An Evaluation of the Safety and Effectiveness of the N-SWEAT Patch for the Treatment of Primary Axillary Hyperhidrosis or Excessive Axillary Sweating
Phase: NA
Conditions: Primary Axillary Hyperhidrosis
Sponsor: Candesant Biomedical, Inc.

CANDESANT 
BIOMEDICAL
CLINICAL STUDY PROTOCOL 
 
SAHARA STUDY 
Document #: CB-CLP-001 
Revision: E 
 
THE SAHARA STUDY 
An Evaluation of the Safety and Effectiveness of the N-SWEAT Patch 
for the Treatment of Primary Axillary Hyperhidrosis or Excessive Axillary 
Sweating  
 
 
 
 
 
 
 
 
 
 
Clinical Study PROTOCOL
(CB-CLP-001)
Version: Rev E
Date:  26 April 2021
IDE NUMBER:  G200196
NCT: 04599907
CONFIDENTIAL 

CANDESANT 
BIOMEDICAL
CLINICAL STUDY PROTOCOL 
 
SAHARA STUDY 
Document #: CB-CLP-001 
Revision: E 
 
 
 
Version E                                                           Confidential  
                                              Page 2 of 78 
 
 
1. PROTOCOL SYNOPSIS 
GENERAL INFORMATION
STUDY TITLE 
An Evaluation of the Safety and Effectiveness of the N-SWEAT Patch 
for the Treatment of Primary Axillary Hyperhidrosis or Excessive 
Axillary Sweating 
INVESTIGATIONAL 
DEVICE
N-SWEAT Patch 
STUDY NAME
The Sahara Study
PATCH 
CHARACTERISTICS 
 A non-invasive energy-based patch, which, when in contact with 
sweat, produces thermal energy intended to target and temporarily 
inactivate sweat glands leading to a reduction in sweat production  
 Patch is self-adhesive with a layer of alkali metal foil pressed into a 
polyimide film 
 Device is inert until it comes into contact with water (sweat) 
 Patch is applied to the axillae for up to 3-minutes in a medical office, 
it is then removed and disposed of by medical staff.   
CONTROL DEVICE
Sham Patch
SPONSOR/ 
MANUFACTURER
Candesant Biomedical, Inc 
INDICATION FOR 
USE (proposed) 
N-SWEAT Patch is indicated for treatment of excessive axillary 
sweating or primary axillary hyperhidrosis in individuals 22 years of 
age or older.  
REGULATORY 
STATUS
The N-SWEAT Patch is under clinical investigation in the US for this 
proposed indication
 
STUDY OVERVIEW
DESIGN
Prospective, multi-center, randomized, blinded, sham-controlled
OBJECTIVE 
The pivotal study is intended to evaluate the safety and effectiveness of 
the N-SWEAT Patch for use in subjects with excessive axillary sweating 
or primary focal axillary hyperhidrosis.  
Safety of the N-SWEAT Patch will be confirmed by assessing the 
occurrence of local skin reactions, treatment-related adverse events 
(AEs) and Serious Adverse Events (SAEs).   
Primary demonstration of effectiveness will be assessed by a significant 
improvement (reduction) in Hyperhidrosis Disease Severity Score 
(HDSS) in subjects treated with the N-SWEAT Patch versus sham 
control subjects.  Secondary and additional endpoints based on 
complementary clinical instruments have been included to further 
demonstrate performance.  
POPULATION 
Healthy male and female subjects in good general health who sweat 
excessively in the axillae or have primary focal axillary hyperhidrosis will 
be considered for study participation.  Enrollment is limited to subjects 
with HDSS scores of 3 or 4.  
STUDY DURATION 
ROLL-IN COHORT: 1.5 months enrollment / 3.5 months follow-up 
RANDOMIZED COHORT: 3 months enrollment / 3.5 months follow-up

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SAHARA STUDY 
Document #: CB-CLP-001 
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ENROLLMENT AND FOLLOW-UP
ROLL-IN COHORT
10 N-SWEAT treated subjects at 1 Study Site
RANDOMIZED 
COHORT 
Up to 110 Subjects at up to 14 Study Sites 
 Subjects will be randomized 1:1; treated with N-SWEAT or sham 
patch, stratified by HDSS 3 and HDSS 4 at Baseline  
 At least 50 subjects will be treated in each group.   
 Up to 10 additional subjects may be enrolled to account for loss 
to follow up or critical missing data
PHONE CALLS
24 hours (±12 hours) and 2-weeks (± 2 days) post-treatment 
CLINIC VISITS 
Required: 48-72 hours (± 24 hours) and 4-week (± 3 days)  
Recommended (phone call permitted): 6-, 8-, 10-, 12-weeks (± 3 days)  
On-site or telehealth visit should be scheduled within 24 hours of a 
treatment site AE with a clinic visit required for any burn injury.  
ELECTRONIC 
Weekly (beginning 1-week post treatment); HDSS and Quality of Life 
(QoL) surveys (QoL-7, Impact, Bother, etc.) via cell phone, tablet or 
computer 
ASSESSMENTS 
 Gravimetric Sweat Production (GSP) Assessments will be conducted 
at screening, baseline and 4-week clinic visits only.   
 In addition, a written daily diary will be distributed to subjects to track 
treatment responses and outcomes.  This will be returned at the 4-
week study visit.  
EXTENDED 
FOLLOW-UP 
COHORT 
Subjects that reach the final Sahara Study visit (12 weeks) and are still 
responding to treatment (i.e. HDSS has not returned to Baseline) will be 
invited to continue follow-up  
 Eligible subjects will provide consent prior to being enrolled into this 
cohort, within 4 weeks of completing their 12-week visit. 
 Subject enrolled in this cohort will not undergo any additional 
treatment, their participation will include extended follow-up only 
through 24-weeks post treatment or when HDSS returns to Baseline 
(whichever occurs first) 
 Subjects will be asked to continue weekly electronic surveys until 
participation is complete. 
 Phone Calls with the site study teams will be scheduled at 16-weeks, 
20-weeks and 24-weeks post treatment during participation
 
 
 
 
 
 
 
 
 
 
 
 

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STUDY ENDPOINTS
SAFETY 
ASSESSMENT
Safety will be confirmed by an assessment of the occurrence of local skin 
reactions, treatment-related AEs and SAEs.   
PRIMARY 
EFFICACY 
ENDPOINT
Primary efficacy endpoint will be assessed as the proportion of patients with 
HDSS of 1 or 2 at 4-week follow-up by treatment group  
SECONDARY 
EFFICACY 
ENDPOINTS 
 
The first evaluation of all secondary endpoints will occur at 4-week time point.  
These endpoints will be evaluated at all available time points.   
1. Mean improvement in QoL scale Bother by treatment group 
2. Mean improvement in QoL scale Impact by treatment group 
3. Proportion of patients with improvement of at least 2 grades from baseline to 4-
weeks in HDSS by treatment group  
4. Proportion of subjects with at least 50% improvement in GSP from baseline 4-
weeks in N-SWEAT treated group only.  
OBSERVATIONAL 
ENDPOINTS 
 
Baseline-adjusted mean improvement in QoL-7 instrument assessed by 
treatment group 
 
Composite - proportion of patients with HDSS 1 or 2 AND 50% 
improvement in GSP assessed by treatment group 
 
Composite - proportion of patients with HDSS 1 or 2 AND 75% 
improvement in GSP assessed by treatment group  
 
Duration of efficacy:  time from treatment to first observed reversion to 
HDSS 3 or 4 (median duration of efficacy will be calculated).  Also 
performed for first reversion to subject’s baseline HDSS.    
 
Mean change from baseline over time in GSP compared between 
treatment groups; Change in GSP at individual timepoints. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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ELIGIBILITY: INCLUSION CRITERA
1. Signed written informed consent, including authorization to release health information.  (Subject must 
be able to read informed consent independently since subjective feedback is required)  
2. At least 22 years old at the time of consent. 
3. Female or male, who experiences excessive sweating or has been diagnosed with primary axillary 
focal hyperhidrosis and is in otherwise good general health 
4. GSP >50mg/5min in each axilla at room temperature/humidity (20-25.6°C/20-80%) at both screening 
and baseline 
5. Reports a score of HDSS score of 3 or 4 at both screening and baseline 
6. Subject agrees to avoid use of topical aluminum compounds, antiperspirants, anticholinergic 
medications or steroids for the duration of study participation.   
7. Subject is willing and able to follow instructions and likely to complete all requirements for the study 
including hair removal   
8. Women of child-bearing age must have a negative pregnancy test at screening and must be 
practicing and willing to continue an effective method of birth control from screening visit until study 
completion.    
 
ELIGIBILITY: EXCLUSION CRITERIA
1. Active skin disease, irritation, or abrasions at either axilla based on physical examination by physician 
at Baseline.   
2. Subject’s medical history is indicative of secondary or diffuse hyperhidrosis and/or subject has a 
diagnosis of secondary or diffuse hyperhidrosis  
3. GSP exceeds 300 mg/5min in either axilla at either screening or baseline 
4. GSP readings differ by more than 100% in either axilla between screening and baseline 
5. Hair bearing area of the axillae is more than 6 in length and/or 2.75 in width or is not able to be fully 
covered by the active (foil) area of one study patch  
6. Treatment with botulinum toxin for excessive sweating or hyperhidrosis within 1 year 
7. Undergone any procedures, including for hyperhidrosis, which may affect the axillary areas (e.g., 
laser hair removal within the last 3 months; Skoog procedure, any type of sympathectomy, gland 
excision, or other surgery; thermolysis, liposuction; or iontophoresis) or is planning to undergo any of 
these procedures during the course of the study 
8. Use of prescription, prescription strength, or clinical strength topical aluminum compounds for axillary 
hyperhidrosis (e.g., Maxim, Drysol, Certain Dri) for 30 days prior to screening  
9. Use of over-the-counter antiperspirants and antiperspirant deodorants for 2 days prior to screening 
10. Concurrent use of oral or topical anticholinergic medications (including Qbrexza, glycopyrronium, 
glycopyrrolate, clonidine, atropine, Bellargal-S), beta blockers, calcium channel blockers, or other 
topical or systemic treatments that may affect hyperhidrosis symptoms starting at screening visit.   
11. Use of a topical steroid (e.g., hydrocortisone, triamcinolone) within or around the axilla (planned 
treatment areas) within 14 days prior to screening 
12. Presence of a psychological disorder which may interfere with perception of self or perception of 
severity of sweating.   
13. Use of neuromodulator (e.g. Botox, Dysport, Xeomin) to the hands in the prior 12 months, 
14. Patients with unevaluated lymphadenitis or enlarged lymph nodes should also not be enrolled in case 
the lymph nodes are reactive or potentially indicative of cancer, 
15. Subjects with allergy to any of the ingredients of the patch, 
16. Patients with conditions or prior treatments in the axilla that may limit the feeling of pain right away or 
are associated with decreased sensitivity, (e.g. diabetic patients or patients with any other 
neurological diseases), 
17. Patients at risk for scarring, collagen vascular diseases, Hidradenitis suppurativa. Patients treated 
with isotretinoin may also experience severe scarring
 

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TREATMENT APPROACH  
Note: There is no difference in the treatment approach for the test vs. control groups.   In the 
randomized cohort personnel are blinded to treatment assignments
INSPECTION 
Final examination of the axilla to confirm freedom from any skin disease or 
irritation, including both visual and tactile assessment of any irregularities. 
Axilla must be free of abrasions, broken skin, or other conditions of concern.  
If both axillae do not meet this requirement, do not proceed with treatment.  
IDENTIFICATION 
OF TREATMENT 
SITE 
The target treatment area should be chosen by identifying a relatively flat 
area with the highest concentration of hair follicles; intended to maximize 
contact with the location of sweat production.  For convenience, site may be 
marked.  
PREP OF 
TREATMENT 
SITE
The subject’s axilla (treatment site) will be cleaned with alcohol to ensure 
that no residual deodorant or other residue remains in the target treatment 
area.  The area shall then be thoroughly dried.
PATCH 
APPLICATION 
The clinician removes the release liner and applies the patch to the prepared 
and dried axillary area.  The patch is held in place by the adhesive backing 
for the duration of the treatment, which is no longer than 3-minutes.  
Throughout the treatment period the clinician will observe the subject closely.  
If the subject experiences discomfort or pain that is significant (8 or greater 
pain level on a Wong-Baker FACES pain scale) the patch should be 
removed immediately even if it has been in place for less than 3 minutes.
POST 
TREATMENT 
Immediately following patch removal, the treatment area will be cleansed 
thoroughly with water.  A gauze pad soaked with water should be used to 
wipe the area a few times.  This step should be repeated until the subject 
does not feel any residual effects.  The patch should be placed into the 
disposal solution per instructions provided.  
SECOND 
AXILLA
All the sequential steps above will be repeated for treatment of the second 
axilla in the same treatment visit.  
 
RANDOMIZATION
RANDOMIZATION 
Subjects in the randomized cohort will be randomized to one of two 
treatment groups in a 1:1 ratio to receive a single administration of N-
SWEAT Patch or sham control patch in both axillae. The randomization 
will be stratified by HDSS 3 vs. 4 at baseline. 
BLINDING 
 Subjects in the randomized cohort will remain blinded to their 
treatment assignment  
 Site personnel conduction follow-up evaluations will be kept blinded 
 The treatment assignments will not be shared with the study sites; the 
sponsor will provide devices accurately labeled to allocate treatment 
assignments 
 The sponsor will identify only those who need to be unblinded to 
conduct the study, all others at the sponsor will remain blinded 
 The statistician conducting the data analysis; a different statistician 
responsible for the randomization codes will be unblinded to the 
treatment assignments.  
 

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STATISTICAL ANALYSIS
SAFETY ANALYSIS 
Adverse Events summaries will be presented overall, by severity, by 
device relatedness as determined by investigator (defined as related or 
with missing relationship). The SAE’s will be summarized by treatment 
group. Evaluation of local skin reactions will also be tabulated.  
Summaries will be presented by treatment group and for all patients. 
Patient listings of SAEs and adverse events leading to withdrawal will be 
presented.  Adverse device events, serious adverse device events and 
unanticipated adverse device events will be summarized by treatment 
group.   
The occurrence of local skin reactions, device-related AEs, and SAEs will 
be assessed to confirm device safety.  This safety analysis will include all 
enrolled subjects (both Roll-in and Randomized Cohorts).  
PRIMARY 
ENDPOINT 
EFFICACY 
ANALYSIS 
Proportions of subjects in the randomized cohort with HDSS of 1 or 2 at 
4-weeks post-treatment will be compared between treatment groups 
using the Cochran-Mantel-Haenszel (CMH) test stratified by baseline 
HDSS value 3 vs. 4.  
SECONDARY 
EFFICACY 
ENDPOINT 
ANALYSIS 
All secondary endpoints will be hierarchically tested at the same 0.05 
two-sided level. Each secondary endpoint will be tested if and only if the 
previous endpoint demonstrated statistical significance at the 0.05 two-
sided level. If prior endpoint on the list did not show statistical 
significance, testing will be stopped and data will be analyzed 
descriptively.
 
DATA SAFETY MONITORING BOARD
Chairperson:
Patricia Walker, MD, PhD
Members: 
Suzanne Kilmer, MD 
Lisa Donofrio, MD
Role1: 
To convene as needed for review of Adverse Events related to stopping 
rules and to determine a root cause analysis of these events
Role 2: 
To conduct a monthly blinded review of all AEs reported during 
enrollment and until the final subject has reported for 4-week follow-up
Role 3:  
If warranted, to request unblinding and fully investigate any potential 
safety signal.  This investigation may result in a recommendation to stop 
the clinical study if the findings indicate an unacceptable or unknown 
safety risk.   
 
