At-Home Dermoscopy Artificial Intelligence for Optimizing Early Triage of Skin Cancers and Atypical Melanocytic Nevi With Uncertain Malignant Potential
Phase: NA
Conditions: Malignant Skin Neoplasm
Sponsor: OHSU Knight Cancer Institute

 
1 
 
 
Full Study Title: 
At-home dermoscopy artificial intelligence for optimizing early triage of skin 
cancers and atypical melanocytic nevi with uncertain malignant potential 
Protocol Number:  STUDY00023727 
ClinicalTrials.gov ID 
NCT05321784 
Investigational Product: 
Sklip System  
Version Number:  5.05 
Version Date: 
09-15-2023 
Replaces: 
First Submission  
Principal Investigator: 
Sancy Leachman MD, PhD 
 
Department of Dermatology 
Oregon Health & Science University 
3181 SW Sam Jackson Park Road 
Portland, OR 97239  
Phone: 503-418-9356  
Fax: (503) 494-6968 
Email: leachmas@ohsu.edu 
Investigational Product 
Evaluation Site 
Participants will test the Sklip System at their home address using the Sklip 
dermatoscope device hardware, the Sklip Mole Scanning Algorithm (SMSA) and 
access to the research version of the Sklip App.  Related training will be virtual. 
Regulatory Sponsor: 
(if different) 
Sklip Inc.  
4800 Meadows Rd Ste 300 
Lake Oswego, OR 97035 
971-867-1069 
Email: service@sklip.Ai 
 
Study Financing is described in a separate agreement(s) between the individual 
Sponsor and each Study Site. 
Statistician: 
Emile Latour, M.S  
Oregon Health and Science University 
Biostatistics Shared Resource 
Phone: (503) 223-1220 
Fax: (503) 494-6968 
Email: latour@ohsu.edu 

 
2 
 
At-Home Dermoscopy Artificial Intelligence 
eIRB#00023727 
Version Number 5.05 
Version Date. 09-15-2023 
PI: Sancy Leachman MD, PhD 
 
SUMMARY OF CHANGES 
 
# 
Section 
Summary of Changes 
Justification 
1 
Synopsis, 3.1 
Clarification that the Dermatology Provider 
performing the clinical full body skin exam 
will be blinded to the skin lesions that were 
selected by the study Participant at home.   
 
Addition of requirement for the Dermatology 
Provider to verbally inform the Study 
Coordinator the Participant’s Fitzpatrick skin 
phototype (1,2,3,4,5 or 6) after leaving the 
patient room. 
Clarification of how selection-bias will 
be avoided. 
 
How the Dermatology Provider assess 
the Participants Fitzpatrick skin 
phototype.   
 
2 
Synopsis, 5.3.1 
Addition of the following text to clarify 
blinding procedures: Specifically, the 
dermatology provider will be instructed to 
say the following to each participant upon 
entering the patient room for the in-person 
FBSE: “Hello, my name is [name and title], 
the purpose of today’s visit is to complete a 
full body skin examination as part of the at-
home dermoscopy study.  In order to avoid 
bias, please hold with any questions related 
to your moles of concern until I have 
verified that I completed your full body skin 
examination and all other study related 
activities.  I will be happy to address your 
questions or concerns at that time.” 
Address FDA concerns regarding 
blinding and provide a uniform 
experience for the patient  
3 
Synopsis, 3.1 
Addition of the following text to clarify 
situations where the Participant did not 
complete a part of at home tasks: 
 
8) If the Participant has taken a set of 
SCI/DDI at home of a PSLC that is not 
intended (qualified because of anatomic 
body site) for the Sklip System, the Study 
Coordinator should still capture a set of 
control SCI/DDI and upload to REDCap 
Cloud.  The Participant standard clinical care 
will not be changed. 
9) If the Participant took a set of SCI/DDI of 
a PSLC at home but did not follow 
instructions – specifically uploading the DDI 
to the Sklip System - the Study Coordinator 
should remind the Participant to complete 
this task in the patient room (using the DDI 
from their mobile device gallery), upload to 
the Sklip System, and record the output on 
their Mole Log Sheet.  If this situation 
occurs, the Study Coordinator should make a 
note in REDCap Cloud; If the Participant 
is/was concerned about a PSLC but did not 
take a set of SCI/DDI at home, this PSLC 
will not be included in the study. 
Provide clarification 

 
3 
 
At-Home Dermoscopy Artificial Intelligence 
eIRB#00023727 
Version Number 5.05 
Version Date. 09-15-2023 
PI: Sancy Leachman MD, PhD 
 
4 
4.1, 14.3 
Removed language regarding legally 
authorized representative (LAR) 
This was discordant with the exclusion 
criteria and now updated 
 
 
 

 
4 
 
At-Home Dermoscopy Artificial Intelligence 
eIRB#00023727 
Version Number 5.05 
Version Date. 09-15-2023 
PI: Sancy Leachman MD, PhD 
SYNOPSIS 
 
Full Study Title 
At-home dermoscopy artificial intelligence for optimizing early triage of skin 
cancers and atypical melanocytic nevi with uncertain malignant potential 
Protocol # 
STUDY00023727 
Study Type 
Prospective single-arm open-label multicenter research Study  
Study Sample Size 
310 Participants 
Lead Study Site  
Oregon Health and Sciences University (OHSU) in Portland, Oregon 
3303 S Bond Ave CHH1 Ste 16 (Department of Dermatology) 
PI: Sancy Leachman MD, PhD (leachmas@ohsu.edu) 
 
Satellite Study 
Site(s) Governance 
OHSU IRB will not be responsible for governing any of the Satellite Study Sites.  
Their governance will be a third-party IRB using this IRB Protocol for guidance. 
Study Site #2 
Skin Cancer Center 
3024 Burnet Ave, Cincinati, OH 45219  
PI: Michael Tassavor MD FAAD (mtassavor2@gmail.com) 
Study Site #3 
The Skin Center Dermatology Group 
200 East Eckerson Rd, New City, NY 10956 
PI: Peter Friedman MD, PhD FAAD (pbc9@cumc.columbia.edu)  
Study Site #4 
The Private Practice of Johnny Gurgen D.O. P.A. 
1340 Citizens Blvd, Leesburg, FL 34748 
PI: Johnny Gurgen DO FAOCD (johngurgen@gmail.com) 
 At-Home Phase 
Duration 
Up to 14 days, completed by Participants at their home address 
 In-Person Phase 
Duration 
Up to 28 days, completed by Participants and Study Coordinators in-office 
Enrollment 
Duration 
Up to 90 days 
Abbreviated 
Definitions in 
Sequential Order 
Sklip System (Sklip dermatoscope device and SMSA (used in the Sklip App)) 
SMSA: Sklip Mole Scanning Algorithm 
SCI: Smartphone clinical images (non-medical-device assisted) 
DDI: Digital dermoscopy images 
PSLC(s): Pigmented skin lesion(s) of concern 
FDA: United States Food and Drug Administration 
PMLS: Participant Mole Log Sheet 
SaMD: Software as a Medical Device 
API: Application Program Interface  
DP: Dermatology Provider 
APP: Advanced Practice Practitioner (Physicians Associate or Nurse Practitioner) 
PCP: Primary Care Provider 
MD3PC: Modified dermoscopy three-point checklist  
DRFs: Dermoscopic remarkable features (based on the MD3PC) 

 
5 
 
At-Home Dermoscopy Artificial Intelligence 
eIRB#00023727 
Version Number 5.05 
Version Date. 09-15-2023 
PI: Sancy Leachman MD, PhD 
SSE(s): Self-skin-exam(s) performed by Participants at-home 
FBSE(s): Full body skin exam(s) performed by DPs in-office 
SCI-TD: Expert dermatologist consensus SCI triage decision 
DDI-GT: Expert dermatologist consensus DDI dermoscopic diagnosis  
DHI: Digital histologic image of a target PSLC biopsied during the In-person 
Phase 
EMR: Electronic medical record 
Study Device 
Hardware 
The Sklip dermatoscope device hardware will be provided to Participants to take 
DDI of their self-selected PSLCs using their smartphone or tablet. The Sklip 
dermatoscope is publicly (commercially) available and registered as a Class 1 
Medical Device (FDA Reg. 3017732705). 
Study Site Secure  
Smartphone and 
Sklip 
The sponsor will provide one (1) smartphone to each Study Site, one (1) unique 
passcode access to the SMSA within the Sklip App, one (1) Sklip dermatoscope 
(with charging cable, instructions, and dermoscopy oil) for use with Participants 
in-office.  Clear instructions will be given to delete all images from the native 
smartphone photo App gallery after Study Site Coordinators upload required data 
and images to the OHSU secure cloud, prior to returning the smartphone to the 
Sponsor.  This will ensure no patient health information leaves the Study Site on 
physical hardware. 
Study App 
The Sklip App is a publicly available smartphone App to download on the Apple 
iOS and Google Play app stores. The Sklip App is non-FDA regulated and part of 
the approved protocol for the Melanoma Community Registry (OHSU IRB# 
10561). A security review of the Sklip App has been performed as part of that 
Study and is transferred to this Study protocol. 
Sklip Mole Scan 
Algorithm (SMSA) 
The proprietary SMSA sensitivity triage performance is: 97.4% for melanoma 
and atypical melanocytic nevi with uncertain malignant potential, 97.0% for 
squamous cell carcinoma, 97.3% for basal cell carcinoma. 
Synopsis of the 
Sklip System 
The Sklip System is a SaMD that received breakthrough designation by the FDA 
on June 22, 2021. The Sklip System is intended to record, store and transfer DDI.  
The Sklip System consists of the Sklip App (used on a smartphone or tablet) and 
SMSA, that accept DDI taken by dermatoscope hardware. The Sklip System also 
displays DDI and non-diagnostic output of DDI analysis from the Sklip System 
software library that implements various DDI processing and artificial 
intelligence (Ai) analysis. This SaMD computes various digital parameters from 
DDI and provides these capabilities in the form of an API library. DDI can be 
incorporated into the Sklip System software to enable algorithmic analysis and 
analytics of DDI by the SMSA. The SMSA, is a software workflow tool designed 
to aid the assessment of DDI data input intended to conduct an initial screening 
of DDI for features suggestive of skin cancer and flag suspicious DDI for 
expedited review by appropriate medical personnel, such as a dermatology 
Provider (Dermatologist or dermatology trained APP), or primary care Provider 
(PCP). Specifically, the SMSA, via the Sklip System " Scan Moles with Ai" 
function, uses a Sklip Inc. proprietary Ai algorithm to provide DDI filtering, 
detection of noisy (non-qualified) DDI and detection of skin lesions containing 
qualified pigment that may be remarkable for MD3PC features ((DRFs): 
dermoscopic asymmetry, dermoscopic round structures and/or dermoscopic blue-
white colors), which may be indicative of skin cancer. 
Brief Description Of 
Study Intervention 
 
This is a new protocol to analyze how the use of the Sklip System enables 
laypersons to safely triage self-selected PSLCs from home with the same or 
better accuracy than pre-specified performance goals* for the detection of PSLCs 
that require biopsy (Melanoma and atypical melanocytic nevi with uncertain 
malignant potential (moderate, severe, and high grade atypia; those with 

 
6 
 
At-Home Dermoscopy Artificial Intelligence 
eIRB#00023727 
Version Number 5.05 
Version Date. 09-15-2023 
PI: Sancy Leachman MD, PhD 
pathology reports that include notes such as: borderline, cannot exclude 
melanoma, cannot exclude early evolving melanoma, unusual features, atypical 
spitz nevi, suspicion for melanoma, re-excision (or further removal) should be 
considered or is recommended in the pathologist management comment), 
Squamous cell carcinoma, Basal cell carcinoma). 
 
The Study  protocol will also compare the accuracy of the Sklip System when 
used by a layperson (Participant) versus near-perfect Sklip System user (Study 
Coordinator), assess whether Sklip System improves triage of PSLCs < 6 mm in 
diameter and triage of thin melanomas with <0.8 mm Breslow depth as 
suspicious, as compared to the current medical provider virtual triage method that 
relies on store-and-forward of smartphone clinical images (SCI), and assess 
accuracy of layperson-performed self-skin-exams (SSEs) at-home in the 
identification of all suspicious PSLCs present on their body as compared to the 
same layperson (Participant) evaluated with a full body skin examination (FBSE) 
by a dermatology Provider (DP) in-person.  
Primary Objective 
The Sklip System enables laypersons to safely triage self-selected pigmented skin 
lesions of concern (PSLCs) from home with the same or better accuracy than pre-
specified performance goals* for detection of PSLCs that require biopsy and are 
malignant: Melanoma and atypical melanocytic nevi with uncertain 
malignant potential (moderate, severe, and high grade atypia; those with 
pathology reports that include notes such as: borderline, cannot exclude 
melanoma, cannot exclude early evolving melanoma, unusual features, atypical 
spitz nevi, suspicion for melanoma, re-excision (or further removal) should be 
considered or is recommended in the pathologist management comment) (≥95% 
sensitivity, ≥30% specificity), Squamous cell carcinoma (≥80% sensitivity, 
≥30% specificity), Basal cell carcinoma (≥80% sensitivity, ≥30% specificity). 
Exploratory 
Objectives 
1. To compare the accuracy of Sklip System triage when used by a layperson 
versus near-perfect Sklip System user  
 
2. To assess whether Sklip System improves triage of pigmented skin lesions of 
concern < 6mm in diameter as suspicious as compared to the current medical 
provider virtual triage method that relies on store-and-forward non-medical-
device assisted smartphone clinical images 
 
3. To assess whether Sklip System improves triage of thin melanomas with < 0.8 
mm Breslow depth as suspicious as compared to the current medical provider 
virtual triage method that relies on store-and-forward non-medical-device 
assisted smartphone clinical images 
 
4. To determine the accuracy of layperson-performed self-skin-exam(s) at-home 
in the identification of all suspicious pigmented skin lesions of concern present 
on their body as compared to the same layperson evaluated with full body skin 
examination by a dermatology Provider in-office 
*Pre-specified 
Performance Goals 
*Pre-specified performance goals have been reviewed with the FDA for testing 
the Sklip System (including SMSA) as a stand-alone device. 
Participant activity 
prior to the At-
home Phase  
A copy of the Participant Mole Log Sheet (PMLS) will be provided to 
Participants at the beginning of the At-home Phase.  All Participants will be 
administered a pre-survey at the start of the Study to assess baseline knowledge 
and comfort in performing a SSE as well as a post-survey at the end of the Study. 
Blinding 
The Study Site PIs and DPs will be fully blinded to all results of the At-home 
Phase, including the PMLS.  Participants will be informed of the blinding activity 
prior to their FBSE to avoid DP selection-bias.   Specifically, the dermatology 
provider will be instructed to say the following to each participant upon entering 

 
7 
 
At-Home Dermoscopy Artificial Intelligence 
eIRB#00023727 
Version Number 5.05 
Version Date. 09-15-2023 
PI: Sancy Leachman MD, PhD 
the patient room for the in-person FBSE: “Hello, my name is [name and title], the 
purpose of today’s visit is to complete a full body skin examination as part of the 
at-home dermoscopy study.  To avoid bias, please hold with any questions related 
to your moles of concern until I have verified that I completed your full body skin 
examination and all other study related activities.  I will be happy to address your 
questions or concerns at that time.” 
Synopsis of the  
At-home Phase in 
sequential order 
Participants will be asked to review the Sklip System instructions, perform a 
SSE at-home, and identify PSLCs based on the following: 
 
(a) General concern (self or partner-identified, or non-dermatology Provider 
identified requiring a referral to a dermatology Provider) 
(b) Concern because the PSLC is different than the rest (i.e. “ugly duck sign”) 
 
Then, Participants will be instructed to carefully follow provided instructions and 
complete the following for each target PSLC: 
1) Mark the target PSLC with a green surgical marker (horizontal line) and the 
number (#) corresponding to the mole log, one (1) inch away from the target 
lesion 
2) Record the target PSLC with a number (#) and anatomic location in the PMLS 
3) Create a new photo album titled: “Moles” in their native smartphone/tablet 
Photo App 
4) Take one (1) smartphone clinical image (SCI) of the target PSLC, twelve (12) 
inches away from the target skin lesion 
5) Save the SCI in the album titled: “Moles” album 
6) Review Sklip dermatoscope instructions for proper use 
7) Take one (1) digital dermoscopy image (DDI) of the target PSLC using the 
Sklip dermatoscope.   
8) Save the DDI of the target PSLC in the “Moles” album 
9) Upload the DDI to the SMSA (“Scan Moles with Ai”) within the Sklip App 
once per target PSLC, until either a Suspicious or Unremarkable result is 
obtained, for a maximum of three attempts.  If after three attempts the user still 
receives an “Error” result, they will be prompted to document this in the 
participant mole log sheet. 
10) Take one (1) screenshot of the SMSA output per target PSLC 
11) Save the SMSA output screenshot in the album titled: “Moles”  
12) Record each SMSA output (SUSPICIOUS, UNREMARKABLE, ERROR) in 
the PMLS once per target PSLC  
13) Contact the Study Site to schedule an in-person FBSE within 28 days, if the 
Participant does not already have a scheduled visit  
Summary of 
Participant data 
acquisition for each 
target PSLC 
One (1) smartphone clinical image (SCI)  
One (1) digital dermoscopy image (DDI)  
One (1) Sklip Mole Scanning Algorithm (SMSA) output recorded in the PMLS 
One (1) SMSA output screenshot 
Synopsis of the In-
person Phase in 
sequential order 
With dermatology Provider present:   
The dermatology Provider (DP) will be blinded to the skin lesions that were 
selected by the study Participant at home.  The DP will perform a FBSE as part of 
the normal clinical care pathway. All PSLCs identified by the DP as 
SUSPICIOUS will be marked with a vertical line one (1) inch away from the 
target PSLC using a green surgical marker.  After completing the FBSE and 

 
8 
 
At-Home Dermoscopy Artificial Intelligence 
eIRB#00023727 
Version Number 5.05 
Version Date. 09-15-2023 
PI: Sancy Leachman MD, PhD 
marking all DP-selected suspicious PSLCs, the DP will verbally inform the Study 
Coordinator the Participant’s Fitzpatrick skin phototype (1,2,3,4,5 or 6) after 
leaving the patient room. 
 
 
Without dermatology Provider present,  
with Study Coordinator present: 
The Participant will be asked to provide their Participant Mole Log Sheet 
(PMLS).  Then, all PSLCs recorded in the PMLS will entered into REDCap 
Cloud by the Study Coordinator.  Any Participant-selected PSLCs that match 
those identified earlier as SUSPICIOUS by the DP will be marked with a 
horizontal line one (1) inch away from the target PSLC using a green surgical 
marker.  Therefore, PSLCs identified by both the DP and Participant will have a 
plus symbol.  Next, the Study Coordinator will take and record (near-perfect) SCI 
and DDI for all PSLCs recorded in the PMLS and those PSLCs identified by the 
DP as SUSPICIOUS (not matching the Participant PSLCs).  Then, the Study 
Coordinator will complete the following: 
 
1) Take one (1) photo of the Participant identification sticker with a Study Site 
secure smartphone/tablet 
2) Take one (1) smartphone clinical image (SCI) of each target PSLC recorded in 
the Participant Mole Log Sheet (PMLS) 
3) Take one (1) digital dermoscopy image (DDI) of each target PSLC using the 
Sklip dermatoscope.   
4) Save the DDI of the target PSLC in the Study Site smartphone/tablet native 
photo gallery 
5) Upload the Study Coordinator-taken DDI to the SMSA (“Scan Moles with 
Ai”) within the Sklip App  
6) Take one (1) screenshot the SMSA output  
7) Record each SMSA output (SUSPICIOUS, UNREMARKABLE, ERROR) in 
REDCap Cloud, per target PSLC  
8) If the Participant has taken a set of SCI/DDI at home of a PSLC that is not 
intended (qualified because of anatomic body site) for the Sklip System, the 
Study Coordinator should still capture a set of control SCI/DDI and upload to 
REDCap Cloud.  The Participant standard clinical care will not be changed. 
9) If the Participant took a set of SCI/DDI of a PSLC at home but did not follow 
instructions – specifically uploading the DDI to the Sklip System - the Study 
Coordinator should remind the Participant to complete this task in the patient 
room (using the DDI from their mobile device gallery), upload to the Sklip 
System, and record the output on their Mole Log Sheet.  If this situation occurs, 
the Study Coordinator should make a note in REDCap Cloud; If the Participant 
is/was concerned about a PSLC but did not take a set of SCI/DDI at home, this 
PSLC will not be included in the study. 
 
Synopsis of Study 
Data Collection 
Study Coordinators at each Study Site will conduct regular EMR chart reviews to 
track Participant requests to begin their In-person Phase, after the Participant has 
completed their the At-home Phase.  
 

 
9 
 
At-Home Dermoscopy Artificial Intelligence 
eIRB#00023727 
Version Number 5.05 
Version Date. 09-15-2023 
PI: Sancy Leachman MD, PhD 
Study Coordinators will use the Participant mole log sheet (PMLS) and 
Participant-taken SCI/DDI (from the native smartphone gallery titled “MOLES”) 
for guidance and create the following Datasets: 
 
A) Total number of PSLCs identified by the Participant at-home 
B) Total number of PSLCs identified by the DP in-office  
C) One (1) SMSA output recorded in the PMLS, per target PSLC  
D) One (1) Participant-taken SCI, per target PSLC 
E) One (1) Participant-taken DDI, per target PSLC 
F) One (1) Participant-taken SMSA output screenshot, per target PSLC 
G) One (1) Study Coordinator-taken DDI (near-perfect image technical quality) 
for each PSLC recorded in the PMLS and suspicious PSLCs identified by the DP 
in-office that were not recorded in the PMLS 
H) One (1) Study Coordinator-taken SMSA output for each PSLC, recorded in 
the PMLS, using Dataset (G)  
I) All other SCI of suspicious PSLCs identified by the DP in-office that were not 
recorded in the PMLS 
J)  All other DDI of suspicious PSLCs identified by the DP in-office that were 
not recorded in the PMLS 
K) Pathology reports for all PSLCs that were biopsied during the In-Person Phase 
L) Number of adverse events reported during the Study 
 
Satellite Study Sites will also complete the above activities and securely submit 
their Datasets (A-L) to the Lead Study Site via OHSU secure cloud storage 
services. The Lead Study Site will prepare individual Qualtrics surveys using 
images from the Datasets above to create the following Datasets: 
 
Dataset M) SCI triage decision (SCI-TD) based on Datasets (D) and (I), when at 
least two of three expert dermatologist readers have a concordant triage decision 
(MONITOR or BIOPSY).  If there is a lack of concordance, an internationally 
recognized dermoscopy expert (dermatologist) will act as a fourth reader to 
determine the final SCI-TD 
 
Dataset N) DDI dermoscopic diagnosis ground truth (DDI-GT) for PSLCs that 
were not biopsied during the In-Person Phase, using images in Datasets (E) and 
(J), when at least two of three expert dermatologist readers have a concordant 
dermoscopic diagnosis.  If there is a lack of concordance, an internationally 
recognized dermoscopy expert (dermatologist) will act as a fourth reader to 
determine the final DDI-GT 
 
Dataset O) Histologic diagnosis ground truth (H-GT) for lesions that were 
biopsied during the In-Person Phase, based on evaluations using either physical 
or digital histologic slides (described in Sections below), when both independent 
expert dermatopathologists have a concordant histologic diagnosis.  If there is a 
lack of concordance, a third internationally recognized expert dermatopathologist 
will determine the final H-GT.   
 
