2 or frontal, both with Fitzpatrick Skin Types I – IV.
2.4 Study Endpoints 
2.4.1 Primary Efficacy Endpoint: 
The primary efficacy endpoint of this study is mean change in hair count from baseline to 16 weeks 
following the initial application at baseline. 
2.4.2 Secondary Efficacy Endpoints: 
Secondary efficacy endpoints will be determined using the following outcome measurement tools 
to evaluate changes at each follow up visit compared to baseline: 
1.
Change from Baseline Hair Count: Like the primary endpoint, change from baseline hair count,
will also be assessed at 8 and 26 weeks.
2.
Rate of Change in Hair Growth: The rate of change in hair growth at 8, 16, and 26 weeks will
be calculated as a ratio of change from baseline to baseline.
3.
Independent Physician’s Global Assessment (iPGA): An independent reviewer will assess over
hair growth over baseline from photographs, using PGA scores at weeks 8, 16 and 26. The PGA
score hair growth as: -3=greatly decreased, -2=moderately decreased, -1=slightly decreased,
0=no change, 1=slightly increased, 2=moderately increased and 3=greatly increased
4.
Site Physician’s Global Assessment (sPGA): The site investigator will assess over hair growth
using the PGA scores at weeks 8, 16, and 26.
In addition, the percentage of participants who achieve success as defined by a PGA ≥2 will be
summarized by treatment and by weeks.
 
5.
Subjective Scalp Hair Growth Score (SSHG): SSHG will be administered beginning at 8 weeks
and then at 16 and 26 weeks.
6.
Hair Specific Skindex-29 Quality of Life Score Questionnaire (HSSQOL): The hair specific
Skindex-29 QOL questionnaire will be administered at baseline, 8, 16, and 26 weeks.
7.
Overall Treatment Success (OTS): Overall treatment success will be defined as the number of
participants who achieve ≥50% reduction in overall QOL scores, plus reported SSHG ≥2 on
every question.

REVIAN® Trial 
Confidential and Proprietary  
 Page 21 of 54  
    Version 6.0 2018-08-22 
2.4.3 Primary Safety Endpoint(s): 
At each follow-up visit, participants will be interviewed to determine if any adverse events (AEs) 
were experienced since the previous follow-up visit. If deemed necessary, a physical assessment 
may be performed for any participant experiencing a serious adverse event or as required by the 
Principal Investigator. The primary safety outcomes will be determined by evaluating by the type, 
frequency, severity, and relatedness of adverse events through the 26-week period for all 
participants. 
2.5 Study Population and Source of Participants 
All participants with diagnosis of androgenic alopecia may be eligible for study participation. 
Potential study candidates will be approached for consent prior to any data collection. A screening 
and enrollment log will be provided to study sites to maintain a record of all screened participants. 
Participants will be identified and recruited by Clinical Investigators and/or their designated research 
staff at facilities affiliated with a maximum of 4 investigative sites. Clinical Investigators selected 
to participate in the study should be able to enroll at least 10 participants per month with a maximum 
of 100 participants enrolled at a single site. 
For the purposes of enrollment, only those participants who meet all eligibility criteria, sign an 
IRB/HREC approved consent form and begin treatment with REVIAN/SHAM will be considered 
enrolled in the study. Participants who consent to participate but withdraw prior to the first treatment 
with REVIAN/SHAM will be considered a screening failure and the reasons for screening failure 
will be documented on the site screening log. All treated participants will be evaluated for the 
primary endpoints at 16-weeks. 
Any participant consented, whether treated or not, will be assigned a screening number. The 
reason for failure to treat will be recorded in his/her study records and the site screening log. 

REVIAN® Trial 
Confidential and Proprietary  
 Page 22 of 54  
    Version 6.0 2018-08-22 
2.6 Participant Eligibility Criteria 
Inclusion Criteria: 
Candidates for this study must meet ALL of the following criteria: 
1.
Male and Female participants between 18 and 65 years of age
2.
Must be able to read and speak English.
3.
Participants who are able to give voluntary, written informed consent to participate in this
clinical investigation and from whom consent has been obtained.
4.
Participants, who, in the opinion of the Clinical Investigator, are able to understand this
clinical investigation, cooperate with the investigational procedures and are willing to
return for all the required follow-up visits.
5.
Participant must be able to visit clinic site at 8-, 16- and 26-weeks study visits and be
available by phone at 4 weeks.
6.
Participant must have the ability to communicate effectively with study personnel in
person or over the phone.
7.
Participant must have diagnosis of Androgenic Alopecia (pattern hair loss).
8.
Participant must have active hair loss consistent with Grades IIa to V, based on Norwood-
Hamilton Scale or Ludwig-Savin Scale I-1 to I-4, II -1, II-2 or frontal and Grades I - IV
using Fitzpatrick Skin Type Scale.
9.
Participant’s hair must be at least 1 inch in length.  The hair style and length shall be the
same for each follow-up visit.  Participants will be instructed to not have their hair
cut/styled within 5 days prior to a follow-up visit.
10.
Participant is willing to have a dot tattoo placed on or around the target area of the scalp.
11.
Participant is willing to undergo all study procedures including consent for global
photographs of hair loss/growth and a 1 mm tattoo to mark the macrophotography site
along the indicated transition area of the scalp between the hairline and the
balding/thinning vertex area.
12.
Participant is willing to avoid the use of wigs, hairpieces, and/or hair extensions during the
study period.
13.
Hair Specific Skindex-29 Quality of Life total overall score of ≥ 45.
14.
Participant is willing to maintain their natural hair colour or including the use of coloring
throughout the study period.
15.
Participant agrees to refrain from using all other hair growth products or treatments (oral or
topical medication including over the counter herbal medications, or Dutasteride) during
the study period.
16.
Participant has the ability to utilize a Bluetooth device and application on a smart device
connected to Wi-Fi.
Exclusion Criteria: 
Candidates will be excluded from the study if ANY of the following apply: 
1.
Female participants of childbearing potential who are not on some form of birth control and
do not have a confirmed negative pregnancy test at baseline
2.
Use of Propecia or any other hair growth supplements within 12 months prior to enrollment.
3.
Use of Rogaine or Minoxidil based products within 6 months prior to enrollment.
4.
Participants have a previous hair transplant, cell treatment, micro needling, tattooing, or any
other treatment to the scalp.
5.
Participant is suffering from an active autoimmune disease such as lupus erythematosus
(systemic and cutaneous) or alopecia areata.
6.
Photosensitivity to visible light operating within 400 – 850 nm or taking medication that

REVIAN® Trial 
Confidential and Proprietary  
 Page 23 of 54  
    Version 6.0 2018-08-22 
increases photosensitivity. 
7.
Currently suffering from a dermatological condition in the treatment area or has a
significant scar in the hair treatment area that, in the opinion of the investigator, will make
hair growth difficult (such as a systemic burn, malignancy, etc.)
8.
Participant has a sensitivity or allergy to tattoo ink.
9.
Using any medication deemed to inhibit hair growth as determined by the physician
investigator.
10.
Employed by the sponsor, clinic site, or entity associated with the conduct of the study.
11.
Has had radiation or chemotherapy in the last 12 months.
12.
Have any condition or situation which, in the Investigator’s opinion, puts the participant at
significant risk, could confound the study results, or may interfere significantly with the
participant’s participation in the study.
13.
Known prior inability to complete required study visits during treatment period;
14.
Use of any other investigational drug, therapy, or device within the past 30 days of
enrollment or concurrent participation in another research study;
15.
Are unable to communicate or cooperate with the Investigator due to language problems,
poor mental development, or impaired cerebral function;
16.
Participants who are currently involved in any investigational drug or device trial or have
been enrolled in such trials within the last 3 months.

REVIAN® Trial 
Confidential and Proprietary  
 Page 24 of 54  
    Version 6.0 2018-08-22 
2.7 Study Duration 
It is anticipated that the enrollment of participants will take approximately 7-months. All participants 
included in this clinical investigation will return for follow-up visits at 8-, 16- and 26-weeks post-
baseline visit. Evaluation of the primary efficacy and safety endpoints will be completed on all 
participants at the 16-weeks post-baseline period and secondary efficacy and safety endpoints will 
be completed at 26-weeks post-baseline. 
3.0 
STUDY PROCEDURES 
3.1 Enrollment Procedure 
Participants will not be recruited until the appropriate governmental regulatory agencies (as 
applicable) and the local Institutional Review Board (IRB) or Human Research Ethics Committee 
(HREC) have approved the study. The Investigator or the Investigator’s designee will inform all 
participants of the purpose of the study, expected duration, number of participants, as well as all 
conditions of the study to include the potential risks and benefits that may result from participation, 
follow-up duration, and study requirements. 
The Investigator or designee will review the participant’s history to determine the participant’s initial 
eligibility for study entry. Upon determination of participant eligibility, the participant will be given 
the opportunity to discuss any aspect of the study, the informed consent, procedure, risks, benefits, 
alternative therapies, and the study requirements with the Investigator or Investigator’s designee 
prior to signing the informed consent document. 
Upon determining a participant’s eligibility status, the participant will be offered the opportunity to 
participate in the study, and the participant’s initials will be entered into the study site’s screening 
log regardless of their decision to participate in the study or not. After the participant has signed the 
Informed Consent, all inclusion and exclusion criteria will be verified. If the participant meets all the 
inclusion and none of the exclusion criteria, the participant will then become eligible for enrollment. 
3.2 Process for Obtaining Informed Consent  
The patients will be informed by the Investigator or Investigator’s designee that they are free to 
refuse participation in this research study. If they elect to participate, it will be made clear that they 
may withdraw from the study at any time without prejudicing further care. 
The Investigator or the Investigator’s designee will inform participants that their medical records 
will be subject to review by the sponsor or appropriate regulatory bodies. This information will be 
used during the analysis of the results of the clinical study, but the participants’ identities will be 
treated as confidential. Participants will be assigned a unique study participant code that will not 
reveal the participants’ identity. This code will be used on all data and data collection forms during 
the study period. 
The Investigator will explain the conditions of the study, giving the participant sufficient time to ask 
questions and to consider whether to participate. Eligible participants who agree to participate will 
be asked to sign and date an IRB/HREC approved informed consent form (ICF). One copy of the 
ICF shall be returned to the Investigator and filed in the participant’s case history; the other copy is 
for the participant to keep. 

REVIAN® Trial 
Confidential and Proprietary  
 Page 25 of 54  
    Version 6.0 2018-08-22 
3.3 Blinding Procedure 
The participants, Principal Investigator and Study Coordinators will be blinded to treatment, 
except in the case of an emergency that requires unblinding of a participant.  In order for each 
Principal Investigator to remain blinded for all participants throughout the study, each site will 
designate a minimum of one, but no more than two, licensed members of the study staff (e.g., 
M.D., D.P.M., P.A., Nurse Practitioner, study assistant, etc.) to be the unblinded Treatment
Administrator.  The role of the Treatment Administrator(s) will be to administer the study device
(both active and SHAM) and maintain and complete the Device Treatment and Training logs.  In
order to verify that the correct application was being used for each participant at each study visit,
the code will be reviewed by the local Study Sponsor during monitoring visits and throughout the
study when a participant is enrolled.
Each participant will register their user name in the mobile app and run an application for the first 
treatment prior to leaving the clinic. The Principal Investigator and/or designated Sub-Investigators 
will serve as the blinded evaluators for all study visits. 
3.4 Participant Assessments 
3.4.1 
Screening – Visit 1 
Participants will be preliminarily qualified to determine eligibility, i.e., those who meet all applicable 
inclusion/exclusion criteria that do not require a study related procedure to be performed. Those 
participants that meet the preliminary qualification and who agree to participate in the study will sign 
an Informed Consent. At the initial screening visit, participants will have their demographic 
information collected, their medical and medication history collected (including duration and severity 
of AGA); as well as a urine pregnancy test, for females of child bearing potential. 
Demographic information will be collected as follows: 
•
Details including age and date of birth
•
Gender
•
Co-morbid conditions
•
Work status
•
Education level
•
Smoking history
3.4.2 
Baseline – Visit 2 
The Baseline visit is the time remaining screening procedures will be completed, with the participant 
enrolled and randomised to a device, if eligible. This visit can take place up to 7 days from Visit 1, 
or it can be conducted the same day. Participants will have a physical examination and will then fill out 
a baseline Hair Specific Skindex-29 Quality of Life Questionnaire. This questionnaire is a well-
established, three-dimensional, dermatology-specific health-related quality-of-life (HRQoL) 
instrument designed to evaluate the impact of androgenetic alopecia (AGA) and treatment outcome on 
a participant’s physical, psychological, social functioning and well-being.  A participant must have a Hair 
Specific Skindex-29 total overall score of ≥ 45 at baseline to be eligible for enrollment. The Skindex-
29 consists of 29 items loading on emotional (10-50), functioning (12-60) and symptom (7-35) 
categories with total scoring ranging from 29-145. The questions refer to the previous 4-week period, 
and scores are given on a 5-point scale, from ‘never’ to ‘all the time’. Greater scores indicate poorer 
quality of life. The scale scores are computed by transforming responses to a 100-point scale, with higher 