 
 
 
 
 
 
 
 
 

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2. CONTENTS 
Table of Contents 
1. 
Protocol Synopsis ................................................................................................................................................................ 2 
2. 
Contents ................................................................................................................................................................................ 8 
Table of Contents ............................................................................................................................................................................ 8 
Table of Tables .............................................................................................................................................................................. 10 
Table of Figures ............................................................................................................................................................................ 10 
Table of Appendices ..................................................................................................................................................................... 10 
Sahara Study Investigator Signature Page ................................................................................................................................ 11 
3. 
Introduction and Background ........................................................................................................................................... 12 
3.1 
The Population: ....................................................................................................................................................... 12 
3.2 
The Unmet Need: ................................................................................................................................................... 12 
3.3 
Early Evidence for N-SWEAT Patch: ...................................................................................................................... 13 
4. 
N-SWEAT Patch Information ............................................................................................................................................. 15 
4.1 
Indications For Use ................................................................................................................................................. 15 
4.2 
Description of the N-SWEAT Patch ........................................................................................................................ 15 
4.3 
Mechanism of Action .............................................................................................................................................. 15 
5. 
Study Objective .................................................................................................................................................................. 17 
6. 
Study Endpoints ................................................................................................................................................................. 18 
6.1 
Safety Assessment ................................................................................................................................................. 18 
6.2 
Primary Efficacy Endpoint ....................................................................................................................................... 18 
6.3 
Secondary Efficacy Endpoints ................................................................................................................................ 18 
6.4 
Observational Endpoints ......................................................................................................................................... 19 
7. 
Subject Population ............................................................................................................................................................. 20 
7.1 
Population Overview ............................................................................................................................................... 20 
7.2 
Eligibility Criteria (Inclusion and Exclusion Criteria) ................................................................................................ 21 
7.2.1 
Inclusion Criteria ................................................................................................................................................ 21 
7.2.2 
Exclusion Criteria ............................................................................................................................................... 22 
7.3 
Subject Reimbursement ......................................................................................................................................... 23 
7.4 
Subject Recruitment ............................................................................................................................................... 23 
7.5 
Subject Informed Consent ...................................................................................................................................... 23 
8. 
Procedures and Assessments .......................................................................................................................................... 24 
8.1 
Initial Screening ...................................................................................................................................................... 24 
8.2 
Active Screening ..................................................................................................................................................... 24 
8.3 
Baseline Assessment ............................................................................................................................................. 25 
8.3.1 
Prior to Enrollment ............................................................................................................................................. 25 
8.3.2 
After Confirmation of Eligibility ........................................................................................................................... 26 
8.4 
Roll-In Cohort .......................................................................................................................................................... 26 
8.5 
Randomization Cohort ............................................................................................................................................ 26 
8.5.1 
Randomization Process ..................................................................................................................................... 26 
8.5.2 
Blinding .............................................................................................................................................................. 27 
8.6 
Enrollment ............................................................................................................................................................... 28 
8.6.1 
Screen Failures .................................................................................................................................................. 28 
8.7 
Procedure ............................................................................................................................................................... 29 
8.7.1 
Immediately Pre-Treatment ............................................................................................................................... 29 
8.7.2 
Patch Application ............................................................................................................................................... 30 
8.7.3 
Immediately Post-Treatment .............................................................................................................................. 31 
8.7.4 
Treatment of the Second Axilla .......................................................................................................................... 31 
8.7.5 
Subject Care and Medications ........................................................................................................................... 31 
8.8 
Follow-up Evaluations ............................................................................................................................................. 32 
8.9 
Extended Follow-Up Cohort .................................................................................................................................... 33 
8.10 
Study Exit or Premature Withdrawal ....................................................................................................................... 35 
9. 
Statistical Methods ............................................................................................................................................................. 36 
9.1 
General Statistical Analysis Methods ..................................................................................................................... 36 
9.2 
Study Design, Randomization and Blinding ............................................................................................................ 36 
9.3 
Sample Size and Power Considerations ................................................................................................................ 36 

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9.4 
Study Success ........................................................................................................................................................ 37 
9.5 
Analysis Sets / Populations .................................................................................................................................... 37 
9.5.1 
Roll-in Cohort ..................................................................................................................................................... 37 
9.5.2 
Intent-to-Treat Population .................................................................................................................................. 37 
9.5.3 
Safety Population ............................................................................................................................................... 37 
9.5.4 
Modified Intent-to-Treat and Full Analysis Set ................................................................................................... 37 
9.5.5 
Per-Protocol Set ................................................................................................................................................. 37 
9.6 
Timing of Analyses ................................................................................................................................................. 38 
9.7 
Assessment of Comparability of Randomized Groups and Evaluation for Pooling ................................................ 38 
9.7.1 
Demographics / Baseline Characteristics and Protocol Administration ............................................................. 38 
9.7.2 
Treatment Characteristics .................................................................................................................................. 38 
9.7.3 
Evaluation for Pooling ........................................................................................................................................ 38 
9.8 
Handling of Missing Data for the Primary Efficacy Endpoint .................................................................................. 39 
9.9 
Primary Safety Analysis .......................................................................................................................................... 39 
9.10 
Efficacy Analysis ..................................................................................................................................................... 39 
9.10.1 
Primary Efficacy ................................................................................................................................................. 39 
9.10.2 
Secondary Efficacy ............................................................................................................................................ 41 
9.10.3 
Observational Endpoints .................................................................................................................................... 45 
9.11 
Specification of Subgroups for Analysis ................................................................................................................. 45 
10. 
Adverse Events .................................................................................................................................................................. 46 
10.1 
Definitions ............................................................................................................................................................... 46 
10.1.1 
Adverse Events .................................................................................................................................................. 46 
10.1.2 
Adverse Device Events ...................................................................................................................................... 46 
10.1.3 
Serious Adverse Events ..................................................................................................................................... 46 
10.1.4 
Serious Adverse Device Events ......................................................................................................................... 47 
10.1.5 
Device Deficiency .............................................................................................................................................. 47 
10.1.6 
Unanticipated Adverse Device Events ............................................................................................................... 47 
10.2 
Adverse Event Review by Investigator ................................................................................................................... 47 
10.2.1 
Severity .............................................................................................................................................................. 47 
10.2.2 
Relationship to N-SWEAT Patch ....................................................................................................................... 48 
10.3 
Adverse Event Reporting ........................................................................................................................................ 48 
10.4 
Independent Adverse Event Review ....................................................................................................................... 49 
11. 
Risk-Benefit Assessment .................................................................................................................................................. 50 
11.1 
Potential Benefits .................................................................................................................................................... 50 
11.2 
Potential Risks ........................................................................................................................................................ 50 
11.3 
Minimization of Anticipated Risks ........................................................................................................................... 50 
11.4 
Protocol Compliance ............................................................................................................................................... 51 
11.5 
Safety-Related Stopping Rules ............................................................................................................................... 51 
12. 
Study Management ............................................................................................................................................................ 53 
12.1 
Key Study Contributors ........................................................................................................................................... 53 
12.2 
Regulatory Considerations ..................................................................................................................................... 53 
12.3 
Approved Informed Consent ................................................................................................................................... 53 
12.4 
IRB Approval ........................................................................................................................................................... 53 
12.5 
Amendment to the Study Protocol .......................................................................................................................... 54 
12.6 
Protocol Deviation ................................................................................................................................................... 54 
12.7 
Investigational Device Accountability ...................................................................................................................... 54 
12.7.1 
Device Records .................................................................................................................................................. 54 
12.7.2 
Device Use ......................................................................................................................................................... 55 
12.7.3 
Device Return .................................................................................................................................................... 55 
12.8 
Training ................................................................................................................................................................... 55 
12.8.1 
Site Training ....................................................................................................................................................... 55 
12.8.2 
Monitor Training ................................................................................................................................................. 55 
12.9 
Monitoring ............................................................................................................................................................... 55 
12.10 
Ethical Considerations ............................................................................................................................................ 56 
12.11 
Protection of Subject Confidentiality ....................................................................................................................... 56 
12.12 
Quality Assurance and Supervision by Authorities ................................................................................................. 57 

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12.13 
Corrective and Preventative Action ........................................................................................................................ 57 
12.14 
Insurance ................................................................................................................................................................ 57 
13. 
Responsibilities .................................................................................................................................................................. 58 
13.1 
Sponsor Responsibilities ........................................................................................................................................ 58 
13.2 
Sponsor Maintenance of Study Records ................................................................................................................ 59 
13.3 
Investigator Responsibilities ................................................................................................................................... 59 
13.4 
Investigator Reports ................................................................................................................................................ 60 
13.5 
Required Documents from the Investigator ............................................................................................................ 60 
13.6 
Other Investigator Reports ...................................................................................................................................... 60 
14. 
Data Management ............................................................................................................................................................... 61 
14.1 
Data Management Responsibilities ........................................................................................................................ 61 
14.2 
Data Entry ............................................................................................................................................................... 61 
14.3 
Data Cleaning ......................................................................................................................................................... 61 
14.4 
Data Retention and Back-up ................................................................................................................................... 61 
14.5 
Confidentiality and Security .................................................................................................................................... 61 
15. 
Study Close-Out ................................................................................................................................................................. 62 
15.1 
Study Suspension or Early Termination ................................................................................................................. 62 
15.2 
Final Report ............................................................................................................................................................ 62 
15.3 
Publication Policy .................................................................................................................................................... 62 
16. 
Abbreviations ..................................................................................................................................................................... 63 
17. 
References .......................................................................................................................................................................... 64 
 
Table of Tables 
Table 1.  Inclusion Criteria .......................................................................................................................... 21 
Table 2.  Exclusion Criteria ......................................................................................................................... 22 
Table 3.  Visit Windows ............................................................................................................................... 33 
Table 4.  Follow-Up Assessments .............................................................................................................. 33 
Table 5.  Subject Visit Schedule ................................................................................................................. 34 
Table 6.  AE Severity .................................................................................................................................. 48 
Table 7.  AE Relationship to Device ........................................................................................................... 48 
Table 8:  Skin Erythema Assessment ......................................................................................................... 66 
Table 9:  Clinical Signs/Symptom Descriptors ............................................................................................ 67 
Table of Figures 
Figure 1.  Diagram of the N-SWEAT Patch ................................................................................................ 15 
Figure 2:  Enrollment Flowchart, Initial Screening through Treatment ....................................................... 29 
Figure 3. Wong-Baker FACES® Pain Rating Scale ................................................................................... 31 
 
Table of Appendices 
APPENDIX A:  HDSS Survey and Instructions 
APPENDIX B:  Assessment for Local Skin Reactions  
APPENDIX C:  QoL Surveys and Instructions 
APPENDIX D:  Instructions for GSP Assessment  
APPENDIX E:  Fitzpatrick Skin Type  
APPENDIX F:  Sample Patient Diary  
APPENDIX G:  Subject Take-Home Care Hand-outs 
APPENDIX H:  Referral to Burn Center 
APPENDIX I:  Recruitment Poster/flyers (RANDOMIZED COHORT) 
APPENDIX J: DSMB Qualifications 
APPENDIX K: N-SWEAT IFU 
APPENDIX L:  pH Sub-Study Protocol (Participating Centers Only) 

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SAHARA STUDY INVESTIGATOR SIGNATURE PAGE 
 
An Evaluation of the Safety and Effectiveness of the N-SWEAT Patch for 
the Treatment of Excessive Axillary Sweating or Primary Axillary 
Hyperhidrosis  
 
 
 
Investigator Attestation of Receipt and Understanding 
 
 
I, the undersigned, certify that I have reviewed and understand the contents of this protocol and 
further agree to abide by the terms described herein.  I am in receipt of and understand the 
contents of the below-listed items:   
 
 
The Sahara Study Protocol Version: _______________________ 
 
N-SWEAT Instructions for Use (IFU) 
 
Case Report Forms (CRFs) 
 
Subject Information Sheet and Informed Consent (ICF) 
 
In addition, I agree to follow the US Food and Drug Administration (FDA) Regulations, the 
ethical principles according to the Declaration of Helsinki and The Belmont Report, Good 
Clinical Practice (GCP) guidelines as applicable (E6 Consolidated Guidance R2) as well as 
any conditions imposed by the reviewing Institutional Review Board (IRB), US FDA, or other 
regulatory agency. 
 
Agreed to by (print name):  _____________________   
 
 
Signature:  ___________________________________  Date: _________________________ 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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3. INTRODUCTION AND BACKGROUND   
 
 
3.1 The Population: 
One-third of adults in the United States believe they sweat too much under their arms 
according to the International Hyperhidrosis Society (IHHS), (Glaser 2018).  Based on 
the 2015 census, this equates to roughly 33 million sufferers in the United States.  Many 
of the people who report heavy sweating have a clinical diagnosis of hyperhidrosis. 
People with primary hyperhidrosis generally sweat from a certain type of sweat gland 
called eccrine sweat glands (Strutton 2004, Hornberger 2004).   These sweat glands 
make up the majority of the 2-4 million sweat glands in the human body. Eccrine sweat 
glands are particularly numerous on the feet, palms, face, and armpit. The prevalence 
of the condition of hyperhidrosis is reported to be 4.8% in the United States (15.3 million 
people). Hyperhidrosis is most prevalent in the age 18-39 group (8.8%) and axillae as 
the most commonly affected area (65%) (Doolittle 2016). Those who sweat excessively 
report a significant negative impact on quality of life ranging from bothersome to 
debilitating (Wade 2017, Hamm 2014).   
Evidence suggests that the disease of hyperhidrosis is both underreported and 
underdiagnosed.  Data indicate that only about 50% of hyperhidrotic patients discuss 
their sweating with a physician and, ultimately, only 27% of actual sufferers will be 
diagnosed with the condition.  Many believe that their sweating does not equate to a 
medical condition and/or that there that there is nothing that can be done to reduce their 
sweating (Doolittle, 2016). Thus, there is a large population of patients with excessive 
axillary sweating that could potentially benefit from treatment but have not been 
diagnosed with primary axillary hyperhidrosis.   
This Sahara study is therefore designed to reach all patients with excessive axillary 
sweating regardless of a diagnosis.  Subject will be required to have a Hyperhidrosis 
Disease Severity Scale (HDSS) Score of 3 or 4 which indicates that sweating is at a 
level that is considered barely tolerable or intolerable and that sweating frequently or 
always interferes with the daily life of the patient.  This study population will permit the 
largest and most diverse set of patients and is therefore the most appropriate to confirm 
the safety and understand the efficacy of the N-SWEAT Patch for the reduction of 
axillary sweating.   
3.2    The Unmet Need: 
Currently, the first line of treatment for axillary hyperhidrosis is over-the-counter 
antiperspirants, while effective for normal sweaters, do not provide an adequate solution 
for most sufferers and are often irritating.  Off-label administration of oral anticholinergic 
medications and topical application with glyopyrronium wipes typically require daily 
administration and have unappealing systemic side effects. Currently available in-office 
procedures (including botulinum toxin injections and use of microwave energy), 
although effective, can be painful and prohibitively expensive.  Moreover, a 2016 IHHS 
survey showed that even though 87.2% of the 1,985 survey participants had received 
some form of treatment for their excessive sweating, satisfaction with the treatments 
received a mean score of “below satisfied” (Glaser 2018).   Thus, despite some 

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currently effective treatments to reduce sweating, there remains a need for additional 
options to help patients reduce axillary sweating for these patients with an approach 
that is easy to administer with minimal side effects.   
To this end, Candesant Biomedical has developed the CDX-101 Patch, which has been 
renamed the N-SWEAT Patch.  This is a non-invasive topical device designed to reduce 
sweat production in patients who report heavy sweating in the underarms.  The patch is 
applied in a physician’s office to the axillae for up to 3-minutes.  During treatment, the 
patch will generate thermal energy in the presence of sweat and is designed to target 
the sweat glands for inactivation. After this treatment, the patch is completely removed 
and disposed of by medical staff.    
3.3  Early Evidence for N-SWEAT Patch:  
The N-SWEAT patch (previously called the CDX-101 Patch) was studied in a feasibility 
study in which 12 subjects (both axillae) were successfully treated; 4 of these subjects 
received an optional (both axillae) retreatment procedure after the initial study period.  
Thus, a total of 32 Patches were used during this study: 24 in the initial treatments and 
8 during the retreatments.  Technical feasibility of heat generation was demonstrated 
across all treatments. The safety endpoint of the study was also met in all patients.  
There were no serious adverse events (SAEs) reported in the study.  Only two (2) 
device related adverse events were reported; both were deemed mild.  Efficacy as 
measured by a 1-point improvement in HDSS was observed in 91% (11/12) subjects, 
64% of the subjects achieved HDSS scores of 1 or 2 at the end of the evaluation period 
(6-weeks).   Mean gravimetric sweat production was reduced an average of 68% across 
the 6-week follow-up period. QoL survey results showed a consistent trend with the 
majority of subjects reporting improvement across all measures.  Device tolerability was 
confirmed with all subjects reporting an acceptable level of pain during the procedure.   
The outcomes of the STAYDRI.1 Study led the company to the decision to initiate a pilot 
study with a control group (STAYDRI.A).  STAYDRI.A was a prospective, randomized, 
controlled, double-blinded pilot study, conducted under IRB approval with a non-
significant risk designation.  Sixteen (16) subjects were successfully randomized (1:1) 
and treated bilaterally, with both axillae receiving the same treatment; 8 subjects (16 
axillae) with the N-SWEAT patch and 8 subjects (16 axillae) with the sham patch. 
Subjects and evaluating clinicians were blinded to the assigned treatment. The device 
was shown to be safe with only one (1) device-related AE observed in the N-SWEAT 
treatment group; the AE was deemed moderate and resolved without sequelae.  There 
were no serious adverse events (SAEs) reported during the study.  The efficacy 
endpoints of the study were also successful.  Subjects treated with the N-SWEAT patch 
demonstrated consistent and sustained improvement in HDSS and additional QoL 
measurements.  A post hoc analysis demonstrated a statistically significant difference in 
subjects with a 2-point improvement in HDSS between the treated and sham groups, 
67% vs 0% respectively at 4-weeks (p=0.0123).  Further, 83% of treated subjects 
reported a HDSS score of 1 or 2 at 4-weeks versus 0% in the sham control (p=0.0032).  
Moreover, improvements in both level of “bother” and “impact on daily living” were 
sustained throughout the study with the difference in QoL scores between the treated 
and sham groups increasing over the follow-up period.  Finally, at the end of the study 

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(6-weeks) 66.7% of N-SWEAT treated subjects demonstrated a reduction in GSP that 
was ≥50%.  Interestingly, subjects treated with the sham also exhibited a reduction in 
GSP (mean 44% / median 46%/ ≥50% reduction 14%).  It is important to note that 
subjects treated with the sham did not have corresponding improvements in the QoL 
assessments as measured by either HDSS or any of the QoL questionnaires.  This 
finding, while on the surface contradictory, is consistent with recent published reports 
that gravimetric sweat production may not be clinically meaningful in determining the 
level of disease.   
 