The Study Sponsor will be responsible for Study costs (logistics, shipping, 
handling, research reading fees) associated with the use of either physical or 

 
10 
 
At-Home Dermoscopy Artificial Intelligence 
eIRB#00023727 
Version Number 5.05 
Version Date. 09-15-2023 
PI: Sancy Leachman MD, PhD 
digital histologic slides to create Dataset O.  If digital histologic images (DHI) 
are chosen, the Lead Study Site will be asked to prepare DHI for their own Study 
Site Participants who received a biopsy during the In-person Phase.  The Lead 
Study Site will have the option to prepare DHI for the Satellite Study Sites.      
 
In order to eliminate biopsy specimen evaluation-bias there will not be a request 
to confirm or rule out any specific dermatologic neoplasm entity.  All biopsy 
specimen slides will be de-identified and presented in blind to expert 
dermatopathologists at an independent Study Site for evaluation with only the 
following information:    
 
Participant age, sex, skin lesion anatomic location, and a written 
dermatopathology request: “Please evaluate for pigmented skin lesion.”   
Study ground truth 
The following method has been discussed with the FDA via Sklip Inc. Q-
Submission Sprint Discussion (#Q211049/S002/A002) 
 
Dataset N) DDI dermoscopic diagnosis ground truth (DDI-GT) for PSLCs that 
were not biopsied during the In-Person Phase, and 
Dataset O) Histologic diagnosis ground truth (H-GT) for lesions that were 
biopsied during the In-Person Phase 
 
Product Labelling 
Product labelling for proper use of the Sklip System by users (Study Participants) 
interpretation of SMSA Outputs (SUSPICIOUS, UNREMARKABLE, ERROR) 
are described in Sections below. 
Key Inclusion Criteria 
Study Site patients >21 years of age, English-speaking, access to a smartphone, 
self-identified having Fitzpatrick Skin Types 1-4. The recruitment source will 
include running an electronic medical record (EMR) patient report for Study 
recruitment (i.e. EPIC at OHSU, ModMed EMA at other Study Sites, or other 
EMR type). 
Key Exclusion Criteria 
Participants who self-identify having Fitzpatrick Skin Types 5 and 6, visionally 
impaired adults, pregnant and breastfeeding mothers. Participants who have had a 
skin check visit with a dermatology Provider within the last 90 days will be 
excluded to avoid self-selection bias, unless the Participant identifies a new 
unexamined (not previously documented) spot of concern. Vulnerable 
populations including children, prisoners, and decisionally impaired adults, will 
not be eligible for this Study. The Sklip System output is currently only available 
in English language, therefore non-English speaking Participants are not eligible. 
Skin lesions not applicable 
for SMSA evaluation 
Sklip System instructions and product labelling clearly define specific device 
limitations and suggest the Participant (user) to contact their healthcare Provider 
with their PSLC as part of normal clinical care, when the target PSLC does not 
qualify, or if the user does not understand the SMSA output result. The following 
anatomical locations, Fitzpatrick Skin Types and skin lesion types are not 
applicable for SMSA evaluation:  
 
Non-qualified anatomical areas: images of skin lesions taken from a non-sun 
exposed area (eyes, mucosal membranes (eyelids, medial canthi, mouth, anus, 
genitals)), hidden or not flat areas (nails, ears, perinasal fold, conchal bowl, 
intergluteal cleft, perianal skin and interdigital spaces) and/or acral lesions (palms 
of hands and soles of feet).  
 
Not applicable Fitzpatrick Skin Types: 5 and 6 

 
11 
 
At-Home Dermoscopy Artificial Intelligence 
eIRB#00023727 
Version Number 5.05 
Version Date. 09-15-2023 
PI: Sancy Leachman MD, PhD 
 
Pink skin lesions: a skin lesion (mole) that does not contain any pigment, contains 
only white, pink, red or uniform-homogenous color similar to the surrounding 
skin within its surface area, contains less than five (5) percent pigment within the 
skin lesion surface area or clearly defined in-focus vasculature that can be 
visualized with a dermatoscope (i.e. actinic keratosis without pigment, clinically 
and dermoscopically pink melanocytic nevi, amelanotic melanoma, basal cell 
carcinoma or squamous cell carcinoma without any pigment). 
Definition of Pigment 
qualified for Sklip System  
Pigment is defined as any color other than the surrounding skin phototype that 
delineates a skin lesion from the background that can be visualized with a 
dermatoscope. This includes: light brown, dark brown, black, white, blue, grey, 
purple, red, pink, yellow, and orange (including clearly distinguishable vascular 
patterns within the skin lesion surface area). 
Follow-up Duration 
After conclusion of the Study intervention, the EMR(s) of all enrolled 
Participants will be monitored for any relevant data obtained from follow up (as 
part of standard clinical pathways). An attempt to contact Participants lost to 
follow-up will be made for up to 30 days. 
Duration of Therapy 
There is no therapy as part of this Study. 
Sponsor Monitoring 
The Sponsor will conduct periodic monitoring of the Study Site data handling 
practices on REDCap Cloud every 45 days on at least one (1) instance to verify 
the integrity of the source data. This will be done in person or virtually with an 
approved Study Site representative responsible for REDCap Cloud use and data 
handling. At the end of the Study, ten percent (10%) of the source data will be re-
evaluated by the Sponsor to re-verify the integrity of the source data. 
Interim Data Analysis 
There will not be any interim data analysis during this Study. 
Medical costs during the 
In-Person Phase 
All medical services that fall under the normal clinical care pathway including: 
scheduling, triage, spot check, FBSE, biopsy, diagnosis and treatment (when 
applicable), will not be covered by the Study Sponsor and will be billed by Study 
Sites directly to patient insurance, or required to be paid out pocket. 
Final Disposition of the 
Sklip dermatoscope and 
Sklip System access 
All Participants will be able to keep their Sklip dermatoscope at the end of the 
Study, at no cost.  SMSA access will expire within fourteen (14) days of 
confirmed delivery of the Sklip dermatoscope at the home address of the 
Participant. 
Participant Safety 
There remains the risk that a Participant may not identify a skin lesion on their 
body that is malignant (both a PSLC and a non-PSLC).  However, all risks are 
associated with the current at-home standard of care protocol for SSEs and not 
increased by use of the Sklip System.   All Participants are required to come for 
an in-person FBSE, regardless of if they identify a PSLC during the At-home 
Phase. The FBSE will ensure that no malignancies are missed.    
 
Synopsis of Statistical 
Analysis 
An intent-to-treat (ITT) analysis set will include those who are enrolled in the 
Study regardless of adherence. All primary analyses will be conducted using the 
intent-to-treat analysis set. Demographic and clinical characteristics will be 
summarized using descriptive statistics (e.g. proportions, mean/median, and 
standard deviation/range).  
 
The Ground Truth will be the combination of the following: 
Dataset N) DDI dermoscopic diagnosis ground truth (DDI-GT) for PSLCs that 
were not biopsied during the In-Person Phase, and 

 
12 
 
At-Home Dermoscopy Artificial Intelligence 
eIRB#00023727 
Version Number 5.05 
Version Date. 09-15-2023 
PI: Sancy Leachman MD, PhD 
Dataset O) Histologic diagnosis ground truth (H-GT) for lesions that were 
biopsied during the In-Person Phase 
 
For the Primary and Secondary endpoints, the SMSA output of “SUSPICIOUS” 
or “UNREMARKABLE” from Participant-taken digital dermoscopy images 
(DDI) will be compared to the Ground Truth. 
 
Primary endpoints 
For the Primary endpoints, the SMSA output of “SUSPICIOUS” or 
“UNREMARKABLE” from Participant-taken digital dermoscopy images (DDI) 
will be compared to the Ground Truth. 
 
For Melanoma and atypical melanocytic nevi with uncertain malignant 
potential, Sensitivity (𝑇𝑇𝑇𝑇÷ (𝑇𝑇𝑇𝑇+ 𝐹𝐹𝐹𝐹)) of the SMSA will be calculated with a 
lower one-sided 95% confidence interval using the Exact (Clopper-Pearson) 
method.  
 
For Squamous cell carcinoma and Basal cell carcinoma, Sensitivity and lower 
one-sided confidence intervals will be estimated in the same manner as for 
Melanoma and atypical melanocytic nevi with uncertain malignant potential. 
 
Specificity (𝑇𝑇𝑇𝑇÷ (𝐹𝐹𝐹𝐹+ 𝑇𝑇𝑇𝑇)) will be the same for Melanoma and atypical 
melanocytic nevi with uncertain malignant potential, Squamous cell carcinoma, 
and Basal cell carcinoma. Specificity will be estimated with a lower one-sided 
95% confidence interval using the Exact (Clopper-Pearson) method. Two-sided 
95% confidence intervals for all sensitivities and specificity will also be 
calculated using the Exact (Clopper-Pearson) method. 
 
Exploratory endpoint 1 
Similar to the Primary endpoint, the accuracy of SMSA output using Participant-
taken DDI will be assessed using a 2x2 table, where the SMSA output of 
“SUSPICOUS” or “UNREMARKABLE” will be compared to the SMSA output 
using Study Coordinator-taken DDI (near-perfect technical quality), simulating a 
laboratory-type environment where the SMSA is fed the near-perfect technical 
quality DDI. 
 
The Sensitivity of the SMSA output from Participant-taken DDI will be 
compared to the Sensitivity of the SMSA output from Study Coordinator-taken 
DDI using McNemar’s Test, given the paired nature of the data, using 0.05 
significance level.  
 
The Specificity of the SMSA output from Participant-taken DDI will be 
compared to the Specificity of the SMSA output from Study Coordinator-taken 
DDI using McNemar’s Test, given the paired nature of the data, using 0.05 
significance level.  
 
This will be done for each disease entity:  
• 
Melanoma and atypical melanocytic nevi with uncertain malignant 
potential (moderate, severe, and high grade atypia; those with pathology 
reports that include notes such as: borderline, cannot exclude melanoma, 
cannot exclude early evolving melanoma, unusual features, atypical 

 
13 
 
At-Home Dermoscopy Artificial Intelligence 
eIRB#00023727 
Version Number 5.05 
Version Date. 09-15-2023 
PI: Sancy Leachman MD, PhD 
 
 
 
spitz nevi, suspicion for melanoma, re-excision (or further removal) 
should be considered or is recommended in the pathologist management 
comment)  
• 
Squamous cell carcinoma,  
• 
Basal cell carcinoma 
 
Exploratory endpoint 2: 
Using only PSLs < 6 mm in diameter, the accuracy of the expert consensus triage 
decision using Participant-taken smartphone clinical images (SCI) will be 
assessed using a 2x2 table, where the expert consensus triage decision of 
“BIOPSY” or “MONITOR” will be compared to the intervention method, for 
both SMSA outputs recorded by Participants and SMSA outputs recorded by 
Study Coordinators for the same target PSLCs. 
 
The Sensitivity of the SMSA output will be compared to the Sensitivity of the 
expert consensus triage decision of Participant-taken SCI using McNemar’s Test, 
given the paired nature of the data (i.e. the same PSLCs < 6mm), using 0.05 
significance level.  
 
The Specificity of the SMSA output will be compared to the Specificity of the 
expert consensus triage decision of Participant-taken SCI using McNemar’s Test 
using 0.05 significance level.  
 
This will be done for each disease entity listed above in Exploratory endpoint 1. 
 
Exploratory endpoint 3: 
Using only Melanomas < 0.8 mm Breslow depth, the accuracy of the expert 
consensus triage decision using Participant-taken smartphone clinical images 
(SCI) will be assessed using a 2x2 table, where the expert consensus triage 
decision of “BIOPSY” or “MONITOR” will be compared to the intervention 
method, for both SMSA outputs recorded by Participants and SMSA outputs 
recorded by Study Coordinators for the same target PSLCs. 
 
The Sensitivity of the SMSA output will be compared to the Sensitivity of the 
expert consensus triage decision of Participant-taken SCI using McNemar’s Test, 
given the paired nature of the data (i.e. the thin melanomas < 0.8 mm Breslow 
depth), using 0.05 significance level.  
 
Exploratory endpoint 4 
We will calculate the following based on Participant self-skin exams (SSEs) 
performed during the At-home Phase:  
 
(a) the mean and standard deviation of the number of PSLCs identified by 
Participants performing a SSE, and  
(b) the mean and standard deviation of the number of PSLCs identified by the 
dermatology Provider during the In-person Phase full body skin exam (FBSE).  
 
The mean difference and 95% confidence interval will be calculated and assessed 
by paired t-test. 

 
14 
 
At-Home Dermoscopy Artificial Intelligence 
eIRB#00023727 
Version Number 5.05 
Version Date. 09-15-2023 
PI: Sancy Leachman MD, PhD 
SCHEMATIC OF STUDY DESIGN  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
15 
 
At-Home Dermoscopy Artificial Intelligence 
eIRB#00023727 
Version Number 5.05 
Version Date. 09-15-2023 
PI: Sancy Leachman MD, PhD 
TABLE OF CONTENTS 
TABLE OF CONTENTS .............................. Error! Bookmark not defined. 
1. 
BACKGROUND INFORMATION AND SCIENTIFIC RATIONALE
................................................................................................................ 22 
1.1 
Background ............................................................................................................... 22 
1.1.1 Overview of study disease(s) ................................................................... 23 
1.1.2 Overview study intervention(s) ................................................................ 23 
1.2 
Study Rationale ......................................................................................................... 23 
1.3 
Risk/Benefit Assessment ........................................................................................... 26 
1.3.1 Known Potential Risks ............................................................................. 26 
1.3.2 Known Potential Benefits ......................................................................... 26 
2. 
OBJECTIVES AND ENDPOINTS ....................................................... 26 
2.1 
Primary Objectives and Endpoints ............................................................................ 26 
2.2 
Secondary Objective and Endpoint ........................... Error! Bookmark not defined. 
3. 
STUDY DESIGN................................................................................... 29 
3.1 
Description of the Study Design ............................................................................... 29 
3.2 
End of Study Definition ............................................................................................ 32 
3.3 
Study Discontinuation and Closure ........................................................................... 32 
4. 
STUDY POPULATION ........................................................................ 33 
4.1 
Participant Inclusion Criteria .................................................................................... 33 
4.2 
Participant Exclusion Criteria ................................................................................... 33 
4.3 
Lifestyle Considerations............................................................................................ 33 
4.4 
Strategies for Recruitment and Retention ................................................................. 34 
4.4.1 Accrual Estimates ..................................................................................... 34 
4.4.2 Inclusion of Children ................................................................................ 35 
5. 
PARTICIPANT SCREENING, ENROLLMENT, AND 
WITHDRAWAL.................................................................................... 35 
5.1 
Consent and Screening .............................................................................................. 35 
5.1.1 Screening Period ...................................................................................... 36 
5.1.2 Re-testing During Screening .................................................................... 36 
5.2 
Enrollment Procedures .............................................................................................. 36 
5.2.1 Enrollment Procedures for the OHSU Site .............................................. 36 
5.2.2 Enrollment Procedures for Sub-Sites ....................................................... 37 
5.3 
Measures to Minimize Bias ....................................................................................... 37 
5.3.1 Randomization/Masking Procedures ........................................................ 37 
5.4 
Screen Failures .......................................................................................................... 37 

 
16 
 
At-Home Dermoscopy Artificial Intelligence 
eIRB#00023727 
Version Number 5.05 
Version Date. 09-15-2023 
PI: Sancy Leachman MD, PhD 
5.4.1 Re-Screening Allowance / Procedures ..................................................... 37 
5.5 
Participant Discontinuation or Withdrawal ............................................................... 37 
5.5.1 Handling Participant Discontinuation from Study ................................... 38 
5.6 
Lost to Follow-up ...................................................................................................... 38 
6. 
STUDY INTERVENTION .................................................................... 38 
6.1 
Name of Study Intervention ...................................................................................... 39 
6.1.1 Study Intervention Description ................................................................ 39 
6.1.2 Acquisition ............................................................................................... 41 
6.1.3 Formulation, Appearance, Packaging and Labeling ................................ 41 
6.1.4 Product Storage and Stability ................................................................... 41 
6.1.5 Compatibility ............................................................................................ 41 
6.1.6 Handling ................................................................................................... 42 
6.1.7 Preparation ............................................................................................... 42 
6.1.8 Administration .......................................................................................... 42 
6.1.9 Special Considerations for Administration .............................................. 42 
6.1.10 
Accountability ..................................................................................... 42 
6.1.11 
Destruction and Return ........................................................................ 43 
6.2 
Device-Specific Considerations ................................................................................ 43 
7. 
TREATMENT PLAN ............................................................................ 43 
7.1 
Dosage and Administration ....................................................................................... 43 
7.1.1 Definition of dose-limiting toxicity (DLT) .............................................. 43 
7.1.2 Definition of maximum tolerated dose (MTD) ........................................ 43 
7.1.3 Dose Delays .............................................................................................. 43 
7.1.4 Dose Escalation ........................................................................................ 43 
7.1.5 Dose de-escalation .................................................................................... 44 
7.1.6 General Dose Modification Guidelines .................................................... 44 
7.2 
Discontinuation from Study Intervention ................................................................. 44 
7.3 
Treatment Period and Maintenance .......................................................................... 44 
7.4 
Concomitant Medication and Supportive Care Guidelines ....................................... 44 
7.5 
Precautionary Medications, Treatments, and Procedures ......................................... 44 
7.6 
Prohibited Medications, Treatments, and Procedures ............................................... 44 
7.7 
Other Treatment Modalities ...................................................................................... 45 
8. 
STUDY PROCEDURES/EVALUATIONS AND SCHEDULE .......... 45 
8.1 
Study-Specific Procedures ........................................................................................ 45 
8.1.1 Medical history ......................................................................................... 45 

 
17 
 
At-Home Dermoscopy Artificial Intelligence 
eIRB#00023727 
Version Number 5.05 
Version Date. 09-15-2023 
PI: Sancy Leachman MD, PhD 
8.1.2 Disease Assessment .................................................................................. 45 
8.1.3 Medication review .................................................................................... 45 
8.1.4 Physical examination ................................................................................ 45 
8.1.5 Radiographic or other imaging assessments ............................................ 45 
8.1.6 Adverse event evaluation ......................................................................... 45 
8.1.7 Counseling procedures ............................................................................. 46 
8.1.8 Assessment of study agent adherence ...................................................... 46 
8.1.9 Assessment of participant-reported outcomes .......................................... 46 
8.2 
Laboratory Procedures and Evaluations.................................................................... 46 
8.2.1 Pregnancy test .......................................................................................... 46 
8.3 
Biomarker, Correlative, and Special Studies ............................................................ 46 
8.3.1 Laboratory Correlative Studies ................................................................ 46 
8.3.2 Special Studies ......................................................................................... 46 
8.4 
Screening Assessments ............................................................................................. 46 
8.5 
Baseline Assessments ............................................................................................... 46 
8.6 
Assessments During Treatment................................................................................. 46 
8.7 
Early Termination or End of Treatment Visit ........................................................... 47 
EaRly termination – n/a; participants do not have a physical study visit ........................... 47 
8.8 
Follow-up .................................................................................................................. 47 
8.9 
Unscheduled Visits ................................................................................................... 47 
8.10 SCHEDULE OF EVENTS ....................................................................................... 47 
9. 
EFFICACY MEASURES ...................................................................... 48 
9.1 
Definition of Efficacy Measures ............................................................................... 48 
9.2 
Disease Evaluation .................................................................................................... 48 
9.3 
Efficacy Criteria for Tumor Response ...................................................................... 48 
10. SAFETY ................................................................................................ 48 
10.1 Specification Of Safety Parameters .......................................................................... 48 
10.2 Definitions ................................................................................................................. 48 
10.2.1 
Adverse Event (AE) ............................................................................ 48 
10.2.2 
Serious Adverse Event (SAE) ............................................................. 49 
10.2.3 
Unanticipated Problems (UP) .............................................................. 49 
10.2.4 
Severity of Event ................................................................................. 49 
10.2.5 
Assessment of Causality Relationship To Study intervention ............ 49 
10.3 Expectedness ............................................................................................................. 50 
10.4 Adverse Event List(s) ................................................................................................ 50 

 
18 
 
At-Home Dermoscopy Artificial Intelligence 
eIRB#00023727 
Version Number 5.05 
Version Date. 09-15-2023 
PI: Sancy Leachman MD, PhD 
10.4.1 
Adverse Event List for Sklip Device and sklip system ....................... 50 
10.4.2 
Adverse Event List for ......................................................................... 50 
10.4.3 
Key Safety Concerns and/or Adverse events of Special Interest ........ 50 
10.5 Time Period And Frequency For Event Assessment And Follow-Up ...................... 50 
10.6 Reporting Procedures ................................................................................................ 51 
10.6.1 
OHSU IRB Reporting of Unanticipated Problems and Adverse Events
 ............................................................................................................. 51 
10.6.2 
Central Reporting of Adverse Events for Multi-Site Studies .............. 51 
10.6.3 
FDA Reporting .................................................................................... 51 
10.6.4 
Suspected Unexpected Adverse Reactions (SUSARs) ........................ 52 
10.6.5 
Sklip INC Reporting Requirements ..................................................... 52 
10.6.6 
Reporting Of Pregnancy ...................................................................... 52 
10.7 Study Stopping Rules ................................................................................................ 52 
11. STATISTICAL CONSIDERATIONS................................................... 52 
11.1 Statistical AIM .......................................................................................................... 52 
11.2 Sample Size Determination ....................................................................................... 52 
11.3 Populations for AnalysIs ........................................................................................... 54 
11.4 Description of Statistical Methods ............................................................................ 54 
11.4.1 
General Approach ................................................................................ 54 
11.4.2 
Analysis of Primary Endpoint(s) ......................................................... 55 
11.4.3 
Analysis Of The Secondary Endpoint . Error! Bookmark not defined. 
11.4.5 
Safety AnalysIs .................................................................................... 57 
11.4.6 
Baseline Descriptive Statistics ............................................................ 58 
11.4.7 
Additional Sub-Group AnalysIs .......................................................... 58 
11.5 Handling of Missing Data ......................................................................................... 58 
12. CLINICAL MONITORING .................................................................. 58 
12.1 OHSU Knight Cancer Institute Data & Safety Monitoring Plan .............................. 58 
12.2 Clinical Data & Safety Monitoring ........................................................................... 58 
12.3 Quality Assurance & Quality Control ....................................................................... 59 
13. SUPPORTING DOCUMENTATION AND OPERATIONAL 
CONSIDERATIONS ............................................................................. 59 
13.1 Source Data/Documents ............................................................................................ 59 
13.1.1 
Participant & Data Confidentiality ...................................................... 59 
13.1.2 
Data Collection & Storage: Privacy, Confidentiality & Security ........ 60 
13.1.3 
Future Use of Stored Specimens and Data .......................................... 60 
13.1.4 
Maintenance of Records ...................................................................... 61 

 
19 
 
At-Home Dermoscopy Artificial Intelligence 
eIRB#00023727 
Version Number 5.05 
Version Date. 09-15-2023 
PI: Sancy Leachman MD, PhD 
13.2 Multi-Site Guidelines ................................................................................................ 61 
13.3 Publication and Data Sharing Policy ........................................................................ 61 
13.3.1 
Data Sharing Policy for Genome-Wide Association Studies (GWAS)
 ............................................................................................................. 61 
13.4 Conflict of Interest Policy ......................................................................................... 61 
13.5 Delivery of Progress Reports to Study Funder ......................................................... 61 
14. ETHICS/PROTECTION OF HUMAN PARTICIPANTS .................... 61 
14.1 Ethical Standard ........................................................................................................ 62 
14.2 Institutional Review Board ....................................................................................... 62 
14.3 Informed Consent ...................................................................................................... 62 
14.3.1 
Consent Procedures and Documentation ............................................. 62 
14.3.2 
PARTICIPANT INCENTIVES ........................................................... 62 
14.4 Protocol Review ........................................................................................................ 62 
14.5 Changes to Protocol .................................................................................................. 63 
15. REFERENCES ...................................................................................... 64 
 
 
 

 
20 
 
At-Home Dermoscopy Artificial Intelligence 
eIRB#00023727 
Version Number 5.05 
Version Date. 09-15-2023 
PI: Sancy Leachman MD, PhD 
 
LIST OF TABLES 
Table 1. Population Demographics by gender and race  
Table 2. Projected Accrual for the Present Study 
Table 3. Schedule of events 
Table 4. Sample size estimates for cutaneous diseases of interest to evaluate the sensitivity of Sklip System based 
on the available target population prevalence data. 
Table 5. Sample size estimates for cutaneous diseases of interest to evaluate the specificity of Sklip System based 
on the available target population prevalence data.  
 