REVIAN® Trial 
Confidential and Proprietary  
 Page 26 of 54  
    Version 6.0 2018-08-22 
scores indicating a lower level of quality of life. The overall score and individual category scores will 
be used to demonstrate improvement over the course of the trial.  Corresponding Skindex-29 cut-off 
scores for severely impaired HRQL are as follows: ≥ 52 points on symptoms, ≥ 39 on emotions, ≥ 
37 on functioning, and ≥ 44 on the overall score. The estimated cut-off scores can be used in clinical 
practice to identify patients with (very) severely impaired HRQL 
The Investigator will conduct a routine physical exam and record the following: 
i.
Medical Assessment will be performed and the following information recorded:
•
Complete history
•
Physical Exam (including vital signs)
•
Previous treatments for AGA
•
Co-morbid conditions and any disabilities
•
Duration and severity of AGA
•
Concomitant medication usage
•
Pregnancy Test – urine dipstick (as required)
ii.
Assessments and Procedures will be collected as follows:
•
Hair Specific Skindex-29 Quality of Life Score Questionnaire
If a participant remains eligible, the Investigator will enter the participant into the study. Eligible 
participants will then have photographic assessments conducted and be trained on the components 
and use of REVIAN/SHAM and will undergo the first treatment at the PI’s office.  The day of the 
first treatment will be considered as the date of participant enrollment. 
•
Global Photography Image of Two Views (superior and vertex scalp)
•
Shave and Tattoo Scalp
•
Hair Count - Macrophotography (1cm2 Area)
•
Instruction and 1st REVIAN/SHAM 10 Minute Treatment
•
Adverse Events
A standard macrophotography technique will be provided to all investigational sites. Please refer 
to the Macrophotography Technique Manual for full instructions on the proper site selection for 
shaving and tattooing the scalp and macrophotography.  
All participating investigators will undergo training on the appropriate use of the REVIAN/SHAM 
device. Only investigators and co-investigators qualified by training or experience in 
dermatological conditions of the scalp will be selected for this clinical trial. 
All participants will be seen at 8-weeks, 16-, and 26-weeks following enrollment. 
3.4.3 Randomization of Treatment Device 
All participants will be randomized to one of four study arms.  The randomization will be a block 
design, stratified across the sites and maintained by the local Study Sponsor. Each site will be 
blinded to the randomization code and will only receive a pre-assigned code to use for each 
participant at time of enrollment.  The code will be pre-assigned to one of the four caps below: 
Study Arm 1:  Active REVIAN Cap 101 
Study Arm 2:  Active REVIAN Cap 102 
Study Arm 3:  Active REVIAN Cap 103 
Study Arm 4:  Non-Active REVIAN (SHAM) Cap 100 

REVIAN® Trial 
Confidential and Proprietary  
 Page 27 of 54  
    Version 6.0 2018-08-22 
3.4.4 Week 1 Phone Call – (7±3 Days), Visit 3 
•
Concomitant medication usage
•
Adverse Events
•
Compliance Follow-up
3.4.5 
Week 8 Follow-Up Visit – (56±5 Days), Visit 4 
•
Subjective Scalp Hair Growth (SSHG) Score
•
Physician’s Global Assessment (PGA) Score
•
Hair Specific Skindex-29 Quality of Life Questionnaire
•
Global Photography Image of Two Views (superior and vertex scalp)
•
Shave and Tattoo Scalp
•
Hair Count - Macrophotography (1cm2 Area)
•
Concomitant medication usage
•
Adverse Events
•
Compliance Follow-up
3.4.6 Week 16 Follow-Up Visit – (112±10 Days), Visit 5 
•
Subjective Scalp Hair Growth (SSHG) Score
•
Physician’s Global Assessment (PGA) Score
•
Hair Specific Skindex-29 Quality of Life Score Questionnaire
•
Global Photography Image of Two Views (superior and vertex scalp)
•
Shave and Tattoo Scalp
•
Hair Count - Macrophotography (1cm2 Area)
•
Concomitant medication usage
•
Adverse Events
•
Compliance Follow up
3.4.7 Week 26 Follow-Up Visit – (182±10 Days), Visit 6 
•
Physical Exam (including vital signs)
•
Subjective Scalp Hair Growth (SSHG) Score:
•
Physician’s Global Assessment (PGA) Score:
•
Hair Specific Skindex-29 Quality of Life Score Questionnaire
•
Global Photography Image of Two Views (superior and vertex scalp)
•
Shave and Tattoo Scalp
•
Hair Count - Macrophotography (1cm2 Area)
•
Concomitant medication usage
•
Adverse Events
•
Compliance Follow up
•
Exit/Termination Form
3.4.8 Unscheduled Visit:  Visit within 26-weeks Follow-Up 
If the participant returns for a study-related unscheduled visit within the 26-weeks follow-up the 
following evaluations will be performed: 
•
Medical treatment
•
Adverse event
•
Concomitant medication

Confidential and Proprietary  
 Page 28 of 54  
    Version 6.0 2018-08-22 
REVIAN® Trial 
The following Study Assessment Table provides an overview of activities to be performed at each study visit. 
1All visit dates are in reference to Baseline, i.e., Visit 4 occurs approximately eight weeks (56 days) after the Baseline Visit.
2 Participants will continue treatments throughout the 26-weeks with a daily 10-minute treatment for a total of 56 treatments over 8 weeks, 112 treatments over 16-weeks, 
   and 182 treatments over 26-weeks. 
3 Participants may have tattoo ink reapplied to original site of ink dot application at these time periods. 
4 SSHG, sPGA and iPGA are not taken at baseline. These assessments are conducted at the follow-up visits only.
PROCEDURES 
Visit 1 
Visit 2 
Visit 3 
Visit 4 
Visit 5 
Visit 6 
Screening 
(Day -7) 
Baseline 
(Day 0) 
Phone Call 
(7 ±3 Days) 
Week 81,2 
(56 ±5 Days) 
Week 161,2 
(112 ±10 Days) 
Week 261,2 
(182 ±10 Days) 
Informed Consent 
X 
X 
Demographics 
X 
X 
Medical History 
X 
X 
Medication History 
X 
X 
Inclusion/Exclusion Criteria 
X 
X 
Pregnancy Test (As required) 
X 
X 
Physical Examination 
X 
X 
Instruction on Device and 1st Application 
X 
Shave and Tattoo Scalp 
X 
X3 
X3 
X3 
Hair Count - Macrophotography (1cm2 Area) 
X
X 
X 
X 
Global Assessment Photography 
(superior and vertex scalp) 
X 
X 
X 
X 
Growth Assessment and Questionnaires: 
(1) Subjective Scalp Hair Growth (SSHG) score4
X 
X 
X 
(2) Physician's Global Assessment (sPGA) score4
X 
X 
X 
(3) Hair Specific Skindex-29 QoL Questionnaire
X 
X 
X 
X 
Blinded Review of Global Photographs (iPGA)4 
X 
X 
X 
Follow-up on Compliance and Use of  
REVIAN/SHAM 
X 
X 
X 
X 
X 
Concomitant Medications 
X 
X 
X 
X 
X 
Adverse Events 
X 
X 
X 
X 
X 
End of Study / Termination / Return Device 
X 

REVIAN® Trial 
Confidential and Proprietary  
 Page 29 of 54  
    Version 6.0 2018-08-22 
3.5 Termination of Participants 
Participants may voluntarily withdraw from the study at any time for any reason. The 
Investigator(s) may elect at any time to withdraw a participant from the study for any reason 
unrelated to the study treatment if such a decision is in the participant’s best medical interest. If 
a participant discontinues the study, or is withdrawn by the Investigator(s), as much follow-up 
data as possible will be obtained. The primary reason for termination or discontinuation will be 
documented on the End of Study case report form. Participants who are withdrawn from the study 
after treatment for any reason will not be replaced. 
Anticipated reasons for not evaluating a participant through the primary endpoint include: 
Participant Lost to Follow-Up: Unable to locate participant despite documented attempts to notify 
the participant via telephone and by certified mail. A participant will not be considered lost to 
follow-up until the last scheduled follow-up visit (26-week secondary study time point). 
Participant Request to Terminate: The participant requests to terminate his/her involvement in the 
study, therefore withdrawing his/her consent to participate in the study (the investigator must 
thoroughly document the reasons for termination). Attempts will be made to retrieve any follow-
up data, prior to the time point at which voluntary consent was withdrawn, when available, 
regarding possible AEs at the time of study discontinuation 
Participant Death: If possible, an autopsy and/or death certificate should be obtained to document 
the cause of death. 
4.0 SAFETY REPORTING 
All adverse events (AEs), whether device- related or not will be recorded and reported. Pain and 
function symptoms are categorized as complications when a participant’s complaint for any of 
these symptoms results in an unscheduled visit or when a participant presents with new or 
worsening symptoms as compared to the previous visit. 
4.1 Adverse Events 
An AE is any undesired clinical response or complication experienced by a participant. All AEs, 
whether device-related or not, will be recorded on the AE case report forms. Data to be collected 
will include the description of the AE, onset and resolution dates (or whether the AE is ongoing), 
severity, management/treatment, outcome, and determination of the relationship to the device 
and/or procedure. In general, AEs should be reported and classified by the Investigator using a 
diagnosis. The diagnosis should be confirmed through specific signs, symptoms, and (if 
necessary) laboratory tests. The Investigator will determine the relationship of the AE to the 
device or the study procedure. 
The Investigator, based on his or her clinical judgment using the following categories (detailed 
definitions provided in Appendix A), will determine the relationship and severity of the AE to the 
device and/or treatment procedure: 
1.
Unrelated:
The adverse event is clearly not related 
2.
Possibly related: The adverse event may be related
3.
Probably related: The adverse event is likely related
4.
Definite:
The adverse event is clearly related 

REVIAN® Trial 
Confidential and Proprietary  
 Page 30 of 54  
    Version 6.0 2018-08-22 
An AE or an adverse device effect may be mild, moderate or severe. 
The term “severe” is used to describe intensity (severity) of a specific event; the mild, moderate 
and severe definitions are listed below. An event itself, may be of relatively minor medical 
significance (such as a severe headache). This is not the same as “serious”, which is based on 
participant/event outcomes or action criteria usually associated with events that pose a threat to 
the participant’s life or functioning. 
Severity will be determined by the Investigator and coded as to the degree of severity as follows: 
1. Mild: Awareness of the event but easily tolerated.
2. 
Moderate: Discomfort enough to cause interference with usual activity.
3. 
Severe: Inability to carry out usual activity (not necessarily the same as a Serious Adverse
Event)
For the purposes of safety reporting in this study, the following definitions will be applied: 
•
An adverse event (AE) is any untoward medical occurrence in a participant whether it is
considered device related or not. Diseases, signs, symptoms, or laboratory abnormalities
already existing at enrollment are not considered AE’s unless they worsen (i.e., increase in
intensity or frequency). Surgical procedures themselves are not adverse events; they are
therapeutic measures for conditions that require surgery. The condition for which the surgery
is required may be an adverse event. Surgical procedures planned prior to enrollment and the
conditions leading to these measures are not adverse events.
•
An adverse device effect (ADE) is any untoward and unintended response to a medical
device, including events arising from insufficient or inadequate instructions for the
employment of the device or its use.
•
A Serious Adverse Event (SAE) is any AE that 1) results in death, 2) is life threatening, 3)
results in or prolong hospitalization, 4) results in permanent impairment of a body function or
permanent damage to a body structure, 5) necessitates medical or surgical intervention to
preclude permanent impairment of a body function or permanent damage to a body structure.
Note: a device malfunction may or may not result in an AE. If a device malfunctions in
a manner that causes an AE or a SAE as defined above, then the consequence of the
malfunction will be reported as an AE or SAE, as appropriate. However, all device
malfunctions will also be tabulated separately, regardless of whether or not an adverse
event results from the malfunction.
Any SAE must be reported to the sponsor or designee by the Investigator within 24 hours of first 
learning about the event. A written report must be sent to the sponsor within ten working days of 
knowledge of the event to the fax number listed on the Serious Adverse Event Report Form. 
The investigator is required to notify the IRB or EC in accordance with local reporting 
requirements. 

REVIAN® Trial 
Confidential and Proprietary  
 Page 31 of 54  
    Version 6.0 2018-08-22 
4.2 Anticipated Adverse Events 
The following AEs may be associated with the REVIAN device: 
•
Mechanical or electrical failure of the device or components
•
Materials of Cap that may cause irritation or tissue reaction
•
Allergies to Materials of Cap
•
Failure to improve symptoms and/or function
•
Hyperpigmentation of the treatment area
4.3 Unanticipated Adverse Device Effects 
ISO 14155:2011 (Clinical Investigation of Medical Devices – Good Clinical Practice) defines an 
unanticipated adverse device effect (UADE) as any serious adverse effect on health or safety, any 
life-threatening problem or death caused by, or associated with a device, if that effect, problem, 
or death was not previously identified in nature, severity, or degree of incidence in the clinical 
investigational plan or risk analysis; or any other unanticipated serious problem associated with 
a device that relates to the rights, safety, or welfare of subjects” (21 CFR 812.3(s)). UADEs must 
be reported by the clinical investigator to the sponsor and the reviewing IRB/EC, as described 
below: 
•
Investigators are required to submit a report of a UADE to the sponsor and the reviewing
IRB/HREC as soon as possible, but in no event later than 10 working days after the
investigator first learns of the event (§ 812.150(a)(1)).
•
PhotonMD will immediately conduct an evaluation of an UADE and report the results
of the evaluation to the appropriate regulatory agency, all reviewing IRB/HRECs and
participating investigators within 10 working days after first notice of the effect (§§
812.46(b), 812.150(b)(1)).
All serious reported events will be followed until resolution, stabilization or 30 days after the last 
participant enrolled has completed the trial, whichever occurs first. 
ALL UNANTICIPATED ADVERSE DEVICE EFFECTS AND SERIOUS ADVERSE 
EVENTS OCCURRING THROUGHOUT THE STUDY PERIOD MUST BE RECORDED 
ON THE ADVERSE EVENT CRF AND FAXED TO THE STUDY SPONSOR AS SOON 
AS POSSIBLE (WITHIN 24 HOURS). 
4.4 Medical Monitor 
To promote early detection of any safety issues routine medical monitoring may be conducted on 
an ongoing basis. A medical monitor would provide evaluation of safety events at routine 
intervals. Process flow, supporting documents, and software programming will allow for 21 CFR 
Part 11 compliant electronic database access, to the medical monitor for real time case review and 
event adjudication.  
The medical monitor may be un-blinded due to the fact the dataset will contain obvious AEs/SAEs 
specific to the active treatment compared to non-active treatment that will, simply by their 
presence, un-blind the individual reviewing the data.  This process requires the dynamic collection 
of unmonitored data as soon as an event is reported. The medical monitor will be responsible to 
review and adjudicate the safety outcome measures and relevant adverse events reported by study 
investigators. Relevant information and source documents will be provided to assist with their 