By these two studies, the N-SWEAT device has demonstrated a favorable safety profile. 
No SAEs have been reported to date. Three (3) total device-related events that 
occurred in this cumulative data set (2 mild and 1 moderate) were all skin reactions that 
were treated topically, and all resolved without sequalae. Moreover, data on the 
subjects’ condition after treatment including HDSS and QoL assessments are also 
consistent; subjects largely feel like their condition is improved. 
These findings establish acute safety and suggest effectiveness sufficiently to warrant 
the initiation of this pivotal trial; the SAHARA Study is intended to confirm safety and 
further demonstrate efficacy of the N-SWEAT Patch in a larger multi-center 
representative population.   
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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4. N-SWEAT PATCH INFORMATION 
 
4.1   Indications For Use  
N-SWEAT Patch is indicated for treatment of excessive axillary sweating or primary 
axillary hyperhidrosis in individuals 22 years of age or older.   
The N-SWEAT Patch requires a prescription. 
4.2     Description of the N-SWEAT Patch 
The N-SWEAT Patch consists of three (3) layers (Figure 1): a thin layer of alkali metal 
foil (active), an adhesive backing (which helps the patch stay in place during treatment) 
and a protective barrier layer.  The barrier layer protects the patch during storage and is 
removed and discarded immediately prior to the treatment.  The N-SWEAT Patch is 
single-use.   
Figure 1.  Diagram of the N-SWEAT Patch 
 
 
The device is provided non-sterile and is not intended to be sterilized. 
There are no accessories, software, or other equipment with the N-SWEAT Patch. 
4.3 
Mechanism of Action 
The N-SWEAT Patch is a non-invasive, topical patch designed to target and temporarily 
inactivate sweat glands using thermal energy, leading to reduced sweat production. 
The N-SWEAT Patch is applied to the surface of dry, unabraded, intact skin by trained 
clinicians.  The patch is activated by water released from sweat glands.  When sweat 
(comprised of up to 99% water, Wilke et al. 2007) comes into contact with the patch, the 
sodium interacts with the water causing the patch to generate thermal energy.  The 
amount and precise location of heat produced depends on the amount and location of 
sweat with which the patch comes into contact.  In the absence of sweat (water), no 
thermal energy is generated. 
Release tab 
Alkali metal foil
Adhesive backing 
Release liner 

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The patch is applied for up to 3 minutes.  Removal may occur prior to the 3-minute time 
point if the patient experiences pain or discomfort (as described in the Instructions for 
Use (IFU)).   
The duration of the effect of the N-SWEAT patch is expected to be 6-8 weeks on 
average although early clinical data showed some patients maintained reduced sweat at 
8-10 weeks. Duration time will be elucidated by this clinical study.   
The N-SWEAT Patch is an Investigational Device and is limited by law for use only for 
subjects enrolled in an approved clinical study.   
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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5. 
STUDY OBJECTIVE 
 
The primary objective of this study is to evaluate the safety and effectiveness of the N-
SWEAT Patch in subjects who experience excessive sweating.  The study is designed 
to confirm device safety shown in previous clinical studies and to demonstrate that the 
cohort of subjects treated with the N-SWEAT Patch will experience a reduction in 
sweating relative to sham treated controls.   
 
The study will begin with a roll-in cohort of 10 subjects treated with the N-SWEAT 
device at one study site.  After enrollment into this cohort is complete, adverse event 
data will be compiled and analyzed.  Enrollment into the randomized cohort will 
commence after these safety data have been reviewed.   
 
This prospective, multi-center, controlled, randomized, blinded, pivotal clinical study is 
intended to demonstrate sufficient safety and effectiveness of the N-SWEAT Patch for 
use in subjects with excessive sweating in order to obtain regulatory approval for 
marketing in the United States and certain other jurisdictions.     
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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6. STUDY ENDPOINTS   
 
6.1   Safety Assessment 
Safety will be confirmed by an assessment of the occurrence of local skin reactions, 
treatment-related AEs and SAEs for all subjects treated with the N-SWEAT device. 
Local skin reactions are defined by the criteria shown in Appendix B.  AE and SAEs 
are defined in Section 10 of this protocol.   
Safety data from the roll-in cohort will be compiled and analyzed after all 10 subjects 
have completed 2-week and 4-week follow-up.  Safety data from the roll-in cohort and 
the randomized cohort will be pooled.   
 
After the 30th, 60th, and 90th subject from the randomized cohort (active and control) is 
treated and followed for 7 days, the running safety report will be submitted to FDA.  The 
report will be submitted within 30 days of treatment.   
 
The interval safety report will include: 
1. Cumulative frequency tables of all AE reported to date for the active patch, and all the 
AE reported to date for the sham patch, using the terminology in Table 9; and   
 
2. A list of AEs in the recently completed 30-subject cohort, to include the device used 
(active or control), time to onset, time to resolution, intervention (including OTC product 
use), whether the AE was procedure- or device-related, and descriptive and 
photographic data. 
 
6.2   Primary Efficacy Endpoint 
Proportion of subjects in the randomized cohort with Hyperhidrosis Disease Severity 
Scale (HDSS) of 1 or 2 at the 4-weeks follow-up visit by treatment group.  HDSS 
Scoring is shown in Appendix A.   
 
6.3     Secondary Efficacy Endpoints 
For sequential hypothesis testing; the primary analysis time point is 4-weeks. 
1. Mean improvement in QoL scale Bother by treatment group (randomized cohort) 
2. Mean improvement in QoL scale Impact by treatment group (randomized cohort) 
3. Proportion of patients with improvement of at least 2 grades from baseline to 4-
weeks in HDSS by treatment group (randomized cohort) 
4. Proportion of N-SWEAT treated subjects in the randomized cohort with at least 
50% improvement in gravimetric sweat production (both axilla combined) (GSP) 
from baseline to 4-weeks.  
All secondary (and primary) endpoints will also be analyzed at all available time points.  
QoL surveys are included in Appendix C.  Instructions for GSP measurements are 
provided in Appendix D.   
 

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6.4   Observational Endpoints 
 Baseline-adjusted mean improvement in QoL-7 instrument assessed by 
treatment group (randomized cohort) 
 Composite - proportion of patients with HDSS 1 or 2 AND 50% improvement in 
GSP assessed by treatment group (randomized cohort) 
 Composite - proportion of patients with HDSS 1 or 2 AND 75% improvement in 
GSP assessed by treatment group (randomized cohort) 
 Duration of efficacy:  time from treatment to first observed reversion to HDSS 3 
or 4 (median duration of efficacy will be calculated) for all N-SWEAT treated 
subjects.  Also performed for first reversion to subject’s baseline HDSS. 
 Mean change from baseline over time in GSP compared between treatment 
groups (randomized cohort); Change in GSP at individual timepoints. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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7. SUBJECT POPULATION 
7.1 
Population Overview 
Healthy male and female subjects in good general health who sweat excessively in the 
axillae and/or who have primary axillary focal hyperhidrosis, defined as subjects with 
HDSS score of 3 or 4, will be considered for study participation.   
The first 10 subjects will be treated with the N-SWEAT Patch and enrolled into the Roll-
In Cohort.  Subsequently, subjects will be enrolled into the Randomized Cohort and will 
be randomized for bilateral treatment with either the N-SWEAT Patch or the Sham 
control patch.   
Subjects enrolled in the study will agree to refrain from the use of over-the counter 
antiperspirants and the use of any topical steroids or any systemic treatment that may 
impact their hyperhidrosis symptoms during their participation in this study.  Subjects 
will also be required to have axillary hair clipped or shaven prior to GSP assessments at 
the screening and the 4-week visits.     
Subjects will be asked to keep a daily written dairy for the first 4 weeks and to answer 
weekly surveys related to their axillary sweating; including the HDSS survey and the 
Quality of Life surveys  (QOL-7, QoL-Impact, Bother, etc) using electronic means (i.e. 
their cell phone, tablet or computer).   
The subject will also be required to report for study visits including screening, baseline 
(on the day of treatment), 2-3 days after treatment, and a 4-week post treatment follow-
up visit.  Additional visits at 6-, 8-, 10-, and 12-weeks are recommended to take place in 
person but may be conducted by phone if an office visit is not possible or practical. 
Ten (10) subjects will be included in the Roll-In Cohort at 1 study site and up to 110 
subjects will be included in the Randomized Cohort at up to 14 study sites.  At least 50 
subjects randomized to each group must undergo the assigned treatment.  Up to 10 
additional subjects may be randomized to account for loss to follow up or other missing 
and critical data.   
Candesant intends to enroll a population with demographics representative of the US.   
Enrollment will be observed to ensure that at least 20% of subjects are Fitzpatrick Skin 
Types IV through VI and that 10-15% of subjects are Fitzpatrick Skin Types V and VI. 
 
 
 
 
 

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7.2 
Eligibility Criteria (Inclusion and Exclusion Criteria) 
Subjects considered for enrollment must demonstrate eligibility as outlined below.  
Documented evidence of eligibility is required and must be housed with the subject’s 
study records. 
7.2.1 
Inclusion Criteria 
The subject must meet all of the criteria listed below at the time of enrollment 
Table 1. Inclusion Criteria 
I-1 Signed written informed consent, including authorization to release health information.  (Subject 
must be able to read informed consent independently since subjective feedback is required) 
I-2
Subject is at least 22 years old at the time of consent
I-3 Female or male, who experiences excessive sweating or has been diagnosed with primary 
focal hyperhidrosis of the axilla and is in otherwise good general health
I-4 GSP >50mg/5min at room temperature/humidity (20-25.6°C/20-80%) at both screening and 
baseline
I-5
Subject reports a score of HDSS score of 3 or 4 at both screening and baseline
I-6 Subject agrees to avoid use of topical aluminum compounds, antiperspirants, anticholinergic 
medications or steroids for the duration of study participation
I-7 Subject is willing and able to follow instructions and likely to complete all requirements for the 
study, including hair removal requirements
I-8 
Women of child-bearing age must have a negative pregnancy test at screening and must be 
practicing and willing to continue an effective method of birth control from screening visit until 
study completion.   
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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7.2.2 
Exclusion Criteria 
If any of the following criteria exist, the subject is not eligible for participation in the 
study.   
Table 2.  Exclusion Criteria 
ELIGIBILITY: EXCLUSION CRITERIA
E-1 
Active skin disease, irritation, or abrasions at either axilla based on physical examination by 
physician at baseline.  
E-2 
Subject’s medical history is indicative of secondary or diffuse hyperhidrosis and/or subject 
has a diagnosis of secondary or diffuse hyperhidrosis   
E-3
GSP exceeds 300 mg/5 min in either axilla at either screening or baseline
E-4
GSP readings differ by more than 100% in either axilla between screening and baseline.
E-5 
Hair bearing area of the axillae is more than 6 in length and/or 2.75 in width or is not able to 
be fully covered by the active (foil) area of one study patch
E-6
Treatment with botulinum toxin for excessive sweating or hyperhidrosis within 1 year
E-7 
Undergone any procedures, including for hyperhidrosis, which may affect the axillary areas 
(e.g., laser hair removal within the last 3 months; or Skoog procedure, any type of 
sympathectomy, gland excision, or other surgery; thermolysis, liposuction; or iontophoresis) 
or is planning to undergo any of these procedures during the course of the study
E-8 
Use of prescription, prescription strength, or clinical strength topical aluminum compounds 
for axillary hyperhidrosis (e.g., Maxim, Drysol, Certain Dri) for 30 days prior to screening 
E-9 
Use of over-the-counter antiperspirants and antiperspirant deodorants for 2 days prior to 
screening 
E-10 
Concurrent use of anticholinergic medications (including Qbrexza, glycopyrronium, 
glycopyrrolate, clonidine, atropine, Bellargal-S), beta blockers, calcium channel blockers, or 
other topical or systemic treatments that may affect hyperhidrosis symptoms starting at 
screening visit  
E-11 
Use of a topical steroid on either of the treatment areas (e.g., hydrocortisone, triamcinolone) 
within 14 days prior to screening 
E-12 
Presence of a psychological disorder which may interfere with perception of self or 
perception of severity of sweating  
E13
Use of neuromodulator (e.g. Botox, Dysport, Xeomin) to the hands in the prior 12 months
E-14 
Patients with unevaluated lymphadenitis or enlarged lymph nodes should also not be 
enrolled in case the lymph nodes are reactive or potentially indicative of cancer
E-15
Subjects with allergy to any of the ingredients of the patch
E-16 
Patients with conditions or prior treatments in the axilla that may limit the feeling of pain right 
away or are associated with decreased sensitivity, (e.g. diabetic patients or patients with any 
other neurological diseases)
E-17 
Patients at risk for scarring, collagen vascular diseases, Hidradenitis suppurativa. Patients 
treated with isotretinoin may also experience severe scarring
 
 
 
 
 

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7.3 
Subject Reimbursement 
Subjects that participate in and complete the study visits per protocol will be 
compensated for their time and contribution.  Subject compensation details will be 
outlined in the site-specific Informed Consent Form (ICF).  Payment will only be made 
for those visits or activities completed.  Subjects will not be compensated for missed or 
incomplete visits, unless extenuating circumstances warrant payment.     
7.4 
Subject Recruitment 
This study may recruit subjects through in-office, online, or other advertising and 
through existing clients or patients.  Any advertising materials to be utilized will be 
approved by the governing Institutional Review Board (IRB) prior to use.   
7.5 
Subject Informed Consent 
All subjects participating in the Sahara study must provide written informed consent.  
The investigator or a designated member of his/her staff will approach subjects to obtain 
this consent and will answer any questions that the subject has.  The background of the 
proposed study and the potential benefits and known risks of the procedures and study 
will be explained to the subject in a written ICF.  The ICF will describe all aspects that 
are relevant to participation.  The ICF will be reviewed and approved by the IRB prior to 
use. 
The subject and the authorized study personnel obtaining informed consent must sign 
and date the ICF, and a copy must be provided to the subject.  Written informed 
consent must be obtained prior to performing any protocol-driven tests or procedures.  
Once written consent has been obtained, the subject will be entered onto a site-specific 
screening log.  All subjects who provide written informed consent will be entered onto 
the screening log regardless of whether or not they are enrolled into the study.  
A legally authorized representative will not be permitted to provide consent on behalf of 
study subjects in the Sahara Study.  The subject must be able to provide active 
feedback on tolerability during the treatment and must be able to read independently in 
order to provide accurate and subjective feedback during follow-up surveys.   
 
 
 
 
 
 
 
 
 

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8. 
PROCEDURES AND ASSESSMENTS 
8.1    Initial Screening 
 
Prior to obtaining written informed consent, the subject’s existing medical (or other 
clinic) records may be reviewed to determine whether or not the subject might be an 
acceptable candidate for the Sahara Study.  If initial review indicates that the subject 
may be eligible, the subject may be approached regarding the study, and the informed 
consent process may commence.   
Once the subject has provided consent, a screening visit may be scheduled to conduct 
final screening assessments.  Note that requirements for cessation of other treatments 
may require a lead time for scheduling this visit.   
 
8.2    Active Screening 
Active study screening will begin at a screening visit.  Assessments conducted at this 
visit will include the following: 
 History and Demographics:  General inclusion and exclusion criteria review 
and health evaluation to ensure that the subject is not planning to undergo a 
surgical procedure during their expected participation in the study, is not actively 
participating in another clinical study that may confound the results of this study, 
and is willing to comply with the requirements should be conducted first.  Only 
after these qualifications are met; should the following 2 assessments (GSP and 
HDSS) be conducted.     
o NOTE:  If excessive hair is present on the axilla at the screening visit the 
hair shall be clipped or shaven during this visit prior to conducting 
assessments.  Stubble or minimal hair is acceptable.   
 GSP:  Gravimetric sweat production should be measured in accordance with 
instructions and training provided by the sponsor (Appendix D).  Any deviation 
from this procedure should be documented and explained.  In summary, 
measurements will be obtained following a period of rest in normal room 
temperature. Subjects will have a pre-weighed filter paper placed in each of their 
axillae for 5 minutes. The difference in the filter paper’s weight before and after 
will be considered the GSP measurement.   
o At the baseline, the GSP assessment is required to show at least 50 mg/5 
min of spontaneous resting axillary sweat production in each axilla and no 
more than 300 mg/5 min in either axilla.   
 HDSS: The Hyperhidrosis Disease Severity Scale should be explained to the 
subject in plain language and in accordance with the instructions and training 
provided by the sponsor (Appendix A).  It should be clear to the subject that they 
are answering these questions to report on their underarm sweating.  The subject 
will be asked to take this test weekly throughout the study via questionnaire that 
will be sent electronically by cell phone, tablet, or computer.   
o At the baseline visit, Subject HDSS score be 3 or 4 

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 Pregnancy Test:  Women of child-bearing potential with no history of 
hysterectomy are required to have a negative pregnancy test and must be 
practicing and willing to continue using an effective method of birth control from 
screening visit until study completion.   
 Assessment for Local Skin Reactions:  The investigator will evaluate axillary 
application sites for any skin irritation. If present (greater than 1) based on the Skin 
Erythema Assessment and the Clinical Signs/Symptom Descriptors (Appendix B), 
the subject may only be treated once the issue has been resolved (less than or 
equal to 1).  
 
Once the subject has completed these initial assessments and has been deemed 
eligible, the subject will be scheduled to report back for baseline assessment and 
potential Treatment.  The baseline/treatment assessment must be scheduled at least 72 
hours after any hair removal. All subjects should be provided with clear instructions that 
no shaving or clipping shall be conducted within 72 hours of the scheduled 
baseline/treatment visit.  The presence of stubble is acceptable.   
An approved deodorant (without antiperspirant) will be provided to all eligible subjects at 
the conclusion of this visit; this deodorant should be used by the subject starting at the 
screening visit through the duration of their participation in the study. If the subject 
wishes to use a different deodorant; it must be approved by the sponsor.  
 
8.3    Baseline Assessment  
8.3.1 
Prior to Enrollment 
No more than 14 days after the screening visit the subject will report for baseline 
assessment and potential treatment. (NOTE: If axillary hair was clipped at the 
screening visit, the baseline visit must be at least 72 hours later).  All efforts should 
be taken to make sure that the subject is prepared to undergo treatment during this 
visit if they meet the eligibility requirements below.   
Baseline Assessments include:  
 GSP:  Gravimetric sweat production should be measured in accordance with the 
instructions and training provided by the sponsor (Appendix D).  Any deviation 
from this procedure should be documented and explained.   
o At baseline, subject GSP assessment is required to show at least 50 mg 
/5min of spontaneous resting axillary sweat production in each axilla and 
no more than 300 mg/5 min in either axilla.  The difference between 
screening and baseline for either axilla may not be >100%.   
 HDSS:  The Hyperhidrosis Disease Severity Scale should be explained to the 
subject in plain language and in accordance with the instructions and training 
provided by the sponsor (Appendix A).  It must be clear that these questions 
relate to underarm sweating.   
o Subject HDSS score must be 3 or 4 

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 Physical Exam:  The subject must be in good general health and able to 
independently assess their sweating in a reasonable way. 
 Assessment for Local Skin Reactions:  The investigator will evaluate axillary 
application sites for any skin irritation. If present (greater than 1) based on the Skin 
Erythema Assessment and the Clinical Signs/Symptom Descriptors (Appendix B), 
the subject may only be treated after the issue has been resolved (less than or 
equal to 1).  
o NOTE:  If abrasions or broken skin are present; the subject may report 
back for re-screening after the skin has had time to heal (at least 72 
hours).  Treatment in the study in the presence of skin irritations or 
abrasions can lead to increased probability of the patient experiencing 
discomfort, pain or skin irritations.   
o NOTE: The subject must meet the criteria above in both axilla since the 
study treatment includes treatment of both axillae in the same procedure.   
Once the subject has completed these assessments and has been deemed eligible, 
the subject can be treated as party of either the Roll-In Cohort or the Randomized 
Cohort and will be considered enrolled as described below.    All efforts should be 
taken for treatment to occur on the same day.  If the subject is not able to have 
treatment on the same day as the baseline visit and is in the Randomized Cohort, 
randomization should not take place.  Randomization should occur immediately 
before treatment.    
8.3.2 
After Confirmation of Eligibility  
The Quality of Life (QoL) questionnaires should be completed by the patient to 
establish the baseline condition.  QOL surveys will include: QOL-7, which has a total 
of 7 questions, QOL (Bother and Impact) which has 2 questions total and an 
additional survey with up to 5 QoL assessment questions may be included to collect 
informative data on the patient population.  If possible, the subject should complete 
these surveys electronically.   
 