LIST OF FIGURES 
Figure 1. Study schematic in the Section above 
 
 
 

 
21 
 
At-Home Dermoscopy Artificial Intelligence 
eIRB#00023727 
Version Number 5.05 
Version Date. 09-15-2023 
PI: Sancy Leachman MD, PhD 
LIST OF ABBREVIATIONS 
 
CFR 
United States Code of Federal Regulations 
CoC 
National Institutes of Health (NIH) Certificate of Confidentiality 
CTCAE 
Common Terminology Criteria for Adverse Events 
DSMB 
Data and Safety Monitoring Board 
DSMC 
Data and Safety Monitoring Committee 
DSMP 
Data and Safety Monitoring Plan 
Ecris 
Electronic Clinical Research Information System 
HIPPA 
Health Insurance Portability and Accountability Act 
ICF 
Informed Consent Form 
IRB 
Institutional Review Board 
N/A 
Not applicable 
OHSU 
Oregon Health & Science University 
[SKLIP  
SYSTEM] 
[Sklip dermatoscope device and SMSA (used in the Sklip App)] 
SMSA 
Sklip Mole Scanning Algorithm 
SCI 
Smartphone clinical images (non-medical-device assisted) 
DDI 
Digital dermoscopy images 
PSLC(s) 
Pigmented skin lesion(s) of concern 
FDA 
United States Food and Drug Administration 
PMLS 
Participant Mole Log Sheet 
SaMD 
Software as a Medical Device 
API 
Application Program Interface  
DP 
Dermatology Provider 
APP 
Advanced Practice Practitioner (Physicians Associate or Nurse Practitioner) 
PCP 
Primary Care Provider 
MD3PC 
Modified dermoscopy three-point checklist  
DRFs 
Dermoscopic remarkable features (based on the MD3PC) 
SSE(s)  
Self-skin-exam(s) performed by Participants at-home 
FBSE(s) 
Full body skin exam(s) performed by DPs in-office 
SCI-TD 
Expert dermatologist consensus SCI triage decision 
DDI-GT 
Expert dermatologist consensus DDI dermoscopic diagnosis  
DHI 
Digital histologic image of a target PSLC biopsied during the In-person Phase 
EMR 
Electronic medical record 
 
 

 
22 
 
At-Home Dermoscopy Artificial Intelligence 
eIRB#00023727 
Version Number 5.05 
Version Date. 09-15-2023 
PI: Sancy Leachman MD, PhD 
1. BACKGROUND INFORMATION AND SCIENTIFIC RATIONALE 
 
1.1 
BACKGROUND 
 
Reduced access: Appointment delays for skin lesion (mole) spot checks and FBSEs average 3-6 months 
nationally and were markedly increased during the COVID-19 Pandemic.  Lack of access to a dermatology 
Provider (DP) is a result of limited number of DPs compared to the increasing population, low output of new DPs 
from MD/DO residency programs and NP/PA training programs compared to the rising population, understaffed 
clinics, and rising incidence of skin cancers that overwhelm the American healthcare system. 
  
Shift to virtual care: There has been a monumental shift towards patient acceptance of virtual dermatology care in 
the last 36 months due to the Pandemic. Traditionally, virtual spot checks are performed using store-and-forward 
(SAF) patient-submitted SCI (non-medical-device assisted) that is evaluated by a DP.  Accuracy of triage using 
SCI is lower than use of DDI for the same target skin lesion due dermoscopy inherently providing more visual 
information through magnification and visualization of surface and subsurface structures that are not detectable 
when using the naked-eye in-office or SCI virtually.1 
 
Subjective selection bias of skin lesions (moles) of concern by patients at-home: Patients select PSLCs based on 
subjective concern and lack of professional triage training.  A large portion of virtual visits initiated by patients 
result in reassurance by a DP that the PSLC is actually benign.     
 
High conversion rate of virtual visits to in-person visits due to image clarity/selection bias: Evaluation of skin 
lesion images virtually using SCI typically results in low triage confidence by the DP.  Provider uncertainty is 
largely due to limitations in image clarity and lack of medical-device assistance in an at-home environment. This 
often leads to a high conversion rate to an in-person evaluation by a DP.  In the majority of cases the in-office DP, 
using a dermatoscope, will find that the PSLC is benign.  This leads to patients being billed twice for triage for 
the same PSLC (1st = virtual visit, 2nd = in-person visit).   
 
Packing the healthcare system can lead to delay of care for other patients: Layperson concern of unknowingly 
benign skin lesions can lead to overloading the healthcare system with unnecessary visits and increased delays for 
patients who may have an actual skin lesion that warrants biopsy, may be malignant, and ultimately requires 
equitable priority.   
  
Interventional device: The Sklip System has been granted FDA Breakthrough Designation in 2021 (reported 
overall sensitivity of 94.47%) for its interpretation of DDI.  The Sklip System will be made available to Study 
Participants via a non-commercial version of Sklip App with SMSA access via dedicated username and password 
(for research use only). The intended use of the Sklip System is stand-alone triage of PSLCs for skin cancer.   
Sklip System is intended for triage only (FDA Class 2).  The Sklip System is not intended for diagnostic use 
(FDA Class 3).  The reported Performance of SMSA for sensitivity of melanoma and atypical melanocytic nevi 
with uncertain malignant potential is 97.4%.2  
 
Study protocol intervention: We will test SMSA output from Participant-taken DDI of Participant-selected PSCLs 
in an at-home environment and evaluate real world performance of the Sklip System.   
 
Potential intervention outcomes: The Sklip System may safely reduce submission of technically unclear images to 
DPs through its two-step SMSA algorithm.  Use of the Sklip System requires a medical-device-assisted image 
(DDI) where the first step of the SMSA is to identify if the image is a DDI, then if the DDI is clear, in-focus and 
free of artifacts.  If the DDI passes the first step, the SMSA then evaluates the uploaded DDI for presence of 
modified dermoscopy three-point checklist criteria.  The average time to obtain a Sklip System result is 5 
seconds.  If positive, the lesion is flagged as SUSPICIOUS and information signals the Sklip System user to 
contact a healthcare Provider with urgency through clear product labelling in the Sklip Mole Analysis Report.   
 
Hence, the Sklip System could potentially identify a malignancy with high sensitivity, safety and help prioritize 
layperson-to-patient triage pathway.  Furthermore, for the purpose of access equity, the current publicly available 
commercial version of the Sklip App (since 03-2023) has a free-access map of every dermatology office location 

 
23 
 
At-Home Dermoscopy Artificial Intelligence 
eIRB#00023727 
Version Number 5.05 
Version Date. 09-15-2023 
PI: Sancy Leachman MD, PhD 
in the United States.  The Sklip app provides free contact information (phone and website) for the layperson to 
request to schedule a visit.  Using the Sklip Network filter in the Sklip App map, verified dermatology offices 
willing to accept new patients for spot checks from the Sklip app within fourteen (14) days and without a referral 
from a primary care Provider are highlighted to the App user. 
 
Possible intervention impact on the healthcare system: U.S. based academic centers represent only a small 
fraction of access to dermatologic care for the American public and access to high quality skin cancer screening 
using medical grade tools (including dermoscopy) is limited.  Outside of academic settings there is a greater than 
fifty (50) percent chance that a layperson (new patient) will be seen in a dermatology office by an advanced 
practice practitioner (APP) (nurse practitioner or physicians associate).  APPs working in a dermatology setting 
typically have a short two (2) week to (1) month rotation in dermatology during their schooling, prior to obtaining 
licensure to practice.   APPs neither receive focused general dermatology training (3 year dermatology residency) 
nor dermoscopy training (3 years in dermatology residency), yet are expected to provide independent, high 
quality dermatologic care to patients, specifically during mole spot checks and full body skin exams.  Many times 
they do not even use a dermatoscope, which is considered a standard of care for all graduates of a formal 
ACGME dermatologic residency program.  Due to this limitation in training and experience, sensitivity of triage 
and diagnosis of skin cancers is often lower than a MD/DO dermatologist and often lower than a MD/DO primary 
care provider (overall reported dermoscopy sensitivity of 79.2% when using a dermatoscope).3,4  
 
The Sklip System can potentially empower both Providers and consumers that already have a concern about a 
pigmented skin lesion and do not have formal dermoscopy training, or multi-year experience, therefore offering 
the potential for safe improvement of triage accuracy in both office-based and home-based settings.   
 
1.1.1 
OVERVIEW OF STUDY DISEASE(S) 
 
Incidence and cost to society: An estimated 1 in 5 Americans will develop skin cancer in their lifetime including 
melanoma, the deadliest form.  Melanoma incidence rates have increased three times over the past three decades 
with two hundred thousand new cases reported in 2020.  This number is expected to increase in 2023.  When skin 
cancers are detected at an early stage, survival rates are 98% — compared to late detection of melanoma with 
metastasis, survival falls to 24% and becomes increasingly fatal.5-8 
 
Skin cancer in the United States: Skin cancer is a problem in the United States with an incidence that has 
increased significantly in the last three decades. The Oregon Health and Science University Department of 
Dermatology and Knight Cancer Institute have initiated a War on Melanoma to combat it through early detection 
(IRB#10561). One crucial component of the War on Melanoma’s early detection program is development and 
implementation of imaging technologies to enable earlier detection of melanomas before they become life-
threatening.9  Previous attempts to provide access to patients through virtual triage from home have relied on 
triage of PSLCs based upon patient selection – which is attune to subjective observation, bias and limitations.  
The current standard of care to evaluate a skin lesion of interest in-office (dermatology) is using a 
dermatoscope.10,11 
 
1.1.2 
OVERVIEW STUDY INTERVENTION(S) 
 
All Participants of this single-arm prospective trial will be given up to 14 days to review the Sklip System 
instructions, perform a self-skin-exam (SSE) at-home, and identify pigmented skin lesions of concern (PSLCs).  
Then, Participants will be instructed to carefully follow provided instructions and complete a series of tasks 
described in Section 3.1 below. 
 
1.2 
STUDY RATIONALE 
 
Limitations that we can overcome for layperson at-home self-selection of PSLCs: 
 

 
24 
 
At-Home Dermoscopy Artificial Intelligence 
eIRB#00023727 
Version Number 5.05 
Version Date. 09-15-2023 
PI: Sancy Leachman MD, PhD 
a) Layperson self-selection triage bias using subjective selection criteria resulting in low sensitivity & 
specificity 
b) Lack of image quality verification prior to doctor consultation which results in patients submitting low 
technical quality images (blurry) to DPs in a virtual communication, that are often difficult to evaluate 
c) DP low confidence when using SCI (non-medical-device assisted) to triage PSLCs in a virtual setting 
d) Overuse of DP resources for benign self-selected PSLs and packing the healthcare system with visits for 
PSLCs that are concerning for laypersons but often verified to be benign by a DP in-office using dermoscopy 
e) Reduced access and delay of care due to increased wait times to see DPs in-office. 
  
Current standard of care for layperson at-home self-selection of PSLCs: 
  
In the current at-home SSE model, the layperson must first identify a specific PSL based on subjective 
observation. Then, the identified PSL must raise adequate concern to prompt communication with a DP through 
scheduling a virtual visit or requesting an in-person spot check.  Currently, there is no objective prescreening 
method for PSLC selection or virtual visit image technical quality submission.   If the layperson chooses to call 
and schedule an in-person visit for a new spot check appointment, the average national wait time to be seen in-
person by a MD/DO dermatologist is 3 to 6 months, sometimes more. Alternatively, the layperson may choose to 
communicate with a DP, typically a MD/DO dermatologist, via virtual communication and send store-and-
forwards SCI of their PSLC. Prior to submission, the PSLC SCI (non-medical-device assisted) image quality is 
not verified and often laypersons send images that are blurry, contain artifacts, or do not make it clear which 
PSLC is the one of concern amongst an image that contains several skin lesions (moles) in the field of view.  This 
makes confident triage difficult for any DP in a virtual setting and often requires the DP or their team to contact 
the patient in order to request retaking the SCI again with better technical quality (clear image). Once an 
appropriate technical quality PSLC SCI is received, the DP uses non-medical-device assisted clinical judgement 
to make their triage decision into one of three categories:  
 
1. UNREMARKABLE (no immediate concern with low clinical suspicion for malignancy, suggest the patient to 
self-monitor until the PSLC becomes unstable) 
2. SUSPICION (concern with moderate to high suspicion for malignancy, recommendation to convert to an in-
person visit to evaluate the PSLC with a dermatoscope, biopsy is possible) 
3. ERROR (ask patient to retake a clear SCI image, if unsuccessful on the second attempt, convert to an in-
person visit to evaluate with a dermatoscope, biopsy is possible).  
 
 
Current evaluation of PSLCs by the Sklip System: 
 
The Sklip System may safely improve triage of layperson self-selected PSLCs in an at-home environment by 
transitioning a regulated triage tool (FDA Class 2) into the hands of laypersons.   
 
After a PSLC is initially identified by the layperson, the SMSA (Sklip Ai), an artificial intelligence tool, 
uses objective modified dermoscopy Three-Point Checklist (MD3PC): (asymmetry (including atypical 
network), round structures and blue-white color) to triage PSLs into one of three categories12-15: 
 
1. UNREMARKABLE (no immediate concern, limited or no positive MD3PC, with low concern for malignancy 
or pre-malignancy, the SMSA output provides information and suggests the layperson to self-monitor the PSLC 
every three months, if the user does not understand the initial SMSA output result (Sklip Mole Scan Result) or the 
PSLC ever becomes unstable (changes), product labelling clearly instructs the user to contact a healthcare 
Provider for an in-person visit, biopsy is possible) 
2. SUSPICIOUS (positive MD3PC with moderate to high concern for malignancy, the SMSA output result 
provides information and strongly suggests the layperson to contact a healthcare Provider for an in-person visit, 
biopsy is very possible) 
3. ERROR (uploaded image does not meet SMSA criteria and an assessment of DDI cannot be made, the SMSA 
output result provides information how to properly retake DDI, if the user is unsuccessful after three (3) attempts, 
clear product labelling instructs the layperson to contact a healthcare Provider for an in-person visit, biopsy is 
possible) 

 
25 
 
At-Home Dermoscopy Artificial Intelligence 
eIRB#00023727 
Version Number 5.05 
Version Date. 09-15-2023 
PI: Sancy Leachman MD, PhD 
 
 
How the Sklip System Improves Triage: 
 
The Sklip System has the potential to improve triage of PSLCs and address the current limitations: 
 
a) Layperson self-selection triage bias using subjective selection criteria resulting in low sensitivity & 
specificity. 
Potential solution: Sklip System uses objective dermoscopy criteria (MD3PC) to evaluate a self-selected PSLC 
which may result in safe accuracy based on pre-specified performance goals by the FDA. 
 
b) Lack of image quality verification prior to doctor consultation which results in patients submitting low 
technical quality images (blurry) to DPs in a virtual communication, that are often difficult to evaluate. 
Potential solution: The Sklip dermatoscope is a medical grade device that enables the layperson user to take a 
medical grade in-office like quality image from home by controlling the light source, magnification and fixed 
placement of the device flat against the skin. The SMSA first verifies whether a digital dermoscopy image (DDI) 
is technically appropriate for evaluation, which may reduce the number of blurry DDI sent to a dermatology 
provider in a virtual communication.  After the SMSA verifies technical quality of the DDI, the second step is the 
evaluation of the DDI based on trained MD3PC as described above. 
 
c) DP low confidence when using SCI (non-medical-device assisted) to triage PSLCs in a virtual setting. 
Potential solution: The Sklip System enables a layperson to take a medical grade DDI. It is well established in 
literature that the use of DDI improves both accuracy and confidence of PSLC triage. Additionally, the Sklip 
System will automatically categorize the PSL into: SUSPICIOUS, UNREMARKABLE, or ERROR, prior to the 
layperson contact with their dermatologist, which may result in safe accuracy based on pre-specified performance 
goals by the FDA. 
 
d) Overuse of DP resources for benign self-selected PSLs and packing the healthcare system with visits for 
PSLCs that are concerning for laypersons but often verified to be benign by a DP in-office using dermoscopy. 
Potential solution: Sklip System may help reduce layperson concerns about benign skin lesions due to safe and 
accurate triage based on pre-specified performance goals by the FDA.  This may allow DPs to have more 
confidence not seeing the patient in person for an otherwise benign concern and improve access for patients with 
actual malignancies that may be detected by the SMSA.  Additionally, in the case of SMSA SUSPICIOUS output, 
the user is clearly prompted to urgently contact a healthcare Provider. 
 
e) Reduced access and delay of care due to increased wait times to see DPs in-office. 
Potential solution: Sklip System would be used by laypersons as a stand-alone device to triage PSLCs.  This 
could potentially improve access for persons with verified SUSPICIOUS PSLCs that require immediate in-person 
evaluation by a DP.  FDA Clearance of the Sklip System could potentially streamline the time to treat for persons 
with skin malignancies who are currently delayed by the current medical system triage status quo. 
  
The Sklip System has been reviewed by the FDA and received “Breakthrough Designation Status” with a 
reported overall sensitivity of 94.47% and specificity of 83.33%, compared to the highest reported accuracy by 
primary care providers using dermoscopy – sensitivity of 79.2% and specificity of 72.5%.  The current SMSA 
Performance reported sensitivity for melanoma and atypical melanocytic nevi with uncertain malignant potential 
is 97.4% (2023).16 
 
Of note, an estimated fifty (50) percent of PSLC biopsies occur in primary care settings.  The functionality of 
DDI based triage using Sklip System by laypersons, that is the same, or superior, to an in-person spot check visit 
with a primary care Provider for a layperson self-selected PSLC, could have a significant impact on streamlining 
and improving the safety of current patient care access.  This should be evaluated in a research setting. 
 
 

 
26 
 
At-Home Dermoscopy Artificial Intelligence 
eIRB#00023727 
Version Number 5.05 
Version Date. 09-15-2023 
PI: Sancy Leachman MD, PhD 
1.3 
RISK/BENEFIT ASSESSMENT 
 
In alignment with the FDA guidance mentioned above and 21 CFR 812.3(m), Sklip Inc. has determined that a 
clinical Study utilizing the Sklip System constitutes a Non-Significant Risk Device Study. From a high level, 
and as described in more detail following, this is because:  
 
 
1. The Sklip System is not of substantial importance in diagnosing, curing, mitigating or treating 
disease.   
2. The Sklip System does not act in a manner that the FDA guidance flags as being considered 
significant risk.  
3. The Sklip System is not included in the list of devices that the FDA considers to be significant risk.  
 
Therefore, the Sklip System and the Study of it can be considered a Non-Significant Risk (NSR) Device Study. 
Our rationale is as follows, the Sklip System is not of substantial importance in diagnosing, curing, mitigating or 
treating disease. Instead, the Sklip System provides a stand-alone triage assessment according to a clinical 
accepted protocol, where the final decision to biopsy or not and diagnosis of a PSLC is intended for confirmation 
by a healthcare provider.  
 
1.3.1 
KNOWN POTENTIAL RISKS  
 
There is a risk of loss of confidentiality in this Study. In addition, Participants in this Study are required to have 
any self-selected PSLCs to be further evaluated in-person and managed as part of normal clinical care pathways, 
which may result in the same increased risks associated with standards of clinical care. This includes possible 
increased identification of PSLCs that warrant conversion to a biopsy (as decided by a DP, not the interventional 
device, which may lead to increased physical biopsies and the risks associated with them. In addition, there 
remains the risk that a Participant in either group may miss identifying a skin lesion on their body that is 
malignant. However, these risks are all associated with current at-home standard of care protocol for SSEs and 
not increased by use of the interventional device. To provide each Participant with safety and peace-of-mind, a 
FBSE will be performed on each Study Participant during their in-person visit. 
 
1.3.2 
KNOWN POTENTIAL BENEFITS 
 
Participants will receive a FBSE as part of this Study as part of normal patient care with their DP after completing 
the Study At-home Phase. The cost of in-person patient care will not be covered by this Study as described in the 
Participant consent form.  Scheduling, triage, biopsy, diagnosis, surgeries, treatment and other medical care for 
suspicious or cancerous lesions are not covered as part of this Study.  However, Participants may benefit by 
having access to expedited time to care with a dermatology Provider (DP) which may lead to earlier detection of 
skin cancer, and therefore may improve patient access and outcomes. Current national wait times for in-person 
dermatology visits average 3 to 6 months.  Participant involvement in this Study may allow the Participant to 
receive care much earlier (within 28 days after completion of the At-home Phase). Participants will receive free 
education material and training that will increase the Participant’s knowledge and awareness of skin cancer and 
also receive the Sklip dermatoscope at no cost and can keep the device after completion of the Study. 
 
2. OBJECTIVES AND ENDPOINTS 
2.1 
PRIMARY OBJECTIVES AND ENDPOINTS 
 
Primary Objective 
Endpoint 
Start  
End  
Sklip System enables laypersons to 
safely triage self-selected pigmented 
skin lesions of concern from home 
with the same or better accuracy than 
pre-specified performance goals* for 
Using all Participant PSLCs 
recorded in the Participant Mole 
Log Sheets, triage accuracy 
measures of the SMSA output 
of Participant-taken DDI will be 
assessed using a 2x2 table, 
First day of 
enrollment 
 
 
Up to 42 days 
after first day 
of enrollment 
 
 

 
27 
 
At-Home Dermoscopy Artificial Intelligence 
eIRB#00023727 
Version Number 5.05 
Version Date. 09-15-2023 
PI: Sancy Leachman MD, PhD 
detection of pigmented skin lesions 
that require biopsy: 
Melanoma and atypical 
melanocytic nevi with uncertain 
malignant potential (moderate, 
severe, and high grade atypia; those 
with pathology reports that include 
notes such as: borderline, cannot 
exclude melanoma, cannot exclude 
early evolving melanoma, unusual 
features, atypical spitz nevi, 
suspicion for melanoma, re-excision 
(or further removal) should be 
considered or is recommended in the 
pathologist management comment): 
≥95% sensitivity, ≥30% specificity 
Squamous cell carcinoma: ≥80% 
sensitivity, ≥30% specificity  
Basal cell carcinoma: ≥80% 
sensitivity, ≥30% specificity  
*Pre-specified performance goals 
have been reviewed with the FDA for 
testing the Sklip System (including 
SMSA) as a stand-alone device. 
 
where the SMSA rating of 
“SUSPICIOUS” or 
“UNREMARKABLE” will be 
estimated to pre-specified 
accuracy metrics discussed with 
the FDA.   
 