REVIAN® Trial 
Confidential and Proprietary  
 Page 32 of 54  
    Version 6.0 2018-08-22 
review and adjudication of events.  During regularly scheduled monitoring visits, the clinical 
research monitors will support the dynamic reporting process through their review of source 
document information. 
The medical monitor would review accumulating safety data to monitor the incidence of Adverse 
Events and other trends that would warrant modification or termination of the trial. The medical 
monitor would review the safety outcomes in both arms to ensure that the risks do not exceed the 
benefits. All reviews conducted by the medical monitor would be reported to the sponsor.  
5.0 STATISTICAL ANALYSIS PLAN 
5.1 Study Objective/Purpose 
The purpose of the study is to collect data on the safety and effectiveness of REVIAN in 
participants with AGA. In general, for continuous variables, the sample size, mean, standard 
deviation, and range will be presented. For categorical variables, the number and percentage in 
each category will be presented. 
Primary Efficacy Endpoint: The primary efficacy endpoint of this study is the mean change in 
hair count from baseline to 16 weeks following the initial application. 
Primary Safety Endpoint: The primary safety outcome will be determined by evaluating by the 
type, frequency, severity, and relatedness of adverse events through the 16 week period for all 
participants. 
Secondary Efficacy Endpoints: The secondary efficacy endpoints include the following: 
(1) Change from Baseline Hair Count: Like the primary endpoint, change from baseline hair
count, will also be assessed at 8 and 26 weeks.
(2) Rate of Change in Hair Growth:  The rate of change in hair growth at 8, 16 and 26 weeks will
be calculated as ratio of change from baseline to baseline.
(3) Independent Physician’s Global Assessment (iPGA): An independent reviewer will assess over
hair growth from photographs, using PGA scores at weeks 8, 16 and 26.  The PGA score hair
growth as: -3=greatly decreased, -2=moderately decreased, -1=slightly decreased, 0=no change,
1=slightly increased, 2=moderately increased and 3=greatly increased.
(4) Site Physician’s Global Assessment (sPGA): The site investigator will assess over hair growth
using the PGA scores at weeks 8, 16 and 26. In addition, the percentage of participants who
achieve success as defined by a PGA ≥2.0 will be summarized by treatment and by weeks.
(5) Subjective Scalp Hair Growth Score (SSHG): Beginning at Week 8, participants will complete
a subjective hair growth questionnaire.  The participants choose the answer that best fits the
following statements:
1) Since the start of the study, I can see my bald spot getting smaller. (1=”strongly agree”
to 5= “strongly disagree”)
2) Because of the treatment, I have received since the starts if the study, the appearance of
my hair is: (1=“a lot better” to 5=“a lot worse”)
3) Ever since the start of the study, how would you describe the growth of your hair?
(1=“greatly increased” to 7=“Greatly decreased”)
4) Ever since the start of the study, how effective do you think the treatment has been in
slowing down your hair loss? (1=“Very effective” to 4=“Not effective at all”)
5) Compared to the beginning of the study, which statement best describes your

REVIAN® Trial 
Confidential and Proprietary  
 Page 33 of 54  
    Version 6.0 2018-08-22 
satisfaction with your appearance of: 
a. The hairline in front of your head? (1=“very satisfied” to 5=“very dissatisfied”)
b. The hair on top of your head? (1=“very satisfied” to 5=“very dissatisfied”)
c. Your hair overall? (1=“very satisfied” to 5=“very dissatisfied”)
SSHG will be administered at 8 weeks, 16 weeks and 26 weeks 
(6) Hair Specific Skindex-29 Quality of Life Questionnaire (HSSQOL): The hair specific Skindex-
29 QOL questionnaire is a 29-item questionnaire with 3 domains: 7 questions for symptoms
domain, 10 questions emotion domain and 12 questions for function domain.  Participants score
each question on a scale from 1 (never) to 5 (all the time).   Scores are then summed within each
domain and overall.  HSSQOL will be administered at baseline, 8, 16 and 26 weeks.
(7) Overall Treatment Success (OTS): Overall treatment success will be defined as the number of
participants who achieve ≥50% reduction in overall QOL scores, plus reported SSHG ≥2 on every
question.
Secondary Safety Endpoint: The primary safety outcome will be determined by evaluating by 
the type, frequency, severity, and relatedness of adverse events through the 26-week period for 
all participants. 
5.2 Study Analysis, Sample Size and Pooling of Data 
Study Analysis: 
The primary efficacy analysis of this study is to compare the mean change in hair count change 
from baseline to 16-weeks following the initial application at baseline of REVIAN to the SHAM. 
This will be performed using mixed effects analysis of covariance (ANCOVA) where baseline 
characteristics and demographics may be considered as covariates. Comparison between active 
groups will not be tested for statistical significance as the study is not powered for these 
comparisons.  Instead, each active will be compared to the SHAM individually.  Details on 
adjustments for multiple testing to a single SHAM will be provided in a statistical analysis plan. 
Power Calculation, Sample Size: 
Prior hair growth studies, regardless of potential efficacy of the SHAM device, showed the delta 
between active treatments and control treatments was consistently at around 15-22 hairs/cm2 
which appears to be the expected level of improvement.  It is estimated that participants in the 
active group will have greater than 15 hairs/cm2 by 16-weeks. The study design is a parallel arm 
study of superiority of PhotonMD devices to SHAM with a minimum of 40 participants per arm.  
Assumptions are 15 hair difference between treatments, standard deviation (SD)=20, 10% drop-
out rate, 5% alpha level, 90% power and 2-sided t-test. 
The study will accrue a total of 200 participants (50 per each Active Study Arm and 50 control 
participants) to make sure, after lost to follow-up, that there is a minimum of 160 evaluable (40 
per arm) participants.  

REVIAN® Trial 
Confidential and Proprietary  
 Page 34 of 54  
    Version 6.0 2018-08-22 
Pooling of Data: 
The clinical study will be conducted under a common protocol for each of 3 investigational sites 
with the intention of pooling the data over all sites for analysis. Every effort will be made to 
promote consistency in study execution at each investigational site.  
5.3 Analysis Populations 
Participants receive either an active REVIAN Cap in three arms or a non-active REVIAN Cap 
(three versions of an active REVIAN Cap and one non-active REVIAN Cap). The following 
participant groups or analysis populations will be used to complete the analysis of data: 
Intent-to-Treat participant population (ITT): The ITT participant population will include all 
participants that started a treatment at Baseline. All baseline characteristics, demographics and 
primary efficacy analyses will be performed on the ITT population. 
Per-Protocol participant population (PP): The PP participant population will include all 
participants in the ITT population with 16-week follow-up data, with no major protocol 
deviations.  The primary and secondary efficacy analyses will be performed on the PP population. 
Safety participant population (SAF): The SAF participant population is the same as the ITT 
population. All safety summaries will be performed on the SAF population. 
5.4 Safety Outcomes 
Safety outcomes will be determined by evaluating by the type, frequency, severity, and 
relatedness of adverse events through the 26-weeks timepoint for all participants. All Adverse 
Events (AEs) will be tabulated and summarized as counts and percentages. AEs will also be cross- 
tabulated according to the following: 
•
Severity (Mild, Moderate, Severe)
•
Seriousness (Serious, Non-serious)
•
Device-Relatedness (Unrelated, Possibly Related, Probably Related, Definite)
•
Procedure-Relatedness (Unrelated, Possibly Related, Probably Related, Definite)
In addition, the occurrence of any Unanticipated Adverse Device Effects (UADE) will be listed. 
The classification of severity, relatedness, and anticipated nature of AEs will be made by the 
investigator. 
5.5 Baseline Variables 
Demographic and baseline variables will be summarized. Sample sizes, means, standard 
deviations and ranges will be presented for all continuous variables. 
5.6 Participant Accountability 
Lost-to-Follow-Up: The primary analysis will be done on the ITT group. Those participants who 
withdraw or who are lost (LTFU) after enrollment will be included in the primary analysis using 
a last observation carried forward (LOCF) approach where the outcome at the most recent visit 
will be carried forward to all subsequent missing assessment times. Participants without at-least 
an 8-week visit will have their baseline observation carried forward (BOCF).   

REVIAN® Trial 
Confidential and Proprietary  
 Page 35 of 54  
    Version 6.0 2018-08-22 
5.7 Missing Values 
Every effort will be undertaken to fulfill all the requirements of the protocol concerning the 
collection of data. If participants refuse to return for data collection, but agree to continue in the 
study, questionnaire data will be collected over the telephone or at home if necessary. Missing 
values may occur under the following conditions. 
•
Participants fail improvement and exit the study.
•
Participants do not return to the clinic but information regarding REVIAN can be
obtained.
•
Participants do not return to the clinic but will complete one or more of the questionnaires.
•
Participants do not return to the clinic and cannot be contacted.
For other secondary endpoints, analyses will be performed first on all available data with no 
imputation and additionally with imputed 26-week data.  
5.8 Follow-Up and Reporting 
All participants enrolled and devices used in the clinical investigation will be accounted for in the 
final report. All reasons for exclusion from analysis will be carefully documented. Similarly, for 
all participants and devices included in an analysis population, the measurements of all important 
variables must be accounted for at all relevant time points. Additional information that is available 
on participants screened for entry but not enrolled will also be summarized. 
Participants lost to follow-up or withdrawn from the study will be identified and a descriptive 
analysis of them provided, including the reasons for their loss to follow-up and known treatment 
outcome. 
For participants with device failures, data up to the time of the participant’s last visit will be 
pooled with all other participants and analyzed on a per protocol (PP) basis.  
5.9 Protocol Deviations 
A protocol deviation is defined as an event where the clinical Investigator or site personnel did 
not conduct the study according to the Investigational Plan or the Investigator Agreement. 
Investigators are required to obtain prior approval from study management before deviating from 
the investigational plan or protocol, except where necessary to protect the life or physical well-
being of a participant in an emergency. Such approval will be documented in writing and 
maintained in study files. Prior approval is generally not expected in situations where 
circumstances are beyond the Investigator’s control, (e.g., participant did not attend scheduled 
follow-up visit, blood sample lost by laboratory, etc.); however, the event is still considered a 
deviation. 
Deviations shall be reported to the study sponsor regardless of whether medically justifiable, pre- 
approved, or taken to protect the participant in an emergency. Participant specific deviations will 
be reported on the Case Report Form. Non-participant specific deviations will be reported to the 
sponsor in writing. Investigators will also adhere to procedures for reporting study deviations to 
their IRB/HREC in accordance with their specific IRB/HREC reporting policies and procedures. 
GCP regulations require that Investigators maintain accurate, complete and current records, 
including documents showing the dates and reasons for each deviation from the protocol. 

REVIAN® Trial 
Confidential and Proprietary  
 Page 36 of 54  
    Version 6.0 2018-08-22 
6.0 STUDY MANAGEMENT 
6.1 Sponsor Ethical and Regulatory Considerations 
As the Sponsor of this clinical study, PhotonMD has the overall responsibility for the conduct of 
the study, including assurance that the study meets US federal and local regulatory requirements 
appropriate to the conduct of the study and is conducted according to the Declaration of Helsinki, 
Protection of Human Volunteers (21 CFR 50), Institutional Review Boards (21 CFR 56), and 
Obligations of Clinical Investigators (21 CFR 312). PhotonMD will have certain direct 
responsibilities and may delegate responsibilities to a Contract Research Organization (CRO). The 
study sponsor will adhere to sponsor general duties as described in ISO 14155:2011, Clinical 
investigation of medical devices for human subjects – Good clinical practice, and CFR Part 812, 
50, 56, 54 and the World Medical Association Declaration of Helsinki. 
To maintain confidentiality, all laboratory specimens, evaluation forms, reports and other records 
will be identified by a unique participant identification code (ID number and participant name code 
– initials only).  All study records will be kept in a locked file cabinet and code sheets linking a
participant’s name to a participant identification number will be stored separately in another locked
file cabinet.  Clinical information will not be released without written permission of the participant,
except as necessary for monitoring by the FDA.  The Investigator must also comply with all
applicable privacy regulations (e.g., Health Insurance Portability and Accountability Act of 1996,
EU Data Protection Directive 95/46/EC).
General Duties 
PhotonMD will ensure that the application is submitted to the appropriate regulatory authorities, 
obtaining copies of IRB/HREC approvals and ensuring documentation of IRB/HREC approvals 
prior to the shipping of devices, ensuring proper clinical site monitoring, ensuring participant 
informed consent is obtained, providing quality data that satisfies regulations and informing the 
Investigators and IRB/ECs of unanticipated adverse device effects, events, and deviations from the 
protocol as appropriate. 
The investigation must be reviewed and approved by the appropriate IRB/HRECs before 
participant enrollment may begin. All proposed changes to the investigational plan must be 
reviewed and approved by PhotonMD. PhotonMD will also obtain any necessary regulatory 
approval, per local requirements. 
Selection of Clinical Sites 
The primary requirements of site and Investigator selection and continued participation in the Trial 
are: adequate experience, commitment to safety, consistency in adherence to the protocol, and 
participant volume. Participating sites will be screened to ensure they have sufficient numbers of 
eligible participants who are representative of the target population. Each center must have facilities 
that are capable of processing participants in the manner prescribed by the protocol. 
The study sponsor, PhotonMD, and its designees will select qualified Investigators, ship or deliver 
devices only to participating Investigators, obtain signed study agreements, and provide 
Investigators with the information necessary to conduct the study. 