8.4 Roll-In Cohort 
Subjects in this cohort are enrolled once they undergo treatment with the N-SWEAT 
Patch.   
 
8.5 Randomization Cohort 
8.5.1 
Randomization Process 
Note:  Randomization should take place immediately before treatment.  If a subject 
meets all eligibility criteria at the screening and baseline visits; but is unable or 
unwilling to undergo treatment.  Do not randomize.  The subject should report back 
for randomization at the time of their planned treatment.  If it is more than 7 days 

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between the qualifying baseline visit and randomization; the HDSS and the physical 
exam should be repeated to confirm eligibility prior to Randomization.   
Randomization will be performed using an electronic system.  Upon entering the 
subject information, the electronic system will assign a unique treatment to the 
subject.  The subject must be treated with the assigned treatment number.  In the 
event that the site is prevented from using the assigned treatment number (either 
due to the patch being missing, damaged or otherwise unusable) the site must 
contact the sponsor to receive an alternate treatment number assignment.  A contact 
list will be provided for this purpose.   
Subjects will be randomized 1:1 to either an active study N-SWEAT Patch 
(Treatment) or a sham patch (Sham).  There will be no procedural difference 
between the Treatment Arm and the Sham Arm.  The randomization will be stratified 
by HDSS 3 vs. 4 at baseline and blocked by investigational center.  Within each 
HDSS stratum, block randomization with a randomly selected block size will be 
used.  Up to 110 subjects will be randomized.  At least 50 subjects randomized to 
each group must be evaluable for the primary efficacy endpoint.  Up to 10 additional 
subjects may be enrolled to account for loss to follow up or other missing and critical 
data. 
Crossovers are not permitted by this protocol.  Subjects may only receive the N-
SWEAT Patch if they are randomized to do so.   
8.5.2 
Blinding  
Subjects in the randomized cohort will be blinded to the Study Arm to which they are 
randomized.    
Site personnel will not be informed of the specific Study Arm assignment (they will 
only know the treatment # assigned); those administering the treatment will observe 
the treatment effect and the disposal process and may be unblinded as a result of 
their observations.  This person will not conduct the follow-up assessments.  These 
personnel will be instructed and trained not to reveal the assumed Study Arm 
assignment to any subject or to any of the other study personnel at the site.  Site 
personnel completing follow-up evaluations will be different from the person who 
conducted the procedure and, therefore, will be blinded to the subject’s treatment.  
Subjects will be instructed (by subject handout Appendix G) not to discuss their 
assumed treatment assignment with anyone at the study site. 
Only necessary persons at the sponsor shall know the treatment assignments and 
only those persons will have access to the database which holds the key for the 
treatment numbers distributed at each site.  All others at the sponsor will remain 
blinded.   
 

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8.6   Enrollment 
As described above, subjects will be considered enrolled if they have given informed 
consent, they meet the study eligibility criteria upon assessment at both screening and 
baseline, and they are treated as part of the Roll-In Cohort or undergo randomization.  A 
schematic overview of the subject enrollment process is shown in Figure 2.   
Enrolled subject will be entered into the study database.  Upon entering the subject into 
the study database, a unique subject ID will be assigned to the subject by the electronic 
system.   
The unique subject ID that is assigned will be based upon the information entered by 
the study site.  In summary, the subject ID will be assigned as follows:  Sahara study 
identifier (SAH), followed by the 3-digit site ID (XXX), a 3-digit unique subject ID (a 
consecutive number determined by the electronic system from the number of patients 
enrolled at the time the subject is added), followed by the subjects initials (YY) (defined 
as first letter of first name then first letter of last name), i.e., SAH-XXX-001YY, SAH-
XXX-002YY, etc.   
Once the subject is added and the unique subject ID is assigned, the subject will be 
automatically assigned to the roll-in cohort, or, randomized and assigned a treatment 
number as explained above.   
The site will maintain a Subject Screening Log, which will link the unique subject ID to 
the subject.  This log will remain confidential and will not be provided to the sponsor, 
but, will only be used for reference during monitoring at the study site.   
 
8.6.1  Screen Failures 
If the subject has consented, but becomes ineligible prior to enrollment, the reason for 
ineligibility will be documented on the Screening Log.  A copy of the subject’s consent 
will be maintained in the site’s study records.  Ineligibility may occur at the screening 
visit, at the baseline visit or prior to randomization. Once a subject is randomized; they 
are enrolled.  Treatment with the assigned treatment number should be conducted.   

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Figure 2: 
Enrollment Flowchart, Initial Screening through Treatment 
 
 
 
8.7    Procedure 
 
The Candesant N-SWEAT Patch is intended for use only by appropriately trained 
personnel.  All investigators and support staff will be provided comprehensive training 
by Candesant Biomedical (or their designee) in the handling, use, and disposal of the 
patch.  Treatment will be performed in a clinic or doctor’s office, by a trained medical 
professional.  
 
8.7.1 
Immediately Pre-Treatment  
The following baseline evaluations will be performed immediately prior to treatment, in 
the following order.  
Treatment Site Identification:  The target treatment area should be chosen by 
identifying a relatively flat area with the highest concentration of hair follicles.  This 
placement is intended to maximize contact with the location of sweat production.  The 
planned treatment site may be marked for convenience.   
Treatment Site Assessment:  Although an assessment should have been conducted 
prior to randomization; the planned treatment area(s) should be inspected a final time 
to ensure the planned site meets treatment requirements as outlined in the N-SWEAT 
Patch Instructions for use (IFU).  The area must be free of residue, and free of 
Initial Screening of Subject Medical Record
OR
Randomize 
Subject 
Subject Signs Consent Form
Screening Visit Complete with 
Eligibility Verified 
Baseline Assessment Complete 
with Eligibility Verified
STOP –
Subject Not 
Included in 
Study
Meets 
Criteria
Does not 
Meet 
Criteria
SCREEN 
FAILURE
Yes
Yes
Yes 
AND 
≥72 hours after 
hair removal
No
No
No
Subject 
Enrolled 
Yes
No
Treatment according to 
assigned device #
N-SWEAT 
Treatment in 
Roll-In Cohort
Yes

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abrasions, broken skin, or other conditions of concern.  The assessment should include 
both visual and tactile assessment of any irregularities.  
Note: Areas with skin tags, moles or other skin abnormalities that are not indicative 
of abraded skin are permissible for treatment.  At the discretion of the treating 
physician the area may be avoided with strategic patch placement and/or use of 
an adhesive strip.   
Note: If skin irritation is noted, it should be assessed in accordance with the 
Erythema and Clinical Signs/Symptoms (Appendix B).  If irritation greater than 1 
is observed, the subject may only be treated after the issue has been resolved 
(less than or equal to 1).   
Hair removal by clipping or shaving should NOT be done within 72 hours prior to the 
procedure.   If the planned area does not meet the IFU requirements, do not proceed 
with treatment.  If the operator has questions or concerns regarding the treatment site, 
the sponsor should be contacted for consultation before moving forward with the 
procedure.  
Treatment Site Preparation:  The subject’s axilla will be cleaned with alcohol to 
ensure that no residual deodorant / anti-perspirent or other residue remains in the 
target treatment area.  The area shall then be thoroughly dried. 
Photos:  Pre-treatment photos are to be taken of each axilla and maintained by the 
study site as a baseline reference in the event that an adverse skin reaction should 
occur or another matter necessitating review for patient safety.  Photos are to be taken 
with a high-resolution camera with the arm in the standardized treatment position and 
adequately illuminated.   Photos are to be marked with Subject ID, date and subject 
side (i.e. Right or Left).  Photos are to be taken with a measurement calibration 
reference visible. 
 
8.7.2 
Patch Application 
An overview of the patch appplication procedure is provided below; however, it is 
critical to reference the IFU provided for additional treatment and handling details.   
Per the IFU, all personnel involved in the handling of the provided patch must have 
gloved hands at all times.  
The patch will be placed on the target treatment area (as previously described).  If the 
subject reports any pain or uncomfortable sensation at the time of patch placement;  
the patch should be immediately removed.    
Upon placement of the patch, the timer shall be started.  Every 30 seconds, the 
subject shall report their pain level on a score of 1 to 10.  If the subject reports a pain 
level greater than 8 or shows a 8 or higher using the Wong-Baker FACES pain scale 
(Figure 3); the patch should be removed immediately regardless of the time that the 
patch has been in place. 

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Figure 3. Wong-Baker FACES® Pain Rating Scale 
 
 
If the timer reaches 3 minutes and the patch is still in place, it should be removed at 
the 3 minute mark.  The actual treatment duration should be documented in the 
subject’s study record. The procedure may be photographed or videotaped (provided 
the subject has consented to video/photography).  The subject’s identity will be 
concealed, and subject confidentiality will be maintained at all times.  
 
NOTE: In the event of excessive exposure to the N-SWEAT patch or insufficient 
cleaning post treatment, an alkaline or thermal burn is possible.  Acute burns are 
treated by flushing with water for 30 minutes followed by routine skin and wound care 
(Sander, 2011).  Please have water and gauze available at all times when using the 
N-SWEAT patch.   
Please refer to Appendix G for guidance on when to refer to a burn center.   
 
8.7.3 
Immediately Post-Treatment  
Immediately following patch removal, the treatment area will be thoroughly cleansed 
with water.  A gauze pad soaked with water should be used to wipe the area a few 
times.  This step should be repeated until the subject does not feel any residual 
effects, such as tingling or stinging.  The subject should be asked to report their pain 
level using the Wong-Baker FACES pain scale during cleaning. The treatment area 
will be visually assessed by the physician, photographs may be taken, and any noted 
Adverse Events (AEs) will be documented.  
Assessment for Local Skin Reactions:  The investigator will evaluate axillary 
application sites for skin irritation to determine if there is an immediate reaction to the 
investigational device. If present it should be documented in accordance with the Skin 
Erythema Assessment and the Clinical Signs/Symptom Descriptors (Appendix B).    
8.7.4 
Treatment of the Second Axilla 
All steps (8.7.1 through 8.7.3) above will be repeated for treatment of the second axilla 
in the same treatment visit.   
8.7.5 
Subject Care and Medications  
Subjects will be provided with instructions for post-treatment care.  They will be 
instructed to rinse the area with water or cleanse with soap and water if they feel any 
discomfort.  Deodorant will be provided for use during study participation.   

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Subjects may take over-the-counter pain medication as needed following treatment. 
Acetaminophen is recommended for pain control.  Prescription strength pain 
medication is not expected to be necessary.   
Subjects must refrain from using over-the-counter or prescription, prescription-
strength, or clinical strength topical aluminum compounds or antiperspirants for the 
duration of study participation.  An approved deodorant (without antiperspirant) will be 
provided at screening for convenience.  Other deodorants without antiperspirant may 
be allowed; however, they must be approved by the investigator.  Subjects must also 
refrain from using topical steroids or hair removal creams on the treatment areas.  
Subjects must refrain from taking anticholinergic medications, beta blockers, calcium 
channel blockers, other systemic treatments, or medications that are known to cause 
heavy sweating during the study.  If one or more of these medications or treatments 
are required, and in the opinion of the investigator would compromise study results, 
the subject will be followed for safety only.   All relevant medications taken will be 
documented. 
 
8.8   Follow-up Evaluations  
Subjects will undergo phone evaluations at 24 hours (± 12 hours) and 2-weeks (±2 
days) following treatment, at which time subjects will be asked about their discomfort 
and if they may have experienced an AE. If the subject has symptoms, a telehealth or 
clinical visit should be scheduled to assess the subject’s condition within 24 hours.  Any 
concern for burn injury should result in an in-person clinic visit.  Please refer to 
Appendix G for conditions under which subjects should be referred to the burn center.   
A follow-up visit is required at 48-72 hours post-treatment. Visit will include a physical 
exam, assessment of vitals, and treatment site assessment.  Any new treatment area 
symptoms should result in a telehealth or clinic visit being scheduled (within 24 hours) 
to assess the subject’s conditions. Any concern for burn injury should result in an in-
person clinic visit.  In addition, a written daily dairy will be provided to subjects to record 
treatment site pain or other symptoms.   
 
Beginning 1-week post treatment, the subject will be asked to complete the HDSS and 
QoL surveys electronically once per week.  The survey may be taken electronically via 
cell phone, tablet or computer.  The subject will receive instructions at the baseline visit.  
Subject will be reminded to complete the surveys via text or email, per their preference.  
In the event that the electronic submission is not possible, the subject will be asked to 
complete the surveys on paper and mail it to the clinic.  If a subject fails to complete the 
survey in a timely matter the site will be notified so that they can make contact with the 
study subject.   
Subjects will be asked to schedule follow-up evaluations at 2-week intervals starting on 
4-weeks (i.e. 4-, 6-, 8-, 10-, and 12-weeks post-treatment). However, the 4-week visit 
is required to take place as an office visit.  The rest of the visits are recommended to 
take place in person but may be conducted by phone if an office visit is not possible or 

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practical. If at any time, the subject reports local skin reaction or an adverse event, a 
clinic visit should be scheduled for direct assessment by the study medical team.   
When possible, subjects are to undergo follow-up visit evaluations at the same time of 
day of the week and around the same time of day as their baseline evaluations.  In the 
event that the subject is not able to report on the same day as the baseline evaluations, 
the visit window permits the subject to report up to 1-3 days earlier or later than the 
target weekday.    The visit windows are shown in Table 3 below.   
Table 3.  Visit Windows 
Visit
Window
24-hour phone call
± 12 hours
48-72 hour visit 
± 1 day 
2-week phone call
± 2 days
4-week, 6-week, 8-week, 10-week, 12-week visits 
± 3 days 
Follow-up evaluations to be conducted at follow-up visits are summarized below in Table 4. 
 
Table 4.  Follow-Up Assessments 
Assessment
Time
Method
Reference
Daily Diary 
Daily through 4-weeks 
Written journal returned at 
4-week visit
Appendix F 
HDSS
Weekly 
Visit or electronic 
Appendix A 
QoL Assessments
Weekly
Visit or electronic
Appendix C
Assessment for Local 
Skin Reactions 
Immediately post 
treatment, AND, at 
every clinic visit
Visit required 
Appendix B 
GSP* 
4-weeks ONLY 
Visit required 
Appendix D 
*NOTE:  If excess hair is present on the axilla at the 4-week visit, the hair shall be clipped prior 
to conducting GSP testing.  Stubble or minimal hair is acceptable.  GSP should be measured in 
accordance with the instructions and training provided by the sponsor.  Any deviation from this 
procedure should be documented and explained.   
Table 5 summarizes the subject schedule for the study.   
 
8.9 
Extended Follow-Up Cohort 
An important outcome to be assessed by the Sahara Study is the duration of the effect 
of the N-SWEAT Patch Treatment.  Therefore, subjects that reach the final Sahara 
Study visit (12 weeks) and are still responding to treatment (i.e. HDSS has not returned 
to Baseline) will be invited to continue follow-up by enrollment into an Extended Follow-
Up Cohort.  Eligible subjects will provide consent prior to being enrolled into this cohort, 
within 4 weeks of completing their 12-week visit.  
Subjects enrolled in this cohort will not undergo any additional treatment, their 
participation will include extended follow-up only through 24-weeks post treatment or 
when HDSS returns to Baseline (whichever occurs first) 

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Subjects enrolled into the Extended Follow-Up Cohort will be asked to continue weekly 
electronic surveys until participation is complete.  Phone Calls shall be scheduled with 
subjects in this cohort by the site study team at 16-weeks, 20-weeks and 24-weeks post 
treatment during participation.   
 