The Sensitivity of the SMSA 
using Participant-taken DDI 
will be estimated to pre-
specified performance goals 
described in sections above, 
using 0.05 significance level 
and 10% margin of error. 
 
Triage accuracy measures of the 
Sklip System (specificity, 
negative predictive value, 
positive predictive value, and 
accuracy) will also be 
calculated. 
 
The Ground Truth will be the 
combination of the following 
described in the Sections above: 
Dataset N) DDI dermoscopic 
diagnosis ground truth (DDI-
GT) for PSLCs that were not 
biopsied during the In-Person 
Phase, and 
Dataset O) Histologic diagnosis 
ground truth (H-GT) for lesions 
that were biopsied during the 
In-Person Phase 
 
 
 
2.2 
EXPLORATORY OBJECTIVES AND ENPOINTS  
 
Exploratory Objectives 
Endpoint 
Start  
End  
1. To compare the accuracy of Sklip 
System triage when used by a 
layperson versus near-perfect Sklip 
System user  
 
First, the Sensitivity of the 
SMSA using Study Coordinator-
taken DDI (near-perfect 
technical quality) will be 
estimated to pre-specified 
performance goals described in 
sections above, using 0.05 
significance level and 10% 
margin of error.   
 
Similar to the Primary endpoint, 
the accuracy of SMSA output 
First day of 
enrollment 
Up to 42 days 
after first day 
of enrollment 
 

 
28 
 
At-Home Dermoscopy Artificial Intelligence 
eIRB#00023727 
Version Number 5.05 
Version Date. 09-15-2023 
PI: Sancy Leachman MD, PhD 
using Participant-taken DDI will 
be assessed using a 2x2 table, 
where the SMSA output of 
“SUSPICOUS” or 
“UNREMARKABLE” will be 
compared to the SMSA output 
using Study Coordinator-taken 
DDI (near-perfect technical 
quality), simulating a laboratory-
type environment where the 
SMSA is fed the best possible 
technical quality DDI. 
2. To assess whether Sklip System 
improves triage of pigmented skin 
lesions of concern < 6mm in diameter 
as suspicious as compared to the 
current medical provider virtual triage 
method that relies on store-and-
forward non-medical-device assisted 
smartphone clinical images 
 
Using only PSLs < 6 mm in 
diameter, the accuracy of the 
expert consensus triage decision 
using Participant-taken 
smartphone clinical images 
(SCI) will be assessed using a 
2x2 table, where the expert 
consensus triage decision of 
“BIOPSY” or “MONITOR” will 
be compared to the intervention 
method, for both SMSA outputs 
recorded by Participants and 
SMSA outputs recorded by 
Study Coordinators for the same 
target PSLCs. 
First day of 
enrollment 
Up to 42 days 
after first day 
of enrollment 
 
3. To assess whether Sklip System 
improves triage of thin melanomas 
with <0.8 mm Breslow depth as 
suspicious as compared to the current 
medical provider virtual triage method 
that relies on store-and-forward non-
medical-device assisted smartphone 
clinical images 
 
 
Using only Melanomas < 0.8 
mm Breslow depth, the accuracy 
of the expert consensus triage 
decision using Participant-taken 
smartphone clinical images 
(SCI) will be assessed using a 
2x2 table, where the expert 
consensus triage decision of 
“BIOPSY” or “MONITOR” will 
be compared to the intervention 
method, for both SMSA outputs 
recorded by Participants and 
SMSA outputs recorded by 
Study Coordinators for the same 
target PSLCs. 
First day of 
enrollment 
Up to 42 days 
after first day 
of enrollment 
 
4. To determine the accuracy of 
layperson-performed SSEs at-home in 
the identification of all suspicious 
PSLs present on their body as 
compared to the same layperson 
evaluated with full body skin 
examination by a dermatology 
Provider in-person 
 
 
We will calculate the following 
based on Participant self-skin 
exams (SSEs) performed during 
the At-home Phase:  
 
(a) the mean and standard 
deviation of the number of 
PSLCs identified by Participants 
performing a SSE, and  
(b) the mean and standard 
deviation of the number of 
PSLCs identified by the 
First day of 
enrollment 
Up to 42 days 
after first day 
of enrollment 
 

 
29 
 
At-Home Dermoscopy Artificial Intelligence 
eIRB#00023727 
Version Number 5.05 
Version Date. 09-15-2023 
PI: Sancy Leachman MD, PhD 
dermatology Provider during the 
In-person Phase full body skin 
exam (FBSE).  
 
 
 
 
3. STUDY DESIGN 
 
3.1 
DESCRIPTION OF THE STUDY DESIGN 
 
Refer to Section 11, Statistical Analysis for additional information regarding statistical methods used in this 
Study. 
 
All Participants of this single-arm prospective trial will be given up to 14 days to review the Sklip System 
instructions, perform a self-skin-exam (SSE) at-home, and identify PSLCs based on the following: 
 
(a) General concern (self or partner-identified, or non-dermatology Provider identified requiring a referral to a 
dermatology Provider) 
(b) Concern because the PSLC is different than the rest (i.e. “ugly duck sign”) 
 
Then, Participants will be instructed to carefully follow provided instructions and complete the following for 
each target PSLC: 
 
1) Mark the target PSLC with a green surgical marker (horizontal line) and the number (#) corresponding to the 
mole log, one (1) inch away from the target lesion 
2) Record the target PSLC with a number (#) and anatomic location in the PMLS 
3) Create a new photo album titled: “Moles” in their native smartphone/tablet Photo App 
4) Take one (1) smartphone clinical image (SCI) of the target PSLC, twelve (12) inches away from the target skin 
lesion 
5) Save the SCI in the album titled: “Moles” album 
6) Review Sklip dermatoscope instructions for proper use 
7) Take one (1) digital dermoscopy image (DDI) of the target PSLC using the Sklip dermatoscope.   
8) Save the DDI of the target PSLC in the “Moles” album 
9) Upload the DDI to the SMSA (“Scan Moles with Ai”) within the Sklip App once per target PSLC, until either 
a Suspicious or Unremarkable result is obtained, for a maximum of three attempts.  If after three attempts the user 
still receives an “Error” result, they will be prompted to document this in the participant mole log sheet. 
10) Take one (1) screenshot of the SMSA output per target PSLC 
11) Save the SMSA output screenshot in the album titled: “Moles”  
12) Record each SMSA output (SUSPICIOUS, UNREMARKABLE, ERROR) in the PMLS once per target 
PSLC  
13) Contact the Study Site to schedule an in-person FBSE within 28 days, if the Participant does not already have 
a scheduled visit  
 
In summary, for each target PSLC the Participant will acquire the following: 

 
30 
 
At-Home Dermoscopy Artificial Intelligence 
eIRB#00023727 
Version Number 5.05 
Version Date. 09-15-2023 
PI: Sancy Leachman MD, PhD 
One (1) SMSA output screenshot 
-----------------------------------------------------End of At-home Phase--------------------------------------------------------- 
 
Study Coordinators at each Study Site will conduct regular EMR chart reviews to track Participant requests to 
begin their In-person Phase, after the Participant has completed their the At-home Phase.  These chart reviews 
will be conducted systematically every 7 days following Participant enrollment.  Participant EMRs will be 
monitored for up to 28 days following conclusion of both Study Phases to account for any relevant data that may 
have not been collected during the Study.  
 
-----------------------------------------------------Start of In-person Phase-------------------------------------------------------
--- 
 
With dermatology Provider present:   
The dermatology Provider (DP) will be blinded to the skin lesions that were selected by the study Participant at 
home.  The DP will perform a FBSE as part of the normal clinical care pathway. All PSLCs identified by the DP 
as SUSPICIOUS will be marked with a vertical line one (1) inch away from the target PSLC using a green 
surgical marker.  After completing the FBSE and marking all DP-selected suspicious PSLCs, the DP will verbally 
inform the Study Coordinator the Participant’s Fitzpatrick skin phototype (1,2,3,4,5 or 6) after leaving the patient 
room. 
 
Without dermatology Provider present,  
with Study Coordinator present: 
The Participant will be asked to provide their Participant Mole Log Sheet (PMLS).  Then, all PSLCs recorded in 
the PMLS will entered into REDCap Cloud by the Study Coordinator.  Any Participant-selected PSLCs that 
match those identified earlier as SUSPICIOUS by the DP will be marked with a horizontal line one (1) inch away 
from the target PSLC using a green surgical marker.  Therefore, PSLCs identified by both the DP and Participant 
will have a plus symbol.  Next, the Study Coordinator will take and record (near-perfect) SCI and DDI for all 
PSLCs recorded in the PMLS and those PSLCs identified by the DP as SUSPICIOUS (not matching the 
Participant PSLCs).  Then, the Study Coordinator will complete the following: 
 
7) Record each SMSA output (SUSPICIOUS, UNREMARKABLE, ERROR) in REDCap Cloud, per target PSLC 
8) If the Participant has taken a set of SCI/DDI at home of a PSLC that is not intended (qualified because of 
anatomic body site) for the Sklip System, the Study Coordinator should still capture a set of control SCI/DDI and 
upload to REDCap Cloud.  The Participant standard clinical care will not be changed. 
9) If the Participant took a set of SCI/DDI of a PSLC at home but did not follow instructions – specifically 
uploading the DDI to the Sklip System - the Study Coordinator should remind the Participant to complete this 
task in the patient room (using the DDI from their mobile device gallery), upload to the Sklip System, and record 
the output on their Mole Log Sheet.  If this situation occurs, the Study Coordinator should make a note in 
One (1) smartphone clinical image (SCI)  
One (1) digital dermoscopy image (DDI)  
One (1) Sklip Mole Scanning Algorithm (SMSA) output recorded in the PMLS 
1) Take one (1) photo of the Participant identification sticker with a Study Site secure smartphone/tablet 
2) Take one (1) smartphone clinical image (SCI) of each target PSLC recorded in the Participant Mole Log Sheet 
(PMLS) 
3) Take one (1) digital dermoscopy image (DDI) of each target PSLC using the Sklip dermatoscope.   
4) Save the DDI of the target PSLC in the Study Site smartphone/tablet native photo gallery 
5) Upload the Study Coordinator-taken DDI to the SMSA (“Scan Moles with Ai”) within the Sklip App  
6) Take one (1) screenshot the SMSA output  

 
31 
 
At-Home Dermoscopy Artificial Intelligence 
eIRB#00023727 
Version Number 5.05 
Version Date. 09-15-2023 
PI: Sancy Leachman MD, PhD 
REDCap Cloud; If the Participant is/was concerned about a PSLC but did not take a set of SCI/DDI at home, this 
PSLC will not be included in the study. 
  
Schedule for data collection:  
In order to avoid Participant PSLC recollection-bias, Study Coordinators will use the Participant Mole Log Sheet  
(PMLS) and Participant taken SCI/DDI for guidance and record the following Datasets in REDCap Cloud:  
 
A) Total number of PSLCs identified by the Participant at-home 
B) Total number of PSLCs identified by the DP in-office  
C) One (1) individual SMSA output recorded in the PMLS, per target PSLC (SUSPICIOUS, UNREMARKABLE 
and ERROR)  
 
Ensuring that no PHI is shared, Study Coordinators will export the following from the Participant 
smartphone/tablet gallery titled “Moles” to the Study Site smartphone/tablet gallery via Bluetooth or secure 
email: 
 
D) One (1) Participant-taken SCI, per target PSLC 
E) One (1) Participant-taken DDI, per target PSLC 
F) One (1) Participant-taken SMSA output screenshot, per target PSLC 
 
Then, Study Coordinators will acquire and export the following from the Study Site smartphone/tablet gallery to 
an OHSU secure cloud storage service: 
 
G) One (1) Study Coordinator-taken DDI (near-perfect image technical quality) for each PSLC recorded in the 
PMLS and suspicious PSLCs identified by the DP in-office that were not recorded in the PMLS 
 
Then, Study Coordinators will upload the DDI in Dataset (G) to the SMSA on a Study Site smartphone/tablet and 
record the following Datasets into REDCap Cloud: 
 
H) One (1) Study Coordinator-taken SMSA output for each PSLC, recorded in the PMLS, using Dataset (G) 
 (SUSPICIOUS, UNREMARKABLE and ERROR), including one (1) screenshots 
 
Then, the Study Coordinator will record the following Datasets into REDCap Cloud: 
 
I) All other SCI of suspicious PSLCs identified by the DP in-office that were not recorded in the PMLS 
J) All other DDI of suspicious PSLCs identified by the DP in-office that were not recorded in the PMLS 
K) Pathology reports for all PSLCs that were biopsied during the In-Person Phase 
L) Number of adverse events reported during the Study 
 
-----------------------------------------------------End of In-person Phase-------------------------------------------------------- 
 
Description of Satellite Study required activities 
Satellite Study Sites will also complete the above activities and securely submit their Datasets (A-L) to the Lead 
Study Site via OHSU secure cloud storage services. The Lead Study Site will prepare individual Qualtrics 
surveys using images from the Datasets above to create the following Datasets: 
 

 
32 
 
At-Home Dermoscopy Artificial Intelligence 
eIRB#00023727 
Version Number 5.05 
Version Date. 09-15-2023 
PI: Sancy Leachman MD, PhD 
Dataset M) SCI triage decision (SCI-TD) based on Datasets (D) and (I), when at least two of three expert 
dermatologist readers have a concordant triage decision (MONITOR or BIOPSY).  If there is a lack of 
concordance, an internationally recognized dermoscopy expert (dermatologist) will act as a fourth reader to 
determine the final SCI-TD 
 
Dataset N) DDI dermoscopic diagnosis ground truth (DDI-GT) for PSLCs that were not biopsied during the In-
Person Phase, using images available in Datasets (E) and (J), when at least two of three expert dermatologist 
readers have a concordant dermoscopic diagnosis.  If there is a lack of concordance, an internationally recognized 
dermoscopy expert (dermatologist) will act as a fourth reader to determine the final DDI-GT 
 
Dataset O) Histologic diagnosis ground truth (H-GT) for lesions that were biopsied during the In-Person Phase, 
based on evaluations using either physical or digital histologic slides (described in Sections below), when both 
independent expert dermatopathologists have a concordant histologic diagnosis.  If there is a lack of concordance, 
a third internationally recognized expert dermatopathologist will determine the final H-GT.   
 
The Study Sponsor will be responsible for Study costs (logistics, shipping, handling, research reading fees) 
associated with the use of either physical or digital histologic slides to create Dataset O.  If digital histologic 
images (DHI) are chosen, the Lead Study Site will be asked to prepare DHI for their own Study Site Participants 
who received a biopsy during the In-person Phase.  The Lead Study Site will have the option to prepare DHI for 
the Satellite Study Sites.      
 
In order to eliminate biopsy specimen evaluation-bias there will not be a request to confirm or rule out any 
specific dermatologic neoplasm entity.  All biopsy specimen slides will be de-identified and presented in blind to 
expert dermatopathologists at an independent Study Site for evaluation with only the following information:    
Participant age, sex, skin lesion anatomic location, and a written dermatopathology request: “Please evaluate 
for pigmented skin lesion.” 
 
3.2 
END OF STUDY DEFINITION 
 
A Participant is considered to have completed the Study if he/she/they have remained a Participant for the entirety 
of the Study period and have completed the applicable end of Study REDCap Cloud survey. Therefore, up to 14 
days for the At-home Phase, including Study intervention, is sufficient time to collect data and evaluate the 
interventional device.  Since Study Sites are required to see all Participants after the At-home Phase, up to 28 
days for the In-person Phase is sufficient time to see all Participants as patients through already scheduled visits, 
overbookings or separate dedicated clinics. Biopsy results typically take 7 days to follow up, however Study 
Coordinators will continue to monitor EMR of Participants to collect relevant data up to 30 days following the 
end of the Study. 
 
3.3 
STUDY DISCONTINUATION AND CLOSURE 
 
This Study may be temporarily suspended or prematurely terminated if there is sufficient reasonable cause. 
Written notification that documents the reason for Study suspension or termination will be provided by the 
suspending or terminating party to OHSU Coordinating Center, local IRB, and other regulatory authority. If the 
Study is prematurely terminated or suspended, the Investigator will promptly inform the IRB and provide the 
reason for the termination or suspension. 
 
Reasons for terminating the Study may include the following: 
 
• 
Unfavorable assessment of risk/benefit ratio 
• 
Incidence or severity of adverse events, in this or other studies, that indicates a potential health hazard to 
Participants 

 
33 
 
At-Home Dermoscopy Artificial Intelligence 
eIRB#00023727 
Version Number 5.05 
Version Date. 09-15-2023 
PI: Sancy Leachman MD, PhD 
• 
Demonstration of efficacy that would warrant stopping 
• 
Data that are not sufficiently complete and/or evaluable 
• 
Investigator not adhering to the Study protocol or applicable regulatory guidelines in conducting the 
Study 
• 
Participant enrollment is unsatisfactory  
• 
Submission of knowingly false information from the Study Site to OHSU Coordinating Center or 
regulatory authority 
• 
Upon instruction by local or other regulatory or oversight authority.  
 
The Study may resume once concerns about safety, protocol compliance, and/or data quality are addressed as 
applicable and requirements of the OHSU Coordinating Center, Study sponsor, IRB and/or other applicable 
regulatory authority are satisfied. 
 
4. STUDY POPULATION 
 
4.1 
PARTICIPANT INCLUSION CRITERIA 
 
To be eligible to participate in this Study, an individual must meet all of the following criteria: 
1. Participant must provide written informed consent before any Study-specific procedures or interventions 
are performed. 
2. Age ≥ 21 years with at least one pigmented skin lesion (PSL)/mole on their body. All genders and 
members of all races and ethnic groups will be included. 
3. Participant self-identifies as having Fitzpatrick Skin Type 1 through 4. 
4. Participant must be a current or new patient through self-referral or Provider-referral at the participating 
Study Site. 
5. Participant must have access to a smartphone/tablet and be willing to set up virtual communication via 
direct message to a Study Site dermatology provider (i.e. MyChart in EPIC, direct message in ModMed 
EMA or other electronic medical record (EMR) type) 
6. Participant must be English-speaking due to FDA Breakthrough Designation of the Sklip System in the 
English language. Therefore, we are unable to accommodate non-English speaking Participants. 
7. Participant must be “Healthy”, which is defined as someone considered not urgently sick or hospitalized. 
This will be determined by the Study principle investigator (PI) at each Study Site, a licensed 
dermatologist, who will be responsible for screening Participants to ensure eligibility criteria is met prior 
to enrollment. 
 
4.2 
PARTICIPANT EXCLUSION CRITERIA 
 
An individual who meets any of the following criteria will be excluded from participation in this Study: 
 
1. Participant who self-identifies having Fitzpatrick Skin Type 5 or 6. 
2. Participant who have had a skin check visit with a dermatology Provider within the last 90 days will be 
excluded to avoid self-selection bias, unless the Participant identifies a new unexamined (not previously 
documented) spot of concern. 
3. Vulnerable populations including children, prisoners, and decisional impaired adults as well as vision 
impaired adults will not be eligible for this Study.  
4. Pregnant individuals will be excluded in this Study. Since this is a minimal pregnancy risk category, no 
special precautions will be taken to determine that the patient is not pregnant 
 
4.3 
LIFESTYLE CONSIDERATIONS 
 
During this study, Participants will not be asked to make any lifestyle changes or restrictions as we do not 
anticipate that these factors will impact the results of this study. 
 

 
34 
 
At-Home Dermoscopy Artificial Intelligence 
eIRB#00023727 
Version Number 5.05 
Version Date. 09-15-2023 
PI: Sancy Leachman MD, PhD 
4.4 
STRATEGIES FOR RECRUITMENT AND RETENTION 
 
Proposed Study Sites have been discussed with the FDA via Sklip Inc. Q-Submission Sprint Discussion 
(#Q211049/S002/A002; completed on 03/31/23).  
 
Four (4) Study Sites will participate in this Study.  The Lead Study Site will be Oregon Health and Science 
University (OHSU) in Portland, Oregon. 
 
Minimum recruitment per Site: 15% of the total Study sample size 
Maximum recruitment per Site: 40% of the total Study sample size 
 
Site #1: Oregon Health and Sciences University in Portland, Oregon 
3303 S Bond Ave CHH1 Ste 16 (Department of Dermatology) 
PI: Sancy Leachman MD, PhD (leachmas@ohsu.edu) 
 
Governance of Satellite Study Sites: OHSU IRB will not be responsible for any of the Satellite Study Sites as they 
will be governed by a third-party IRB and use this IRB Protocol for guidance. 
 
Site #2: Skin Cancer Center 
3024 Burnet Ave, Cincinati, OH 45219  
PI: Michael Tassavor MD FAAD (mtassavor2@gmail.com) 
 
Site #3: The Skin Center Dermatology Group 
200 East Eckerson Rd, New City, NY 10956 
PI: Peter Friedman MD, PhD FAAD (pbc9@cumc.columbia.edu)  
 
Site #4 Johnny Gurgen D.O. P.A. 
1340 Citizens Blvd, Leesburg, FL 34748 
PI: Johnny Gurgen DO FAOCD (johngurgen@gmail.com) 
 
Participants for this Study will be recruited from participating Study Site dermatology practices. Participants may 
be identified by a member of the research team, the PI, or medical and surgical oncology clinics part of the Study 
Site. As a member of the treatment team, Investigator(s) will screen their patients’ medical records for suitable 
research Study Participants and compile a list of eligible Participants to contact and discuss the Study and their 
potential for enrolling in the research Study. The Investigator(s) may also screen the medical records of potential 
Participants with whom the investigator does not have a treatment relationship. This will be done for the limited 
purpose of identifying patients who would be eligible to enroll in the Study and to record appropriate contact 
information in order to approach these potential individuals regarding the possibility of participating in the Study.  
Participants may also be recruited to the Study through existing primary care referrals wait lists for spot checks to 
rule out skin cancer, or FBSE due to the increased likelihood to identify a skin cancer, in particular the rarer form 
– melanoma, when there is an existing patient PSLC. 
 