REVIAN® Trial 
Confidential and Proprietary  
 Page 37 of 54  
    Version 6.0 2018-08-22 
Site Training 
The training of appropriate clinical site personnel will be the responsibility of the Sponsor or 
designee. The Investigator is responsible for ensuring that his/her staff conduct the study according 
to the protocol. To ensure proper device usage, uniform data collection, and protocol compliance, 
the Sponsor or designee will present a formal training session to study site personnel which will 
review the instructions for use of the device, the Investigational Plan, instructions on in-hospital 
data collection, methods for soliciting data from alternative sources, schedules for follow-up with 
the study site coordinators, and regulatory requirements. Detailed feedback regarding completion 
of forms will be provided by the Sponsor or designee through the regular site monitoring. 
Investigator Training 
The Sponsor will provide appropriate Investigator training on the use of the REVIAN System, 
including the mobile app and the REVIAN Cap. Training will take place prior to the initiation of 
the clinical investigation. Training will address topics including indications for use of the device, 
management of complications, and instructions to participants. Training will be documented for 
each physician on a training log, signed by both the physician and training representative 
Participant Confidentiality 
Participant confidentiality will be maintained throughout the clinical study in a way that ensures 
the information can always be tracked back to the source data. For this purpose, a unique participant 
identification code (ID number and participant name code) will be used that allows identification 
of all data reported for each participant. 
Data relating to the study might be made available to third parties (for example in case of an audit 
performed by regulatory authorities) provided the data are treated confidentially and that the 
participant’s privacy is guaranteed. 
Record Retention 
PhotonMD will maintain copies of correspondence, data, shipment of devices, adverse device 
effects, Investigator agreements and other records related to the clinical trial. All study records and 
reports will remain on file at the sites for a minimum of 2 years after completion of the Study, and 
will further be retained in accordance with local guidelines as identified in the clinical study 
agreement. Study records are to be discarded only upon notification by the study sponsor. The 
Investigator must contact the study sponsor before the destruction of any records and reports 
pertaining to the study to ensure they no longer need to be retained. In addition, the sponsor should 
be contacted if the Investigator plans to leave the investigational site. All required data for this 
study will be collected on standardized CRFs or an electronic data capture system. All information 
and data sent to the Sponsor or Contract Research Organizations (CROs) concerning participants 
or their participation in this study will be considered confidential. All data used in the analysis and 
reporting of this evaluation will be used in a manner without identifiable reference to the 
participant. The principal Investigator consents to visits by the staff of the Sponsor and its 
authorized representatives and the U.S. Food and Drug Administration or any other local 
governmental body to review the study participants’ medical records including any test or 
laboratory data that might have been recorded on diagnostic tests media (e.g., photographs, etc.). 

REVIAN® Trial 
Confidential and Proprietary  
 Page 38 of 54  
    Version 6.0 2018-08-22 
6.2 Investigator Responsibilities 
The Investigator shall ensure that all work and services described herein, or incidental to those 
described herein, shall be conducted in accordance with the highest standards of medical and 
clinical research practice. The Investigator will provide current copies of the study protocol to all 
Sub-Investigators or other site personnel responsible for study conduct. 
Upon completion or termination of the study, the Investigator will submit a final written report to 
the study sponsor and the reviewing IRB/EC. The report should be submitted to the study sponsor 
within three (3) months of study completion or termination. The Investigator will provide the study 
sponsor or designee with copies of all IRB/HREC actions regarding the study. 
6.2.1 
IRB/HREC Approval and Informed Consent 
The investigation must be reviewed and approved by the appropriate IRB/HREC before participant 
enrollment may begin. All proposed changes to the investigational plan must be reviewed and 
approved by PhotonMD. 
Prior to shipment of study devices, a signed copy of the IRB/HREC Committee approval letter 
identifying the clinical study must be submitted to PhotonMD, signifying study approval. 
Investigators are responsible for obtaining and maintaining approval of the study by the IRB/EC. 
Written informed consent is mandatory and must be obtained from all participants prior to 
performing any study procedures in this clinical study. PhotonMD will provide each investigator 
site with a Sponsor approved consent template. Each site is expected to modify the template, if 
necessary, to meet their facilities requirements. Modified ICF templates must be reviewed by the 
Sponsor prior to submission to their IRB/EC. 
Informed consent must be obtained and shall inform the participant as to the objective and 
procedures of the study and possible risks involved. The participants must be informed about their 
right to withdraw from the study at any time and for any reason without sanction, penalty, or loss 
of benefits to which the participant is otherwise entitled and that withdrawal from the study will 
not jeopardize their future medical care. The clinical study informed consent must be used in 
addition to any institutional standard consent form for participation in clinical research. The 
institutional standard informed consent form does not replace the study consent form. 
It is the responsibility of the investigator to obtain both an authorization for participant health 
information and study consent. 
The IRB/HREC approved Informed Consent Forms must be retained at the investigational site 
along with the other investigational case report forms. A signed copy of the consent form must be 
given to each participant enrolled in the study. 
6.2.2 
Data Collection and Reporting 
Case report forms will be used to record demographic, procedural, and follow-up data, as well as 
any unscheduled visits or adverse clinical events which may occur during the study period. The 
AEs and incidence of morbidity and mortality will be reviewed with Investigators to assess the 
safety of the device and the procedure. 
Qualified study staff at each clinical site will perform primary data collection drawn from source- 
document (hospital chart) reviews. The clinical monitor will perform clinical monitoring, including 
review of CRFs with verification of study eligibility, informed consent process, scheduled and 
unscheduled follow-up visits and AEs to the source documentation. 

REVIAN® Trial 
Confidential and Proprietary  
 Page 39 of 54  
    Version 6.0 2018-08-22 
6.2.3 
CRF Completion and Submission 
Investigators should complete case report forms (CRF)s in a timely fashion, preferably within 7 
days after participant enrollment or follow-up visit. This will enable timely monitoring visits. 
Serious adverse events and reports of device failures should be faxed to the study sponsor within 
24 hours of first knowledge of the event. Contact information is included on the CRF form. 
6.2.4 
Data Management 
PhotonMD or a representative of the Sponsor will be responsible for database creation and 
validation. Prior to finalizing and locking the database, all decisions concerning the inclusion or 
exclusion of data from the analysis for each participant will be determined by appropriate clinical 
and statistical personnel. All exclusions related to either safety or efficacy will be documented in 
participant listings. 
6.2.5 
Device Accountability 
The Investigator shall maintain adequate records of the receipt and disposition of all study devices. 
When the enrollment is complete, the Investigator shall return any unused devices to the study 
sponsor. At the completion of the study, all devices shall be returned to the sponsor. The 
Investigator’s copy of the Device Accountability Log must document devices that have been 
returned to the sponsor. 
The device accountability log will include records of receipt, use or disposition of a device that 
relate to: 
1. The type and quantity of the device, the dates of its receipt, and the lot number.
2. The names of all persons who received, used, or disposed of each device.
3. Why and how many units of the device have been returned to the sponsor, or otherwise
disposed of.
6.2.6 
Source Documents 
The investigator shall maintain accurate, complete, and current records relating to the investigator's 
participation in an investigation including records of each participant's case history and exposure 
to the device. Case histories include the case report forms and supporting data including, for 
example, signed and dated consent forms and medical records including, progress notes of the 
physician, the individual's hospital chart(s), and the nurses' notes. Such records shall include: 
1. 
Documents evidencing informed consent and, for any use of a device by the investigator
without informed consent, any written concurrence of a licensed physician and a brief
description of the circumstances justifying the failure to obtain informed consent. The case
history for each participant shall document that informed consent was obtained prior to
participation in the study.
2. 
All relevant observations, including records concerning adverse device effects (whether
anticipated or unanticipated), information and data on the condition of each participant upon
entering, and during the investigation, including information about relevant previous medical
history and the results of all diagnostic tests.
3. 
A record of the exposure of each participant to the investigational device, including the date
and time of each use, and any other therapy.

REVIAN® Trial 
Confidential and Proprietary  
 Page 40 of 54  
    Version 6.0 2018-08-22 
The following records must be maintained in designated study administrative files: 
•
Clinical Protocol and all amendments
•
Signed Investigator Agreement
•
IRB/HREC approval letter(s) and approved Informed Consent(s) (including any revisions)
•
Correspondence relating to this study (with Sponsor, Clinical Monitors, other Investigators,
etc.)
•
Correspondence with the IRB/HREC
•
Instructions for Use
•
Curriculum Vitae for all Investigators
•
Device log
•
Device related paperwork (including shipping documents, invoices, device return log)
•
Monitor sign-in log
•
Site authorized personnel signature list
•
Blank set of CRFs and instructions for completion
•
CRF monitoring forms
•
Reports (including Adverse Event reports, annual reports and final reports from Investigator
and Sponsor)
The following records must be maintained for each participant enrolled in the study: 
•
Signed participant Informed Consent Form
•
All completed CRFs
•
Record of any side effects/adverse events, device malfunctions, and treatment failures (with
supporting documentation)
•
Procedure reports, physician dictations, nursing notes, and participant medical records
•
Copies of all participant photographs
•
Records of any interventions (procedure reports, physician dictations, nursing notes, etc.)
•
Records related to participant deaths during the investigation (including death records, death
certificate and autopsy report, if performed).
Investigator files containing all records and reports of the investigation should be retained for a 
minimum of 5 years after the completion or termination of the investigational study or until two 
years after they are no longer needed to support product approval. They may be discarded upon 
notification by PhotonMD. To avoid any error, the Investigator should contact PhotonMD before 
destroying any records and reports pertaining to the study to ensure they no longer need to be 
retained. 
6.2.7 
Audits/Inspections 
In the event that audits are initiated by the Sponsor (or its designate), or national/international 
regulatory authorities, the Investigator shall allow access to the original medical records and 
provide all requested information. 
6.2.8 
Publication Policy 
At the conclusion of the study, the sponsor will decide whether a multi-center manuscript will be 
prepared for publication. The publication of the principal results from any single-site experience 
within the study is not allowed until the preparation and publication of the multi-center results have 
been published. 

REVIAN® Trial 
Confidential and Proprietary  
 Page 41 of 54  
    Version 6.0 2018-08-22 
7.0 RISK ANALYSIS 
7.1 Potential Risks 
There are always risks associated with any medical device and to the medical procedure used to 
treat a disease.  The risks associated with the use of the REVIAN System are minimal because of 
the unique design and use of low-risk electronic components in the system, including LEDs and 
low voltage battery. In comparison to other medical devices that use Helmets, Caps or Wand 
Devices for the treatment of alopecia, the risk to the participant using the REVIAN System is 
extremely low or negligible. The risk of retinal or thermal damage due to laser exposure is not 
present with REVIAN. The LEDs are non-coherent (radiating in all directions) and divergent as 
compared to devices using laser diodes.  It is expected that the risks and complication rates strictly 
associated with the procedure using REVIAN would be like other products that are currently used 
in the home setting to treat alopecia.  In addition, as compared to using Minoxidil (Rogaine) or 
Finasteride (Propecia) REVIAN has no systemic adverse effects like current pharmaceutical agents, 
especially in women of child-bearing potential. 
In addition to the safety profile discussed above the only other additional risk with REVIAN are 
the fabric and plastic materials used in the inner construction of the cap, however materials are 
medical grade.  In rare circumstances, the fabric or continued use may cause allergies, irritation, 
tissue reactions, allergic reactions or inflammation that may result in discomfort; or the REVIAN 
may fail to improve symptoms. 
7.2 Justification for Investigation 
In summary, the development of new treatments for AGA is highly desirable as current available 
therapies fail to deliver the outcomes desired by participants.  While current light-therapy devices 
for hair growth have proven clinical safety and efficacy, these therapies were developed based on 
limited preclinical testing and do not represent optimum modes of treatment including dosing and 
wavelength.  REVIAN 102 and 103 are improvements on the current therapies because they may 
improve both the ability to release Nitric Oxide (NO) from its bound form and increase enzymatic 
generation of NO. The downstream effects of NO in the scalp may include improved 
microcirculation (via vasodilation and angiogenesis), increased proliferation of hair follicle cells, 
decreased inflammation, and elongation of the anagen phase of hair growth.  These downstream 
effects of NO are believed to progress the health of hair follicles, promote hair growth, and increase 
hair thickness (diameter).  Additionally, the REVIAN products have been designed with safe LEDs, 
a sensor based automatic turn-off, and programmed treatment schedule to help improve both safety 
and compliance. 
The proposed study will collect data on the safety and effectiveness of the REVIAN System for the 
treatment of symptoms associated with AGA. 

REVIAN® Trial 
Confidential and Proprietary  
 Page 42 of 54  
    Version 6.0 2018-08-22 
7.3 Study Population 
The study population will consist of up to 200 participants (120 men and 80 women) who are 
between the ages of 18 and 65 years of age, with diagnosis of Androgenic Alopecia, consistent with 
males who have Norwood Hamilton Classification IIa to V patterns of hair loss and females who 
have Ludwig-Savin Scale I-1 to I-4, II -1, II-2 or frontal, both with Fitzpatrick Skin Types I – IV.  
8.0 ANTICIPATED CHANGES DURING INVESTIGATION 
The only product change that is anticipated during the investigation are modifications to the cap 
assembly for mass production but no changes that affect function or delivery of energy. 
The anticipated change will not alter the mechanism of operation or functional requirements 
of the system. Any potential changes will be managed through the PhotonMD design control 
process and verified prior to implementation. 
9.0 MONITORING PLAN 
The monitoring for this study will be conducted by Sponsor or designee. The study will be 
monitored to ensure that the protocol, applicable regulations, and Good Clinical Practice Guidelines 
are followed. The study monitor will ensure that the rights and well-being of participants are 
protected and the clinical trial data are accurate, complete, and verifiable. 
Prior to participant enrollment, the sponsor (or designee) will obtain the essential regulatory 
documents required to initiate the study. The sponsor will be responsible for the review and 
approval of the following essential documents: 
•
Protocol Signature Page
•
Current Protocol Revision
•
Investigator Agreement
•
Financial Disclosure or Certification
•
IRB/HREC approval letter for the protocol and consent form
•
IRB/HREC approved consent form
•
IRB/HREC membership roster or assurance number Copies of file documents will be
maintained by the sponsor.
9.1 Site Qualification/Initiation 
All sites will undergo qualification process to confirm acceptability for participation into the study. 
SOPs will be followed to determine that a site is qualified for participation in the study. The study 
monitor or designee will perform an on-site visit to verify the site qualifications and record his or 
her findings on the site report. 
Study initiation visits are performed at the start of the clinical study to ensure that the study 
personnel have a complete understanding of the protocol, procedures, responsibilities, and 
regulations involved with the conduct of a clinical trial. Study personnel will be trained on all 
essential aspects of the trial prior to the first participant being enrolled in the study. This training 
will include an in-depth review of the protocol and case report forms, regulatory requirements, 
serious adverse experience reporting, and other activities as documented in the site initiation plan. 
Following the visit, a report is generated and circulated for review. 