Table 5.  Subject Visit Schedule 
 
Screening 
Baseline 
24 hours 
48-72 
hours 
Week 1 
Week 2 
Week 3 
Week 4 
Week 5 
Week 6 
Week 7 
Week 8 
Week 9 
Week 10 
Week 11 
Week 12 
 
 
 
±12 
hrs 
±1 
day
± 2 
days
All other follow-up visits window include ± 3 days 
Clinical Visit Required 
X 
X 
 
X 
 
 
 
X 
 
 
 
 
 
 
 
 
Clinical Evaluation  
(Visit Recommended) 
 
 
 
 
 
 
 
 
 
X 
 
X 
 
X 
 
X 
Clinical Evaluation  
(Phone Call 
Required, Visit if 
symptomatic)  
 
 
X 
 
 
X 
 
 
 
 
 
 
 
 
 
 
Daily Diary 
 
 
 
Daily completion through 
4-week visit 
 
 
 
 
 
 
 
 
 
ELECTRONIC ASSESSMENTS (cell phone, tablet, computer) 
HDSS  
 
 
 
 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
QoL-7  
 
X 
 
 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
QoL (Bother and 
Impact) 
 
X 
 
 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Additional QoL 
Assessments 
 
X 
 
 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
HDSS by Site 
X 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
GSP 
X 
X 
 
 
 
 
 
X 
 
 
 
 
 
 
 
 
Assessment for Local 
Skin Reactions 
X 
X 
 
 
 
 
 
X1 
 
X1 
 
X1 
 
X1 
 
X1 
Physical Exam 
X 
X 
 
 
 
 
 
X1 
 
X1 
 
X1 
 
X1 
 
X1 
Pregnancy Test (for 
women of child-
bearing potential 
ONLY) 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Assessment for AEs 
since last visit 
 
 
X 
 
 
 
 
X 
 
X 
 
X 
 
X 
 
X 
1 To be conducted at all clinic visits 
 
 

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8.10 
Study Exit or Premature Withdrawal 
Subjects will be formally exited from the study through the completion of the Study Exit 
CRF at the time of study completion, provided the subject has not experienced an AE 
directly attributable to the study device or procedure that is ongoing and unstable and/or 
unexplained.   
Subjects may be prematurely terminated or withdrawn from the study for the following 
reasons: 
 Not eligible for treatment  
 Subject starts a medication or treatment that, in the opinion of the investigator, may 
skew study results 
 Lost to follow-up (following 3 documented attempts to reach subject) 
 In the investigator’s opinion, it is not in the best interest of the subject to continue 
study participation   
 Voluntary withdrawal, meaning that the subject voluntarily chooses not to 
participate in the study 
All subjects enrolled (including those prematurely withdrawn) shall be accounted for and 
documented. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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9. 
STATISTICAL METHODS  
9.1    General Statistical Analysis Methods 
Categorical variables will be summarized by counts and percentages.  Continuous 
variables will be summarized by n, mean, standard deviation, minimum, median and 
maximum.  
When the arithmetic mean is found not to be an appropriate measure of central 
tendency, alternative statistics will be considered (e.g. median).  When the distribution 
of a variable does not support the use of parametric statistics, nonparametric 
approaches or data transformations may be implemented.  If data transformations are 
used, they will be specified in the final clinical report. 
 
9.2   Study Design, Randomization and Blinding 
The Sahara Study is a prospective, multi-center, randomized, blinded, pivotal study to 
evaluate the safety and effectiveness of the N-SWEAT Patch.  
Subjects with primary axillary hyperhidrosis or excessive sweating (defined by a score 
of 3 or 4 on the HDSS), who have provided informed consent and have met the study 
eligibility criteria, will participate. Up to 120 adult subjects will be enrolled. The first 10 
subjects will be treated with the N-SWEAT patch and constitute the roll-in cohort and up 
to 110 subjects will be randomized to 1 of 2 treatment groups in a 1:1 ratio to receive a 
single administration of the N-SWEAT Patch or a sham control patch. The 
randomization will be blocked by investigational center and stratified by HDSS 3 vs. 4 at 
baseline.  Up to 10 additional subjects may be enrolled to account for loss to follow up 
or other missing and critical data. 
Randomized subjects will be blinded to their treatment assignment.  Site personnel 
administering the treatment will observe the treatment effect and the disposal process 
and may be unblinded as a result of their observations.  This person will not conduct the 
follow-up assessments and will not reveal the assumed treatment assignment to the 
subject, other site personnel, or the investigator at any time during the study follow-up 
period.   Study subjects and study staff will be instructed not to discuss assumptions 
about the treatment received.  
The sponsor will identify those who need to be unblinded in order to conduct the study.  
All others at the sponsor will remain blinded. 
9.3  Sample Size and Power Considerations 
The primary effectiveness evaluation is driving the randomized sample size for the trial.   
The maximum of two scenarios considered required 50 evaluable per randomized group 
at 4 weeks of follow-up.   Increasing that number for up to 10% attrition requires 55 
randomized subjects per group or 110 randomized subjects.   This number provides at 
least 80% power for the primary efficacy objective.    

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The trial is also designed to also enroll a roll-in cohort of N=10 treatment subjects at one 
investigational center prior to randomizing any subjects in the trial.    
9.4   Study Success 
The Sahara study will be deemed a success with a statistically significantly higher 
proportion of patients with HDSS score of 1 or 2 at 4 weeks post-treatment in subjects 
randomized to treatment vs. sham (primary effectiveness endpoint) accompanied by an 
acceptable safety profile.   
  
9.5  Analysis Sets / Populations 
9.5.1 
Roll-in Cohort 
The roll-in cohort is an initial cohort of N=10 treatment subjects enrolled at one 
investigational site to provide FDA with an initial assessment for safety of the device.  
Efficacy endpoints for roll-in subjects will be restricted to summary statistics and 
reported separately for roll-in subjects. 
 
9.5.2 
Intent-to-Treat Population 
The intent-to-treat (ITT) population will include all randomized patients assigned to 
treatment. In this population, treatment will be based on the treatment to which 
patients were randomly assigned regardless of which treatment they actually 
received. 
 
9.5.3 
Safety Population 
 The safety population is the ITT population plus the roll-in cohort. 
9.5.4 
Modified Intent-to-Treat and Full Analysis Set 
The modified intent to treat (mITT) will include all randomized patients in the ITT 
population who were exposed to randomized treatment.  The full-analysis set (FAS) 
is those mITT subjects that have evaluable data for the endpoint.   
The mITT population, like the ITT population, will include all randomized patients 
assigned to treatment regardless of which treatment they actually received. 
However, unlike the ITT population, the mITT population excludes patients who are 
randomized but fail to initiate treatment (treatment or control patch).   
9.5.5 
Per-Protocol Set 
The Per Protocol Set (PP) will include all randomized subjects in the FAS who did 
not have any major protocol violations. Definitions of major and minor protocol 
violations will be included in the Statistical Analysis Plan (SAP) prior to data lock and 
unblinding of the person(s) determining major or minor status. If no subjects are 
excluded from the PP, the PP will not be required. The PP will be used for 
supporting analyses of efficacy data.  
 

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9.6 
Timing of Analyses 
Safety for the Roll-in cohort will be summarized when at least 2 weeks of follow-up is 
available on the last enrolled roll-in subject.     
Once all subjects complete 4 weeks of follow-up, the data will be summarized for 
evaluation of the endpoints.   Lastly, the data will be summarized when all subjects 
complete 12 weeks of follow-up.   
 
9.7 
Assessment of Comparability of Randomized Groups and Evaluation for 
Pooling  
9.7.1 Demographics / Baseline Characteristics and Protocol Administration 
Patient disposition will be listed and summarized for the mITT, ITT and roll-in 
data sets by treatment group.  Protocol deviations will be collected and 
summarized by randomized group in the ITT population and roll-in group.   
Demographics (age, gender, race/ethnicity) and baseline characteristics 
(HDSS, GSP, Fitzpatrick skin type, and BMI) will be summarized by treatment 
group for ITT, mITT and roll-in groups.   
The randomized groups will be compared at time of randomization for the 
important demographics and baseline characteristics specified.   Should 
additional important baseline parameters be identified prior to the analysis, they 
will be evaluated in the same manner.  Any of the variables that are significant 
at a two-sided =0.05 will be evaluated as covariates or strata variables in the 
primary effectiveness analysis or as an additional or supporting analysis to the 
primary effectiveness endpoint and if desired, secondary/observational 
endpoints as well.  Continuous variables will be evaluated both as stratification 
variables by dichotomizing the subjects into two groups based on the median or 
other appropriate value and as a continuous variable in the statistical models.   
Logistic regression analysis may be used for the primary efficacy endpoint 
should it be desirable to evaluate multiple covariates simultaneously in a 
statistical model.       
9.7.2 Treatment Characteristics 
At a minimum, the duration of patch placement, pain level during treatment and 
cleaning will be summarized by randomized group for the mITT and roll-in  
population.   
9.7.3 Evaluation for Pooling 
Pooling of the investigational sites will be evaluated for the primary efficacy 
endpoint.  Investigational centers with less than 10 randomized subjects will be 
combined for this purpose.  The Breslow-Day test will be used to assess the 
treatment by site interaction and if statistically significant at p<0.15, an overall 
response rate will be evaluated at 4-weeks using CMH test stratified by site.   If 
not statistically significant, the data will be pooled for analysis.   

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9.8 Handling of Missing Data for the Primary Efficacy Endpoint  
 
A sensitivity analysis to the missing data in the mITT sample will be conducted for the 
primary efficacy endpoint.   The sensitivity analysis will include a best case, worst case 
and tipping point analysis.  The best case analysis will impute successes for subjects 
randomized to treatment with missing data and failures for subjects randomized to sham 
with missing data.   The worst case analysis will impute failures for subjects randomized 
to treatment with missing data and success for subjects randomized to sham with 
missing data.   The tipping point analysis completes the matrix of imputations possible 
between the best case and worst analysis to determine where statistical significance is 
maintained or lost.   If the worst case analysis maintains statistical significance, the 
tipping point analysis is not necessary.   
 
9.9  Primary Safety Analysis  
Subjects Included in Analysis:  All subjects in the Safety Cohort.     
Endpoint(s):  Local skin reactions and adverse events.   
Hypothesis:  A single hypothesis test associated with a specific safety endpoint is not 
being proposed for the primary safety outcome.  Rather, the local skin reaction and 
adverse event profile in total will be reviewed for acceptability.   
Primary Statistical Analysis:   Number and percent of subjects affected by each event 
or reaction will be summarized.   Subgroups of events/reactions will also be summarized 
and include but are not limited to serious events, those related to the treatment, and those 
that are both serious and related to the treatment.  
   
9.10 Efficacy Analysis 
9.10.1 Primary Efficacy 
The proportion of subjects with HDSS of 1 or 2 at 4-weeks in subjects randomized to 
treatment (pT) will be higher than that in subjects randomized to sham (pS).  
Subjects Included in Analysis:  All mITT subjects.   
Endpoint(s): The proportion of subjects with HDSS of 1 or 2 at 4 weeks of follow-
up.     
Hypothesis:   
Ho:  The proportion of subjects with HDSS of 1 or 2 at 4-weeks in subjects 
randomized to treatment (pT) will be lower than or equal to that in subjects 
randomized to sham (pS),  pT ≤ pS 
Ha:  The proportion of subjects with HDSS of 1 or 2 at 4-weeks in subjects 
randomized to treatment (pT) will be greater than that in subjects randomized to 
sham (pS),  pT > pS 

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Sample Size Rationale: .  The sample size and power calculations for the 
randomized cohort are based on the company’s clinical trial data as well as on 
published data (Glaser et al., 2012). To account for substantial variability in the 
proportion of responders across various trials, multiple scenarios were considered. 
Per definition of the primary endpoint a responder is a patient with HDSS values of 1 
or 2 at 4-weeks post treatment. If proportions of responders in the treated vs. sham 
arms are 85% vs. 60%, respectively, then using PASS 2019, testing two proportions 
using the Mantel-Haenszel test,  50 patients per arm will be needed to detect the 
treatment difference with the 80% power at the 0.05 two-sided significance level. If 
proportions of responders in the treated vs. sham arms are 73% vs. 44%, then 45 
patients per arm will be needed. The evaluable sample size of 50 patients per arm 
was chosen 
Primary Statistical Analysis:   The proportion of patients with HDSS of 1 or 2 at 4 
weeks post-treatment will be compared between treatment vs. sham using the 
Cochran-Mantel-Haenszel (CMH) test stratified by baseline HDSS value of 3 vs. 4 in 
the FAS population.  Statistical significance is achieved with two-sided p-value <0.05 
equivalent to one-sided p-value < 0.025.   
Additional Statistical Analysis:  Additional analyses include those summarized in 
Section 9.7.3 Evaluation for Pooling of Data and Section 9.8 Handling of Missing 
Data for the Primary Efficacy Endpoint.  The primary statistical analysis will be 
completed in the PP population as well.   
An analysis will also be performed using all available time points with complete 
follow-up at the time of the analysis.  A generalized linear mixed model  be used to 
compare the proportion of subjects with HDSS of 1 or 2 between randomized groups 
over time on study.   The dependent variable is HDSS of 1 or 2 (Y/N) with 
independent variables to include randomized group, follow-up time, baseline HDSS 
and two-way interaction terms.  The covariance structure among the compound 
symmetric, auto-regressive and unstructured that provides the best model fit by the 
Schwarz BIC criterion will be used.   
A hierarchical stepwise backward elimination technique will be used to reduce the 
model.   The two-way interactions will be reviewed first, the two-way interaction with 
the largest p-value provided that p-value is greater than 0.05 will be removed from 
the model and the model refit and process repeated until only two-way interactions 
with p-values < 0.05 are retained.  The main effects for any two-way interactions 
retained in the model must remain in the model as well as the randomized treatment.   
With that said, the main effects will be evaluated in the same manner as two-way 
interactions.   This analysis will be repeated in the PP population as well.  

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9.10.2   Secondary Efficacy 
9.10.2.1 Type I Error Control, Additional Claims and Labeling 
Should the primary effectiveness endpoint be found to be statistically significant, 
additional secondary endpoints will be evaluated for inclusion in the labeling for the 
device including p-values and 95% confidence intervals.   The secondary 
endpoints listed in Section 9.10.2.2 are in priority order and will be evaluated in 
that order.   If statistical significance is achieved for the highest priority endpoint 
the testing will move to the next highest until either statistical significance is not 
reached, or the list has ended.   This ordered hypothesis approach permits each 
hypothesis to be evaluated at two sided =0.05 or equivalently one-side =0.025  
and controls the study-wide Type I error at 5%.    
Secondary endpoints or additional analysis outside of those that do support 
additional claims are supportive in nature and not intended to support additional 
claims.   Data may be included in labelling per agreement with the FDA and will be 
limited to summary statistics (e.g. mean, standard deviation, minimum, median, 
maximum, number and percent) and will not include 95% confidence intervals or p-
values.  For more information about the secondary endpoint analyses see Section 
9.10.2.3 Secondary Objectives.  
9.10.2.2 Priority Order and Hypothesis Tests 
 
These hypothesis tests will be evaluated in the FAS population.  
 
1.  To prove that the mean improvement in QoL scale Bother from 
baseline to 4-weeks is statistically significantly greater in the 
treatment group as compared to the sham group. 
Hypothesis:   
Ho:  The mean improvement in QoL scale Bother from baseline to 4-weeks in 
subjects randomized to treatment (T) will be lower than or equal to that in 
subjects randomized to sham (S), (T) ≤ S. 
Ha:  The mean improvement in QoL scale Bother from baseline to 4-weeks in 
subjects randomized to treatment (T) will be greater than that in subjects 
randomized to sham (S), T > S. 
Success is defined as a statistically significant difference (at the 0.05 two-sided 
significance level) between least squared means for randomized groups. 
 
2. To prove that the mean improvement in QoL scale Impact from 
baseline to 4-weeks is statistically significantly greater in the 
treatment group as compared to the sham group. 
 

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Hypothesis:   
Ho:  The mean improvement in QoL scale Impact from baseline to 4-weeks in 
subjects randomized to treatment (T) will be lower than or equal to that in 
subjects randomized to sham (S), T ≤ S 
Ha:  The mean improvement in QoL scale Impact from baseline to 4-weeks in 
subjects randomized to treatment (T) will be greater than that in subjects 
randomized to sham (S), T > S 
Success is defined as a statistically significant difference (at the 0.05 two-sided 
significance level) between least squared means for randomized groups. 
 
3. To prove that the proportion of patients with improvement of at least 
2 grades from baseline to 4-weeks in HDSS is statistically 
significantly greater in the treatment group as compared to the sham 
group. 
Hypothesis:   
Ho:  The proportion of subjects with improvement of at least 2 grades from 
baseline to 4 weeks in HDSS in subjects randomized to treatment (pT) will be 
lower than or equal to that in subjects randomized to sham (pS),  pT ≤ pS 
Ha:  The proportion of subjects with improvement of at least 2 grades from 
baseline to 4 weeks in HDSS in subjects randomized to treatment (pT) will be 
greater than that in subjects randomized to sham (pS),  pT > pS 
Success is defined as a statistically significant difference (at the 0.05 two-sided 
significance level) between proportions of patients with at least 2 grade 
improvement in HDSS from baseline to 4 weeks between randomized group 
using CMH test stratified by baseline HDSS (3 vs. 4). 
4. Proportion of subjects with at least 50% improvement in gravimetric 
sweat production (GSP) in subjects treated with the N-SWEAT Patch 
only at 4-weeks.  (GSP will be calculated based on the total sweat 
produced by both axillae.)  
Ho:  The proportion of subjects with at least 50% improvement in gravimetric 
sweat production (GSP) in subjects randomized to treatment (pT) is not 
statistically significantly different from 0, pT = 0. 
Ha:  The proportion of subjects with at least 50% improvement in gravimetric sweat 
production (GSP) in subjects randomized to treatment (pT) is statistically 
significantly different from 0, pT ≠ 0. Success is defined as a statistically significant 
result (at the 0.05 two-sided significance level).  It is expected that at least 50% of 
subjects will have at least 50% improvement in gravimetric sweat production from 
baseline at 4-weeks.  