4.4.1 
ACCRUAL ESTIMATES 
 
Total accrual of all PSLCs based on sample size estimates is anticipated to take a total of up to 42 days from 
enrollment.  
No OHSU Knight Cancer Institute Study will focus on any gender, racial or ethnic subset. No Participant will be 
excluded from the Study based on gender, racial or ethnic origin. Male, female and minority volunteers will be 

 
35 
 
At-Home Dermoscopy Artificial Intelligence 
eIRB#00023727 
Version Number 5.05 
Version Date. 09-15-2023 
PI: Sancy Leachman MD, PhD 
recruited for this Study from the general patient population and approximately 50% men and 50% women will be 
studied. Gender-nonconforming and gender-fluid individuals will also be recruited.  
The projected gender, racial and ethnic composition of the Study will include different proportions of patients 
with Fitzpatrick Skin Types 1—3 and Fitzpatrick Skin Type 4 because the prevalence of skin cancers differs 
between Fitzpatrick Skin Types. There are no available estimates of the prevalence of Fitzpatrick Skin Types in 
the general population and so estimates of White populations and Non-white populations will be used for accrual 
estimation purposes only9–11. Actual stratification will depend on participants’ self-selected Fitzpatrick Skin Type. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
All histories  
Female 
Male 
Total 
White 
29.7% 
29.7% 
59.3% 
Non-white 
20.4% 
20.4% 
40.7% 
Total 
50.0% 
50.0% 
100.0% 
 
*Source: adapted from the 2017 U.S. Census Bureau 
 
Table 4. Projected Accrual for the Present Study  
All histories 
Female 
Male 
Other/unknown 
Total 
Fitzpatrick 1-3 
90 
87 
2-3 
180 
Fitzpatrick 4 
65 
62 
2-3 
130 
Total 
155 
149 
4-6 
310 
 
 
4.4.2 
INCLUSION OF CHILDREN 
 
This protocol does not include children for the following reasons: 
 
1. The number of children with melanoma or non-melanoma skin cancer is limited 
2. In order to be in alignment with FDA guidance where the intended use of the Sklip System is in persons 
21 years or older. 
 
5. PARTICIPANT SCREENING, ENROLLMENT, AND WITHDRAWAL 
 
5.1 
CONSENT AND SCREENING 
 
Table 3. Population Demographics by gender and race  

 
36 
 
At-Home Dermoscopy Artificial Intelligence 
eIRB#00023727 
Version Number 5.05 
Version Date. 09-15-2023 
PI: Sancy Leachman MD, PhD 
In order to participate in this Study, signed informed consent must be obtained from the Participant. The current 
IRB approved informed consent form must be signed and dated by each Participant prior to undergoing any Study 
procedures. The informed consent discussion must be documented, and a copy of their signed IRB approved 
informed consent form must be scanned in the Participant’s medical record. 
 
The Participant will be contacted with a targeted virtual communication message (i.e. MyChart message) that 
includes a brief purpose and summary of the Study with an included embedded link to self-screen through an 
nPhase REDCap Cloud survey for recruitment or by phone for patients who already have a scheduled visit with a 
dermatology Provider at the Study Site and meet Study inclusion criteria.  Participants may also be recruited at 
health and/or wellness events in the community using a printed version of the approved virtual communication 
message with the included link to nPhase REDCap Cloud self-screening survey.  
 
During this time, the Study Coordinators, under the supervision of the PI, will screen the Participants on nPhase 
REDCap Cloud to ensure they meet our eligibility criteria. Participants that complete the survey and meet the 
eligibility criteria will be contacted using the phone number provided in the screening survey and have their 
personal and contact information confirmed.  Then a nPhase REDCap Cloud e-consent will be sent to the email 
given by the Participant.  The Participants will be given ample time to review the consent form thoroughly and 
privately to avoid feeling pressured.  If they indicate interest to participate in the Study and submit the nPhase 
REDCap Cloud screening and e-consent, they will be contacted by a Study Coordinator by phone to discuss in 
detail the consent form, what the Study entails, and answer any additional questions the Participant may have. If 
the Participant is unable to sign the e-consent form, they may be invited in-person to obtain written consent. If the 
subject does not respond after at least two call attempts made during the screening process over the span of a 
week, we will consider the subject as screen failed. 
 
5.1.1 
SCREENING PERIOD 
 
When a Study Coordinator reaches out to a potential Participant to discuss the Study and obtain informed consent, 
the Study Coordinator, who is supervised by our PI, will ensure the Participant meets our eligibility criteria. The 
inclusion criteria for this Study does not require consistent screening or monitoring and therefore initial screening 
period at time of consent is sufficient. Most of the eligibility criteria for Participants can be decided via chart 
review (i.e. age, no recent visit with a dermatology Provider) however, Study Coordinators will still additionally 
ensure this via verbal confirmation that will be documented during the screening and consenting period. 
 
5.1.2 
RE-TESTING DURING SCREENING 
 
There are no laboratory tests or baseline imaging required for screening, therefore re-testing is not applicable. 
 
5.2 
ENROLLMENT PROCEDURES 
 
This is a prospective single-arm open-label multicenter research Study. After recruitment, those who have 
indicated interest in enrolling in the Study will be contacted by one of the Study Site Coordinators to further 
explain the Study and consent the Participant. Participants will be enrolled on a continuous rolling basis until the 
target number of Participants have been met.  
 
5.2.1 
ENROLLMENT PROCEDURES FOR THE OHSU SITE 
 
Eligibility must be confirmed and documented by a Study Coordinator, under the supervision of the Study PI, 
prior to enrollment. Materials required to complete the eligibility review include, at minimum: 
 
• 
Current IRB-approved consent form and HIPAA Authorization for the Study signed & dated by the 
Participant 
• 
Documented (signed and dated) attestation by the PI confirming Participant’s eligibility based on 
available source documentation and authorizing enrollment 
 

 
37 
 
At-Home Dermoscopy Artificial Intelligence 
eIRB#00023727 
Version Number 5.05 
Version Date. 09-15-2023 
PI: Sancy Leachman MD, PhD 
Once eligibility is confirmed and consent forms have been signed by the Participant, the Participant is considered 
‘enrolled’ and Study intervention may begin. 
 
5.2.2 
ENROLLMENT PROCEDURES FOR SUB-SITES 
 
Once interested Participants have been identified at Satellite Study Sites, the list of potential recruits to screen 
will be given to the Lead coordinating Site (OHSU) to contact via E-mail, phone or text message. 
Communications during the screening process will use IRB-approved text or phone scripts and will include a 
message with the URL to the nPhase REDCap Cloud Survey to screen for inclusion and exclusion criteria. Upon 
completion of the screening survey and phone call and meeting inclusion and exclusion criteria, recruits will be 
sent a link to e-consent for enrollment. 
 
5.3 
MEASURES TO MINIMIZE BIAS 
 
5.3.1 
RANDOMIZATION/MASKING PROCEDURES  
 
Blinding is considered unnecessary to reduce bias for all the observations because follow up evaluation for all 
Participants will follow standard clinical care pathways and is not affected by this interventional Study. The 
Study Site PIs and DPs will be fully blinded to all results of the At-home Phase, including the Participant Mole 
Log Sheet.  Participants will be informed of the blinding activity prior to their FBSE to avoid DP selection-bias.  
Specifically, the dermatology provider will be instructed to say the following to each participant upon entering 
the patient room for the in-person FBSE: “Hello, my name is [name and title], the purpose of today’s visit is to 
complete a full body skin examination as part of the at-home dermoscopy study.  To avoid bias, please hold with 
any questions related to your moles of concern until I have verified that I completed your full body skin 
examination and all other study related activities.  I will be happy to address your questions or concerns at that 
time.” 
 
5.4 
SCREEN FAILURES 
 
Any Participant that has signed the consent form but does not meet all the Study eligibility criteria or meets Study 
eligibility criteria but terminates their participation prior to receiving Study interventional materials, will be 
considered a screen failure and not counted towards total number of planned enrollments. The reason for screen 
failure will be captured in the research record for each Participant who fails to meet all the eligibility criteria. 
 
5.4.1 
RE-SCREENING ALLOWANCE / PROCEDURES 
 
This Study permits the re-screening of a Participant that has discontinued the Study as a screen failure (i.e. early 
termination prior to receiving intervention, lack of proper medical records that confirm criteria eligibility). If re-
screened, the Participant must be re-consented. 
 
5.5 
PARTICIPANT DISCONTINUATION OR WITHDRAWAL 
 
Participants are free to withdraw consent and discontinue participation in the Study at any time and without 
prejudice to further treatment. If a Participant withdraws consent, they should be asked to specify if they are 
withdrawing consent to all further participation in the Study or if they are choosing to withdraw only from further 
Study intervention, meaning that further follow-up and data collection about their disease and health status is 
allowable. The Participant should also be asked about their consent to the future use of their Study-generated data 
and any biological samples, as applicable.  
 
No further Participant contact will be made if the Participant withdraws consent for participation in the Study. 
Information about the reason(s) for discontinuation will be collected at the time the Participant withdraws 
consent.  
 
A Participant may also be withdrawn from the Study by the Investigator, local IRB, or regulatory authorities.  

 
38 
 
At-Home Dermoscopy Artificial Intelligence 
eIRB#00023727 
Version Number 5.05 
Version Date. 09-15-2023 
PI: Sancy Leachman MD, PhD 
 
Reasons for a Participant to discontinue the Study may include the following: 
 
• 
Participant dies or is lost to follow-up 
• 
Participant withdraws consent for any further participation 
• 
The end of Study is reached 
• 
Significant Study intervention non-compliance  
• 
If any clinical adverse event (AE), laboratory abnormality, or other medical condition or situation occurs 
such that continued participation in the Study would not be in the best interest of the Participant 
• 
If the Participant meets an exclusion criterion (either newly developed or not previously recognized) that 
precludes further Study participation 
 
In the event of a pregnancy, the Study intervention will be immediately reported to the appropriate committees 
and their participation in the Study will be discontinued. Refer to Section 10.6.6 regarding reporting of pregnancy 
 
In the event a Participant withdraws early from the Study, Investigator(s) will attempt to find a replacement to 
enroll in the Study to meet target number of Participants.  
 
5.5.1 
HANDLING PARTICIPANT DISCONTINUATION FROM STUDY 
 
When a Participant discontinues participation in the Study, the reason the Participant is no longer participating, 
the Study Site, Study name, IRB Study number, and the date of discontinuation will be documented in the 
Participant’s medical record. The change in Study status will be documented in the appropriate clinical trial 
management system for the applicable Study Site (i.e. eCRIS) per OHSU policy.  
 
Subjects who sign the informed consent form but do not receive the Study intervention may be replaced. Subjects 
who sign the informed consent form and receive the Study intervention, and subsequently withdraw, or are 
withdrawn or discontinued from the Study may be replaced. 
 
5.6 
LOST TO FOLLOW-UP 
 
A Participant will be considered lost to follow-up if the individual fails to submit the REDCap Cloud survey 
administered at the end of each Phase.  
 
The following actions must be taken if a Participant fails to complete the end of Study survey: 
 
• 
A Study Coordinator will attempt to contact the Participant and counsel Participant on importance of 
completing the survey 
• 
Before a Participant is deemed lost to follow-up, the investigator or designee will make every effort to 
regain contact with the Participant (2 attempts to contact via virtual communication message, text 
messages, email, or phone call). All contact attempts made by the Study team will be documented in the 
Participant’s medical record or Study file 
• 
Should the Participant continue to be unreachable, he or she will be considered to have withdrawn from 
the Study with a primary reason of lost to follow-up 
 
 
 
6. STUDY INTERVENTION 
 
A list of the adverse events and potential risks associated with the study intervention administered in this study 
can be found in Section 10.4, Adverse Events. 
 

 
39 
 
At-Home Dermoscopy Artificial Intelligence 
eIRB#00023727 
Version Number 5.05 
Version Date. 09-15-2023 
PI: Sancy Leachman MD, PhD 
6.1 
NAME OF STUDY INTERVENTION 
 
6.1.1 
STUDY INTERVENTION DESCRIPTION 
 
Device Study Risk Evaluation 
Please refer to Section 1.3 RISK/BENEFIT ASSESSMENT. 
 
Device Description 
The Sklip dermatoscope device hardware will be provided to Participants to take DDI of their self-selected 
PSLCs using their smartphone or tablet. The Sklip dermatoscope is publicly (commercially) available and 
registered as a Class 1 Medical Device (FDA Reg. 3017732705). 
 
The Sklip App is a publicly available smartphone App to download on the Apple iOS and Google Play app 
stores. The Sklip App is non-FDA regulated and part of the approved protocol for the Melanoma Community 
Registry (OHSU IRB# 10561). A security review of the Sklip App has been performed as part of that Study and 
is transferred to this Study protocol. 
 
The proprietary SMSA evaluation of DDI has a reported Melanoma and atypical melanocytic nevi with uncertain 
malignant potential sensitivity Performance of 97.4% (2023). 
 
The Sklip System is a SaMD that received breakthrough designation by the FDA on June 22, 2021. The Sklip 
System is intended to record, store and transfer DDI.  The Sklip System consists of the Sklip App (used on a 
smartphone or tablet) and SMSA, that accept DDI taken by dermatoscope hardware. The Sklip System also 
displays DDI and non-diagnostic output of DDI analysis from the Sklip System software library that implements 
various DDI processing and artificial intelligence (Ai) analysis. This SaMD computes various digital parameters 
from DDI and provides these capabilities in the form of an API library. DDI can be incorporated into the Sklip 
System software to enable algorithmic analysis and analytics of DDI by the SMSA. The SMSA, is a software 
workflow tool designed to aid the assessment of DDI data input intended to conduct an initial screening of DDI 
for features suggestive of skin cancer and flag suspicious DDI for expedited review by appropriate medical 
personnel, such as a dermatology Provider (Dermatologist or dermatology trained APP), or primary care Provider 
(PCP). Specifically, the SMSA, via the Sklip System " Scan Moles with Ai" function, uses a Sklip Inc. 
proprietary Ai algorithm to provide DDI filtering, detection of noisy (non-qualified) DDI and detection of skin 
lesions containing qualified pigment that may be remarkable for MD3PC features ((DRFs): dermoscopic 
asymmetry, dermoscopic round structures and/or dermoscopic blue-white colors), which may be indicative of 
skin cancer. 
 
The Sklip System (SMSA component) is not currently commercially available in the United States. Sklip Inc. is 
currently discussing ultimate classification and premarket submission type with the FDA.  
 
Clear SMSA output graphic language is provided to the Sklip System user: [SUSPICIOUS, UNREMARKABLE, 
or ERROR].  Additionally, more specific information and guidance is available by clicking the informational 
(“i”) button graphic clearly visible in the Sklip App “Mole Scan Analysis Result.”  The following language has 
been reviewed with the FDA and will be included in the Sklip System during this Study: 
 
SMSA Output: [SUSPICIOUS]:  
 
“A SUSPICIOUS Sklip MOLE SCAN RESULT means that the proprietary Sklip Ai (artificial intelligence) has 
detected a possible presence of at least one remarkable feature in the dermoscopy photo uploaded for scan.  This 
result is not a diagnosis, it is a possible finding. 
 
What should you do? 
a) Consult this result in person with your established local healthcare provider, or 

 
40 
 
At-Home Dermoscopy Artificial Intelligence 
eIRB#00023727 
Version Number 5.05 
Version Date. 09-15-2023 
PI: Sancy Leachman MD, PhD 
b) Consult this result in person with a dermatology provider by searching your geographic location within the 
Sklip network map.  Click the TAKE ACTION button in this result to find a local dermatology office in the 
Sklip map. 
c) Consult this result in person and get a prioritized office visit within 14 days without the need for a 
referral.  Click the TAKE ACTION button in this result to find local dermatology offices in your area.  Then 
click the SKLIP NETWORK filter button to identify a Sklip verified dermatology office. 
 
Costs associated with consulting your mole scan result with a healthcare provider are your financial 
responsibility and Sklip is not responsible for costs associated with medical care or verifying insurance 
coverage” 
 
SMSA Output: [UNREMARKABLE]:  
 
“An UNREMARKABLE Sklip MOLE SCAN RESULT means that the proprietary Sklip Ai (artificial 
intelligence) has not detected a possible presence of at least one remarkable feature in the dermoscopy photo 
uploaded for scan.  This results is not a diagnosis, it is a possible finding. 
 
What should you do? 
a) Self-monitor the color, size or shape of this mole (skin lesion) after 1 month, then every 3 months.  If you find 
that the mole changes at any time in the future you may re-scan the mole with Sklip Ai or consult with your local 
healthcare provider in person.   
b) Submit this mole today for a Sklip anonymous informational, non-diagnostic second opinion by a real 
dermatologist (additional fees may apply), or 
c) Consult this result in person with your established local healthcare provider if you do not understand this result 
or are still concerned about the mole.  If you do not have an established provider click the TAKE ACTION 
button in this result to find a local dermatology office in the Sklip map. 
 
Costs associated with consulting your mole scan result with a healthcare provider are your financial 
responsibility and Sklip is not responsible for costs associated with medical care or verifying insurance 
coverage” 
 
SMSA Output: [ERROR]:  
 
“An ERROR Sklip MOLE SCAN RESULT means that the proprietary Sklip Ai (artificial intelligence) has 
detected that you have not uploaded a qualified Sklip dermoscopy photo.  This may be because you uploaded a 
photo taken without a Sklip dermatoscope (not applicable), or you uploaded a photo with a Sklip dermatoscope 
that is not qualified due to artifacts.  This results is not a diagnosis, it is a possible finding.  Please review the 
below requirements to take a clear Sklip dermoscopy photo and minimize artifacts.   
 
What should you do? 
1. Open your smartphone/tablet native camera App  
2. Clip (attach) the Sklip dermatoscope to your rear facing smartphone/tablet camera  
3. Turn ON the Sklip light by pressing the external oval button on the Sklip dermatoscope front side  
4. Center the Sklip dermatoscope image view (you will see either a circle or rectangle)  
5. Zoom the image 1.5X to 2.0X (maximum) until you eliminate the black border created from the circle 
or rectangle  
6. Apply THREE drops of dermoscopy oil (Sklip provided) on the target skin lesion (mole)   
7. Press the Sklip contact plate (clear front window) flat to the skin surface (ensure there is no angle)  
8. Apply gentle pressure to eliminate artifact air bubbles from the field of view  
9. Capture the Sklip digital dermoscopy (DDI) image in your native phone camera App  
10. Open the Sklip App, then Click “SCAN MOLE WITH Ai” to access the SMSA (Sklip Ai)  
11. Click the gallery icon in (bottom left screen), Upload the DDI from native photo App gallery  
12. Press SCAN to initiate the SMSA (Sklip Ai) and obtain the Sklip Ai Mole Analysis Report  

 
41 
 
At-Home Dermoscopy Artificial Intelligence 
eIRB#00023727 
Version Number 5.05 
Version Date. 09-15-2023 
PI: Sancy Leachman MD, PhD 
13. REPEAT PROCESS FOR EACH MOLE  
  
TECHNICAL SUGGESTIONS FOR PIGMENTED SKIN LESIONS OF CONCERN (PSLCs)  
*Apply Sklip System to a target PSLC without hair (remove hair with a shaver if needed)  
*Apply Sklip System to a target PSLC that can be flattened by Step #7 above, nodular lesions are not 
applicable  
*Apply Sklip System to a target PSLC that has at least 3 mm of diameter  
 
If you fail to obtain a result other than ERROR (i.e. UNREMARKABLE or SUSPICIOUS) after 3 attempts*, 
please Consult this result in person with a healthcare provider.  Click the TAKE ACTION button in this result to 
find a local dermatology office in the Sklip map.”  
 
*Reason for maximum of 3 attempts: 
The number of SMSA attempts on the same target PSLC that result in an output of ERROR will be recorded up to 
the third attempt.  The reason for this is to prompt users of the Sklip System to seek medical care from a 
healthcare Provider if they cannot obtain a binary output (SUSPICIOUS or UNREMARKABLE) within the first 
three attempts.   
 
6.1.2 
ACQUISITION 
 
The brand new Sklip dermatoscope devices used in this Study will be shipped by the Study Sponsor to the OHSU 
Department of Dermatology in order to prepare, sanitize, and ensure all materials are packaged prior to sending to 
Participants. The devices will be provided on a rolling basis for enrolled Participants enrolled for a targeted goal 
of 310 total devices used. The Sklip dermatoscope device and access to the SMSA will be provided at no cost to 
all Study Participants. The OHSU Department of Dermatology will offer shipping to Study Participants at other 
Study Sites.  Costs for shipping will be covered by the Study Sponsor.   
 
6.1.3 
FORMULATION, APPEARANCE, PACKAGING AND LABELING  
 
The description of the proposed device, indications for use, manufacturing process, device storage, handling, 
accountability, and access (limited to appropriate personnel and only by appropriate Study subjects) are provided 
in this document above in Section 6.1.1 Study Intervention Description.  The device has been granted FDA 
Breakthrough Designation record number Q211049.  Sklip System instructions for use that include safety 
instructions and warnings are included in the devices sent out to Study Participants.   
 
1. Sklip dermatoscope device hardware is currently registered as a Class 1 Medical Device with the FDA. 
2. Sklip Mole Scanning Algorithm (SMSA) has been evaluated by the FDA and received FDA Breakthrough 
Designation. The intended use for the Sklip System is a stand-alone triage tool (FDA Class 2).  The 
Sklip System is not intended for diagnostic use (FDA Class 3)   
 
6.1.4 
PRODUCT STORAGE AND STABILITY 
 
The SMSA will be available to Participants for research use only using a dedicated username and password on a 
non-commercial version of the Sklip App.  Use of the Sklip System is completely anonymous. Sklip 
dermatoscope device storage will be on the CHH1 14th floor in a secure location dedicated to the Department of 
Dermatology.  
 
6.1.5 
COMPATIBILITY 
 
Not applicable.  Our Study does not involve any drug or therapeutic agent. 
 

 
42 
 
At-Home Dermoscopy Artificial Intelligence 
eIRB#00023727 
Version Number 5.05 
Version Date. 09-15-2023 
PI: Sancy Leachman MD, PhD 
6.1.6 
HANDLING 
 
Access to Sklip dermatoscope devices will be limited to appropriate personnel within the OHSU Department of 
Dermatology and other Study Sites. Access to the non-commercial version of Sklip app for the purpose of 
research will be limited to enrolled Study Participants. OHSU dedicated employees will have access to the master 
list to match patient MRN to the anonymous username for the purpose of this Study. An OHSU Study team 
member will provide usernames and passwords to the additional Study Sites. Since this Study is anonymous the 
Sponsor will not receive any patient health information (PHI) during this Study. All Sklip dermatoscope devices 
will be sent one way to Participants via USPS or UPS. 
 
6.1.7 
PREPARATION 
 
Once a Participant is officially enrolled in the Study, a designated Study Coordinator will properly sanitize and 
prepare a package of the necessary materials the Participant will need for the Study. The following are items that 
will be prepared to be shipped to the Participant via USPS or UPS: 
 
• 
Instructions for Participants 
• 
One (1) printed Participant Mole Log Sheet 
• 
One (1) Sklip dermatoscope device (charging cable and dermoscopy oil) 
• 
One (1) username/password enabling SMSA access using the Sklip App  
 
6.1.8 
ADMINISTRATION 
 
1) All necessary materials will be shipped to all Participants via USPS or UPS as described in 6.1.7 
PREPARATION. 
 
2) Study Coordinators will provide specific onboarding training: 
 
a. 
The Participants will be trained on how to log their SSE self-selected PSLCs in their Participant 
Mole Log Sheet. They will also be asked to submit a copy of their Participant Mole Log Sheet 
using nPhase REDCap image upload, or email (athomederm@ohsu.edu).  Participants will be 
reminded to bring it in person during their in-person visit. 
b. The Participants will be informed on the requirement to follow up in-person for a FBSE with a 
Study Site dermatology Provider within 28 days of completing the At-home Phase. 
c. 
The Participant will be informed that all costs associated with normal medical care activities 
will not be covered by the Study Sponsor as described in the sections above. 
 