REVIAN® Trial 
Confidential and Proprietary  
 Page 43 of 54  
    Version 6.0 2018-08-22 
9.2 Periodic Monitoring 
Periodic monitoring visits will be made at all active investigational sites throughout enrollment of 
the clinical study to assure that the Investigator obligations are fulfilled and all applicable 
regulations and guidelines are being followed. These visits will assure that the facilities are still 
acceptable; the protocol and investigational plan are being followed, the IRB/HREC has been 
notified of approved protocol changes as required, complete records are being maintained, 
appropriate and timely reports have been made to the Sponsor and the IRB/EC, device and device 
inventory are controlled and the Investigator is carrying out all agreed activities. The monitor will 
verify accuracy of CRF completion against source documents maintained at the site. 
During monitoring visits, the Monitor will perform a review of study eligibility, 
Inclusion/Exclusion criteria, informed consent, all reports of device malfunction, all events meeting 
criteria for serious adverse event reporting as well as safety and efficacy endpoints. 
Additional review will be performed on a site-by-site basis, as warranted by the findings of previous 
monitoring visits. 
The monitor will ensure that Investigators are aware of the regulatory requirement to maintain 
information in the study participant’s medical records which corroborate data collected on the CRF. 
To comply with these regulatory requirements, the following information will be maintained and 
made available as required by the sponsor and/or regulatory inspectors: 
• Medical history/physical condition of the study participant before involvement in the study
sufficient to verify protocol entry criteria.
• Medical record documenting that informed consent was obtained for the participant’s
participation in the study.
• Description of device accountability and treatment details.
• Dated and signed notes for each study participant visit including results of examinations.
• Description of AEs and follow-up of the AEs (minimal event description, severity, onset date,
duration, relation to study device, outcome and treatment for AE).
• Notes regarding concomitant medications taken during the study (including start and stop dates).
• Study participant’s condition upon completion of or withdrawal from the study.
The monitor will compare key variables (demographics, inclusion/exclusion criteria, and safety) 
on the CRFs with each participant’s source documents. Any discrepancies will be noted and 
resolved. Following the visit, a report will be generated and circulated to the sponsor for review. 
9.3 Site Close-Out 
Upon completion of the clinical study (when all participants enrolled have completed the follow-
up visits and the CRFs and queries have been completed), the Sponsor or designee will notify the 
site of closeout and a study closeout visit will be performed. All CRFs, unused study devices, and 
any unused study materials will be collected and returned to the Sponsor. The Monitor will ensure 
that the Investigator’s regulatory files are up to date and complete and that any outstanding issues 
from previous visits have been resolved. Other issues which will be reviewed at this visit include: 
discussing retention of study files, possibility of site audits, publication policy, and notifying the 
EC of study closure. Following the visit, a report is generated and circulated for review. 

REVIAN® Trial 
Confidential and Proprietary  
 Page 44 of 54  
    Version 6.0 2018-08-22 
9.4 Monitoring Trip Reports and Follow up Letters 
The following reports will be completed, and submitted to the Project Manager for review within 
one week following the conclusion of any given visit: initiation visit reports, periodic site 
monitoring reports and closeout reports. A follow up letter summarizing the monitoring trip report 
will be sent to the study staff within two weeks following the visit. 
9.5 Frequency of Monitoring Visits 
Study monitoring will be carried out in compliance with FDA regulations (21CFR 812) and all 
Good Clinical Practices (GCP) guidelines. The clinical investigation will be monitored throughout 
its active phase.  The first Monitoring Visit will occur shortly after the first participant has been 
enrolled and treated at any site. Subsequent Monitor Visits will occur as the frequency of 
enrollment dictate but no less than 2 times annually through the conclusion of the primary endpoint. 
9.6 Qualifications of Study Monitor 
PhotonMD’s study monitor is qualified by training and experience to monitor the progress of the 
investigation. The study monitor has suitable academic training, applicable clinical experience, 
and knowledge of the investigational device. 
9.7 Name and Address of Monitor 

REVIAN® Trial 
Confidential and Proprietary  
 Page 45 of 54  
    Version 6.0 2018-08-22 
10.0 REFERENCES 
1.
Olsen EA, Messenger AG, Shapiro J, Bergfeld WF, Hordinsky MK, Roberts JL, et al.
Evaluation and treatment of male and female pattern hair loss. J Am Acad Dermatol.
2005;52(2):301–311.
2.
Hoffmann R, Happle R. Current understanding of androgenetic alopecia: Part I.
Etiopathogenesis. Eur J Dermatol. 2000;10(4):319–327.
3.
Gan DC, Sinclair RD. Prevalence of male and female pattern hair loss in Maryborough. J
Investig Dermatol Symp Proc. 2005;10(3):184–189.
4.
McElwee KJ, Shapiro JS. Promising therapies for treating and/or preventing androgenic
alopecia. Skin Therapy Lett. 2012;17(6):1–4.
5.
Rangwala S, Rashid RM. Alopecia: a review of laser and light therapies. Dermatol Online J.
2012;18(2):3.
6.
Avram MR, Rogers NE. The use of low-level light for hair growth: part I. J Cosmet Laser
Ther. 2009;11(2):110–117.
7.
Lanzafame RJ, Blanche RR, Bodian AB, Chiacchierini RP, Fernandez-Obregon A, Kazmirek
ER. The growth of human scalp hair mediated by visible red light laser and LED sources in
males. Lasers Surg Med. 2013;45(8):487–495.
8.
Leavitt M, Charles G, Heyman E, Michaels D. HairMax LaserComb laser phototherapy
device in the treatment of male androgenetic alopecia: a randomized, double-blind, sham
device-controlled, multicentre trial. Clin Drug Investig. 2009;29(5):283–292.
9.
Satino JL, Markou M. Hair regrowth and increased hair tensile strength using the HairMax
LaserComb for low-level laser therapy. Int J Cosmetic Surg Aesthetic Dermatol.
2003;5(2):113–117.
10. Norwood OT. Male pattern baldness: classification and incidence. South Med J.
1975;68(11):1359–1365.
11. Ludwig E. Classification of the types of androgenetic alopecia (common baldness) occurring
in the female sex. Br J Dermatol. 1977;97(3):247–254.
12.  Price VH, Roberts JL, Hordinsky M, Olsen EA, Savin R, Bergfeld W, et al. Lack of efficacy
of finasteride in postmenopausal women with androgenetic alopecia. J Am Acad Dermatol.
2000;43(5 Pt 1):768–776.
13.  Savin R. Evaluating androgenetic alopecia in male and female patients: an improved visual
method of classifying and tracking hair loss using computer-generated male and female
pattern and density scales. Kalamazoo: The Upjohn Company; 1994.
14.  Chren MM, Lasek RJ, Flocke SA, Zyzanski SJ. Improved discriminative and evaluative
capability of a refined version of Skindex, a quality-of-life instrument for patients with skin
diseases. Arch Dermatol. 1997;133:1433–1440.
15. Han SH1, Byun JW, Lee WS, Kang H, Kye YC, Kim KH, Kim DW, Kim MB, Kim SJ, Kim
HO, Sim WY, Yoon TY, Huh CH, Hwang SS, Ro BI, Choi GS. Quality of life assessment in
male patients with androgenetic alopecia: result of a prospective, multicenter study. Ann
Dermatol. 2012 Aug;24(3):311-8.

REVIAN® Trial 
Confidential and Proprietary  
 Page 46 of 54  
    Version 6.0 2018-08-22 
16. Cash TF. The psychosocial consequences of androgenetic alopecia: a review of the research
literature. Br J Dermatol. 1999;141:398–405.
17. Schmidt S, Fischer TW, Chren MM, Strauss BM, Elsner P. Strategies of coping and quality
of life in women with alopecia. Br J Dermatol. 2001;144:1038–1043.
18. Fischer TW, Schmidt S, Strauss B, Elsner P. Hairdex: a tool for evaluation of disease-specific
quality of life in patients with hair diseases. Hautarzt. 2001;52:219–227.
19. Chren MM, Lasek RJ, Sahay AP, Sands LP. Measurement properties of Skindex-16: a brief
quality-of-life measure for patients with skin diseases. J Cutan Med Surg. 2001;5:105–110.
20. Kim HJ, Sim WY, Song JY. Assessment of the characteristics of illness behavior and quality
of life in patients with androgenetic alopecia. Korean J Dermatol. 2001;39:1094–1099.
21. Cash TF. The psychological effects of androgenetic alopecia in men. J Am Acad Dermatol.
1992;26:926–931.
22. Drake LA, Dinehart SM, Farmer ER, Goltz RW, Graham GF, Hordinsky MK, et al. Guidelines
of care for androgenetic alopecia. J Am Acad Dermatol. 1996;35:465–468.
23. Mester, E.; Szende, B.; Gärtner, P., The effect of laser beams on the growth of hair in mice.
Radiobiol. Radiother. (Berl.) 1968, 9 (621-626).
24. Chung, H.; Dai, T. Sharma, S. K.; Huang, Y.-Y.; Carroll, J. D.; Hamblin, M. R., The nuts and
bolts of low-level laser (light) therapy. Ann. Biomed. Eng. 2012, 40 (2), 516-533.
25. Hamblin, M. R.; Demidova, T. N., Mechanisms of low level light therapy. Proc. SPIE 2006.
26. Karu, T., Mitochondrial mechanisms of photobiomodulation in context of new data about
multiple roles of ATP. Photomed. Laser. Surg. 2010, 28 (2), 159-160.
27. Eells, J. T.; Wong-Riley, M. T.; VerHoeve, J.; Henry, M.; Buchman, E. V.; Kane, M. P.;
Gould, L. J.; Das, R.; Jett, M.; Hodgson, B. D., Mitochondrial signal transduction in
accelerated wound and retinal healing by near-infrared light therapy. Mitochondrion 2004, 4
(5), 559-567.
28. Karu, T. I., Multiple roles of cytochrome c oxidase in mammalian cells under action of red
and IR‐A radiation. IUBMB Life 2010, 62 (8), 607-610.
29. Avci, P.; Gupta, G. K.; Clark, J.; Wikonkal, N.; Hamblin, M. R., Low-level laser (light)
therapy (LLLT) for treatment of hair loss. Lasers Surg. Med. 2014, 46 (2), 144-51.
30. Hamblin, M. R., The role of nitric oxide in low level light therapy. Proc. SPIE 2008.
31. Daniela, B.-G.; Thomas, R.; Kolb-Bachofen, V., Nitric oxide in human skin: current status
and future prospects. J. Invest. Dermatol. 1998, 110 (1), 1-7.
32. Cals-Grierson, M.-M.; Ormerod, A., Nitric oxide function in the skin. Nitric Oxide 2004, 10
(4), 179-193.
33. Brown, G. C., Nitric oxide and mitochondrial respiration. BBA-Bioenergetics 1999, 1411 (2),
351-369.
34. Karu, T., Primary and secondary mechanisms of action of visible to near-IR radiation on cells.
J. Photochem. Photobiol. B, Biol. 1999, 49 (1), 1-17.

REVIAN® Trial 
Confidential and Proprietary  
 Page 47 of 54  
    Version 6.0 2018-08-22 
35. Goralczyk, K.; Szymanska, J.; Lukowicz, M.; Drela, E.; Kotzbach, R.; Dubiel, M.; Michalska,
M.; Goralczyk, B.; Zajac, A.; Rosc, D., Effect of LLLT on endothelial cells culture. Lasers
Med. Sci. 2015, 30 (1), 273-8.
36. Saygun, I.; Karacay, S.; Serdar, M.; Ural, A. U.; Sencimen, M.; Kurtis, B., Effects of laser
irradiation on the release of basic fibroblast growth factor (bFGF), insulin like growth factor-
1 (IGF-1), and receptor of IGF-1 (IGFBP3) from gingival fibroblasts. Lasers Med. Sci. 2008,
23 (2), 211-215.
37. Song, S.; Zhang, Y.; Fong, C.-C.; Tsang, C.-H.; Yang, Z.; Yang, M., cDNA microarray
analysis of gene expression profiles in human fibroblast cells irradiated with red light. J.
Invest. Dermatol. 2003, 120 (5), 849-857.
38. de Freitas, L. F.; Hamblin, M. R., Proposed mechanisms of photobiomodulation or low-level
light therapy. IEEE J. Sel. Top. Quantum Electron. 2016, 22 (3), 1-17.
39. Jimenez, J. J.; Wikramanayake, T. C.; Bergfeld, W.; Hordinsky, M.; Hickman, J. G.; Hamblin,
M. R.; Schachner, L. A., Efficacy and safety of a low-level laser device in the treatment of
male and female pattern hair loss: a multicenter, randomized, sham device-controlled, double-
blind study. Am. J. Clin. Dermatol. 2014, 15 (2), 115-127.
40. Leavitt, M.; Charles, G.; Heyman, E.; Michaels, D., HairMax LaserComb® Laser
Phototherapy Device in the Treatment of Male Androgenetic Alopecia. Clin. Drug Investig.
2009, 29 (5), 283-292.
41. Lohr, N. L.; Keszler, A.; Pratt, P.; Bienengraber, M.; Warltier, D. C.; Hogg, N., Enhancement
of nitric oxide release from nitrosyl hemoglobin and nitrosyl myoglobin by red/near infrared
radiation: potential role in cardioprotection. J. Mol. Cell. Cardiol. 2009, 47 (2), 256-263.
42. Makihara, E.; Masumi, S.-i., Blood flow changes of a superficial temporal artery before and
after low-level laser irradiation applied to the temporomandibular joint area. J. Jpn.
Prosthodont. Soc. 2008, 52 (2), 167-170.
43. Samoilova, K. A.; Zhevago, N. A.; Petrishchev, N. N.; Zimin, A. A., Role of nitric oxide in
the visible light-induced rapid increase of human skin microcirculation at the local and
systemic levels: II.  Healthy volunteers. Photomed. Laser Surg. 2008, 26 (5), 443-449.
44. Lee, P. C.; Salyapongse, A. N.; Bragdon, G. A.; Shears, L. L.; Watkins, S. C.; Edington, H.
D.; Billiar, T. R., Impaired wound healing and angiogenesis in eNOS-deficient mice. Am. J.
Physol. Heart Circ. Physiol. 1999, 277 (4), H1600-H1608.
45. Chen, C. H.; Hung, H. S.; Hsu, S. h., Low‐energy laser irradiation increases endothelial cell
proliferation, migration, and eNOS gene expression possibly via PI3K signal pathway. Lasers
Med. Sci. 2008, 40 (1), 46-54.
46. Chaves, M. E. d. A.; Araújo, A. R. d.; Piancastelli, A. C. C.; Pinotti, M., Effects of low-power
light therapy on wound healing: LASER x LED. An. Bras. Dermatol. 2014, 89 (4), 616-623.