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9.10.2.3 
Secondary Objectives 
9.10.2.3.1 
To compare the mean improvement over baseline for QOL scale 
Bother between subjects randomized to treatment as compared to sham 
   
Subjects Included in Analysis:  All FAS subjects will be included in the analysis.    
Endpoint(s): QOL scale Bother score  
Statistical Analysis:  An analysis will be performed using all available time points with 
complete follow-up at the time of the analysis.  A generalized linear mixed model  be 
used to compare average change in QOL Bother from baseline to follow-up between  
randomized groups over time on study.   The dependent variable change in QOL Bother 
from baseline to follow-up with independent variables to include randomized group, 
follow-up time, baseline HDSS and two-way interaction terms.  The covariance structure 
among the compound symmetric, auto-regressive and unstructured that provides the 
best model fit by the Schwarz BIC criterion will be chosen.   
A hierarchical stepwise backward elimination technique will be used to reduce the 
model.   The two-way interactions will be reviewed first, the two-way interaction with the 
largest p-value provided that p-value is greater than 0.05 will be removed from the 
model and the model refit and repeated until only two-way interactions with p-values < 
0.05 are retained.  The main effects for any two-way interaction retained in the model 
must remain in the model as well as the randomized treatment.   That being said, the 
main effects will be evaluated in the same manner as the two-way interaction terms.  
This analysis will be repeated in the PP population.  
9.10.2.3.2 
To compare the mean improvement over baseline for QOL scale 
Impact between subjects randomized to treatment as compared to sham  
Subjects Included in Analysis:  All FAS subjects will be included in the analysis.    
Endpoint(s): QOL scale Impact score  
Statistical Analysis:  An analysis may also be performed using all available time points 
with complete follow-up at the time of the analysis.  A generalized linear mixed model  
be used to compare average change in QOL Impact from baseline to follow-up between  
randomized groups over time on study.   The dependent variable change in QOL Impact 
from baseline to follow-up with independent variables to include randomized group, 
follow-up time, baseline HDSS and two-way interaction terms.  The covariance structure 
among the compound symmetric, auto-regressive and unstructured that provides the 
best model fit by the Schwarz BIC criterion will be chosen.   
A hierarchical stepwise backward elimination technique will be used to reduce the 
model.   The two-way interactions will be reviewed first, the two-way interaction with the 
largest p-value provided that p-value is greater than 0.05 will be removed from the 
model and the model refit and repeated until only two-way interactions with p-values < 
0.05 are retained.  The main effects for any two-way interaction retained in the model 
must remain in the model as well as the randomized treatment.   That being said, the 

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main effects will be evaluated in the same manner.  This analysis will be completed in 
the PP population as well.    
9.10.2.3.3 
To compare the proportion of patients with at least a 2 grade 
improvement in HDSS from baseline between subjects randomized to 
treatment as compared to sham 
Subjects Included in Analysis:  All FAS subjects will be included in the analysis.    
Endpoint(s): HDSS.    
Statistical Analysis: The proportion of patients with at least a 2 grade improvement in 
HDSS from baseline to 4 weeks will be compared between treatment vs. sham using the 
Cochran-Mantel-Haenszel (CMH) test stratified by baseline HDSS value of 3 vs. 4 in the 
FAS population.  Statistical significance is achieved with two-sided p-value <0.05 
equivalent to one-sided p-value < 0.025.  This analysis will be completed in the PP group 
as well.   
An analysis will  be performed using all available time points with complete follow-up at 
the time of the analysis.  A generalized linear mixed model will be used to compare the 
proportion of subjects with at least 2 grade improvement from baseline to 4 weeks 
between randomized groups over time on study.   The dependent variable is 2 grade 
improvement over baseline (Y/N) with independent variables to include randomized 
group, follow-up time, baseline HDSS and two-way interaction terms.  The covariance 
structure among the compound symmetric, auto-regressive and unstructured that 
provides the best model fit by the Schwarz BIC criterion will be chosen.   
A hierarchical stepwise backward elimination technique will be used to reduce the 
model.   The two-way interactions will be reviewed first, the two-way interaction with the 
largest p-value provided that p-value is greater than 0.05 will be removed from the 
model and the model refit and repeated until only two-way interactions with p-values < 
0.05 are retained.  The main effects for any two-way interaction retained in the model 
must remain in the model as well as the randomized treatment.   That being said, the 
main effects will be evaluated in the same manner as the two-way interactions.   This 
analysis will be completed in the PP group as well.  
9.10.2.3.4 
To estimate the proportion of subjects randomized to treatment with 
at least 50% improvement from baseline to 4 weeks in gravimetric sweat 
production (GSP) 
Subjects Included in Analysis:  All FAS subjects randomized to receive the N-SWEAT 
patch.    
Endpoint(s):   The average of 2 accurate GSP measurements will be conducted for 
each Axilla at each time point.    The total sweat production at each timepoint will be 
calculated by summing the average sweat production from both axilla.   The percentage 
change at 4 weeks will be calculated based on the total sweat production at baseline 
and 4 weeks.   

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Statistical Analysis:  The potential confounding factors of room temperature, position 
during evaluation and time of evaluation will be summarized for baseline and 4 weeks.   
The difference in temperature, time of evaluation and whether or not the baseline and 4 
week evaluation were performed in the same or different position will be summarized.  
These factors will be evaluated with respect to their relationship with the endpoint and 
association with outlying values, if any, using graphical techniques and summary statistics.   
Depending on this evaluation, outlying values may be excluded from the analysis with 
justification provided and relationships, if any found, will be summarized.     
The proportion of patients with 50% or greater improvement in percentage change from 
baseline to 4 weeks will be statistically compared to zero by calculating the Wilson’s 95% 
two-sided confidence interval and comparing the lower bound to zero.  If the lower bound 
is greater than zero, there is statistically significant evidence that the proportion of 
subjects with a clinically relevant improvement exists and is greater than 0.   This analysis 
will be completed in the PP population as well.      
 
9.10.3 
  Observational Endpoints 
Observational endpoints will be summarized at all available time points at the time of 
analysis. These endpoints will be analyzed with standard statistical methods 
summarized in detail in the stand-alone statistical analysis plan that will be completed 
prior to formal analysis of the data.  Standard statistical methods will be employed 
consistent with those summarized for the secondary endpoints.  Statistical significance 
will be determined based on a two-sided p-value of 0.05.   Only summary statistics (no 
p-values or 95% confidence intervals) will be provided in labelling upon agreement 
between Candesant and FDA. The p-values for the observational endpoints will not be 
adjusted for multiplicity and should be interpreted with caution. 
 Baseline-adjusted mean improvement in QoL-7 instrument assessed by treatment 
group. 
 Composite - proportion of patients with HDSS 1 or 2 AND 50% improvement in GSP 
assessed by treatment group. 
 Composite - proportion of patients with HDSS 1 or 2 AND 75% improvement in GSP 
assessed by treatment group. 
 Duration of efficacy:  time from treatment to first observed reversion to HDSS 3 or 
4 (a Kaplan-Meier analysis using median duration of efficacy will be compared 
between the treatment groups).  Also performed for first reversion to subject’s 
baseline HDSS. 
 Mean change from baseline at 4 weeks in GSP by treatment group.  
 
9.11 Specification of Subgroups for Analysis 
The primary efficacy endpoint will be summarized within subgroups defined by Baseline 
HDSS, age, gender and race/ethnicity.  Adverse events and local skin reactions will be 
summarized by Fitzpatrick Skin Types.   It is important to note that the study is not 
powered to demonstrate statistical significance within subgroups and therefore it is not 
an expectation of the analysis that statistical significance be demonstrated with the 
subgroups. 

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10. 
ADVERSE EVENTS 
10.1 
Definitions 
The definitions below are in accordance with ISO 14155.  Both the investigator and the 
sponsor will comply with all local medical device reporting requirements.   
Adverse Events (AEs) may occur during the investigational procedure or during the 
follow-up phase.  AEs occurring prior to the use of the N-SWEAT device will be 
documented in the subject’s medical record but will not count as related to the 
investigational device or procedure.   
10.1.1   Adverse Events 
An AE is defined as any untoward medical occurrence, unintended disease or injury, 
or untoward clinical signs (including abnormal laboratory finding) in study participants, 
users, or other persons, whether or not related to the investigational medical device.  
This definition includes events related to the investigational medical device and events 
related to the procedures involved except for events in users or other persons, which 
only include events related to investigational devices. 
10.1.2 
  Adverse Device Events 
An Adverse Device Event (ADE) is defined as an AE related to the use of an 
investigational medical device. This definition includes any adverse events resulting 
from insufficient or inadequate instructions for use, deployment, implantation, 
installation, or operation, or any malfunction of the investigational medical device as 
well as any event resulting from use error or from intentional misuse of the 
investigational medical device. 
10.1.2.1 Treatment-Related Adverse Event 
A treatment-related AE is any AE that starts on or after the time of treatment that a 
physician considers a result of treatment; the AE may or may not be related to the 
study device.   Treatment-related events will be assessed for relationship to the 
device.  The occurrence of treatment-related AEs will be summarized as part of the 
assessment for safety.   
10.1.3 
  Serious Adverse Events 
A Serious Adverse Event (SAE) is an AE that: 
 Led to death. 
 Led to serious deterioration in the health of the participant, that either resulted in: 
 A life-threatening illness or injury.  The term life-threatening in the definition of 
serious refers to an event in which the participant was at risk of death at the 
time of the event.  It does not refer to an event that hypothetically might have 
caused death if it were more severe. 
 A permanent impairment of a body structure or a body function 

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 Inpatient or prolonged hospitalization.  Planned hospitalization for a pre-
existing condition, or a procedure required by the protocol, without serious 
deterioration in health, is not considered an SAE. 
 Medical or surgical intervention to prevent life-threatening illness or injury or 
permanent impairment to a body structure or a body function. 
 Led to fetal distress, fetal death, or a congenital abnormality or birth defect. 
If an event is not an AE per the definition above, then it cannot be an SAE even if 
serious conditions are met (e.g., hospitalization for signs/symptoms of the disease 
under study, death due to progression of disease). 
10.1.4 
  Serious Adverse Device Events 
A Serious Adverse Device Event (SADE) is defined as an ADE that has resulted in 
any of the consequences characteristic of an SAE. 
10.1.5 
Device Deficiency 
A device deficiency is an inadequacy of a medical device with respect to its identity, 
quality, durability, reliability, safety, or performance.  Device deficiencies include 
malfunctions, use errors, and inadequate labeling. 
10.1.6 
Unanticipated Adverse Device Events 
According to 21 CFR 812.3(s), a Unanticipated Adverse Device Event (UADE) is any 
serious adverse effect on health or safety or any life-threatening problem or death 
caused by, or associated with, a device, if that effect, problem, or death was not 
previously identified in nature, severity, or degree of incidence in the investigational 
plan or application (including a supplementary plan or application), or any other 
unanticipated serious problem associated with a device that relates to the rights, 
safety, or welfare of subjects. 
 
10.2 
Adverse Event Review by Investigator 
Each AE will be assessed by the investigator as to its relationship and level of 
relatedness to the device and/or procedure.  In addition, the investigator will identify the 
date of onset, any required treatment or intervention, severity, and duration.  All AEs will 
be monitored until they are adequately resolved, stabilized and/or explained.   
10.2.1 Severity 
The investigator will use the terms below to rate the severity of each AE.   
Note that an event is defined as serious when it meets at least one of the predefined 
outcomes as described in the definition of an SAE, NOT when it is rated as severe per 
the table below.    
 

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Table 6.  AE Severity 
Severity
Description
Mild 
Awareness of signs or symptoms, but easily tolerated and are of minor 
irritant type causing no loss of time from normal activities. Symptoms do 
not require therapy or a medical evaluation; signs and symptoms are 
transient.  
Moderate 
Events introduce a low level of inconvenience or concern to the participant 
and may interfere with daily activities, but are usually improved by simple 
therapeutic measures; moderate experiences may cause some 
interference with functioning
Severe* 
Events interrupt the participant’s normal daily activities and generally 
require systemic drug therapy or other treatment; they are usually 
incapacitating
Based on the National Institute on Aging (NIA) Adverse Event and Serious Adverse Event Guidelines (2018) 
*Severe does not indicate an SAE (Serious Adverse Event).  Please see 10.1.3 for a definition of Serious Adverse Event. 
 
10.2.2 
  Relationship to N-SWEAT Patch 
The investigator will use the terms below to rate the relationship of the AE to the 
patch. 
Table 7.  AE Relationship to Device 
Relationship
Description
Not Related 
 not associated with patch 
due to an underlying or concurrent illness or effect of another device or drug
Unlikely 
 little or no temporal relationship to the patch  
a more likely alternative etiology exists
Possible 
 temporal sequence between patch and event 
 is such that the relationship is not unlikely or  
Subject’s condition or concomitant therapy could have caused the AE 
Probable 
 temporal sequence is relevant or 
 event abates upon patch application completion/removal or  
event cannot be reasonably explained by the Subject’s condition
Highly 
Probable 
 temporal sequence is relevant and  
 event abates upon patch application completion/removal or reappearance of the 
event on repeat patch application 
 
10.3 Adverse Event Reporting 
All AEs and ADEs will be recorded by the investigator or designee on the case report 
forms (CRFs) provided. The investigator at each site is ultimately responsible for 
reporting AEs to the IRB according to IRB requirements and to the sponsor in 
accordance with the Investigational Plan and applicable FDA regulations. The site will 
be instructed to report all AEs considered moderate or severe and all local skin 
reactions to Candesant within 5 working days of the identification of the AE.    
If an Adverse Event is considered a local skin reaction within the treated area, photos 
are required to be submitted as part of the Adverse Event Report.  Submitted photos 
should show documentation of AE onset, AE progression and/or healing and AE 

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resolution (if applicable).  Photos are to be taken with a high-resolution camera with the 
arm in the standardized treatment position and adequately illuminated.  Photos are to 
be marked with Subject ID, date and subject side (i.e. Right or Left).  Photos are to be 
taken with a measurement calibration reference visible. 
AEs or complications meeting the definition for UADEs must be reported by the 
investigator to the sponsor as soon as possible, but in no event, later than 10 working 
days after the investigator first learns of the event. The sponsor will conduct an 
evaluation of any reported UADEs and will report the results of this evaluation to the 
FDA, IRBs, and participating investigators within 10 working days after first receiving 
notice of the event.  
Descriptive and photographic data will be recorded and maintained on file for all AEs 
regardless of severity or device-relatedness. All observed local skin reactions will also 
be recorded.   
 
10.4 
Independent Adverse Event Review 
An independent Data Safety Monitoring Board (DSMB) will be established to protect 
patient safety and ensure data integrity for the Sahara Study.  The board will be 
comprised of 3-5 clinical physicians with expertise in dermatology who are not 
participants in the study.  The DSMB will serve in three roles in the safety overview of 
the Sahara study: 
 To convene as needed for review of Adverse Events related to stopping rules 
and to determine a root cause analysis of these events.  
 To conduct a monthly blinded review of all AEs reported during enrollment and 
until the final subject has reported for 4-week follow-up.  
 If warranted, to request unblinding and fully investigate any potential safety 
signal.  This investigation may result in a recommendation to stop the clinical 
study if the findings indicate an unacceptable or unknown safety risk.    
A charter will establish the DSMB details on the operation of the DSMB.   
 
 
 
 
 
 
 
 
 

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11. RISK-BENEFIT ASSESSMENT 
11.1 
Potential Benefits  
It is expected that the Candesant Biomedical N-SWEAT Patch may provide some 
benefit to the subject by reducing the amount of sweat that they produce after 
treatment.  This sweat reduction would be expected to offer a quality of life improvement 
to the subject.  The true benefits are not fully known but will be assessed and measured 
during this study.  It is possible that there is no benefit to the N-SWEAT Patch.   
Since this a randomized study with a sham control, the subjects who receive the sham 
patch are not expected to have any immediate benefit in the reduction of sweating with 
their participation.  However, their participation may be beneficial in the future in helping 
to assess the potential of having this technology available to all patients with excessive 
sweating or primary hyperhidrosis. 
11.2 
Potential Risks  
The identified potential risks to the study subject that may be associated with treatment 
for excessive sweating or hyperhidrosis of the axilla are shown below.  The risks of these 
events occurring for subjects treated during the Sahara Study have been mitigated as 
much as possible by device design and training  
 Allergic reaction to device materials 
 Blister formation  
 Burning or stinging  
 Decreased hair growth  
 Discomfort / Pain 
 Discomfort during post-treatment cleaning 
 Infection 
 Injury to eyes or mouth, if gloves or hands that 
handled the device touch 
 Intolerance of deodorant 
 Irritation 
 Itching, tightness, tingling 
 Numbness or altered sensation 
 Redness (erythema), blotchiness, 
bumps 
 Scar or contracture 
 Skin corrosion  
 Skin discoloration 
 Skin erosion 
 Sweating in other parts of the body 
 Swelling (edema) or bruising 
 Thermal Injury  
 
11.3 
Minimization of Anticipated Risks 
Risks associated with the N-SWEAT Patch are minimized by design and training.  Risks 
are minimized under this protocol due to: 
 Only operators with proper training and experience will use the device 
 Clinician users will be given the opportunity to use their discretion and medical 
expertise throughout the treatment and appropriately respond to the patient’s 
reaction to treatment 
 Only certified personnel will dispose of the device 
 Extensive non-clinical evaluation of the device (animal and bench top testing) 
 The use of standard medical grade materials in the manufacture of the device 

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11.4 
Protocol Compliance 
As with any clinical investigation, it is critical to conduct the study per the study protocol 
so as to not compromise the study results.  Areas of particular criticality are as follows: 
 Eligibility criteria (all treated subjects must be eligible per the protocol) 
 Compliance with the protocol follow-up activity including patient reported 
outcomes and quality of life assessments 
 Thorough, accurate, and timely reporting of AEs  
 Thorough, accurate, and timely reporting of all clinical trial data 
 
11.5 
Safety-Related Stopping Rules 
The study sponsor will be charged with monitoring the study for safety and for auditing 
the quality of the data.  Stopping rules will be activated if there are any perceived safety 
concerns related to the N-SWEAT Patch as demonstrated by the occurrence of any of 
the following:   
 
        FIRST 10 SUBJECTS 
1.  One report of a Serious Adverse Event due to:  
 thermal or caustic injury 
 blister 
 erosion 
 pustule 
 erythema lasting > 7 days or developing >7 days after the treatment 
 infection 
 suspected infection of the skin or soft tissue in the axilla  
 
           AFTER 10 SUBJECTS  
 
1. If 10% of N-SWEAT treated subjects have a reported severe device-related 
Adverse Event as defined in Table 6, or 
 
2. If the DSMB recommends stopping due to a safety signal as described in section 
10.4.     
 
Should a stopping rule be triggered: 
 
1. 
Enrollment and treatment will be suspended and a root cause 
investigation into all involved AEs will be conducted within 5 days 
by an independent Data Safety Monitoring Board to determine the  
cause of the event(s), to look at any trends and to evaluate 
potential safety issues.    
 