At the end of the Study, the Participants will be sent an nPhase REDCap Cloud survey that will document 
Participant responses to the number of self-selected PSLCs and the number of suspicious PSLCs identified by the 
dermatology Provider during the Study. 
 
6.1.9 
SPECIAL CONSIDERATIONS FOR ADMINISTRATION  
 
N/A 
 
6.1.10 ACCOUNTABILITY 
 
The Investigators, or a responsible party designated by the Investigators, will maintain a careful record of the 
inventory and disposition of the Study agent.  
 
Responsibility for device accountability at Study Sites rests with its Investigator; however, the Investigator may 
assign some of the device accountability duties to an appropriate designee. Inventory and accountability records 

 
43 
 
At-Home Dermoscopy Artificial Intelligence 
eIRB#00023727 
Version Number 5.05 
Version Date. 09-15-2023 
PI: Sancy Leachman MD, PhD 
will be maintained and readily available for inspection by the Study monitor and are open to inspection at any 
time by any applicable regulatory authorities or other oversight bodies. 
 
The Investigator or designee will collect and retain all used, unused, and partially used containers of the Study 
device or devices unwanted by Participant at the end of the Study until full accounting has been completed. The 
Investigator or designee will maintain records that document: 
 
• Investigational product delivery to the Study Site. 
• The inventory at the Site. 
• Number of investigational products shipped to Participant and date of shipment 
• Any return of investigational product to the Investigator or designee. 
 
These records will include dates, quantities, and the unique code numbers assigned to the investigational product 
and Study Participants. 
 
The investigational product must be used only in accordance with the protocol. The Investigator will also 
maintain records adequately documenting that the Participants were provided the correct Study materials 
specified based off the Participants randomly assigned group. Completed accountability records will be archived 
by the Site. 
 
6.1.11 DESTRUCTION AND RETURN 
 
At the completion of the Study, the Investigator or designee will oversee repurposing or redistribution of any 
remaining Study product to be used in other applicable studies. There is no indication for destruction of unused 
Study devices. 
 
6.2 
DEVICE-SPECIFIC CONSIDERATIONS 
 
Device Description 
 
Please refer to 6.1.1 (Device Description) 
 
7. TREATMENT PLAN 
7.1 
DOSAGE AND ADMINISTRATION 
 
N/A 
 
7.1.1 
DEFINITION OF DOSE-LIMITING TOXICITY (DLT) 
 
N/A 
 
7.1.2 
DEFINITION OF MAXIMUM TOLERATED DOSE (MTD) 
 
N/A 
 
7.1.3 
DOSE DELAYS 
 
N/A 
 
7.1.4 
DOSE ESCALATION 
 

 
44 
 
At-Home Dermoscopy Artificial Intelligence 
eIRB#00023727 
Version Number 5.05 
Version Date. 09-15-2023 
PI: Sancy Leachman MD, PhD 
N/A 
 
7.1.5 
DOSE DE-ESCALATION 
 
N/A 
 
7.1.6 
GENERAL DOSE MODIFICATION GUIDELINES 
 
N/A 
 
7.2 
DISCONTINUATION FROM STUDY INTERVENTION 
 
Discontinuation from the Study intervention (reported discontinued use of Sklip System by Participants) does not 
mean discontinuation from the Study, and remaining Study procedures (nPhase REDCap Cloud survey, chart 
reviews) should be completed as indicated by the Study protocol.  
 
The data to be collected at the time of Study intervention discontinuation will include the following: 
 
a) Anonymous Sklip App analytics per Study Participant (frequency of use) 
b) Data obtained from chart reviews to track the number of submitted PSLCs, the number of PSLCs 
identified as SUSPICIOUS by the dermatology Provider during the in-person FBSE, the chosen method 
of follow-up, and any relevant pathology results for each Participant. 
c) Data from the end of Study REDCap Cloud survey. 
 
Participants MUST discontinue investigational product for any of the following reasons: 
 
• Participant’s request to stop Study intervention. Participants who request to discontinue using the provided 
Sklip System will remain in the Study and must continue to be followed for protocol specified follow-up 
procedures. The only exception to this is when a Participant specifically withdraws consent for any 
further contact (refer to Section 5.2) 
• Loss of ability to freely provide consent through imprisonment, or involuntarily incarceration for treatment 
of either a psychiatric or physical (e.g., infectious disease) illness. 
 
All Participants who discontinue Study intervention should comply with protocol specified follow-up procedures 
as outlined in Section 8. If Study intervention is discontinued prior to the Participant’s completion of the Study, 
the reason for the discontinuation must be documented in the Participant’s medical records and entered on the 
appropriate CRF. 
 
7.3 
TREATMENT PERIOD AND MAINTENANCE 
 
Interventional treatment will not be provided in this Study. All treatment and management for Participants will 
follow standard OHSU clinical care protocol.  
 
7.4 
CONCOMITANT MEDICATION AND SUPPORTIVE CARE GUIDELINES 
 
N/A 
 
7.5 
PRECAUTIONARY MEDICATIONS, TREATMENTS, AND PROCEDURES 
 
N/A 
 
7.6 
PROHIBITED MEDICATIONS, TREATMENTS, AND PROCEDURES  
 
There are no restrictions on specific medications, treatments, or procedures for this study. 

 
45 
 
At-Home Dermoscopy Artificial Intelligence 
eIRB#00023727 
Version Number 5.05 
Version Date. 09-15-2023 
PI: Sancy Leachman MD, PhD 
 
7.7 
OTHER TREATMENT MODALITIES  
 
N/A 
 
8. STUDY PROCEDURES/EVALUATIONS AND SCHEDULE  
 
8.1 
STUDY-SPECIFIC PROCEDURES 
 
8.1.1 
MEDICAL HISTORY  
 
The Participant’s medical history will be obtained from their medical records. Relevant medical history for this 
Study include: 
 
• 
Demographic information (age, gender, race, location of residence) 
• 
History of melanoma skin cancer confirmed by pathology report 
• 
History of non-melanoma skin cancer confirmed by pathology report 
• 
Whether the Participant has had a virtual communication (MyChart encounter, virtual video visit, direct 
message, e-visit) or in-person visit with a dermatology Provider within the last 90 days. 
 
8.1.2 
DISEASE ASSESSMENT 
 
All Participants will be required to obtain an in-person FBSE.  Since PSLCs will be evaluated per standard 
clinical care pathways, the evaluating dermatology Provider may or may not be involved in the Study. The 
dermatology Provider will be blinded to Participant activity, including the Participant Mole Log Sheet.  The 
dermatology Provider may choose to perform biopsy, when applicable, independent of Participant at-home 
findings. 
 
Biopsies may be performed for suspicious lesions identified by the dermatology Provider during the FBSE and 
will be assessed by histologic assessment as part of current standards of care for diagnosis, independent of the 
Study.  The use of the Sklip System is for triage only and is not intended to act as a substitute for official 
diagnosis via pathology results, and all subsequent management and treatment of disease will be based off 
official histologic diagnosis and in accordance current guidelines.  
 
8.1.3 
MEDICATION REVIEW  
 
N/A 
 
8.1.4 
PHYSICAL EXAMINATION  
 
In-person Phase activity is described in Section 3.1 above. 
 
8.1.5 
RADIOGRAPHIC OR OTHER IMAGING ASSESSMENTS  
 
Not applicable.  All Participant-identified suspicious lesions that require further evaluation will be assessed with 
digital dermoscopy.  
 
8.1.6 
ADVERSE EVENT EVALUATION  
 
The device does not pose a serious risk to the health, safety, or welfare of subjects. The clinical trial design is 
such that the potential risk of not flagging a suspicious lesion is appropriately mitigated and the trial itself does 
not pose a potential for serious risk to the health, safety, or welfare of a subject. 
 

 
46 
 
At-Home Dermoscopy Artificial Intelligence 
eIRB#00023727 
Version Number 5.05 
Version Date. 09-15-2023 
PI: Sancy Leachman MD, PhD 
8.1.7 
COUNSELING PROCEDURES 
 
The results of this Study will not be made available to Participants. Participants will receive direct dermatology 
Provider care after visit summaries and biopsy results, when applicable, as part of standard of care according to 
their individual case. 
 
8.1.8 
ASSESSMENT OF STUDY AGENT ADHERENCE 
 
Participants are not required to adhere to the interventional product. Frequency of use of the Study agent is 
measured and recorded (via Sklip analytics or nPhase REDCap Cloud survey), however use of the Study 
intervention is voluntary and at the discretion of the Participant. 
 
8.1.9 
ASSESSMENT OF PARTICIPANT-REPORTED OUTCOMES 
 
Study Coordinators will provide specific onboarding training for all Participants on how to record each self-
selected PSLC in their Participant Mole Log Sheet. Participants will be asked to record this information and self-
report it at the end of the Study in the nPhase REDCap Cloud survey.  
 
8.2 
LABORATORY PROCEDURES AND EVALUATIONS 
 
8.2.1 
PREGNANCY TEST  
 
N/A 
 
8.3 
BIOMARKER, CORRELATIVE, AND SPECIAL STUDIES 
 
N/A 
 
8.3.1 
LABORATORY CORRELATIVE STUDIES 
 
N/A 
 
8.3.2 
SPECIAL STUDIES 
 
N/A 
 
8.4 
SCREENING ASSESSMENTS 
 
Screening will be done once during the initial contact by a Study Coordinator to have informed consent explained 
and signed. Since the eligibility criteria measurements are unlikely to change (of age, English speaking, access to 
smartphone, etc.) during the Study, only an initial baseline screening is required.  
 
8.5 
BASELINE ASSESSMENTS 
 
After confirming whether the Participant meets the eligibility criteria, no further baseline screening or assessment 
is necessary to obtain prior to beginning the Study. 
 
8.6 
ASSESSMENTS DURING TREATMENT 
 
Not applicable.  There is no interventional treatment or therapies in this Study. The number of submitted PSLCs, 
the number of PSLCs qualified for follow-up, the chosen method of follow-up, and any relevant pathology results 
for each Participant will be recorded and analyzed as part of period retrospective chart reviews conducted by a 
Study Coordinator as described in Sections above. 
 

 
47 
 
At-Home Dermoscopy Artificial Intelligence 
eIRB#00023727 
Version Number 5.05 
Version Date. 09-15-2023 
PI: Sancy Leachman MD, PhD 
8.7 
EARLY TERMINATION OR END OF TREATMENT VISIT 
 
EARLY TERMINATION – N/A; PARTICIPANTS DO NOT HAVE A PHYSICAL STUDY VISIT 
 
END OF TREATMENT – N/A 
 
8.8 
FOLLOW-UP 
 
There will be no scheduled follow-up after completion of the Study. Any follow up for Participants after 
conclusion of the 42 day Study will be part of the Participant’s standard clinical care pathways and not the 
responsibility of Study Coordinators or the Study Sponsor. 
 
8.9 
UNSCHEDULED VISITS 
All Participants will be requested to engage in an in-person visit at their Study Site within 28 days of completing 
the at-home Phase to obtain a FBSE. If the Participant does not already have a scheduled visit, Study Site 
dermatology providers will agree to accommodate overbookings to ensure that each participant can obtain an in-
person visit within the   
 
8.10 
SCHEDULE OF EVENTS 
 
 
 
 
 
 
 
 
 
Table 3. Schedule of events 
Days (± 3 Days) 
Recruitment 
Enrollment 
Data Entry 
Phase 1 Survey 
Days 
-28 to -1 
Day 1 
Continuously  
Day 42 
Invite Participants 
X 
 
 
 
Screening, 
Inclusion/exclusion 
criteria 
X 
 
 
 
Informed Consent 
X 
X 
 
 
Onboard training 
 
X 
 
 
MyChart, Direct 
message, Calls, Email, 
or Text 
 
X 
 
X 
 
 
X 
EMR Chart Review 
 
 
X 
X 
Participant nPhase 
REDCap Cloud Survey 
X 
X 
 
 
X 

 
48 
 
At-Home Dermoscopy Artificial Intelligence 
eIRB#00023727 
Version Number 5.05 
Version Date. 09-15-2023 
PI: Sancy Leachman MD, PhD 
9. EFFICACY MEASURES 
 
Assessment of any Participant self-selected PSLCs as part of the intervention in this Study will be conducted by the 
Sklip System. The Sklip System incorporates proprietary artificial intelligence (Ai) DDI analysis (SMSA) of PSLCs 
based on a modified dermoscopy Three-Point Checklist (MD3PC).  PSLs presented to the SMSA are triaged into 
three categories: UNREMARKABLE, SUSPICIOUS or ERROR, and its performance has been verified and 
validated in alignment with expectations necessary for the safety and effectiveness of the device aligned with its 
intended use.  
 
9.1 
DEFINITION OF EFFICACY MEASURES 
 
Measurable disease: Measurable PSLCs are defined as those that can be accurately measured in at least one 
dimension as > 3 mm diameter by naked-eye examination and confirmed using a medical ruler or professional 
dermatoscope (i.e. Heine D30) with a fixed measurement ruler in the field of view.  There is no therapy introduced 
or evaluated in this Study, therefore parameters for determining disease response are unnecessary. 
 
9.2 
DISEASE EVALUATION 
 
Any suspicious skin lesions (including PSLCs) that get further evaluated in this Study will be via Study Site normal 
clinical care pathways. Per current guidelines, all definitive diagnosis of dermatology Provider verified suspicious 
skin lesions with concern for malignancy must be made via biopsy and histologic assessment by the Study Site. 
 
9.3 
EFFICACY CRITERIA FOR TUMOR RESPONSE 
 
N/A.  
 
 
10. SAFETY 
 
10.1 
SPECIFICATION OF SAFETY PARAMETERS 
 
The investigational device being assessed in this Study (Sklip System) is not of substantial importance in 
diagnosing, curing, mitigating, or treating disease. Instead, it provides a triage assessment according to a clinically 
accepted protocol, which is intended for confirmation by a healthcare professional. Therefore Participants enrolled 
in the Study are not exposed or introduced to any additional medical safety risks that would warrant scheduled 
screening assessments. The Participants have the option to be evaluated by a dermatology Provider via standard 
clinical care pathways, not part of the Study, and would be considered an unscheduled visit (Section 8.9 
Unscheduled Visits). 
 
There is minimal risk of psychological or behavioral effects that may be experienced by the Participant during the 
Study. At the start of enrollment for each Participant, he/she/they will have onboarding training by a Study 
Coordinator on how to contact a research team member to report any adverse psychological or behavioral effects 
throughout the duration of their enrollment. 
 
If a Participant reports any adverse events, the investigator will immediately be informed of the event. The 
investigator will be responsible for assessing the reported adverse events and will be followed by a member of the 
Study team until resolution/stabilization. The Participant will be offered the voluntary option to withdraw from the 
Study and discontinue any intervention. The report will be documented in the Participant’s record. 
 
10.2 
DEFINITIONS 
 
10.2.1 ADVERSE EVENT (AE) 
 
An adverse event is defined as any undesirable physical, psychological or behavioral effect experienced by a 
Participant during their participation in an investigational Study, in conjunction with the use of the investigational 

 
49 
 
At-Home Dermoscopy Artificial Intelligence 
eIRB#00023727 
Version Number 5.05 
Version Date. 09-15-2023 
PI: Sancy Leachman MD, PhD 
product (Sklip System). In general, this includes signs or symptoms experienced by the Participant from the time of 
signing the informed consent to completion of the Study. Although we do not anticipate that the intervention in this 
Study poses significant risk to Participants, the following AEs for this Study may include but are not limited to: 
 
• 
Subjective reports of increased psychological stress induced by self-skin-examinations (SSEs) 
• 
Subjective reports of significant changes in behavior experienced by the Participant 
• 
Allergic reaction to the Sklip provided dermoscopy oil (not reported to date) 
 
10.2.2 SERIOUS ADVERSE EVENT (SAE) 
 
In alignment with the FDA guidance and 21 CFR 812.3(m), Sklip has determined that a clinical Study utilizing the 
Sklip System constitutes a Non-Significant Risk Device Study. Please refer to Section 1.3 RISK/BENEFIT 
ASSESSMENT. 
 
10.2.3 UNANTICIPATED PROBLEMS (UP) 
 
The Office for Human Research Protections (OHRP) considers UPs involving risks to Participants or others to 
include, in general, any incident, experience, or outcome that meets all of the following criteria: 
 
1. Unexpected in terms of nature, severity, or frequency given (a) the research procedures that are described in the 
protocol-related documents, such as the IRB-approved research protocol and informed consent document; and 
(b) the characteristics of the Participant population being studied; 
2. Related or possibly related to participation in the research (“possibly related” means there is a reasonable 
possibility that the incident, experience, or outcome may have been caused by the procedures involved in the 
research); and 
3. Suggests that the research places Participants or others at a greater risk of harm (including physical, 
psychological, economic, or social harm) than previously known or recognized. 
 
Our Study additionally includes an unanticipated adverse device effect, 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, or any 
other unanticipated serious problem associated with a device that relates to the rights, safety, or welfare of 
Participants (21 CFR 812.3(s)) 
 
10.2.4 SEVERITY OF EVENT 
 
The Investigator will grade the severity of each AE using, when applicable, the current version of the CTCAE v5.0. 
In the event of an AE for which no grading scale exists, the Investigator will classify the AE as defined below:  
 
Grade 1: Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not 
indicated.  
Grade 2: Moderate; minimal, local or noninvasive intervention indicated; limiting age-appropriate 
instrumental ADL  
Grade 3: Severe or medically significant but not immediately life-threatening; hospitalization or 
prolongation of hospitalization indicated; disabling; limiting self-care ADL.  
Grade 4: Life-threatening consequences; urgent intervention indicated.  
Grade 5: Death related to AE.  
 
10.2.5 ASSESSMENT OF CAUSALITY RELATIONSHIP TO STUDY INTERVENTION 
 
For all collected AEs, the clinician who examines and evaluates the Participant will determine the AE’s causality 
based on temporal relationship and his/her clinical judgment. The degree of certainty about causality will be graded 
using the categories below. 

 
50 
 
At-Home Dermoscopy Artificial Intelligence 
eIRB#00023727 
Version Number 5.05 
Version Date. 09-15-2023 
PI: Sancy Leachman MD, PhD 
Related – The AE is known to occur with the Study intervention, there is a reasonable possibility that the Study 
intervention caused the AE, or there is a temporal relationship between the Study intervention and event. Reasonable 
possibility means that there is evidence to suggest a causal relationship between the Study intervention and the AE. 
 
Not Related – There is not a reasonable possibility that the administration of the Study intervention caused the 
event, there is no temporal relationship between the Study intervention and event onset, or an alternate etiology has 
been established. 
 
10.3 
EXPECTEDNESS 
 
The Investigator will be responsible for determining whether an AE is expected or unexpected. An AE will be 
considered unexpected if the nature, severity, or frequency of the event is not consistent with the risk information 
previously described for the Study agent. 
 
10.4 
ADVERSE EVENT LIST(S)  
 
10.4.1 ADVERSE EVENT LIST FOR SKLIP DEVICE AND SKLIP SYSTEM 
 
Detailed information about the risks and expected AEs of the Sklip System may be found in the current edition of 
the manufacturer’s instruction manual.  
 
In alignment with the FDA guidance mentioned above and 21 CFR 812.3(m), Sklip has determined that a clinical 
Study utilizing the Sklip System constitutes a Non-Significant Risk Device Study. Please refer to Section 1.3 
RISK/BENEFIT ASSESSMENT. 
 
10.4.2 ADVERSE EVENT LIST FOR  
 
N/A 
 
10.4.3 KEY SAFETY CONCERNS AND/OR ADVERSE EVENTS OF SPECIAL INTEREST 
 
All Participants 
Key safety 
concern/AESI: 
Threshold for action: 
Participant management: Special reporting 
requirements: 
Increased 
psychological 
stress/burden 
Participant reports significant 
increase in psychological 
stress and requests for 
additional action 
Participant will be offered 
the option to discontinue 
the Study or be offered a 
referral to an appropriate 
provider within the Study 
Site provider network 
N/A 
 
 
10.5 
TIME PERIOD AND FREQUENCY FOR EVENT ASSESSMENT AND FOLLOW-UP 
 
The occurrence of an UP, AE or SAE may come to the attention of Study personnel during Study visits and 
interviews of a Study Participant presenting for medical care, upon review by a Study monitor, or during an audit. 
All AEs including local and systemic reactions not meeting the criteria for SAEs will be captured on the appropriate 
CRF. Information to be collected includes event description, time of onset, clinician’s assessment of severity, 
seriousness, expectedness, relationship to Study product (assessed only by those with the training and authority to 
make a diagnosis), and date of resolution/stabilization of the event. All AEs occurring while on Study must be 
documented appropriately regardless of relationship. All AEs will be followed to adequate resolution. 
 
Any medical condition that is present at the time that the Participant is screened will be considered as baseline and 
not reported as an AE. However, if the Study Participant’s condition deteriorates at any time during the Study, it will 

 
51 
 
At-Home Dermoscopy Artificial Intelligence 
eIRB#00023727 
Version Number 5.05 
Version Date. 09-15-2023 
PI: Sancy Leachman MD, PhD 
be recorded as an AE after enrollment. Changes in the severity of an AE will be documented to allow an assessment 
of the duration of the event at each level of severity to be performed. AEs characterized as intermittent require 
documentation of onset and duration of each episode.  The Investigator will record all reportable events with start 
dates occurring any time after enrollment until the last day of Study participation. AEs will be evaluated using the 
current version of the CTCAE v5.0. If a Participant electively schedules a follow up visit with a provider, the 
investigator will inquire about the occurrence of AE/SAEs. Events will be followed for outcome information until 
resolution or stabilization.  
 
10.6 
REPORTING PROCEDURES 
 
10.6.1 OHSU IRB REPORTING OF UNANTICIPATED PROBLEMS AND ADVERSE EVENTS 
 
Unanticipated Problems (UP) and Adverse Events (AE) at the coordinating Study Site will be reported to OHSU 
IRB according to the policies, procedures and guidelines posted on the OHSU IRB website.  
 
Fatal and life-threatening UP will be reported to OHSU IRB no later than 7 days of notification of the event. All 
other UP reports will be submitted to OHSU IRB no later than 15 days of occurrence or notification of the event. 
Copies of the report documents will be kept on REDCap. 
 
Unanticipated Problems and AEs at the satellite Study Site(s) will be reported to their respective IRB according to 
their respective policies, procedures and guidelines and to OHSU study Site members. 
 
Events that must be reported by the Investigator to the IRB are detailed in the OHSU IRB Investigator Guidance: 
Prompt Reporting Requirements (HRP-801). Events that meet the criteria for OHSU RNI must be reported to the 
IRB within 5 days of learning of the event. At a minimum, events requiring reporting to the IRB include: 
 
• 
Any new or increased risk related to the research, including AEs or IND safety reports that require a change 
to the protocol or consent,  
• 
New FDA black box warning,  
• 
Publications identifying new risks,  
• 
Data Safety Monitoring Board/Committee letters recommending changes or discussing new risks 
• 
Unanticipated adverse device effect 
• 
Unauthorized disclosure of confidential Participant information 
 
10.6.2 CENTRAL REPORTING OF ADVERSE EVENTS FOR MULTI-SITE STUDIES  
 
All Adverse Events (AE) should be reported as soon as possible but no later than 7 days of notification of the event. 
AEs should be reported to the respective Site’s IRB accordance to their policies, procedures and guidelines and to 
OHSU study Site members. 
 