REVIAN® Trial 
Confidential and Proprietary  
 Page 48 of 54  
    Version 6.0 2018-08-22 
APPENDIX A: DEFINITIONS 
ADVERSE EVENT 
An adverse event (AE) is any untoward medical occurrence in a participant whether it is 
considered device related or not. Diseases, signs, symptoms, or laboratory abnormalities already 
existing at enrollment are not considered AE’s unless they worsen (i.e., increase in intensity or 
frequency). Surgical procedures themselves are not described as adverse events in this study. The 
condition for which the surgery is required may be an adverse event. Surgical procedures planned 
prior to enrollment and the conditions leading to these measures are not adverse events. 
The Investigator, based on his or her clinical judgment and the following definitions, will determine 
the relationship and severity of the AE to the device and/or surgical procedure: 
1. 
Unrelated: The adverse event is determined to be solely caused by the underlying disease,
disorder or condition of the participant, or attributable solely to other extraneous causes
(unrelated to the device, device malfunction, or the procedure.
2. 
Possibly related: The adverse event has onset within a clinically relevant temporal relationship
to exposure to the device or procedure, and is plausibly at least partially caused by or
aggravated using the device, device malfunction, or the procedure. It must also meet one of the
following criteria: (1) follows a known or easily foreseen pattern of response to device use or
procedure and (2) is not fully attributable to the underlying disease, disorder or condition of
the participant, or attributable to other extraneous causes.
3. 
Probably related: The adverse event has onset within a clinically relevant temporal relationship
to exposure to the device or procedure, and is more likely than not to be at least partially caused
by or aggravated using the device, device malfunction, or the procedure. It must also meet both
criteria: (1) follows a known or easily foreseen pattern of response to device use or procedure;
and (2) is not fully attributable to the underlying disease, disorder or condition of the
participant, or attributable to other extraneous causes. In addition, if the adverse effect is
reversible upon reoperation or device exchange, and such a procedure is done, the effect
disappears or lessens in severity within the expected time interval.
4. 
Definitely related: The adverse event is clearly caused by using the device, device
malfunction, or the procedure.  It must meet all following criteria: (1) has a clear temporal
relationship between device exposure and onset of the event; (2) follows a known pattern of
response to device use or procedure; and (3) is not reasonably attributable to the underlying
disease, disorder or condition of the participant, or attributable to other extraneous causes. In
addition, if the adverse effect is reversible upon reoperation or device exchange, and such a
procedure is done, the effect disappears or lessens in severity within the expected time interval.
ANTICIPATED ADVERSE EVENT 
Any undesirable experience (sign, symptom, illness, abnormal laboratory value, or other medical 
event) occurring to a patient, whether or not considered related to the investigational product(s) 
prescribed as part of the protocol, predefined in the protocol and/or Instructions For Use (IFU), 
that is identified or worsens during a clinical study. 

REVIAN® Trial 
Confidential and Proprietary  
 Page 49 of 54  
    Version 6.0 2018-08-22 
DEVICE FAILURE: 
A device has failed if it is used in accordance with the Instructions for Use, but does not perform 
according to the Instructions for Use. 
DEVICE MISUSE 
A misused device (one that is used by the Investigator in a manner that is contradictory to the 
Instructions for Use) will not be considered a malfunction. 
DEVICE RELATED ADVERSE EVENT 
A device related adverse event is defined as any adverse event, for which a causal relationship 
between the device and the event is at least a reasonable possibility, i.e., the relationship cannot 
be excluded. 
LIFE THREATENING 
Life-threatening means that the participant was, in the view of the investigator, at immediate 
risk of death from the adverse event as it occurred. It does not include an adverse event that, 
had it occurred in a more severe form, might have caused death. 
LOW-LEVEL LASER THERAPY (LLLT) 
Low-level laser therapy is a form of alternative medicine that uses low-level lasers or light-
emitting diodes (LEDs). Whereas high-power lasers used in laser medicine destroy or cut tissue, 
low-power lasers are claimed to stimulate it and to encourage the cells to function.  
MODULATED LIGHT THERAPY (MLT™) 
Modulated light therapy is a form of alternative medicine that uses modulated light-emitting 
diodes (LEDs) customized by PhotonMD to treat participants with AGA.  
PROTOCOL DEVIATION 
An incident where the Investigator or site personnel did not conduct the study according to the 
investigational plan, protocol or the Investigator agreement. 
Major deviation: Any deviation from participant inclusion and exclusion criteria or participant 
informed consent procedures. 
Minor deviation: Deviation from a protocol requirement such as incomplete/inadequate 
participant testing procedures, non-compliance with medication regimens, follow-ups performed 
outside specified time windows, etc. 
SERIOUS ADVERSE EVENT 
A Serious Adverse Event (SAE) is any AE that 1) leads to death, 2) leads to serious deterioration 
in health resulting in a life-threatening illness or injury, 3)results in permanent impairment of a 
body structure or a body function, 4) requires in-patient hospitalization or prolongs existing 
hospitalization, 5) results in medical or surgical intervention to prevent permanent impairment to 
body structure or a body function, or 6) leads to fetal distress, fetal death or a congenital 
abnormality or birth defect. 

REVIAN® Trial 
Confidential and Proprietary  
 Page 50 of 54  
    Version 6.0 2018-08-22 
Note:  
A device malfunction may or may not result in an AE. If a device malfunctions in a manner that 
causes an adverse event (AE) or a serious adverse event (SAE) as defined above, then the 
consequence of the malfunction will be reported as an AE or SAE, as appropriate. However, all 
device malfunctions will also be tabulated separately, regardless of whether an adverse event results 
from the malfunction. Any surgical interventions for device malfunctions will also be reported as 
subsequent surgical interventions. 
SOFT TISSUE IRRITATION 
Superficial Tissue Irritation An inflammatory condition of superficial layers of the skin as a 
result of an aseptic irritant, such as skin reaction to suture or dressings. 
Periprosthetic Soft Tissue Irritation An inflammatory condition of the tissues about the implant 
resulting from aseptic tissue irritation. Fluid may accumulate in the periprosthetic tissues possibly 
resulting in the tissue swelling, localized tenderness, pain and/or joint motion is restriction. 
UNANTICIPATED ADVERSE DEVICE EFFECT (UADE) 
The investigational device exemption (IDE) regulations and ISO 14155:2011 (Clinical 
Investigation of Medical Devices – Good Clinical Practice) defines an unanticipated adverse 
device effect (UADE) as any serious adverse effect on health or safety, any life-threatening 
problem or death caused by, or associated with a device, if that effect, problem, or death was not 
previously identified in nature, severity, or degree of incidence in the clinical investigational plan 
or risk analysis; or any other unanticipated serious problem associated with a device that relates to 
the rights, safety, or welfare of participants” (21 CFR 812.3(s)). UADEs must be reported by the 
clinical investigator to the sponsor and the reviewing IRB/EC. 

REVIAN® Trial 
Confidential and Proprietary  
 Page 51 of 54  
    Version 6.0 2018-08-22 
APPENDIX B: HAIR SPECIFIC SKINDEX-29 QUALITY OF LIFE QUESTIONNAIRE 
  ALL THE  
NEVER  RARELY   SOMETIMES     OFTEN    TIME 
1. My scalp hurts (Sx).
□1
□2
□3
□4
□5
2. My alopecia affects how well I sleep (Fx).
□1
□2
□3
□4
□5
3. I worry that my alopecia may be serious (Em).
□1
□2
□3
□4
□5
4. My alopecia makes it hard to work or do hobbies (Fx).
□1
□2
□3
□4
□5
5. My alopecia affects my social life (Fx).
□1
□2
□3
□4
□5
6. My alopecia makes me feel depressed (Em).
□1
□2
□3
□4
□5
7. My scalp burns or stings (Sx).
□1
□2
□3
□4
□5
8. I tend to stay at home because of my alopecia (Fx).
□1
□2
□3
□4
□5
9. I worry about getting scars from my alopecia (Em).
□1
□2
□3
□4
□5
10. My scalp itches (Sx).
□1
□2
□3
□4
□5
11. My alopecia affects how close I can be with those I love (Fx). 
□1      □2       □3
□4
□5
12. I am ashamed of my alopecia (Em).
□1
□2
□3
□4
□5
13. I worry that my alopecia may get worse (Em).
□1
□2
□3
□4
□5
14. I tend to do things by myself because of my alopecia (Fx).
□1
□2
□3
□4
□5
15. I am angry about my alopecia (Em).
□1
□2
□3
□4
□5
16. Water bothers my scalp (bathing, washing hands) (Sx).
□1
□2
□3
□4
□5
17. My alopecia makes showing affection difficult (Fx).
□1
□2
□3
□4
□5
18. My scalp is irritated (Sx).
□1
□2
□3
□4
□5
19. My alopecia affects my interactions with others (Fx).
□1
□2
□3
□4
□5
20. I am embarrassed by my alopecia (Em).
□1
□2
□3
□4
□5
21. My alopecia is a problem for the people I love (Fx).
□1
□2
□3
□4
□5
22. I am frustrated by my alopecia (Em).
□1
□2
□3
□4
□5
23. My scalp is sensitive (Sx).
□1
□2
□3
□4
□5
24. My alopecia affects my desire to be with people (Fx).
□1
□2
□3
□4
□5
25. I am humiliated by my alopecia (Em).
□1
□2
□3
□4
□5
26. My scalp bleeds (Sx).
□1
□2
□3
□4
□5
27. I am annoyed by my alopecia (Em).
□1
□2
□3
□4
□5
28. My alopecia interferes with my sex life (Fx).
□1
□2
□3
□4
□5
29. My alopecia makes me tired (Fx).
□1
□2
□3
□4
□5
Scoring: 
 Sx: Symptom (7-35), Em: Emotion (10-50), Fx: Function (12-60) 
 Total Scoring = (29-145) 

REVIAN® Trial 
Confidential and Proprietary  
 Page 52 of 54  
    Version 6.0 2018-08-22 
APPENDIX C: Physician’s Global Assessment (PGA) Scoring and Subjective 
Scalp Hair Growth (SSHG) Evaluations 
A Canfield stereotactic positioning device will be used for obtaining global photographs where the participant’s 
chin and forehead are fixed, and on which a given camera and flash device are mounted to standardize the view, 
magnification and lighting at consecutive study visits. Participants will be asked to keep the same hair style and 
colour and the coordinators attempt to duplicate baseline hair parting and combing in subsequent follow-up 
visits. Two standard views (superior and vertex) will be taken at baseline, 8-, 16, and 26-weeks (Figure 5).  The 
digital images will be graded.  Paired baseline and post-treatment photographs will be evaluated by each site 
study doctor (at the Week 8, 16 & 26 follow up visits) in order to provide a physician global assessment (sPGA) 
score.  
In addition, the photographs will then be independently reviewed by two blinded evaluators, to evaluate the 
independent physician’s global assessment (iPGA) 
The PGA score used is the standardized 7-point rating scale (–3 = greatly decreased, –2 = moderately decreased, 
–1 = slightly decreased, 0 = no change, +1 = slightly increased, +2 = moderately increased, +3 = greatly
increased).
Figure 5. Global Photography, demonstrating fixation of the participant on a brow and chin rest with the camera 
mounted on a rotating arm. 

REVIAN® Trial 
Confidential and Proprietary  
 Page 53 of 54  
    Version 6.0 2018-08-22 
Participants will be asked to assess subjective scalp hair growth (SSHG). They will be provided with the 
following questionnaire at each follow up visit (8, 16 and 26 weeks after baseline). 
Subjective Scalp Hair Growth (SSHG) 
1. Since the start of the study, I can see my bald spot getting smaller
Strongly Agree 
Agree 
No opinion either 
way 
Disagree 
Strongly Disagree 
1 
2 
3 
4 
5 
2. Because of the treatment I have received since the start of the study, the appearance of my hair is:
A lot better 
Somewhat 
better 
A little 
better 
Same 
A little 
worse 
Somewhat 
worse 
A lot worse 
1 
2 
3 
4 
5 
6 
7 
3. Ever since the start of the study, how would you describe the growth of your hair?
Greatly 
increased 
Moderately 
increased 
Slightly 
increased 
No change 
Slightly 
decreased 
Moderately 
decreased 
Greatly 
decreased 
1 
2 
3 
4 
5 
6 
7 
4. Ever since the start of the study, how effective do you think the treatment has been in slowing down your hair loss
Very effective 
Somewhat effective 
Not very effective 
Not effective at all 
1 
2 
3 
4 
5. Compared to the beginning of the study, which statement best describes your satisfaction with the appearance of:
a)
The hairline front of your head?
Very satisfied 
Satisfied 
Neutral 
Dissatisfied 
Very Dissatisfied 
1 
2 
3 
4 
5 
 
b)
The hair on top of your head?
Very satisfied 
Satisfied 
Neutral 
Dissatisfied 
Very Dissatisfied 
1 
2 
3 
4 
5 
c)
Your hair overall?
Very satisfied 
Satisfied 
Neutral 
Dissatisfied 
Very Dissatisfied 
1 
2 
3 
4 
5 

REVIAN® Trial 
Confidential and Proprietary  
 Page 54 of 54  
    Version 6.0 2018-08-22 
APPENDIX D: TrichoScan Procedure for Hair Counts 

REVIAN® Trial 
Confidential and Proprietary  
 Page 55 of 54  
    Version 6.0 2018-08-22 
 APPENDIX E: Informed Consent Form (ICF) 

REVIAN® Trial
2019-11 
Page 1 of 47 
Statistical Analysis Plan 
(Version 4.0) 
Protocol No.: REV-01   
Protocol Title: 
A Prospective, Randomized, Controlled, Double-Blind Study that Evaluates the Safety and 
Efficacy of Three Active REVIAN Caps versus a Non-Active REVIAN Cap (Sham) in 
Participants with Pattern Hair Loss (Androgenic Alopecia) 

REVIAN® Trial 
 
 
 