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2. 
A full report (including photos, description, onset, duration, severity, 
causality, intervention, and sequalae) will be sent to FDA no later 
than 5 working days after DSMB review is complete.   
 
3. 
Candesant will work with FDA, DSMB and study investigators to 
establish a process to re-start the study.   
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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12. 
STUDY MANAGEMENT 
For this study, Candesant Biomedical will have certain direct responsibilities and will 
delegate other responsibilities to appropriate consultants and Clinical Research 
Organizations (CROs).  Together, Candesant, consultants, and CROs will ensure that 
the study is conducted according to the protocol and all applicable regulations. 
 
12.1 
Key Study Contributors 
A Master Contact List will be maintained to include all key study personnel (e.g., 
monitors, data management personnel) and reviewing IRBs as well as the primary site 
contacts (investigators, study coordinators).  The Master Contact List will be provided to 
the study sites.     
All personnel to participate in the conduct of this clinical study will be qualified by 
education or experience to perform their tasks.   
 
12.2 
Regulatory Considerations 
As the study sponsor, Candesant Biomedical has the overall responsibility for the 
conduct of the study in accordance with 21 CFR 812; E6 Good Clinical Practice (GCP) 
Consolidated Guidance; and any conditions imposed by FDA or the reviewing IRB(s).  
The study will not commence until the necessary approvals have been obtained.  The 
rights, safety and well-being of clinical investigation subjects have been protected in a 
manner consistent with the ethical principles that have their origin in the Declaration of 
Helsinki, as amended. 
 
12.3 
Approved Informed Consent  
The sponsor will provide each study center with an example Informed Consent Form 
(ICF).  The study center, to meet specific requirements, may modify this example ICF; 
however, the ICF to be used for subject consent under this protocol must contain all of 
the elements required by the study sponsor.  The sponsor and the investigational site 
shall develop a mutually agreed upon ICF.  The reviewing IRB must review and approve 
the ICF prior to use.  The original signed and dated ICF for each subject must be 
retained by the investigational site for monitoring, and a copy provided to the Subject. 
 
12.4 
IRB Approval 
IRB approval is required prior to study commencement.  IRB approval is also required 
for any protocol amendments.   The investigator is responsible for fulfilling any 
conditions of approval imposed by the reviewing IRB.  IRB renewal should be obtained 
as required.  Documentation of all IRB approvals and renewals will be maintained in the 
study files.   
 

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12.5 
Amendment to the Study Protocol 
The sponsor is responsible for management, processing, and approval of any 
amendment to the study protocol.  Study protocol amendments will be submitted to 
FDA, to the reviewing IRB(s) and to other governing agencies, as applicable.  Any 
necessary approvals will be received in writing before the requested change is 
implemented.   
 
12.6 
Protocol Deviation 
Measures will be taken to ensure compliance with the study protocol.  Investigators may 
request approval from Candesant Biomedical and, where applicable, from the reviewing 
IRB, if they identify a situation in which a deviation from the protocol is warranted.  Prior 
approval is not necessary when the deviation is intended to protect the life or physical 
well-being of a subject in an emergency.  Protocol deviation waivers, when issued, shall 
be documented in writing and maintained in the study files.  Prior approval is not 
expected in situations where unforeseen circumstances are beyond the investigator’s 
control, (e.g., subject was not available for scheduled evaluation); however, such event 
is still considered a deviation and will be reported on the appropriate CRF. 
Deviations must be reported to Candesant Biomedical regardless of whether medically 
justifiable, pre-approved by the sponsor, or taken to protect the subject in an 
emergency.  Subject related deviations will be reported on the Protocol Deviation CRF.  
Non-Subject-specific deviations (e.g., unauthorized use of an investigational device 
outside the study, unauthorized use of an investigational device by a clinician who has 
not signed an investigator agreement or not been trained in the use of the patch) will be 
reported to the sponsor.  Investigators will also adhere to procedures for reporting study 
deviations to their IRB in accordance with their specific IRB reporting policies and 
procedures. 
Regulations require that investigators maintain accurate, complete, and current records, 
including documents showing the dates of and reasons for each deviation from the 
protocol.   
 
12.7 
Investigational Device Accountability 
12.7.1 
Device Records 
The sponsor will only distribute investigational devices to sites that are part of the 
clinical investigation. The sponsor will maintain complete, current and accurate 
records pertaining to the distribution of the investigational devices and follow record 
keeping requirements in accordance with GCP and FDA Regulations.  
The investigator is responsible for maintenance of adequate records of the receipt, 
disposition, and/or return of all investigational devices distributed to their site. 
 

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12.7.2 
  Device Use 
The device must be used in accordance with the study protocol and the instructions 
for use provided with the device. Prior to use, investigators should inspect the product 
package and product label. Irregularities in packaging or labeling concerns should be 
notified to the sponsor immediately. Product demonstrating any potential packing 
integrity issue or expired product must not be used.  
Access to the device inventory at the study site will be controlled and housed in a 
secure location.  Use of the investigational device outside of the protocol is strictly 
forbidden and may constitute grounds for removal of the investigator/site from the 
study.  After use the N-SWEAT Patch must be disposed of per the IFU instructions 
and in consideration of the facility’s standard institutional practice. 
12.7.3 
 Device Return 
At study termination, the sponsor will provide specific instructions to the study sites on 
unused investigational devices.   
If the device is associated with a possible device-related AE or device deficiency, the 
device should be returned to Candesant Biomedical for evaluation per instructions 
from the sponsor.   
 
12.8 
Training 
12.8.1 
Site Training  
All investigators/trial personnel are required to attend sponsor training sessions, which 
may be conducted at an investigator's meeting, a site initiation visit or other 
appropriate training sessions. Over-the-phone training will take place as required. 
Training of investigators/study personnel will include, but is not limited to, the 
investigational plan, investigational device usage, protocol requirements, case report 
form completion, and trial personnel responsibilities. All investigators/study personnel 
that are trained must sign a training log (or an equivalent) upon completion of the 
training. Investigator/trial personnel must not perform any study-related procedures 
prior to being trained.  
12.8.2 
Monitor Training  
The sponsor or designee will engage monitors that are qualified by appropriate 
training and experience to review the conduct and quality of the study. Prior to working 
on the study, monitors will be trained to the investigational plan, case report forms, 
and device specifications. Such training will be documented.  
 
12.9 
Monitoring  
Monitors engaged by the sponsor and/or designee will monitor the study over its 
duration according to standard operating procedures and the pre-specified monitoring 
plan. The study monitor will visit each site at appropriate intervals to review 

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investigational data for accuracy and completeness and ensure compliance with the 
protocol, FDA regulations, and IRB requirements. The study monitor may inspect all 
study related documents and required records that are maintained by the 
investigator/site.  
The investigator/site will permit access to such documents including medical records 
(office, clinic or hospital) for the patients in this study. Source documentation must be 
available to substantiate proper informed consent procedures, adherence to protocol 
procedures, adequate reporting and follow-up of adverse events, accuracy of data 
collected on case report forms, IRB submissions/approvals, and device information. 
Furthermore, the investigator and/or research coordinator will be available for 
monitoring visits. It is also expected that the investigator will provide the study monitor 
with a suitable working environment for review.  
 
12.10 
Ethical Considerations 
The rights, safety, and well-being of subjects shall be protected consistent with the 
ethical principles that have their origin in the Declaration of Helsinki.  These principles 
shall prevail over interests of science and society and shall be understood, observed, 
and applied at every step in this clinical study.   
It is expected that all parties will share in the responsibility for ethical conduct in 
accordance with their respective roles in the investigation.  The sponsor and the 
investigator(s) shall avoid improper influence or inducement of the subject, monitor, the 
clinical investigator(s) or other parties participating in or contributing to the clinical 
investigation. 
 
12.11 
Protection of Subject Confidentiality 
At all times throughout the clinical investigation, confidentiality will be observed by all 
parties involved.  All data shall be secured against unauthorized access.  Privacy and 
confidentiality of information about each subject shall be preserved in the reports and in 
any publication.  Each subject participating in this study will be assigned a unique 
identifier.  All CRFs or other study-related data (such as imaging) will be tracked, 
evaluated, and stored using only this unique identifier.   
The investigator will maintain a confidential study subject list identifying all enrolled 
subjects. This list will contain the assigned study subject’s unique identifier and name.  
The investigator bears responsibility for keeping this list confidential.  A copy of this list 
will not be provided to the study sponsor and is only to be used at the study center.   
While on site, monitors and auditors will have access to the study subject list and other 
personally identifying information of study subjects to ensure that data reported in the 
CRF corresponds to the person who signed the ICF and the information contained in 
the original source documents.  Such personal identifying information may include but is 
not limited to the subject’s name, address, date of birth, gender, race, and medical 
record number.  The subject’s name, medical record number, or address will NOT be 
recorded in the monitor’s visit report or the database.   

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Any source documents copied for monitoring purposes by the sponsor will be identified 
by using the assigned subject’s unique identifier in an effort to protect subject 
confidentiality.  Any subject identifiers will be blacked or scratched out and replaced with 
the subject’s study identification code.  
Photographs of the procedure and treatment areas will not include subject faces or any 
other personally identifying features.  Subject images will be tracked using the unique 
study ID. 
   
12.12 
Quality Assurance and Supervision by Authorities 
All documents and data shall be produced and maintained in such a way to assure 
control of documents and data to protect the subject’s privacy as far as reasonably 
practicable.  The sponsor and representatives of the FDA or other regulatory authorities 
are permitted to inspect the study documents (e.g., study protocol, CRFs, and original 
study-relevant medical records/files) as needed.  All attempts will be made to preserve 
subject confidentiality. 
All clinical sites are subject to audit by sponsor or designee for protocol adherence, 
accuracy of CRFs, and compliance with applicable regulations.  Any evident pattern of 
non-compliance with respect to these standards will be cause for corrective action. 
The study protocol, data-recording procedures, data handling, and study reports are 
subject to an independent clinical Quality Assurance audit by the study sponsor, its 
designee, or health authorities. 
 
12.13 
Corrective and Preventative Action 
Aside from an official site audit, non-compliance may be discovered through other 
means such as monitoring, site management, general communication, or site visits.  
Any evident pattern of non-compliance with respect to 21 CFR 812, E6 GCP 
Consolidated Guidance, the Declaration of Helsinki, or conditions imposed by the 
reviewing IRB(s), the study protocol, or other governing requirements may be cause for 
corrective action.  Such corrective action may range from communication of the non-
compliance to the site being placed on probation until corrective action is taken.  In 
more serious circumstances, enrollment may be terminated at the site.  Corrective 
actions will be followed through resolution, and any resulting documentation 
surrounding the corrective and preventative action will be kept in the central study files. 
 
12.14 
Insurance 
The sponsor will maintain the appropriate and necessary insurance coverage for the 
duration of the study.   

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13. 
RESPONSIBILITIES 
13.1 
Sponsor Responsibilities 
Candesant Biomedical, Inc. is the sponsor of this study.  The study sponsor has the 
overall responsibility of the study and will work to ensure compliance with the study 
protocol, 21 CFR 812, GCP: Consolidated Guidance, and signed study agreements.  
The sponsor will be responsible for, but not limited to, the following:  
 Select qualified investigators, monitors, and contract study personnel 
 Maintain Control and properly manage all Investigational Devices 
 Obtain required agreements including investigator eligibility and financial 
disclosure 
 Provide the study protocol and any subsequent amendments to the investigators 
 Provide appropriate information and training to investigators and study site staff  
 Ensure that no study related activities commence at any site prior to receipt of all 
required documented approvals, at minimum FDA and IRB  
 Promptly inform the investigators and where applicable any regulatory authorities 
and IRBs if the study is prematurely terminated or suspended and the reason for 
the termination or suspension 
 Provide protocol-initiation training to include review of the IFU, CRF completion, 
and guidelines for obtaining informed consent 
 Each study center will undergo Site Initiation which will include but is not 
limited to a review of the following by key study personnel (investigators, 
coordinators): 
o Study Protocol 
o Consenting procedures 
o IFU 
o AE Reporting requirements  
o CRF completion  
o Device handling and accountability procedures 
o Protection of subject confidentiality 
 Coordinate ongoing communication with CRO(s), consultants, and study sites to 
resolve any problems concerning the protocol or data collection.  Every effort will 
be made to ensure compliance with the protocol 
 Retain ownership of all clinical data generated in this study and control the use of 
the data for purposes of regulatory submissions  
 Protect subject confidentiality  
 Collect, store, and keep secure, at a minimum, the following documents: 
 Curriculum Vitae (CV) of each investigator 
 The name of the institutions where the study will be conducted 
 The IRB opinion and/or approval, in writing, and relevant correspondence 
 IRB-approved ICF 
 Correspondence with authorities (as required) 
 Investigator Agreement for each investigator  
 Conflict of Interest and Financial Disclosure Form for each investigator 
 Protocol Signature Page 

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 Insurance certificates (as necessary) 
 Names/contact information for study monitor(s) 
 Records of any AEs  
 Statistical analyses and underlying supporting data 
 Final report 
 
13.2 
Sponsor Maintenance of Study Records 
The sponsor will be responsible for maintaining study records per 21 CFR 812.140(b) 
and GCP: Consolidated Guidance. 
The sponsor will be responsible for monitoring the investigation per 21 CFR 812.46 and 
GCP: Consolidated Guidance. 
The sponsor will be responsible for reporting per 21 CFR 812.50(b). 
 
13.3 
Investigator Responsibilities 
The investigator(s) shall be responsible for the day-to-day conduct of the investigation 
as well as for the safety and well-being of the human subjects involved in the clinical 
investigation.  The investigator is expected to be compliant with the Study Protocol, 
Investigator Agreement, Instructions for Use and other provided materials at all times.    
To ensure proper execution of the study protocol, each investigator can identify a study 
coordinator for this study.  Working with and under the authority of the investigator, the 
study coordinator can help assure that all study requirements are fulfilled and is the 
contact person at the site for all aspects of study administration.  The investigator is 
responsible for ensuring that the study coordinator and all other study staff at the clinical 
site are compliant with the study requirements.   
The investigator is responsible for maintaining medical and study records for every 
subject participating in the clinical study (including information maintained electronically 
such as digital imaging).  The study center will also maintain original source documents 
from which study-related data are derived, which may include, but are not limited to: 
 Progress notes recording subject’s medical history and medications 
 Medical records regarding AEs, including treatment and clinical outcome  
 Notes of phone calls and/or correspondence concerning the subject 
The investigator must ensure that all study subject records are stored for at least 
2 years after the date a marketing application is approved for the device for the 
indication for which it is being investigated or, if no application is to be filed, until 2 years 
after the applicable agency(ies) has been notified (if applicable).  To avoid error, the 
study site must contact Candesant Biomedical prior to the destruction of study records 
to ensure that they no longer need to be retained.  In addition, Candesant Biomedical is 
to be contacted if the investigator plans to leave the investigational site so that 
arrangements can be made for the handling or transfer of study records. 
The investigator(s) will allow auditing of their clinical investigation procedure(s). 

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13.4 
Investigator Reports 
The investigator(s) will be responsible for reporting per 21 CFR 812.150(a) and 
according to applicable IRB requirements and GCP: Consolidated Guidance.  Reports 
must identify subjects using the unique identifier to protect confidentiality. 
 
13.5 
Required Documents from the Investigator 
At a minimum, the following documents will be provided by the investigational site to the 
study sponsor prior to study start (consent of the first subject): 
 Signed Investigator Agreement 
 Documentation of Financial Disclosure 
 Signed Protocol Signature Page 
 IRB approval   
 IRB approved ICF 
 Investigator and Co-investigator’s current CV 
A site may not begin study participation until all of the above-listed documents have 
been provided to the study sponsor. The study may begin once the CV of the site 
Principal Investigator has been received.  No additional investigators may participate 
until a copy of their CV and a signed Investigator Agreement has been provided to the 
study sponsor. 
Additional study-required documents will be collected, as applicable, and maintained, as 
necessary.   
 
13.6 
Other Investigator Reports 
The investigator for each study center is responsible for submission of reports to the 
sponsor according to the schedule shown below.  All reporting timelines are “within 
knowledge of the occurrence.”  Reports must identify subjects using the study’s unique 
identifier to protect subject’s confidentiality. 
Type of Notification 
Time Constraints 
Withdrawal of IRB Approval 
verbal report within 24 hours followed by a written 
report within 5 working days 
Informed Consent NOT 
Obtained 
verbal or written report within 5 working days 
 
 

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14. 
DATA MANAGEMENT  
Study data will be collected using a standardized eCRF.  The CRF will be designed to 
accommodate the specific features of the study design.  Modification of the CRF will 
only be made if deemed necessary to support the study design and will be done by the 
study sponsor.  
 
14.1 
Data Management Responsibilities  
Candesant Biomedical will be responsible for the management of the database and 
resulting study data.  Conventional data verification routines will be performed.  Data 
Management will be performed according to the study’s Data Management Plan.  The 
study sponsor may manage directly or outsource data management to a qualified data 
management group. 
 
14.2 
Data Entry 
Subject data will be recorded on CRFs and entered into a limited access secure 
database.  The software and database will be compliant with laws and regulations 
applicable to the conduct of clinical studies pertaining to the use of electronic records 
and signatures. 
Changes made to the clinical data will be captured in an audit trail and available for 
review. 
  
14.3 
Data Cleaning 
Data review will be performed to identify possible data discrepancies.  Manual and/or 
automatic queries will be created and the resulting Data Clarification Form, or 
equivalent, issued to the clinical site(s) for appropriate resolution (as applicable). 
 
14.4 
Data Retention and Back-up 
System backups are performed regularly.  The database will be managed on a secure 
server and computer access password controlled.  The secure server will be backed up 
periodically. Upon study completion, the data will be archived. 
 
14.5 
Confidentiality and Security 
Passwords will be utilized by data entry, data verification, and other personnel who have 
database access to ensure confidentiality and protection of data.    
 