10.6.3 FDA REPORTING  
 
Some events must be reported to the FDA through the MedWatch Voluntary reporting program, even if the trial 
involves a commercially available agent. Events to be reported include any UPs and any SAEs with a suspected 
association to the Study intervention.  An eligible person at the OHSU Coordinating Center will evaluate any 
reported UADE at the coordinating Study Site or satellite Study Site(s). The sponsor will provide to the FDA, all 
reviewing IRB's, and all sub-investigators an IDE Safety Report for any UADE that meets all of the following 
criteria: 1) an adverse effect caused by or associated with the device, 2) serious, and 3) Unanticipated. The sponsor 
will provide this no later than 10 working days after first notice of the effect. Thereafter, the sponsor will report any 
additional information concerning the effect per FDA request, and as warranted.  
 
If the sponsor determines that the UADE presents an unreasonable risk to subjects, the sponsor will terminate all 

 
52 
 
At-Home Dermoscopy Artificial Intelligence 
eIRB#00023727 
Version Number 5.05 
Version Date. 09-15-2023 
PI: Sancy Leachman MD, PhD 
investigations or parts of investigations that present risk as soon as possible (no later than 5 working days after the 
sponsor makes this determination), and no later than 15 working days after the sponsor first receives notice of the 
effect. 
 
10.6.4 SUSPECTED UNEXPECTED ADVERSE REACTIONS (SUSARS) 
 
Per regulatory requirements, if an event is assessed by the Sponsor Institution as a Serious Unexpected Adverse 
Reaction (SUSAR), it is the responsibility of the Sponsor Institution to submit the SUSAR to Regulatory Authorities 
according to applicable regulations. In addition, the SUSAR will be distributed to the Investigators/Sites utilizing a 
Council for International Organizations of Medical Sciences (CIOMS) report form, or the MedWatch 3500A form). 
The Investigator will submit a copy of the report to their respective IRB or IEC per the governing institutional 
requirements and in compliance with local laws and guidelines. 
 
10.6.5 SKLIP INC REPORTING REQUIREMENTS 
 
All events reported to the FDA will also be reported to Sklip Inc. as provided in the Research Agreement within 24 
hours of reporting. 
 
10.6.6 REPORTING OF PREGNANCY 
 
N/A 
 
10.7 
STUDY STOPPING RULES 
 
The overall Study will be paused and appropriate authorities notified if indicated by statistical stopping rules in this 
protocol.  
 
11. STATISTICAL CONSIDERATIONS 
 
11.1 
STATISTICAL AIM 
 
The statistical aim of this pivotal trial is the estimation of diagnostic accuracy of the Sklip System estimated to pre-
specified criteria: 95% sensitivity and 30% specificity for Melanoma and atypical melanocytic nevi with 
uncertain malignant potential (moderate, severe, and high grade atypia; those with pathology reports that include 
notes such as: borderline, cannot exclude melanoma, cannot exclude early evolving melanoma, unusual features, 
atypical spitz nevi, suspicion for melanoma, re-excision (or further removal) should be considered or is 
recommended in the pathologist management comment), 80% sensitivity and 30% specificity for Squamous cell 
carcinoma, 80% sensitivity and 30% specificity for Basal cell carcinoma. 
  
11.2 
SAMPLE SIZE DETERMINATION 
 
Sample size was calculated using formulas based on normal approximation to the binomial distribution. Previously 
recorded historical biopsy results for Melanoma, Squamous cell carcinoma, and Basal cell carcinoma across the 
proposed Study Sites averaged 2.3%, 12.5% and 29.2% of in-person dermatology Provider visits (i.e. cases), 
respectively.   This represents disease prevalence rates in this pivotal Study target population of interest (i.e. patients 
who visited a Study Site within a 365 day period specifically for a mole spot check with concern for skin cancer, or 
a full body skin exam (FBSE) for the purpose of skin cancer prevention.  This calculation presumes the exclusion of 
all other dermatology visits not related to a concern for skin cancer.  Formulae (1) and (2) were used to estimate the 
sample size needed to evaluate the sensitivity (Se) and specificity (Sp), based on the diagnostic performance data 
available for melanoma from the SMSA Performance Study, and the target population case prevalence rates. The 
following values are inserted: Zα/2 = 1.96 for α = 0.05 level of significance, and d = 10% margin of error for 95% 
Confidence Interval. 
 

 
53 
 
At-Home Dermoscopy Artificial Intelligence 
eIRB#00023727 
Version Number 5.05 
Version Date. 09-15-2023 
PI: Sancy Leachman MD, PhD 
 
 
 
 
 
 
 
(1) 
 
 
 
 
 
 
 
(2) 
 
Table 4 and Table 5 below summarizes the sample size estimates for cutaneous diseases of interest to evaluate the 
sensitivity and specificity of the investigational device (Sklip System). As can be seen from the table, the size 
estimate calculated using the sensitivity value for detecting melanoma (423 cases [lesions]) yields the largest 
number. The expected numbers of lesions that will be accordingly captured during the Study are summarized in 
Table 6.  
 
Considering the larger number of cases required for evaluation of sensitivity (423 for Melanoma; based on SMSA 
performance of sensitivity for melanoma of 97.4%) as opposed to specificity (114 for SCC), a 49% specificity can 
be estimated from the hypothetical sample data.  Previous peer-reviewed studies, exclusive to virtual visits, showed 
that participants submitted an average of 1.02 to 1.9 images per participant.1  Considering the aforementioned and 
average case submission rates reported by the proposed Study Sites, we expect a case submission rate of 1.5 per 
Study Participant.  Assuming a 10% drop-out rate a total number of 310 Participants (dropout-inflated sample size) 
will be needed for the current study (310 = 423 ÷1.5 × 1.10). 
 
 
 
 
Table 4. Sample size estimates for cutaneous diseases of interest to evaluate the sensitivity of Sklip System 
based on the available target population prevalence data. 
 
Sample Size Estimate to Test for Sensitivity 
 
Melanoma 
BCC 
SCC 
AMN 
Lesions 
Confirmed 
Excluded 
Total 
Confirmed 
Excluded 
Total 
Confirmed 
Excluded 
Total 
Confirmed 
Excluded 
Total 
Suspicious 
9 
248 
257
17
89
107
17 
31
48
17
243 
260
Non-Suspicious 
1 
165 
166
1
38
39
1 
13
14
1
104 
105
Total Scanned 
10 
413 
423
18
128
146
18 
44
63
18
347 
365
Prevalence 
2.3% 
 
12.5%
29.2% 
5.0%
 
Sensitivity 
97.4% 
 
95%
95% 
95%
 
Specificity 
40% 
 
30%
30% 
30%
 
The sample size was estimated using formulae (1) and (2) to test for sensitivity and specificity, respectively, with α = 0.05 significance level and 
10% margin of error for 95% Confidence Interval. The respective sensitivity and specificity values were used to estimate the numbers of 
suspicious and non-suspicious lesions confirmed or excluded by the Ground Truth as described in the Sections above. BCC: Basal cell carcinoma, 
SCC: Squamous cell carcinoma, AMN: Atypical melanocytic nevi with uncertain malignant potential. 
 
 
 
 
 
 

 
54 
 
At-Home Dermoscopy Artificial Intelligence 
eIRB#00023727 
Version Number 5.05 
Version Date. 09-15-2023 
PI: Sancy Leachman MD, PhD 
Table 5. Sample size estimates for cutaneous diseases of interest to evaluate the specificity of Sklip System 
based on the available target population prevalence data.  
Sample Size Estimate to Test for Specificity 
Melanoma 
BCC 
SCC 
AMN 
Confirmed 
Excluded 
Total 
Confirmed 
Excluded 
Total 
Confirmed 
Excluded 
Total 
Confirmed 
Excluded 
Total 
2 
55
57
11 
56
67 
32 
56 
88
4
56 
61
0 
37
37
1 
24
25 
2 
24 
26
0
24 
24
2 
92
94
12 
81
92 
33 
81 
114
4
81 
85
2.3% 
12.5% 
 
29.2% 
 
5.0%
 
97.4% 
95% 
 
95% 
 
95%
 
40% 
30% 
 
30% 
 
30%
 
The sample size was estimated using formulae (1) and (2) to test for sensitivity and specificity, respectively, with α = 0.05 significance level and 
10% margin of error for 95% Confidence Interval. The respective sensitivity and specificity values were used to estimate the numbers of 
suspicious and non-suspicious lesions confirmed or excluded by the Ground Truth as described in the Sections above. BCC: Basal cell carcinoma, 
SCC: Squamous cell carcinoma, AMN: Atypical melanocytic nevi with uncertain malignant potential.  
 
 
 
 
 
Table 6. Numbers of PSLCs expected to be captured in the estimated sample from the target population. 
 
Lesions 
Melanoma 
Confirmed 
Melanoma 
Excluded 
BCC 
SCC 
AMN 
Total non-
Melanoma 
Cancers 
Total 
Malignant 
Lesions 
Total Negative 
for Malignancy 
Lesions 
Total 
Suspicious 
9 
248 
36 
84 
14 
135 
144 
113 
257 
Non-Suspicious 
0 
165 
15 
36 
6 
58 
58 
107 
166 
Total 
10 
413 
52 
121 
21 
193 
203 
220 
423 
Prevalence 
2.3% 
97.7% 
12.5% 
29.2% 
5.0% 
46.7% 
49.0% 
51.0% 
100% 
Lesions per Melanoma 
1 
42 
5 
13 
2 
20 
21 
22 
43 
 
A review of all histologically confirmed Melanoma diagnosis made at OHSU within the past 10 years revealed over 
3,500 cases. A review of all histologically confirmed non-Melanoma skin cancer diagnosis made at OHSU within 
the past 5 years revealed over 30,000 cases. Based off these findings, since three (3) additional Satellite Study Sites 
are each required to contribute at least fifteen (15) percent of the total sample size each, a maximum of 124 
Participants at Site #1 OHSU (FDA suggested maximum enrollment cap of 40%) and a minimum of 47 participants 
(FDA suggested minimum enrollment of 15%) at each additional Site is feasible. 
 
11.3 
POPULATIONS FOR ANALYSIS  
 
An intent-to-treat (ITT) analysis set will include those who are enrolled in the Study regardless of adherence. All 
primary analyses will be conducted using the intent-to-treat analysis set.  
 
11.4 
DESCRIPTION OF STATISTICAL METHODS 
 
11.4.1 GENERAL APPROACH 
 

 
55 
 
At-Home Dermoscopy Artificial Intelligence 
eIRB#00023727 
Version Number 5.05 
Version Date. 09-15-2023 
PI: Sancy Leachman MD, PhD 
This is a new statistical protocol to analyze how the use of the Sklip System enables laypersons to safely triage self-
selected pigmented skin lesions of concern (PSLCs) from home with the same or better accuracy than pre-specified 
performance goals* for detection of PSLCs that require biopsy and are malignant: Melanoma and atypical 
melanocytic nevi with uncertain malignant potential (moderate, severe, and high grade atypia; those with 
pathology reports that include notes such as: borderline, cannot exclude melanoma, cannot exclude early evolving 
melanoma, unusual features, atypical spitz nevi, suspicion for melanoma, re-excision (or further removal) should be 
considered or is recommended in the pathologist management comment)  (≥95% sensitivity, ≥30% specificity), 
Squamous cell carcinoma (≥80% sensitivity, ≥30% specificity), Basal cell carcinoma (≥80% sensitivity, ≥30% 
specificity). 
 
*Pre-specified performance goals have been reviewed with the FDA for testing the Sklip System (including SMSA) 
as a stand-alone device. 
 
The Study  protocol will also compare the accuracy of the Sklip System when used by a layperson (Participant) 
versus near-perfect Sklip System user (Study Coordinator), assess whether Sklip System improves triage of PSLCs 
< 6 mm in diameter and triage of thin melanomas with <0.8 mm Breslow depth as suspicious, as compared to 
the current medical provider virtual triage method that relies on store-and-forward of smartphone clinical images 
(SCI), and assess accuracy of layperson-performed self-skin-exams (SSEs) at-home in the identification of all 
suspicious PSLCs present on their body as compared to the same layperson (Participant) evaluated with a full body 
skin examination (FBSE) by a dermatology Provider (DP) in-person.  
 
The following method has been discussed with the FDA via Sklip Inc. Q-Submission Sprint Discussion 
(#Q211049/S002) to establish the Study Ground Truth, described in the full IRB protocol: 
 
Dataset O) Histologic diagnosis ground truth (H-GT) for lesions that were biopsied during the In-Person Phase 
 
For Primary and Secondary endpoints below, the first SMSA output for each target PSLC will be used. If the first 
SMSA output for the target PSLC yields ERROR, then the second SMSA output for the same target PSLC will be 
used. If the first and the second SMSA outputs for the same target PSLC yield ERROR, then the third SMSA output 
for the same target PSLC will be used. If all three SMSA outputs yield ERROR, then the SMSA outputs for the 
target PSLC will be excluded.  In other words, for each PSLC, there will be one SMSA output for analysis with a 
binary outcome “SUSPICIOUS” or “UNREMARKABLE.” Else, that target PSLC may be excluded from some 
analyses. 
 
Descriptive statistics will be used to describe the demographic and clinical characteristics of the Study Participants. 
Categorical data will be summarized using counts and percentages; continuous data will be summarized using means 
and standard deviations. Underlying statistical assumptions will be checked with the analysis. We do not anticipate a 
need to transform any of the data; if assumptions are violated, then alternative methods will be considered. 
 
11.4.2 ANALYSIS OF PRIMARY ENDPOINT(S) 
 
For the Primary Endpoints, the SMSA outputs of “SUSPICIOUS” or “UNREMARKABLE” from Participant-taken 
DDI will be compared to the Ground Truth, described in the Sections above.  For Melanoma and atypical 
melanocytic nevi with uncertain malignant potential (moderate, severe, and high grade atypia; those with 
pathology reports that include notes such as: borderline, cannot exclude melanoma, cannot exclude early evolving 
melanoma, unusual features, atypical spitz nevi, suspicion for melanoma, re-excision (or further removal) should be 
considered or is recommended in the pathologist management comment), a 2x2 table consisting of the following 
counts (number of PSLCs): 
 
• 
True Positives (TP): the SMSA output of SUSPICIOUS agrees with the Ground Truth for PSLCs that were 
Dataset N) DDI dermoscopic diagnosis ground truth (DDI-GT) for PSLCs that were not biopsied during the In-
Person Phase, and 

 
56 
 
At-Home Dermoscopy Artificial Intelligence 
eIRB#00023727 
Version Number 5.05 
Version Date. 09-15-2023 
PI: Sancy Leachman MD, PhD 
biopsied and were diagnosed as Melanoma or atypical melanocytic nevi with uncertain malignant potential, 
using Dataset (O) (Histologic diagnosis ground truth (H-GT)), 
• 
False Positives (FP): the SMSA output of SUSPICIOUS does not agree with the benign Ground Truth 
using Dataset (N) (DDI dermoscopic diagnosis ground truth) and Dataset (O)  
• 
False Negatives (FN): the SMSA output of UNREMARKABLE does not agree with the Ground Truth for 
PSLCs that were biopsied and diagnosed as Melanoma or atypical melanocytic nevi with uncertain 
malignant potential using Dataset (O)  
• 
True Negatives (TN): the SMSA output of UNREMARKABLE agrees with the benign Ground Truth, 
using both Dataset (N) and Dataset (O)  
 
For Melanoma and atypical melanocytic nevi with uncertain malignant potential, Sensitivity (𝑇𝑇𝑇𝑇÷
(𝑇𝑇𝑇𝑇+ 𝐹𝐹𝐹𝐹)) of the Sklip System will be calculated with a lower one-sided 95% confidence interval using the Exact 
(Clopper-Pearson) method.   For Squamous cell carcinoma and for Basal cell carcinoma, Sensitivity and lower 
one-sided confidence intervals will be estimated in the same manner as for Melanoma and atypical melanocytic nevi 
with uncertain malignant potential. 
 
Specificity (𝑇𝑇𝑇𝑇÷ (𝐹𝐹𝐹𝐹+ 𝑇𝑇𝑇𝑇)) will be the same for Melanoma and atypical melanocytic nevi with uncertain 
malignant potential, SCC, and BCC, where:  
 
• 
False Positives (FP): the SMSA output of SUSPICIOUS does not agree with the benign Ground Truth, 
using Dataset (N) and Dataset (O)  
• 
True Negatives (TN): the SMSA output of UNREMARKABLE agrees with the benign Ground Truth, 
using Dataset (N) and Dataset (O)  
 
Specificity will be estimated with a lower one-sided 95% confidence interval using the Exact (Clopper-Pearson) 
method.  Two-sided 95% confidence intervals for all Sensitivities and Specificities will also be calculated using the 
Exact (Clopper-Pearson) method. 
 
We also will estimate the following measures of triage accuracy for each cutaneous disease entity with two-sided 
95% confidence intervals using the Exact (Clopper-Pearson) method : 
- 
𝐴𝐴𝐴𝐴𝐴𝐴𝐴𝐴𝐴𝐴𝐴𝐴𝐴𝐴𝐴𝐴 (𝑃𝑃) = (𝑇𝑇𝑇𝑇+ 𝑇𝑇𝑇𝑇) ÷ (𝑇𝑇𝑇𝑇+ 𝐹𝐹𝐹𝐹+ 𝐹𝐹𝐹𝐹+ 𝑇𝑇𝑇𝑇) 
- 
𝑃𝑃𝑃𝑃𝑃𝑃𝑃𝑃𝑃𝑃𝑃𝑃𝑃𝑃𝑃𝑃 𝑝𝑝𝑝𝑝𝑝𝑝𝑝𝑝𝑝𝑝𝑝𝑝𝑝𝑝𝑝𝑝𝑝𝑝𝑝𝑝 𝑣𝑣𝑣𝑣𝑣𝑣𝑣𝑣𝑣𝑣 (𝑃𝑃𝑃𝑃𝑃𝑃) = 𝑇𝑇𝑇𝑇÷ (𝑇𝑇𝑇𝑇+ 𝐹𝐹𝐹𝐹) 
- 
𝑁𝑁𝑁𝑁𝑁𝑁𝑁𝑁𝑁𝑁𝑁𝑁𝑁𝑁𝑁𝑁 𝑝𝑝𝑝𝑝𝑝𝑝𝑝𝑝𝑝𝑝𝑝𝑝𝑝𝑝𝑝𝑝𝑝𝑝𝑝𝑝 𝑣𝑣𝑣𝑣𝑣𝑣𝑣𝑣𝑣𝑣 (𝑁𝑁𝑁𝑁𝑁𝑁) = 𝑇𝑇𝑇𝑇÷ (𝐹𝐹𝐹𝐹+ 𝑇𝑇𝑇𝑇) 
- 
𝑃𝑃𝑃𝑃𝑃𝑃𝑃𝑃𝑃𝑃𝑃𝑃𝑃𝑃𝑃𝑃𝑃𝑃𝑃𝑃= (𝑇𝑇𝑇𝑇+ 𝐹𝐹𝐹𝐹) ÷ (𝑇𝑇𝑇𝑇+ 𝐹𝐹𝐹𝐹+ 𝐹𝐹𝐹𝐹+ 𝑇𝑇𝑇𝑇) 
 
 
11.4.3 ANALYSIS OF THE EXPLORATORY ENDPOINTS  
 
Exploratory endpoint 1 
Similar to the Primary endpoint, the accuracy of SMSA output using Participant-taken DDI will be assessed using a 
2x2 table, where the SMSA output of “SUSPICOUS” or “UNREMARKABLE” will be compared to the SMSA 
output using Study Coordinator-taken DDI (near-perfect technical quality), simulating a laboratory-type 
environment where the SMSA is fed the near-perfect technical quality DDI. 
 
The Sensitivity of the SMSA output from Participant-taken DDI will be compared to the Sensitivity of the SMSA 
output from Study Coordinator-taken DDI using McNemar’s Test, given the paired nature of the data, using 0.05 
significance level.  
 
The Specificity of the SMSA output from Participant-taken DDI will be compared to the Specificity of the SMSA 
output from Study Coordinator-taken DDI using McNemar’s Test, given the paired nature of the data, using 0.05 
significance level.  

 
57 
 
At-Home Dermoscopy Artificial Intelligence 
eIRB#00023727 
Version Number 5.05 
Version Date. 09-15-2023 
PI: Sancy Leachman MD, PhD 
 
This will be done for each disease entity:  
• 
Melanoma and atypical melanocytic nevi with uncertain malignant potential,  
• 
Squamous cell carcinoma,  
• 
Basal cell carcinoma 
 
Exploratory endpoint 2 
Using only PSLs < 6 mm in diameter, the accuracy of the expert consensus triage decision using Participant-taken 
smartphone clinical images (SCI) will be assessed using a 2x2 table, where the expert consensus triage decision of 
“BIOPSY” or “MONITOR” will be compared to the intervention method, for both SMSA outputs recorded by 
Participants and SMSA outputs recorded by Study Coordinators for the same target PSLCs. 
 
The Sensitivity of the SMSA output will be compared to the Sensitivity of the expert consensus triage decision of 
Participant-taken SCI using McNemar’s Test, given the paired nature of the data (i.e. the same PSLCs < 6mm), 
using 0.05 significance level.  
 
The Specificity of the SMSA output will be compared to the Specificity of the expert consensus triage decision of 
Participant-taken SCI using McNemar’s Test using 0.05 significance level.  
 
Estimates with two-sided 95% confidence intervals will be calculated using the Exact (Clopper-Pearson) method. 
 
This will be done for each disease entity:  
• 
Melanoma and atypical melanocytic nevi with uncertain malignant potential,  
• 
Squamous cell carcinoma,  
• 
Basal cell carcinoma 
 
Exploratory endpoint 3 
Using only Melanomas < 0.8 mm Breslow depth, the accuracy of the expert consensus triage decision using 
Participant-taken smartphone clinical images (SCI) will be assessed using a 2x2 table, where the expert consensus 
triage decision of “BIOPSY” or “MONITOR” will be compared to the intervention method, for both SMSA outputs 
recorded by Participants and SMSA outputs recorded by Study Coordinators for the same target PSLCs. 
 
The Sensitivity of the SMSA output will be compared to the Sensitivity of the expert consensus triage decision of 
Participant-taken SCI using McNemar’s Test, given the paired nature of the data (i.e. the thin melanomas < 0.8 mm 
Breslow depth), using 0.05 significance level.  
 
Estimates with two-sided 95% confidence intervals will be calculated using the Exact (Clopper-Pearson) method. 
 
Exploratory endpoint 4 
We will calculate the following based on Participant self-skin exams (SSEs) performed during the At-home Phase:  
 
(a) the mean and standard deviation of the number of PSLCs identified by Participants performing a SSE, and  
(b) the mean and standard deviation of the number of PSLCs identified by the dermatology Provider during the In-
person Phase full body skin exam (FBSE).  
 
The mean difference and 95% confidence interval will be calculated and assessed by paired t-test. 
 