2019-11 
Page 2 of 47 
 
TABLE OF CONTENTS 
 Page 
1. 
Preface ..................................................................................................................... 4 
2. 
Study Objectives and Endpoints ............................................................................... 4 
3. 
Study Design ............................................................................................................ 4 
4. 
Sequence of Planned Analyses ................................................................................ 6 
5. 
Sample Size Considerations .................................................................................... 7 
6. 
Analysis Populations ................................................................................................ 7 
7. 
Interim Analyses ....................................................................................................... 7 
8. 
General considerations for data analyses ................................................................. 7 
8.1. Missing and Imputed Data ............................................................................... 9 
8.2. Hypothesis Testing.......................................................................................... 9 
8.3. Covariates ..................................................................................................... 10 
8.4. Examination of Subgroups ............................................................................ 10 
8.5. Study Centers ............................................................................................... 10 
8.6. Data Review.................................................................................................. 10 
8.7. Derived Data ................................................................................................. 10 
8.8. Transformed Data ......................................................................................... 10 
9. 
Study population .................................................................................................... 11 
9.1. Participant Accountability .............................................................................. 11 
9.2. Protocol Deviations ....................................................................................... 11 
9.3. Treatment Compliance .................................................................................. 11 
9.4. Other Descriptions of Study Population ......................................................... 11 
10. Efficacy Analyses ................................................................................................... 12 
10.1. Primary Endpoint .......................................................................................... 12 
10.2. Secondary Analyses ..................................................................................... 12 
11. Safety Analyses ..................................................................................................... 13 
11.1. Concomitant Medications .............................................................................. 13 
11.2. Adverse Events ............................................................................................. 13 
12. Reporting Conventions ........................................................................................... 14 
List of Tables ................................................................................................................. 15 
 

REVIAN® Trial
2019-11 
Page 3 of 47 
Abbreviations and Definitions:  
AE 
Adverse event 
AGA 
Androgenic alopecia 
ANCOVA 
Analysis of covariance 
ATC 
Anatomical therapeutic class 
cm 
Centimetre 
CMH 
Cochran-Mantel-Haenszel 
eCRF 
Electronic case report form 
FPC 
Flexible printed circuit board  
ICH 
International Conference on Harmonisation 
LED 
Light emitting diode 
MedDRA 
Medical Dictionary for Regulatory Activities 
MLT 
Modulated light therapy 
PCBA 
Printed circuit board assembly 
PDF 
Portable document format 
SAE 
Serious Adverse Event 
SAS 
Statistical Analysis Software, Inc 
SOC 
System Organ Classification 
TEAE 
Treatment Emergent Adverse Events 
WHO 
World Health Organization 

REVIAN® Trial
2019-11 
Page 4 of 47 
1.
PREFACE
This document describes in detail the methods that will be used to summarize and analyze the 
efficacy and safety data from protocol REV-01 (V6; August 22, 2018). 
2.
STUDY OBJECTIVES AND ENDPOINTS
The REVIAN device is a soft dome-shaped cap that contains integrated electronics and battery 
technology to control delivery of modulated light therapy (MLT™) for a daily         10 minute 
treatment to treat androgenic alopecia (AGA) and promote hair growth in men and women. 
The cap contains a flexible printed circuit board (FPC), LEDs, printed circuit board assembly 
(PCBA), lithium-polymer battery, elastic fabric and foam fitting pieces.  The cap is controlled 
and operated by a mobile app. 
The primary objective of this study is to collect data on the safety and effectiveness of REVIAN 
in male and female participants with AGA through 26-weeks of treatment. 
3.
STUDY DESIGN
This study is designed as a prospective, randomized, controlled, double-blind, four-arm study. 
Up to 3 clinical sites will enroll up to 200 participants over an approximate 6-month duration.  
Eligible participants with AGA meeting all inclusion and exclusion criteria will be enrolled 
and randomized to one of four study arms in a 1:1:1:1 ratio: 
•
Arm 1:  Active REVIAN 101 (___mW/cm2 of 625 nm and 660 nm)
•
Arm 2:  Active REVIAN 102 (___ mW/cm2 of 425 nm)
•
Arm 3:  Active REVIAN 103 (___ mW/cm2 of 425 nm + ___ mW/cm2 of 
625 nm and 660 nm)
•
Arm 4:  Non-Active REVIAN Cap 100 (SHAM)
Male and female participants will be randomized from separate randomization schedules to 
ensure balance among treatment arms in each gender. 
All data except for Global Assessment Photography and Macrophotography will be captured 
in an electronic clinical report form (eCRF). Global Assessment Photography and 
Macrophotography data will be imported from external vendor. Demographic, baseline 
characteristics, efficacy and safety data will be collected at regularly scheduled visits according 
to the planned schedule of procedures (Table 1).   
Screening procedures will be performed at Visit 1.   
Participants who are eligible to enroll will return within 7 days for Visit 2 to obtain baseline 
data and to be randomized to one of the treatment arms. The first treatment will be performed 
in the clinic on Visit 2. 

REVIAN® Trial
2019-11 
Page 5 of 47 
Visit 3 will occur approximately 7 days later via telephone interviews to assess treatment 
compliance, to report use of concomitant medications and to report any adverse events. 
Visits 4 and 5 will occur approximately 8 and 16 weeks, respectively, after Visit 1.  Participants 
will return to the investigation centers for efficacy assessments and questionnaires.  
The final visit (Visit 6) will occur approximately 10 weeks after Visit 5.  Participants will 
undergo a final assessment of efficacy and safety at Visit 6.  Participants will return the caps 
at Visit 6.  If there are no adverse events requiring follow-up, participants will not need to 
return for any follow up assessments. 
Any participant who competes the Week 16 efficacy assessments (at Visit 5) will be 
considered a completer.  

REVIAN® Trial
2019-11 
Page 6 of 47 
Table 1: Planned Visits and Procedures. 
1 All visit dates are in reference to Baseline, i.e., Visit 4 occurs about eight weeks (56 days) after the Baseline Visit.
2  Participants will continue treatments throughout the 26-weeks with a daily 10-minute treatment for a total of 56 
treatments over 8 weeks, 112 treatments over 16-weeks, 
   and 182 treatments over 26-weeks. 
3 Participants may have tattoo ink reapplied to original site of ink dot application at these time periods. 
4  SHG & PGA is not taken at baseline. These are assessed only at the follow up visits 
4.
SEQUENCE OF PLANNED ANALYSES
All analyses outlined in this document will be carried out after: 
•
The study database has been authorized by the PhotonMD Review team as complete
and final;
•
Protocol deviations that warrant exclusion from the per protocol analyses have been
identified.
PROCEDURES 
Visit 1 
Visit 2 
Visit 3 
Visit 4 
Visit 5 
Visit 6 
Screening 
(Day -7) 
Baseline 
(Day 0) 
Phone Call 
(7 ±3 Days) 
Week 81,2 
(56 ±5 
Days) 
Week 161,2 
(112 ±10 
Days) 
Week 261,2 
(182 ±10 
Days) 
Informed Consent 
X 
X 
Demographics 
X 
X 
Medical History 
X 
X 
Medication History 
X 
X 
Inclusion/Exclusion Criteria 
X 
X 
Pregnancy Test (As required) 
X 
X 
Brief Physical Examination 
X 
X 
Instruction on Device and 1st 
Application 
X 
Shave and Tattoo Scalp 
X 
X3 
X3 
X3 
Hair Count - Macrophotography 
(1cm2 Area) 
X 
X 
X 
X 
Follow-up on Compliance and 
Use of REVIAN 
X 
X 
X 
X 
X 
Growth Assessment and 
Questionnaires: 
Subjective Scalp Hair Growth 
(SHG) score4 
X 
X 
X 
Physician's Global Assessment 
(PGA) score4 
X 
X 
X 
Hair Specific Skindex-29 
Questionnaire 
X 
X 
X 
X 
Global Assessment Photography 
(superior and vertex scalp) 
X 
X 
X 
X 
Blinded Review of Global 
Photographs 
X 
X 
X 
X 
Participant Compliance Review 
X 
X 
X 
X 
Concomitant Medications 
X 
X 
X 
X 
X 
Adverse Events 
X 
X 
X 
X 
X 
End of Study / Early Termination 
/ Return Device 
X 

REVIAN® Trial
2019-11 
Page 7 of 47 
5.
SAMPLE SIZE CONSIDERATIONS
Prior hair growth studies, regardless of potential efficacy of the Sham device, showed the delta 
between active treatments and control treatments was consistently at around 15-22 hairs/cm2
which appears to be the expected level of improvement.  It is estimated that participants in the 
active group will have increases of 15 hairs/cm2 by 16-weeks.  Assumptions are 15 hair count 
difference between treatments, standard deviation (SD)=20, 10% drop-out rate, 5% alpha level, 
90% power and 2-sided t-test. Based on these assumptions, the study requires a minimum of 
40 evaluable participants per arm. 
The study will accrue a maximum of 200 participants (50 per each Active Study Arm and 50 
control participants) to target, after lost to follow-up, a minimum of 160 evaluable (40 per arm) 
participants.  
6.
ANALYSIS POPULATIONS
Participants receive either an active REVIAN Cap or a non-active REVIAN Cap (three versions 
of an active REVIAN Cap and one non-active REVIAN Cap). The following participant groups 
or analysis populations will be used to complete the analysis of data: 
Intent-to-Treat participant population (ITT): The ITT participant population will include all 
participants that started a treatment at Baseline. All baseline characteristics, demographics and 
primary efficacy analyses will be performed on the ITT population. 
Per-Protocol participant population (PP): The PP participant population will include all 
participants in the ITT population with 16-week follow-up data, with no major protocol 
deviations and at least 80% compliance.  The primary and secondary efficacy analyses also 
will be performed on the PP population.  
Safety participant population (SAF): The SAF is the same as the ITT population. All safety 
summaries will be performed on the SAF population.   
7.
INTERIM ANALYSES
No interim analyses are planned for this study. 
8.
GENERAL CONSIDERATIONS FOR DATA ANALYSES
The purpose of the study is to collect data on the safety and effectiveness of REVIAN in 
participants with AGA. In general, for continuous variables, the sample size, mean, standard 
deviation, minimum and maximum will be presented. For categorical variables, the number 
and percentage in each category will be presented.  All statistical analyses will be performed 
using SAS version 9.4 for PC. Unless otherwise specified, statistical significance will be 
determined using p≤0.05. 
All outcomes will be provided in listings by participant and treatment group. In addition, some 
endpoints will be summarized in tables by treatment group.   

REVIAN® Trial
2019-11 
Page 8 of 47 
Primary Efficacy Endpoint: The primary efficacy endpoint of this study is the change in hair 
count from baseline to 16-weeks following the initial application (CFB_HC16). 
Primary Safety Endpoint: The primary safety outcome will be determined by evaluating by 
the type, frequency, severity, and relatedness of adverse events through the 16-week period for 
all participants. 
Secondary Efficacy Endpoints: 
Change from Baseline Hair Count: Like the primary endpoint, change from baseline hair 
count, will also be assessed at 8 (CFB_HC08) and 26 (CFB_HC26) weeks. 
Rate of Change in Hair Growth: The rate of change in hair growth at 8, 16, and 26 weeks will 
be calculated as a ratio of change from baseline to baseline. 
Independent Physician’s Global Assessment (iPGA):  Two independent reviewers will assess 
overall hair growth from photographs, using PGA scores at weeks 8, 16 and 26.  The PGA 
score hair growth as: -3=greatly decreased, -2=moderately decreased, -1=slightly decreased, 
0=no change, 1=slightly increased, 2=moderately increased and 3=greatly increased. In the 
event the two independent reviewers do not agree, a third assessment will be made by the PI. 
The PI’s score will superceed the two other independent reviewers’ score. 
Site Physician’s Global Assessment (sPGA): The site investigator will assess overall hair 
growth using the PGA scores at weeks 8, 16 and 26. 
Subjective Scalp Hair Growth Score (SHG): Beginning at Week 8, participants will complete 
a subjective hair growth questionnaire.  The participants choose the answer that best fits the 
following statements: 
1) Since the start of the study, I can see my bald spot getting smaller. (1=”strongly agree”
to 5=”strongly disagree”)
2) Because of the treatment, I have received since the starts if the study, the appearance
of my hair is: (1=”a lot better” to 5=”a lot worse”)
3) Ever since the start of the study, how would you describe the growth of your hair?
(1=”greatly increased” to 7=”Greatly decreased”)
4) Ever since the start of the study, how effective do you think the treatment has been in
slowing down your hair loss? (1=”Very effective” to 4=”Not effective at all”)
5) Compared to the beginning of the study, which statement best describes your
satisfaction with your appearance of:
a.
The hairline in front of your head? (1=”very satisfied” to 5=”very dissatisfied”)
b. The hair on top of your head? (1=”very satisfied” to 5=”very dissatisfied”)
c.
Your hair overall? (1=”very satisfied” to 5=”very dissatisfied”)

REVIAN® Trial
2019-11 
Page 9 of 47 
SHG will be administered at 8 weeks, 16 weeks and 26 weeks 
Hair Specific Skindex-29 Quality of Life Questionnaire (HSSQOL):  The hair specific skindex-
29 QOL questionnaire is a 29-item questionnaire with 3 domains: 7 questions for symptoms 
domain, 10 questions for emotion domain and 12 questions for function domain.  Participants 
score each question on a scale from 1 (never) to 5 (all the time).   Total scores will be summed 
at Week 8, 16 and 26.  HSSQOL will be administered at baseline, 8, 16 and 26 weeks. 
Secondary Safety Endpoint: The secondary safety outcome will be determined by evaluating 
by the type, frequency, severity, and relatedness of adverse events through the 26-week period 
for all participants. 
8.1. 
Missing and Imputed Data 
Every effort will be undertaken to fulfill all the requirements of the protocol concerning the 
collection of data. If participants refuse to return for data collection, but agree to continue in 
the study, questionnaire data and safety data will be collected over the telephone or at a home 
visit, if necessary.  
The primary analysis will be performed on the ITT group. Those participants who withdraw 
or who are lost to follow up (LTFU) after enrollment will be included in the primary analysis 
using a last observation carried forward (LOCF) approach where the outcome at the most 
recent visit will be carried forward to all subsequent missing assessment times. Since all post-
baseline efficacy assessments are first assessed at approximately Week 8, participants without 
an 8-week visit will have their baseline observation carried forward (BOCF) for the primary 
and secondary efficacy analyses.  Analyses will also be performed on all available data with 
no imputations. 
8.2. 
Hypothesis Testing 
The treatment consists of 3 active caps and one Sham cap.  Each active cap group will be 
compared to the same Sham group using 1 degree of freedom contrasts in general linear models 
analysis of covariance (ANCOVA). Comparisons will be adjusted for multiple comparisons to 
the same Sham group using Dunnett’s correction. 
The primary outcome is the change from baseline in hair count after 16 weeks of treatment 
with a cap. The null hypothesis is there is no difference in outcome between an active cap 
compared to a Sham cap, while the alternative hypothesis is there is a difference outcome 
between active compared Sham cap:  
Hnull: Dactive = DSham 
Halternative: Dactive ≠ DSham 
The null hypothesis will be rejected in favor of the alternative hypothesis for each active cap 
if the Dunnett’s corrected p-value for the contrast ≤ 0.05.  Treatment superiority will be 