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15. 
STUDY CLOSE-OUT  
At the time of the site close-out visit, the site monitor or designee will collect all 
outstanding study documents, ensure that the investigator’s files are accurate and 
complete, review record retention requirements with the investigator, make a final 
accounting of all study supplies, and ensure that all applicable requirements are met for 
the study.  The observations and actions made at this visit will be documented in a 
close-out visit report. 
Once all sites are considered closed, the study may be closed.  Study closeout will 
include a final report which will be submitted to each participating investigator, IRB, and 
other governing agency, as required. 
 
15.1 
Study Suspension or Early Termination 
The study can be discontinued at the discretion of the investigator or study sponsor for 
reasons including, but not limited to, the following: 
 Occurrence of AEs unknown to date in respect to their nature, severity, or 
duration, or the unexpected incidence of known AEs 
 Obtaining new scientific knowledge that shows that the study is no longer valid or 
necessary 
 Insufficient recruitment of subjects 
 UADE presenting an unreasonable risk to subjects (Sponsor may terminate the 
study immediately) 
 Persistent non-compliance with the protocol 
 Persistent non-compliance with IRB or regulatory requirements 
If the study is discontinued or suspended prematurely, the sponsor shall promptly inform 
all clinical investigator(s)/investigational center(s) of the termination or suspension and 
the reason(s) for this.  The IRB shall also be informed promptly and provided with the 
reason(s) for the termination or suspension by the sponsor or by the clinical 
investigator/investigational center(s).  Regulatory authorities and the personal 
clinician(s) of the subjects may also need to be informed if deemed necessary.   
 
15.2 
Final Report  
A final report will be prepared even if the study is prematurely terminated.  
 
15.3 
Publication Policy 
At the conclusion of the study, a multi-center abstract reporting the results will be 
prepared and may be presented at a major meeting(s).  A multi-center publication may 
also be prepared for publication in a reputable scientific journal.  The publication of results 
from any single center experience within the study is not allowed until the aggregate study 
results have been published, unless there is written consent from the study sponsor.  

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16. 
ABBREVIATIONS  
 
AE
Adverse Event
ADE
Adverse Device Event
CDX-101
N-SWEAT Patch was previously called CDX-101
CLP
Clinical Protocol
CMH
Cochran-Mantel-Haenszel
CRF
Case Report Form
CRO
Clinical Research Organization
CV
Curriculum Vitae
DSMB
Data Safety Monitoring Board
eCRF
Electronic Case Report Form
FACES
Wong-Baker Pain Scale
FAS
Full Analysis Set
FDA
US Food and Drug Administration
GCP
Good Clinical Practice
GEE
General Estimating Equation
GSP
Gravimetric Sweat Production
HDSS
Hyperhidrosis Severity Scale
ICF
Informed Consent Form
ICH
International Council on Harmonization
ID
Identifier
IDE
Investigation Device Exemption
IFU 
Instructions for Use
IHHS
International Hyperhidrosis Society
IRB
Institutional Review Board
ITT
Intent to Treat
N-SWEAT
Candesant Biomedical Patch to reduce sweating
PPS
Per Protocol Set
QoL
Quality of Life
QoL-7
A Specific QoL Survey with 7 questions
SADE
Serious Adverse Device Event
SAE
Serious Adverse Event
SAP
Statistical Analysis Plan
STAYDRI 
SafeTy and FeasibilitY Evaluation of the CDX-101 Device in Patients 
who ExpeRience Heavy or Excessive SweatIng
UADE
Unanticipated Adverse Device Event
US
United States
 
 
 
 
 
 
 

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17. References 
 
Doolittle J, Walker P, Mills T, Thurston J.  Hyperhidrosis: an update on prevalence and 
severity in the United States. Arch Dermatol Res.  2016;308(10):743-749. 
Glaser DA, Coleman W, Fan L, Kaminer M, Kilmer S, Nossa R, Smith S, 
O’Shaughnessy K.  A Randomized, Blinded Clinical Evaluation of a NovelMicrowave 
Device for Treating Axillary Hyperhidrosis: TheDermatologic Reduction in Underarm 
Perspiration Study.  Dermatol Surg 2012;38:185–191 
Glaser DA, Hebert A, Pieretti L, Pariser D.  Understanding patient experience with 
hyperhidrosis: a national survey of 1,985 patients.  J Drugs Dermatol.  2018;17(4):392-
396.  
Hamm H. Impact of hyperhidrosis on quality of life and its assessment. Dermatol Clin. 
2014;32(4):467-476. 
Hornberger J, Grimes K, Naumann M, Glaser DA, Lowe NJ, Naver H, et al; Multi-
Specialty Working Group on the Recognition, Diagnosis, and Treatment of Primary 
Focal Hyperhidrosis.  Recognition, diagnosis, and treatment of primary focal 
hyperhidrosis.  J Am Acad Dermatol.  2004;51(2):274-286. 
Stander, M and  Wallis, LA  The Emergency Management and Treatment of Severe 
Burns Emerg Med Int. 2011; 2011: 
Strutton DR, Kowalski JW, Glaser DA, Stang PE.  US prevalence of hyperhidrosis and 
impact on individuals with axillary hyperhidrosis: results from a national survey.  J Am 
Acad Dermatol. 2004;51(2):241-248. 
Wade R, Rice S, Llewellyn A, Moloney E, Jones-Diette J, Stoniute J, et al. Interventions 
for hyperhidrosis in secondary care: a systematic review and value-of-information 
analysis. Health Technol Assess. 2017;21(80):1-280. 
Wilke K, Martin A, Terstegen L, Biel, S.  Review Article:A short history of sweat gland 
biology.   International Journal of 170 Cosmetic Science, 29, 169–179 
 
 
 
 
 
 
 
 
 
 
 
 
 

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APPENDIX A: HDSS 
 
Information and Instructions:  
About Sweating:
Sweating is a natural and healthy part of life. Sweating helps to cool the body and maintain a normal body 
temperature in a warm environment or during exercise. It is normal to sweat when you are hot, when you are 
exercising, and when you are feeling stressed.   
About Excessive Sweating:  
You are in this study because you feel like you sweat too much.  You may sweat at times other than when you are 
warm, exercising, or stressed.  The questions below are designed to measure the severity and impact of your 
excessive underarm sweating during the past week. While you may experience excessive sweating on other parts of 
your body, these questions are designed to measure the impact of the treatment on your underarm sweating ONLY.   
Instructions:
 Please only think about your underarm sweat as you answer these questions.  
 Please remember that sweating when you are hot, exercising or stressed is normal, so when you are answering 
the questions, think about sweating that is beyond normal.  For example, you may sweat when you work out at 
the gym and still answer “never” since sweating at the gym during a strenuous workout is considered to be the 
body’s natural response to keep the body cool. 
 There are no right or wrong answers; you should answer truthfully about your excessive underarm sweating 
experiences during this past week  
 If you have any questions, you may contact the study team  
 
The box next to the statement that best describes your feelings about your underarm 
sweating at the current time should be checked.  
Prior to each statement there is a number (1, 2, 3, and 4). This number is the “HDSS score”. 
 
HDSS SURVEY 
ASSESSMENT 
TIME: 
☐ Screening 
☐ Baseline 
☐ 1 week 
☐ 2 weeks 
☐ 3 weeks 
☐ 4 weeks 
☐ 5 weeks 
☐ 6 weeks 
☐ 7 weeks 
☐ 8 weeks 
☐ 9 weeks 
☐ 10 weeks 
☐ 11 weeks 
☐ 12 weeks 
☐ Other 
☐  1.   
My underarm sweating is never noticeable and never interferes with 
my daily activities  
☐  2. 
My underarm sweating is tolerable but sometimes interferes with 
my daily activities  
☐  3. 
My underarm sweating is barely tolerable and frequently interferes 
with my daily activities 
☐  4. 
My underarm sweating is intolerable and always interferes with my 
daily activities 

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APPENDIX B:  LOCAL SKIN REACTIONS 
 
 
An assessment for local skin reactions is conducted by the investigator pre-
treatment, immediately post-treatment and at all clinic visits following treatment. .  
The assessment is also used during the course of evaluating and reporting an AE 
that is a local skin reaction.   
  
The overall scoring system is comprised of an erythema rating scale plus the addition of 
clinical descriptors adapted from Dykes, 1992 and the FDA Guidance for Industry: Skin 
Irritation and Sensitization Testing of Generic Transdermal Drug Products (1999). The 
severity of erythema is rated on a scale of 0–5 along with the presence of other clinical 
signs or symptoms. These descriptors noted by letters, are then added to the numerical 
score (e.g., 3S).  For example:  Erythema spreading outside the treatment site with 
subject reporting scaling = 3 S 
 
 
Table 8: Skin Erythema Assessment 
Rating
Description
0 
No reaction/No erythema 
1 
Minimal erythema (barely perceptible) 
2 
Erythema (easily visible) 
3 
Erythema, spreading outside of treated site 
4 
Erythema, spreading outside of treated site with either edema (swelling) or vesicles 
(elevated, circumscribed lesions up to 1 cm in size that are filled with serous fluid) 
5 
Severe reaction with ulceration (irregularly sized and shaped erosions of the skin 
extending into the dermis) 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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Table 9: Clinical Signs/Symptom Descriptors* 
Descriptor
Description
 O 
No Clinical Signs/Symptoms 
 BS 
Burning or stinging (sensation as described by the subject) 
 I 
Itching (sensation as described by the subject) 
 E 
Edema  
 S 
Scaling 
 F 
Fissures  
 C 
Crusts  
If C:
Give Color: ___________
Thickness:   thin  thick 
Describe:   dry  macerated   adherent   loose 
Culture Results:  positive   negative  N/A 
 V 
Vesicles  
If V: Give size _____ mm x ______mm
 BU 
Bulla   
If BU: Give size _____ mm x ______mm
 P 
Pustule 
If P: Give size _____ mm x ______mm
 R 
Erosion  
If R: Give size _____ mm x ______mm
 U 
Ulcer 
 A 
Scarring 
If A:
☐ Contracture   ☐ Hypertrophic  ☐ Keloid 
 OTH 
Other 
If OTH:
Describe Other:  
*Clinical Symptoms are assessed as mild, moderate or severe per Table 6 of this protocol.   
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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APPENDIX C:  QoL SURVEYS 
 
Information and Instructions for Study Subjects:   
About Sweating:
Sweating is a natural and healthy part of life. Sweating helps to cool the body and maintain a normal body 
temperature in a warm environment or during exercise. It is normal to sweat when you are hot, when you are 
exercising, and when you are feeling stressed.   
About Excessive Sweating:  
You are in this study because you feel like you sweat too much.  You may sweat at times other than when you are 
warm, exercising, or stressed.  The questions below are designed to measure the severity and impact of your 
excessive underarm sweating during the past week. While you may experience excessive sweating on other parts of 
your body, these questions are designed to measure the impact of the treatment on your underarm sweating ONLY.   
Instructions:
 
Please only think about your underarm sweat as you answer these questions. 
 
Please remember that sweating when you are hot, exercising or stressed is normal, so when you are 
answering the questions, think about sweating that is beyond normal.  For example, you may sweat when 
you work out at the gym and still answer “never” since sweating at the gym during a strenuous workout is 
considered to be the body’s natural response to keep the body cool.  
 
If you have any questions, you may contact the study team  
 
 
QUALITY OF LIFE ASSESSMENT QUESTIONS                  Version:  Draft _IDE Submission
TIME OF 
ASSESSMENT:
☐ Baseline 
☐ 1 week 
☐ 2 weeks 
☐ 3 weeks 
☐ 4 weeks 
☐ 5 weeks 
☐ 6 weeks 
☐ 7 weeks 
☐ 8 weeks 
☐ 9 weeks 
☐ 10 weeks 
☐ 11 weeks 
☐ 12 weeks 
☐ Other 
BOTHER: 
During the past week how bothered were 
you by your underarm sweating? 
☐ Not at all bothered  
☐ A little bothered 
☐ Moderately bothered 
☐ Very Bothered 
☐ Extremely Bothered 
IMPACT: 
During the past week how often did your 
underarm sweating impact your daily 
activities? 
☐ Not at all  
☐ A little bit 
☐ A moderately amount 
☐ A great deal 
☐ An extreme amount 
QoL-7:
How has your underarm sweating impacted certain areas of your life over the past week?   Please 
indicate Yes or No to the following statements 
1. I felt embarrassed because of my underarm sweating 
☐Y   ☐N 
2. I felt frustrated because of my underarm sweating 
☐Y   ☐N 
3. I felt less confident because of my underarm sweating 
☐Y   ☐N 
4. I had to change my shirt during the day because of my underarm sweating 
☐Y   ☐N 
5. I had to take more than 1 shower or bath a day because of my underarm sweating 
☐Y   ☐N 
6. My underarm sweating kept me from doing an activity that I wanted or needed to do 
☐Y   ☐N 
7. I wanted to avoid interactions with other people because of my underarm sweating 
☐Y   ☐N 
 
 
 
 

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APPENDIX D:  GSP INSTRUCTIONS 
 
Materials Required 
 
 Quantitative Filter Papers, 90 mm 
 Room temperature environment (26°C-30°C recommended).  Actual room 
temperature must be documented to ensure that the same temperature is applied for 
each gravimetric test.   
 
Procedure 
 
GSP should be measured at screening, baseline (˜72 hours later) and at the 4-week 
follow-up visit.  Measurements should be performed in the same position(s) (sitting, 
standing, or walking) at every visit.  The position used should be document in the 
subject records.  If the screening GSP Measurement and the Baseline GSP 
Measurement differ by more than 100%, the subject should not be enrolled.  GSP 
should not exceed 300 mg/5 min in either axilla at either screening or baseline 
 
 
IMPORTANT:  Each gravimetric measurement must be taken in similar room 
conditions (same humidity and temperature as baseline). Whenever possible all 
Gravimetric tests for this study (screening, baseline and 4-weeks) should be taken at 
the same time of day (±3 hours).   
 
A minimum of two (2) measurements should be taken in each axilla at every timepoint 
to ensure accuracy of results. If following the 2nd readings there is concern regarding the 
measurement accuracy, a 3rd reading may be performed.  An average of accurate 
reading(s) will be reported.   
 
 Weigh the plastic tube (vial) with filter paper to be used for the assessment (in 
milligrams) and document the baseline combined weight of the filter paper and vial.   
 Dry the subject’s axilla with an absorbent tissue or similar. Allow subject to sit for 15 
minutes at room temperature (20-25.6°C) 
 Determine the planned treatment area and desired location for filter paper 
placement. Paper should be placed centrally, just under the axilla crease formed 
when arms are down by their side.   
 Place the previously weighed filter paper in the subject’s armpit and ask them to 
hold it there for 5 minutes.  
 
Following the 5-minute application of the filter paper, the filter paper and vial together 
will be weighed again.  The result is the difference in the weight from baseline filter 
paper and vial weight and post filter paper application (paper placed in vial and 
weighed).  The difference is calculated in milligrams and recorded as mg/5mins.   
 
 
 
 

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APPENDIX E:  FITZPATRICK SKIN TYPE 
 
The subject will be evaluated by the study site to determine their Fitzpatrick skin type 
based upon the categories as described below.  The resulting skin type will be entered 
into the subjects CRF.   
 
Skin Type I 
Pale white skin, blue/green eyes, blond/red hair 
Always burns, does not tan 
 
Skin Type II 
Fair skin, blue eyes 
Burns easily, tans poorly 
 
Skin Type III 
Darker white skin 
Tans after initial burn 
 
Skin Type IV 
Light brown skin 
Burns minimally, tans easily 
 
Skin Type V 
Brown skin 
Rarely burns, tans darkly easily 
 
Skin Type VI 
Dark brown or black skin 
Never burns, always tans darkly 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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APPENDIX F:  SAMPLE PATIENT DIARY 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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Appendix G:  Sample Subject Take Home Care Hand-Outs 
 
 
 
4. 
 Post-Screening Postcard (CB-CLO-001.4, RevA) 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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2. 
Post-Treatment Hand-out (CB-CLO-001.2, Rev B) 
 
 
 
 
 
 

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Appendix H:  Referral to Burn Center* 
 
Severity Determination 
First Degree (Partial Thickness): Superficial, red, sometimes painful.  
Second Degree (Partial Thickness): Skin may be red, blistered, swollen. Very painful.  
Third Degree (Full Thickness): Whitish, charred or translucent, no pin prick sensation in 
burned area.  
 
Percentage Total Body Surface Area (TBSA)  
 
 
Burn Center Referral Criteria  
A burn center may treat adults, children, or both. Burn injuries that should be referred to a 
burn center include:  
1. Partial thickness burns greater than 10% total body surface area (TBSA).  
2. Burns that involve the face, hands, feet, genitalia, perineum, or major joints.  
3. Third degree burns in any age group.  
4. Electrical burns, including lightning injury.  
5. Chemical burns.  
6. Inhalation injury.  
7. Burn injury in patients with preexisting medical disorders that could complicate 
management, prolong recovery, or affect mortality.  
8. Any patient with burns and concomitant trauma (such as fractures) in which the burn 
injury poses the greatest risk of morbidity or mortality. In such cases, if the trauma 
poses the greater immediate risk, the patient may be initially stabilized in a trauma 
center before being transferred to a burn unit. Physician judgment will be necessary 
in such situations and should be in concert with the regional medical control plan and 
triage protocols.  
9. Burned children in hospitals without qualified personnel or equipment for the care of 
children.  
10. Burn injury in patients who will require special social, emotional, or rehabilitative 
intervention.  
* Excerpted from Guidelines for the Operation of Burn Centers (pp. 79-86), Resources for Optimal Care of the Injured 
Patient 2006, Committee on Trauma, American College of Surgeons  

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APPENDIX I: Sample Recruitment Poster/flyers (CB-CLO-001.1, Rev A)  
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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APPENDIX J: DSMB QUALIFICATIONS 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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APPENDIX K:  N-SWEAT IFU 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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Appendix L (for Participating Centers)