11.4.4 SAFETY ANALYSIS 
 
Adverse events will be tabulated by the Medical Dictionary for Regulatory Activities. The severity of the AE will be 
assessed by National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 
5.0 criteria. Descriptive statistics using the safety evaluable population, will be used to report on all on-Study AEs, 
grade 3-4 AEs, treatment-related AEs, grade 3-4 treatment-related AEs, SAEs, treatment-related SAEs, and AEs 

 
58 
 
At-Home Dermoscopy Artificial Intelligence 
eIRB#00023727 
Version Number 5.05 
Version Date. 09-15-2023 
PI: Sancy Leachman MD, PhD 
leading to discontinuation per CTCAE v5.0. Grade 3-4 laboratory abnormalities will be summarized using worst 
grade NCI CTCAE v 5.0 criteria. 
 
11.4.5 BASELINE DESCRIPTIVE STATISTICS 
 
Summaries of demographics, baseline characteristics, and baseline disease characteristics will be presented for 
Participants will include the following:  
 
1. Demographics: Sex (Male, Female); Age (continuous); Ethnicity; Race; Region  
2. Baseline Characteristics: Height (cm); Weight (kg);  
 
11.4.6 ADDITIONAL SUB-GROUP ANALYSIS  
 
If actual sample size will permit sub-group analysis, the analysis of the primary and secondary endpoints will be 
repeated but stratified by Fitzpatrick Skin Types 1—3 and 4. Additional sub-group, analysis by Site may also be 
performed. 
 
11.5 
HANDLING OF MISSING DATA 
 
Missing data will not be imputed. Whenever possible, the analysis will be conducted using all available data. 
Missing data will be reported in the descriptive summary, and it will be noted if Participants were excluded from the 
analysis due to missing data. 
 
12. CLINICAL MONITORING 
 
12.1 
OHSU KNIGHT CANCER INSTITUTE DATA & SAFETY MONITORING PLAN 
 
All clinical trials at the Knight are required to have Data and Safety Monitoring Plan (DSMP). This Study is under 
the oversight of the Knight Cancer Institute’s DSMC as described in the Knight institutional DSMP. The Knight 
DSMP outlines the elements required to ensure the safety of clinical trial Participants, the accuracy and integrity of 
the data, and the appropriate modification of cancer-related clinical trials for which significant benefits or risks have 
been discovered or when the clinical trial cannot be successfully concluded. The Knight DSMP also describes the 
methods and procedures for ensuring adequate, risk-based oversight of cancer-related research at OHSU. 
 
As described in the Knight DSMP, regardless of a trial’s risk level and any specific Knight oversight in place, the 
Investigator is singularly responsible for overseeing every aspect of the design, conduct, and final analysis of his/her 
investigation. 
 
12.2 
CLINICAL DATA & SAFETY MONITORING 
 
As part of the Quality Assurance plan and in full agreement with NIH policy (NIH Guide, NIH Policy for Data and 
Safety Monitoring, June 10, 1998) that states all clinical trials require monitoring to ensure the safety of Study 
Participants and the validity and integrity of the data, monitoring will be a continuous, ongoing and multifaceted 
process. This includes external review by the DSMC and IRB(s), as well as internal data quality control, review and 
evaluation. Site monitoring visits are central to this process, and will include reporting to appropriate individuals 
with oversight responsibilities.  
 
Details of monitoring activities, including designation of assigned monitoring entities, scope of monitoring visits, 
timing, frequency, duration of visits, and visit reporting, will be included in a separate Data and Safety Monitoring 
Plan (DSMP). 
 
The Study Site Investigator is ultimately, singularly responsible for overseeing every aspect of the investigation, 
including design, governing conduct at all sub-Sites, and final analysis of Study data.  
 

 
59 
 
At-Home Dermoscopy Artificial Intelligence 
eIRB#00023727 
Version Number 5.05 
Version Date. 09-15-2023 
PI: Sancy Leachman MD, PhD 
In the absence of a formal monitoring plan, the Investigator may work with his/her Study team to conduct and 
document internal monitoring of the Study to verify protection of human Participants, quality of data, and/or 
ongoing compliance with the protocol and applicable regulatory requirements. 
 
If at any time Investigator noncompliance is discovered at OHSU or the satellite Study Site the corresponding 
Investigator shall promptly either secure compliance or end the Investigator’s participation in the Study. 
 
Independent audits will be conducted by the Knight DSMC to verify that the rights and well-being of human 
Participants are protected, that the reported trial data are accurate, that the conduct of the trial is in compliance with 
the protocol and applicable regulatory requirements, and that evidence of ongoing investigator oversight is present. 
 
12.3 
QUALITY ASSURANCE & QUALITY CONTROL 
 
The investigational Study Sites will provide direct access to all trial related source data/documents, and reports for 
the purpose of monitoring by the monitor and/or sponsor, and auditing by the Knight DSMC and/or regulatory 
authorities.  
 
All clinical trials at the Knight Cancer Institute are required to have a Data and Safety Monitoring Plan (DSMP). All 
clinical work conducted under this protocol is subject to ICH GCP guidelines. This includes inspection of Study-
related records by the lead Site, Sponsor, its designee, or health authority representatives at any time. 
 
QA audit activities will occur as detailed in the Knight’s institutional DSMP. All discrepancies, queries, deviations, 
observations, and findings of non-compliance will be compiled into a final audit report. The PI must review and 
assess each finding, and generate a response to the audit report that incorporates Corrective and Preventative Action 
(CAPA). A CAPA must approach analyzes root cause(s) of noncompliance in order to identify and determine 
changes to correct and resolve issues, and prevent recurrence. 
 
Quality Control (QC) activities will occur to monitor and ensure the safety of Study Participants and the validity and 
integrity of data. Monitoring will be a continuous, ongoing and multifaceted process. This includes review by the 
Knight DSMC and applicable IRB(s), as well as internal data quality control, review and evaluation. Site monitoring 
visits are central to this process, and will include reporting to appropriate individuals with oversight responsibilities. 
 
The Sponsor-Investigator, or Study monitor, will verify that the clinical trial is conducted and data are generated, 
documented, and reported in compliance with the protocol, GCP, and the applicable regulatory requirements (e.g., 
Good Laboratory Practices (GLP), Good Manufacturing Practices (GMP)). 
 
13. SUPPORTING DOCUMENTATION AND OPERATIONAL CONSIDERATIONS 
 
13.1 
SOURCE DATA/DOCUMENTS 
 
The Investigator is responsible for ensuring the accuracy, completeness, legibility, and timeliness of the data 
reported. All source documents will be completed in a neat, legible manner to ensure accurate interpretation of data. 
The Investigator will maintain adequate case histories of Study Participants, including accurate CRFs, electronic 
(e)CRFs and relevant electronic data capture (EDC) system and all relevant source documentation. 
 
13.1.1 PARTICIPANT & DATA CONFIDENTIALITY 
 
The information obtained during the conduct of this clinical Study is confidential, and unless otherwise noted, 
disclosure to third parties is prohibited. Information contained within this Study will be maintained in accordance 
with applicable laws protecting Participant privacy, including the provisions of the Health Insurance Portability and 
Accountability Act (HIPAA). 
 
Participant confidentiality is strictly held in trust by the Site Investigator(s) and Study team. This confidentiality is 
extended to cover testing of biological samples and genetic tests in addition to the clinical information relating to 
Participants. Therefore, the Study protocol, documentation, data, and all other information generated will be held in 

 
60 
 
At-Home Dermoscopy Artificial Intelligence 
eIRB#00023727 
Version Number 5.05 
Version Date. 09-15-2023 
PI: Sancy Leachman MD, PhD 
strict confidence. No information concerning the Study or the data will be released to any unauthorized third party 
without prior written approval of the sponsor. 
 
 
The Study monitor, other authorized representatives of the sponsor, representatives of the IRB or manufacturer 
supplying Study product may inspect all documents and records required to be maintained by the Investigator, 
including but not limited to, medical records (office, clinic, or hospital) and pharmacy records for the Participants in 
this Study. The clinical Study Site will permit access to such records.  
 
The Study Participant’s contact information will be securely stored at each clinical Site for internal use during the 
Study. At the end of the Study, all records will continue to be kept in a secure location for as long a period as 
dictated by local IRB and institutional regulations. Study Participant research data, which is for purposes of 
statistical analysis and scientific reporting, will be transmitted to and stored within the Knight Cancer Institute per 
OHSU’s Information Security Directives. Individual Participants and their research data will be identified by a 
unique Study identification number. The Study data entry and Study management systems used by clinical Sites and 
by Knight Cancer Institute research staff will be secured and password protected per OHSU’s Information Security 
Directives. At the end of the Study, or after the appropriate period of record retention stated in Section 13.1.4, all 
Study databases will be de-identified and archived within the Knight Cancer Institute. 
 
13.1.2 DATA COLLECTION & STORAGE: PRIVACY, CONFIDENTIALITY & SECURITY  
 
Data collection is the responsibility of the clinical trial staff at the Site under the supervision of the Study Site 
Investigator. The Investigator is responsible for ensuring the accuracy, completeness, legibility, and timeliness of the 
data reported. Standard institutional practices will be followed as described in the OHSU’s Information Security 
Directives to maintain the confidentiality and security of data collected in this Study. Study staff will be trained with 
regard to these procedures. 
 
Confidentiality: Loss of Participant confidentiality is a risk of participation. Efforts will be made to keep Study 
Participant identities confidential except as required by law. Participants’ samples will be identified by code only. 
Specifically, each consenting Participant will be assigned a unique coded identifier consisting of numbers. This 
identifier will be associated with the Participant throughout the duration of their participation in the trial. The coded 
identifier will also be used to identify any Participant specific samples. 
 
Basic accrual tracking information (demographic, consent, visit information) will be captured in OHSU’s electronic 
clinical research information system (eCRIS), hosted on OHSU secure servers and managed by OHSU’s information 
technology group at their data center in downtown Portland, Oregon. Any additional printed documents containing 
Participant identifiers, such as those from the medical record to confirm eligibility, will be filed in binders and kept 
in a locked, secure location. 
 
Data for this project will be stored in nPhase REDCap Cloud, a highly secure and robust web-based research data 
collection and management system. Study outcome data will be captured in electronic CRFs (eCRFs) using the 
electronic data capture (EDC) system nPhase REDCap Cloud. nPhase REDCap Cloud EDC is a web-hosted 
application hosted by nPhase (located in Encinitas, CA), and is an approved EDC system that has been reviewed by 
OHSU Security. To further preserve confidentiality, PHI in the EDC system will be limited to just birth date and 
visit dates. The web-accessible EDC system is password protected and encrypted with role-based security, and 
administered by designated informatics staff within OHSU or Knight Cancer Institute. All users of the database are 
assigned a unique username and password and must complete training appropriate to their role before they are 
authorized to enter, access, and store data in the database. 
 
13.1.3 FUTURE USE OF STORED SPECIMENS AND DATA 
 
After the Study is completed, the de-identified, archived data will be transmitted and stored in a secure database on 
OHSU computers with encryption. A Study Coordinator will enter data from Participant surveys or charts into the 
secure database only for the purposes of this Study. In order to provide security for data and specimens, all Study 
members will be familiar with this protocol and the procedures and analyses described herein. Access to the nPhase 

 
61 
 
At-Home Dermoscopy Artificial Intelligence 
eIRB#00023727 
Version Number 5.05 
Version Date. 09-15-2023 
PI: Sancy Leachman MD, PhD 
REDCap database will be limited to the PI, co-investigators and Study personnel. We have no plans at this time to 
accept data from sources other than those described in this protocol. Permission to transmit data to the data 
repository will be included in the consent form. 
 
13.1.4 MAINTENANCE OF RECORDS 
 
Records and documents pertaining to the conduct of this Study, source documents, consent forms, laboratory test 
results and medication inventory records, will be retained by the Investigator for a period of 2 years following the 
date a marketing application is approved for the device being investigated. It is the responsibility of the sponsor to 
inform the Investigator when these documents no longer need to be retained. 
 
If the Investigator relocates or for any reason withdraws from the Study, the Study records will be transferred to an 
agreed upon designee, such as another institution or another investigator at OHSU. Records must be maintained 
according to institutional or FDA requirements.  
 
13.2 
MULTI-SITE GUIDELINES  
 
Once interested Participants have been identified at Satellite Study Sites, the list of potential recruits to screen will 
be given to the OHSU Lead Study Site to contact via E-mail, phone or text message. Communications during the 
screening process and further activities are described in the Sections above.  The OHSU Lead Site will administer all 
Study activities, outside of the in-person FBE, and any data collected will be stored on the nPhase REDCap Cloud 
database. 
 
13.3 
PUBLICATION AND DATA SHARING POLICY 
 
This Study will adhere to the requirements set forth by the ICMJE and FDAAA that requires all clinical trials to be 
registered in a public trials registry (e.g., ClinicalTrials.gov) prior to Participant enrollment.  
 
13.3.1 DATA SHARING POLICY FOR GENOME-WIDE ASSOCIATION STUDIES (GWAS) 
 
N/A 
 
13.4 
CONFLICT OF INTEREST POLICY 
 
Two researchers associated with this Study are Dr. Joanna Ludzik MD, PhD and Dr. Alexander Witkowski MD, 
PhD.  They have developed the interventional device used in this Study and have a company that sells the hardware 
component (Sklip dermatoscope). The nature of this potential conflict of interest and the design of this Study have 
been reviewed by two committees at OHSU and a management plan is in place to help ensure that this research is 
not affected by these financial interests. Dr. Ludzik and Dr. Witkowski will be exclusively providing normal clinical 
care to Study Participants, when applicable for an in-person visit, and will not be involved in communication with 
Study Participants or data collection. If you would like more information, please contact the OHSU Research 
Integrity Office at (503) 494-7887. 
 
13.5 
DELIVERY OF PROGRESS REPORTS TO STUDY FUNDER 
 
Upon the request of Sklip Inc. the Institution will submit oral or written reports on the progress of the Study as 
provided by this protocol. Within thirty (30) days following the completion or termination of the Study, Institution 
will furnish Study Funder with a final report detailing the results of the Study. 
 
14. ETHICS/PROTECTION OF HUMAN PARTICIPANTS 
 

 
62 
 
At-Home Dermoscopy Artificial Intelligence 
eIRB#00023727 
Version Number 5.05 
Version Date. 09-15-2023 
PI: Sancy Leachman MD, PhD 
14.1 
ETHICAL STANDARD 
 
The Investigator will ensure that this Study is conducted in full conformity with Regulations for the Protection of 
Human Participants of Research codified in 45 CFR Part 46, 21 CFR Part 50, 21 CFR Part 56, 21 CFR 812, and/or 
the ICH E6. 
 
14.2 
INSTITUTIONAL REVIEW BOARD 
 
The protocol, informed consent forms, recruitment materials, and all Participant materials will be submitted to the 
IRB for review and approval. Approval of both the protocol and the consent form must be obtained before any 
Participant is enrolled. Any amendment to the protocol will require review and approval by the IRB before the 
changes are implemented to the Study. All changes to the consent form will be IRB approved; a determination will 
be made regarding whether previously consented Participants need to be re-consented. 
 
14.3 
INFORMED CONSENT 
 
Written informed consent will be obtained from all Participants participating in this trial, as stated in the Informed 
Consent section of 21 CFR Part 50. Documentation of the consent process and a copy of the signed consent shall be 
maintained in the Participant’s medical record.  
 
14.3.1 CONSENT PROCEDURES AND DOCUMENTATION 
 
Informed consent is a process that is initiated prior to the individual’s agreement to participate in the Study and 
continues throughout the individual’s Study participation. Extensive discussion of risks and possible benefits of 
participation will be provided to the Participants and their families as appropriate. Consent forms will be IRB-
approved and the Participant will be asked to read and review the document. The Investigator will explain the 
research Study to the Participant and answer any questions that may arise. All Participants will receive a verbal 
explanation in terms suited to their comprehension of the purposes, procedures, and potential risks/benefits of the 
Study, alternatives to participation, and of their rights as research Participants. Participants will have the opportunity 
to carefully review the written consent form and ask questions prior to signing. The Participants should have the 
opportunity to discuss the Study with their surrogates or think about it prior to agreeing to participate. The 
Participant will sign the informed consent document prior to any procedures being done specifically for the Study. 
The Participants may withdraw consent at any time throughout the course of the trial. A copy of the informed 
consent document will be given to the Participants for their records. The rights and welfare of the Participants will 
be protected by emphasizing to them that the quality of their medical care will not be adversely affected if they 
decline to participate in this Study. 
 
14.3.2 
PARTICIPANT INCENTIVES 
 
There will be direct payment incentive to participate in this Study. At the end of this Study each Participant will be 
able to keep their commercially available Sklip dermatoscope device hardware (research value: $99.99). The ability 
for Study Participants to keep or obtain a Sklip device at the end of the Study is not considered coercive neither 
expected to create any bias for a Participant to choose to participate in this Study. 
 
14.4 
PROTOCOL REVIEW 
 
The protocol and informed consent form for this Study must be reviewed and approved in writing by the OHSU 
Knight Cancer Institute’s Clinical Research Review Committee (CRRC) and the appropriate IRB prior to any 
Participant being consented on this Study.  
 

 
63 
 
At-Home Dermoscopy Artificial Intelligence 
eIRB#00023727 
Version Number 5.05 
Version Date. 09-15-2023 
PI: Sancy Leachman MD, PhD 
14.5 
CHANGES TO PROTOCOL  
 
Any modification of this protocol must be documented in the form of a protocol revision or amendment submitted 
by the Investigator and approved by the CRRC and IRB, before the revision or amendment may be implemented. 
The only circumstance in which the amendment may be initiated without regulatory approval is for a change 
necessary to eliminate an apparent and immediate hazard to the Participant. In that event, the Investigator must 
notify the IRB/FDA/or sponsor within 5 business days after the implementation. An Investigator who holds an IND 
or IDE application must also notify the FDA of changes to the protocol per 21 CFR 812. 
 
 

 
64 
 
At-Home Dermoscopy Artificial Intelligence 
eIRB#00023727 
Version Number 5.05 
Version Date. 09-15-2023 
PI: Sancy Leachman MD, PhD 
15. REFERENCES 
 
1. Lee C, Witkowski A, Żychowska M, Ludzik J. The role of mobile teledermoscopy in skin cancer triage and 
management during the COVID-19 pandemic. Indian J Dermatol Venereol Leprol. 2022 Dec 8:1-6. doi: 
10.25259/IJDVL_118_2022. Epub ahead of print. PMID: 36688890. 
 
2. Sklip Inc. – FDA Breakthrough Designation.  Accessed April 21, 2023.  
https://sklipapp.com/2022/01/29/breakthrough/ 
 
3. Argenziano G, Puig S, Zalaudek I, Sera F, Corona R, Alsina M, Barbato F, Carrera C, Ferrara G, Guilabert A, 
Massi D, Moreno-Romero JA, Muñoz-Santos C, Petrillo G, Segura S, Soyer HP, Zanchini R, Malvehy J. 
Dermoscopy improves accuracy of primary care physicians to triage lesions suggestive of skin cancer. J Clin Oncol. 
2006 Apr 20;24(12):1877-82. doi: 10.1200/JCO.2005.05.0864. PMID: 16622262. 
 
4. Argenziano G, Puig S, Zalaudek I, Sera F, Corona R, Alsina M, Barbato F, Carrera C, Ferrara G, Guilabert A, 
Massi D, Moreno-Romero JA, Muñoz-Santos C, Petrillo G, Segura S, Soyer HP, Zanchini R, Malvehy J. 
Dermoscopy improves accuracy of primary care physicians to triage lesions suggestive of skin cancer. J Clin Oncol. 
2006 Apr 20;24(12):1877-82. doi: 10.1200/JCO.2005.05.0864. PMID: 16622262. 
 
5. Skin Cancer Facts & Statistics.  The Skin Cancer Foundation.  Accessed April 21, 2023. 
https://www.skincancer.org/skin-cancer-information/skin-cancer-facts/ 
 
6. Melanoma of the Skin – Cancer Stat Facts.  SEER.  Accessed April 21, 2023.  https://www.skincancer.org/skin-
cancer-information/skin-cancer-facts/ 
 
7. U.S. Census Bureau Quick Facts: United States.  Accessed April 21, 2023.  
https://www.census.gov/quickfacts/fact/table/US/PST045221 
 
8. Ward-Peterson M, Acuña JM, Alkhalifah MK, Nasiri AM, Al-Akeel ES, Alkhaldi TM, Dawari SA, Aldaham SA. 
Association Between Race/Ethnicity and Survival of Melanoma Patients in the United States Over 3 Decades: A 
Secondary Analysis of SEER Data. Medicine (Baltimore). 2016 Apr;95(17):e3315. doi: 
10.1097/MD.0000000000003315. PMID: 27124020; PMCID: PMC4998683. 
 
9. War on Melanoma.  Accessed April 21, 2023. https://www.ohsu.edu/war-on-melanoma 
 
10. Leachman SA, Cassidy PB, Chen SC, Curiel C, Geller A, Gareau D, Pellacani G, Grichnik JM, Malvehy J, 
North J, Jacques SL, Petrie T, Puig S, Swetter SM, Tofte S, Weinstock MA. Methods of Melanoma Detection. 
Cancer Treat Res. 2016;167:51-105. doi: 10.1007/978-3-319-22539-5_3. PMID: 26601859. 
 
11. Petrie T, Samatham R, Witkowski AM, Esteva A, Leachman SA. Melanoma Early Detection: Big Data, Bigger 
Picture. J Invest Dermatol. 2019 Jan;139(1):25-30. doi: 10.1016/j.jid.2018.06.187. Epub 2018 Oct 25. PMID: 
30482597; PMCID: PMC6685706. 
 
12. Soyer HP, Argenziano G, Zalaudek I, Corona R, Sera F, Talamini R, Barbato F, Baroni A, Cicale L, Di Stefani 
A, Farro P, Rossiello L, Ruocco E, Chimenti S. Three-point checklist of dermoscopy. A new screening method for 
early detection of melanoma. Dermatology. 2004;208(1):27-31. doi: 10.1159/000075042. PMID: 14730233. 
 
13. Ludzik J, Becker AL, Lee C, Witkowski A. Augmenting pigmented lesion assay results with the three-point 
dermoscopy checklist to improve pigmented lesion triage. Skin Res Technol. 2022 Nov;28(6):877-879. doi: 
10.1111/srt.13205. Epub 2022 Sep 27. PMID: 36165335; PMCID: PMC9907711. 
 
14. Foltz E, Ludzik J, Witkowski A. Dermoscopy and reflectance confocal microscopy-augmented characterization 
of pigmented micro-basal cell carcinoma (less than 2 mm diameter). Skin Res Technol. 2023 Jan;29(1):e13250. doi: 
10.1111/srt.13250. Epub 2022 Dec 8. PMID: 36482801; PMCID: PMC9838765. 
 

 
65 
 
At-Home Dermoscopy Artificial Intelligence 
eIRB#00023727 
Version Number 5.05 
Version Date. 09-15-2023 
PI: Sancy Leachman MD, PhD 
15. Ludzik J, Becker AL, Latour E, Lee C, Witkowski A. Dermoscopic features associated with 3-GEP PLA: 
LINC00518, PRAME, and TERT expression in suspicious pigmented lesions. Skin Res Technol. 2023 
Apr;29(4):e13323. doi: 10.1111/srt.13323. PMID: 37083005. 
 
16. OHSU IRB Study #24957: Sklip Mole Scanning Algorithm (SMSA) performance for the triage of pigmented 
skin lesions. 
 

 
66 
 
At-Home Dermoscopy Artificial Intelligence 
eIRB#00023727 
Version Number 5.05 
Version Date. 09-15-2023 
PI: Sancy Leachman MD, PhD