REVIAN® Trial
2019-11 
Page 10 of 47 
demonstrated if the significant difference is in favor of the active cap (e.g., greater increase in 
hair count for the active cap. No comparisons between active caps will be performed. 
Secondary outcomes will the same hypotheses testing process as the primary outcome, but 
with statistical methods appropriate for the type of endpoints to be tested.  For example, 
continuous outcomes will be analysed by parametric methods, such as ANCOVA, while 
categorical outcomes will be analysed by non-parametric methods, such as Cochran-Mantel-
Haenszel (CMH) test.  Details of analyses by outcomes are provided in Section 10. 
8.3. 
Covariates 
Demographic and baseline characteristics, such, but not limited to age, gender, race and 
baseline hair count, will be consider as covariates in the ANCOVA.  Any covariate that 
significantly accounts for variability (p<0.10) in the ANOVA model or Chi-Square test will be 
retained for the hypothesis testing. 
8.4. 
Examination of Subgroups 
There are no specific plans to perform any subgroup analyses.  However, subgroup analyses 
may be performed for categories of gender, age, race or other baseline characteristics as 
deemed clinically relevant and appropriate in further characterizing treatment effects. 
8.5. 
Study Centers 
The clinical study will be conducted under a common protocol for each of 4 investigational 
sites with the intention of pooling the data over all sites for analysis. Every effort will be made 
to promote consistency in study execution at each investigational site.  Assuming there is not 
a high degree of imbalance in the number of participants from each site an initial analysis will 
be performed with Site as a blocking factor and accounting for site by treatment interaction. If 
there is no site by treatment interaction, the factor will be dropped from subsequent analyses. 
If site is deemed to significantly account for outcome variability, then subgroup analyses by 
site will be performed. 
8.6. 
Data Review 
Prior to unblinding of the study database, the data will be reviewed by the Clinical Project 
Manager.  The investigational sites will be queried about any discrepancies or unclear data 
and, if necessary, these will be corrected in the database. 
8.7. 
Derived Data  
No variables will be derived. 
8.8. 
Transformed Data 
No data transformations are planned. 

REVIAN® Trial
2019-11 
Page 11 of 47 
9.
STUDY POPULATION
9.1. 
Participant Accountability
The number of participants in the study will be summarized by treatment and overall. The 
number of participants who were screened, the number who were randomized, the number in 
the SAF population, the number in the ITT population, and the number in the PP population 
will be summarized by treatment and overall. 
9.2. 
Protocol Deviations 
Participant data will be reviewed for major protocol violations by a qualified clinical reviewer 
prior to database lock and unblinding. Participants with any major protocol violations will be 
excluded from the Per Protocol Population. The major protocol deviation is defined as:  
•
Outside the age window
•
Deleterious concomitant medications
•
Compliance < 80%
•
Tattoo outside the specified location
All other protocol deviations will be considered as minor. The major protocol deviations and 
the descriptions will be listed by participants. 
9.3. 
 Treatment Compliance 
A review of treatment compliance will begin with a telephone interview at Visit 3 
(approximately 7 days after baseline).  Participants are expected to use the use the caps for 10 
minutes every day.  The percent compliance will be based on the actual number of days used 
divided by the expected number of days available to use.  For example, if a participant uses 
the cap 50 times over the course of 56 days, compliance will be 89.3%.  The number of days 
of participation and percent compliance by will be summarized by treatment group. 
9.4. 
Other Descriptions of Study Population 
Demographics data will be summarized by treatment group and overall. Demographics will 
include age, gender, baseline height and baseline weight.  
Baseline characteristics will be summarized by treatment group and overall. Baseline 
characteristics include hair count, responses to Hair Specific Skindex-29 questionnaire, and 
blinded reviewer Physician’s Global Assessments from photographs. 
Medical history, physical exam and vital signs findings will be summarized by treatment group 
and overall. 
Prior medications are any medications taken and stopped prior to initiating treatment with a 
Revain cap. Prior medications will be collected as part of the medication history. These will 
be coded to Anatomical Therapeutic Classification (ATC) and by the preferred medication 

REVIAN® Trial
2019-11 
Page 12 of 47 
names using WHO-Drug dictionary (WHODrug Mar-15) Incidence of participants having 
taken prior medications will be summarized by treatment group and overall. 
Concomitant medications are defined as any medication that started prior to treatment initiation 
and is ongoing, or any medication that starts after the initiation of treatment. These will be 
handled as part of the safety assessments.  
10.
EFFICACY ANALYSES
10.1. 
Primary Endpoint
The primary efficacy endpoint is the change from baseline in hair count, over a pre-specified 
1 cm2 area of scalp after 16 weeks of treatment (CFB_HC16). 
As specified in Section 9.2, each active cap will be compared to the same Sham treatment using 
1 degree of freedom contrasts in an analysis of covariance (ANCOVA). Analyses will be 
adjusted for multiple comparisons using Dunnett’s correction.  An example of SAS code to be 
used for the primary analysis is as follows: 
PROC MIXED; 
CLASS SITE ARM; 
MODEL CFB_HC16 = SITE ARM SITE*ARM <covariates>; 
LSMEANS ARM /ADJUST=DUNNETT DIFF=CONTROL(‘SHAM’); 
RUN; 
If the SITE*ARM interaction is not significant (p>0.05), this interaction will be dropped from 
the subsequent model. SITE will remain in the model if it significantly attributes to variability 
of the outcome. All subsequent analyses of secondary endpoints will retain the same factors 
and covariates as the primary outcome analysis. 
10.2. 
Secondary Analyses 
Secondary efficacy endpoints will be analysed as follows:  
Change from Baseline Hair Count: the change from baseline hair count at 8 (CFB_HC08) and 
26 (CFB_HC26) weeks will be analyzed in the same manner as the primary endpoint. 
Rate of Change in Hair Growth:  The rate of change in hair growth at 8, 16 and 26 weeks will 
be analyzed in the same manner as the primary endpoint. 
Independent Physician’s Global Assessment (iPGA): The percentage of participants with each 
score will be summarized by treatment group and by week.  The active cap groups will be 
compared to the Sham group using Cochran-Mantel Haenszel (CMH) chi-squared method for 
detecting shifts in distribution of answers.  The modified RIDIT scores will be used to take 
into account the ordered nature of the categorical responses.  An example of SAS code for this 
analysis is as follows: 
IF ARM IN (‘SHAM’, ‘CAP101’); 
PROC FREQ; 

REVIAN® Trial
2019-11 
Page 13 of 47 
TABLE ARM*(iPGA08 iPGA16 iPGA26) 
/CMH SCORE=MODRIDIT; 
RUN; 
Site Physician’s Global Assessment (sPGA): The site investigator will assess over hair growth 
using the PGA scores at weeks 8, 16 and 26.  These outcomes will be summarized and analysed 
in the same manner as the iPGA, above.  
Subjective Scalp Hair Growth Score (SHG): The percentage of participants with each score in 
for each question will be summarized by week and by treatment group.  The active cap groups 
will be compared to the Sham group using Cochran-Mantel Haenszel (CMH) chi-squared 
method for detecting shifts in distribution of answers.  The modified RIDIT scores will be used 
to take into account the ordered nature of the categorical responses.  An example of SAS code 
for this analysis is as follows: 
IF ARM IN (‘SHAM’, ‘CAP101’); 
PROC FREQ; 
TABLE ARM*(SHG1 SHG2 SHG3 SHG4 SHG5A SHG5B SHG5C) 
/CMH SCORE=MODRIDIT; 
RUN; 
Hair Specific Skindex-29 Quality of Life Questionnaire (HSSQOL): The sum of scores for 
overall will be summarized by treatment group for each visit. These outcomes will be 
summarized and analysed in the same manner as the SHG above.  
11.
SAFETY ANALYSES
11.1. 
Concomitant Medications 
Concomitant medications are defined as any medication that started prior to treatment initiation 
and is ongoing during treatment, or any medication that starts after the initiation of treatment. 
These will be coded to Anatomical Therapeutic Classification (ATC) and by the preferred 
medication names using WHO-Drug dictionary (WHODrug Mar-15).  Incidence of 
participants taking concomitant medications will be summarized by treatment group.  
11.2. 
Adverse Events 
All treatment emergent Adverse events (TEAEs) will be recorded and classified on the basis 
of Medical Dictionary for Regulatory Activities (MedDRA) terminology (Version 20.0). 
TEAEs will be defined as AEs reported after the first treamtment into the study. 
TEAEs will be summarized by the number of participants reporting a TEAE, SOC, preferred 
term, severity, relationship to treatment (causality), and seriousness. When summarizing AEs 
by severity and relationship, each participant will be counted only once, within a system organ 
class or a preferred term, by using the event with the highest severity and greatest relationship 
within each classification.  

REVIAN® Trial
2019-11 
Page 14 of 47 
In addition, a summary table  of participants who prematurely discontinue treatment due to an 
AE will be provided. 
12.
REPORTING CONVENTIONS
Reporting conventions will adhere when possible to the International Conference on 
Harmonization (ICH) Guidance document E3, “Structure and Content of Clinical Study 
Reports”.  Some specific conventions are outlined below: 
1.
All tables and listings will be in landscape format.
2.
All SAS output for tables and listings will be distributed in PDF files.

REVIAN® Trial
2019-11 
Page 15 of 47 
LIST OF TABLES 
Table 
Number 
Title 
Population Summarized 
14.1.1 
Summary of Participants Disposition 
(All Participants) 
14.1.2 
Demographics 
(ITT Population) 
14.1.3 
Family History of Hair Loss 
(ITT Population) 
14.1.4 
General Medical and Surgery History 
(ITT Population) 
14.2.1.1 
Hair Counts at Week 16 
(ITT Population) 
14.2.1.2 
Hair Counts at Week 16 
(PP Population) 
14.2.2.1 
Hair Counts at Week 8 
(ITT Population) 
14.2.2.2 
Hair Counts at Week 8 
(PP Population) 
14.2.3.1 
Hair Counts at Week 26 
(ITT Population) 
14.2.3.2 
Hair Counts at Week 26 
(PP Population) 
14.2.4.1 
SECONDARY EFFICACY - Independent Physician Global Assessment 
(ITT Population) 
14.2.4.2 
SECONDARY EFFICACY - Independent Physician Global Assessment 
(PP Population) 
14.2.5.1 
SECONDARY EFFICACY - Investigative Site Physician Global Assessment 
(ITT Population) 
14.2.5.2 
SECONDARY EFFICACY - Investigative Site Physician Global Assessment 
(PP Population) 
14.2.6.1 
SECONDARY EFFICACY – Subjective Scalp Hair Growth Score at Week 8 
(ITT Population) 
14.2.6.2 
SECONDARY EFFICACY – Subjective Scalp Hair Growth Score at Week 8 
(PP Population) 
14.2.7.1 
SECONDARY EFFICACY – Subjective Scalp Hair Growth Score at Week 16 
(ITT Population) 
14.2.7.2 
SECONDARY EFFICACY – Subjective Scalp Hair Growth Score at Week 16 
(PP Population) 
14.2.8.1 
SECONDARY EFFICACY – Subjective Scalp Hair Growth Score at Week 26 
(ITT Population) 
14.2.8.2 
SECONDARY EFFICACY – Subjective Scalp Hair Growth Score at Week 26 
(PP Population) 
14.2.9.1 
SECONDARY EFFICACY – Hair Specific Skindex-29 QOL At Week 8 
(ITT Population) 
14.2.9.2 
SECONDARY EFFICACY – Hair Specific Skindex-29 QOL At Week 8 
(PP Population) 
14.2.10.1 
SECONDARY EFFICACY – Hair Specific Skindex-29 QOL At Week 16 
(ITT Population) 
14.2.10.2 
SECONDARY EFFICACY – Hair Specific Skindex-29 QOL At Week 16 
(PP Population) 
14.2.11.1 
SECONDARY EFFICACY – Hair Specific Skindex-29 QOL At Week 26 
(ITT Population) 
14.2.11.2 
SECONDARY EFFICACY – Hair Specific Skindex-29 QOL At Week 26 
(PP Population) 
14.3.1.1 
Overall Summary of Treatment Emergent Adverse Events 
(SAF Population) 
14.3.1.2 
Summary of Treatment Emergent Adverse Events by System Organ Class(SOC) 
(SAF Population) 
14.3.1.3 
Summary of Treatment Emergent Adverse Events by System Organ Class(SOC)and 
Severity 
(SAF Population) 
14.3.1.4 
Summary of Treatment Emergent Adverse Events by System Organ Class(SOC)and 
Relatedness 
(SAF Population) 

REVIAN® Trial
2019-11 
Page 16 of 47 
Table 
Number 
Title 
Population Summarized 
14.3.1.5 
Summary of Serious Treatment Emergent Adverse Events 
(SAF Population) 
14.3.1.6 
Summary of Treatment Emergent Adverse Events Resulting in Discontinuation 
(SAF Population) 
14.3.2 
Concomitant Medications 
(SAF Population) 
14.3.3 
Physical Examination Findings 
(SAF Population) 
14.4 
Device Issues at Disposition 
(ITT Population) 
14.5 
Treatment Compliance 
(ITT Population) 

REVIAN® Trial
2019-11 
Page 17 of 47 
LIST OF LISTINGS 
Lising 
Number 
Title 
Population Summarized 
1.1.1 
Major Protocol Deviation 
(SAF Participants) 

REVIAN® Trial
2019-11 
Page 18 of 47